Hướng dẫn thực hành tốt sản xuất thực phẩm gmp năm 2024
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Chi cục an toàn thực phẩm tỉnh Thái Bình Địa chỉ: Số 239 Hai Bà Trưng, Phường Đề Thám, Thành phố Thái Bình, Thái Bình Điện thoại: 02273 645 515 & 0989991950 Thiết kế bởi và phát triển bởi ViettelStudy The Circular No. 18/2019/TT-BYT dated July 17, 2019 of the Minister of Health on guidelines on Good Manufacturing Practices (GMP) for health supplements, which has been effective since July 17, 2019, is amended by: The Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health on amendments to and annulment of certain legislative documents on food safety promulgated by the Minister of Health, which has been effective since November 09, 2023. Pursuant to the Law on Food Safety dated June 17, 2010; Pursuant to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety; Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining the functions, tasks, powers and organizational structure of the Ministry of Health; At the request of the Director of the Vietnam Food Administration; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Article 1. Scope This Circular provides for: 1. Principles and requirements of Good Manufacturing Practices (GMP) for health supplements and application of GMP by domestic manufacturers of health supplements. 2. Certificates equivalent to the Certificate of compliance with GMP for imported health supplements. Article 2. Regulated entities This Circular applies to organizations and individuals that manufacture or sell health supplements in Vietnam and other relevant organizations and individuals. Article 3. Principles and requirements of GMP for health supplements and application of GMP by domestic manufacturers of health supplements 1. Domestic manufacturers of health supplements shall satisfy food safety conditions specified in Clause 1 Article 28 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety and the following principles and requirements of GMP for health supplements:
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dd) Every manufacturer should establish a system of clearly written documentation that consists of procedures, standards, manufacturing formulae, processing and packaging instructions, is able to record executed activities for manufacturing, quality control, distribution and other matters linked to GMP, and permits tracing of batch history of the product, from receiving of starting materials to the distribution of finished products.
... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3. Any manufacturer of herbal medicinal products and traditional medicinal products that has been issued with the effective Certificate of compliance with GMP for herbal medicinal products and traditional medicinal products by the Drug Administration of Vietnam - the Ministry of Health or the Traditional Medicine Administration of Vietnam - the Ministry of Health in accordance with regulations of law on pharmacy is entitled to manufacture health supplements whose dosage forms are equivalent to those that have been certified and is not required to apply for issuance of the Certificate of GMP compliance with health supplements. The provisions of this Clause shall come into force on the effective dates of the legislative documents mentioned in Clause 2 Article 5 of this Circular. Article 4. Application of GMP and certificates equivalent to the Certificate of compliance with GMP for imported health supplements 1. Imported health supplements shall be manufactured by a manufacturer that has been granted one of the following certificates with forms equivalent to those of the imported health supplements by a competent authority of the manufacturing country or organization designated or acknowledged by the regulatory authority of the manufacturing country:
- Compliance with HACCP - Hazard Analysis and Critical Control Point; - Compliance with ISO 22000 - International Organization for Standardization 22000; - Compliance with IFS - International Food Standard; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Compliance with FSSC 22000 - Food Safety System Certification 22000.
2. The certificate specified in clause 1 of this Article shall at least contain:
dd) Name and address of the certificate holder;
... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1. This Circular comes into force from July 17, 2019. Article 6. Transitional clauses 1. Regarding domestically manufactured or imported health supplements issued with the Certificate of Declaration of conformity with food safety regulations or Certificate of registered product declaration that remains effective but not issued with the Certificate of compliance with GMP for health supplements or an equivalent certificate as prescribed in this Circular:
2. Applications for registration of the health supplement declaration submitted before July 01, 2019 (including those submitted before July 01, 2019 and revised after July 01, 2019) shall be processed as prescribed in Article 8 of the Government’s Decree No. 15/2018/ND-CP . Article 7. Responsibility for implementation 1. The Vietnam Food Administration shall:
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2. The Drug Administration of Vietnam and Traditional Medicine Administration of Vietnam shall, within their jurisdiction, take charge or cooperate with the Vietnam Food Administration in inspecting the compliance with principles and requirements of GMP for health supplements by manufacturers of herbal ingredients, semi-finished herbal ingredients, herbal medicinal products and traditional medicinal products that have been issued with the Certificate of eligibility for pharmacy business or Certificate of compliance with GMP for medicinal products and medicinal materials, which allows manufacturing of health supplements. 3. Organizations and individuals that manufacture or sell health supplements shall:
4. The Director of the Vietnam Food Administration, Chief of the Ministry Office, Chief Inspector of the Ministry of Health, Directors and General Directors of Departments and General Departments affiliated to the Ministry of Health and relevant organizations and individuals are responsible for the implementation of this Circular. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Vietnam Food Administration) for consideration./. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. PP. THE MINISTER THE DEPUTY MINISTER Do Xuan Tuyen APPENDIX: PRINCIPLES AND REQUIREMENTS OF GMP FOR HEALTH SUPPLEMENTS (Enclosed with the Circular No. 18/2019/TT-BYT dated July 17, 2019 of the Minister of Health) Page Acronyms Glossary ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Principle Quality assurance Quality control Product quality review ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. II. Personnel Principle Organization, qualification and responsibilities Training III. Premises and equipment ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Principle Premises General Production areas Storage areas ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Quality control areas Ancillary areas Equipment IV. Sanitation and hygiene Principle ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Personnel Premises Equipment and utensils
Principle ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. General Quality control documents Specifications Specifications for natural materials Specifications for starting materials and packaging materials ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Specifications for intermediate and bulk products Specifications for finished products Production documents Manufacturing Formula and Processing Instructions Packaging Instructions ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Batch processing records Batch packaging records Standard Operating Procedures (SOPs) and records VI. Production Principle ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. General Verification Prevention of cross-contamination in production Starting materials Processing operations: Intermediate and bulk products ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Packaging materials Packaging Operations Finished products Rejected, recovered and returned materials VII. Quality control ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Principle General Sampling Testing Ongoing stability programme ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. VIII. Contract manufacture and analysis Principle Contract manufacture Contract analysis The contract giver ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. The Contract Acceptor The Contract IX. Complaints and product recalls Principle Product complaints ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Product recalls Complaints on adverse product reactions
Principle XI. Other contents: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. List of internationally accepted references for test methods Verification Guidelines on stability study and shelf-life of health supplements Self-inspection checklist Templates for Manufacturing processes, Batch processing/packaging records and List of finished product batch records ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Acronyms: 1. ASEAN: Association of South East Asian Nations 2. ATTP: An toàn thực phẩm (“Food safety”) 3. FEFO: First Ended, First Out 4. FEFO: First In, First Out 5. GMP: Good Manufacturing Practice 6. HEPA: High Efficiency Particulate Air 7. HVAC: Heating Ventilation and Air Conditioning System, which is able to: ● Air ventilation ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ● Dust filtering (if required) 8. NRA: National Regulatory Authority 9. QA: Quality Assurance 10. QC: Quality Control 11. SOP: Standard Operating Procedure 12. VAFF: Vietnam Association of Functional Food. 13. WHO: World Health Organization Glossary: For the purposes of this Appendix, the terms below shall be construed as follows: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 2. Packaging Material: Material that contains foods, encloses foods completely or partially and is divided into 02 categories: - Consumer packaging, which is directly attached to goods and sold together with goods to consumers, and include: + Primary packaging, which is designed to contain goods, comes into direct contact with goods, shapes goods or encloses goods in the shape of goods. + Secondary packaging, which is designed to contain one or more primary packaging materials together. - Non-consumer packaging, which is not retailed together with goods, has various types and used for transportation and storage of goods on vehicles or warehouses. 3. Quarantine or separation: The status of starting materials, intermediate, bulk and finished products set apart physically or by system while awaiting a decision on their suitability for processing, packaging, distribution, reprocessing or rejection. 4. National Regulatory Authority: It is the country regulatory authority which exercises a legal right to control the import, manufacture and export and which may take regulatory action to ensure that the health supplement products marketed within its jurisdiction comply with regulatory requirement. 5. Qualification: Action approving and documenting the equipment or ancillary systems are properly installed, work correctly and actually lead to expected results. 6. Packaging: All operations, including filling and labeling, that a bulk product has to undergo in order to become a finished product. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 8. Expiry Date: A date fixed for each individual batch before which the batch still meets the required standard specifications for quality. After this date, the batch is not permitted for sale. 9. Sanitation: Hygienic control on manufacturing processes, including personnel, premises, equipment and handling of materials from starting materials to finished products. 10. Documentation: Any document that shows results obtained or provides evidence of the activities performed. 11. Control: Any necessary activity performed to ensure maintenance of standards specified in the manufacturing process. 12. In-Process Control: Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control. 13. Batch (or Lot): A quantity of any health supplement produced during a given cycle of manufacture and from a specific formulation order, that is uniform in character and quality (the essence of a manufacturing batch is its homogeneity). 14. Rejected: The status of starting materials, intermediate, bulk or finished products which are not permitted to be used for processing, packaging or distribution and shall be discarded in a safe manner. 15. Reference sample: A sample is representative of the batch of starting/packaging materials or intermediate/finished products from which they are taken, stored for the purpose of being analyzed shall the need arise during the shelf life of the batch concerned. 16. Hazard: A biological, chemical or physical agent in a food with the potential to cause an adverse health effect. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 18. Authorized Person: A person who is formally and properly empowered and has the authority to perform specified duties associated with the company. 19. Risk: The chance or (probability) that a hazard will occur. 20. Starting Materials: Any substance or mixture of substances (pre-mix) used in the production of a traditional medicine or health supplement excluding packaging material. 21. Raw Materials: All materials whether active or inactive that are employed in the processing of health supplements. 22. Natural raw materials: materials used in the manufacture of health supplements and existing in a natural state and unprocessed form. 23. Natural Materials: Comminuted or powdered natural materials, extracts, tinctures, fatty or essential oils, resins, gums, balsams, expressed juices, etc. prepared from plant, animal or mineral, and preparations whose production involves a fractionation, purification or concentration process, excluding chemically defined isolated constituents. 24. Contamination: The introduction of any foreign matter (food contaminants may be biological, chemical or physical agent) into a food. 25. Product: The result of a process or of a set of activities that are interrelated or that interact with one another. 26. Intermediate Product: Any material or mixture of materials which have to undergo one or more stages of processing to become a bulk or finished product. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 28. Reprocessing: A method of repeating the process of all or part of a batch with an unacceptable quality to undergo special or additional processing before release. 29. Finished Product: A product which has undergone all the stages of manufacture, including packaging in its final container and labelling. 30. Verification: Confirmation, through the provision of objective evidence, that the requirements for any procedure, process, equipment, material, activity or system have been fulfilled. 31. Product Recall: It is an action taken to remove a product from the market. Recalls maybe initiated by the NRA or a voluntary action on the part of manufacturer and distributor to carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise deceptive. 32. (repealed) 33. Packaging Materials: Any material, including printed material, employed in the packaging of a health supplement, such as containers, closures, bags, packing, label materials, seals, binding materials, adhesives and tapes. 34. Released or Passed: The status of starting materials, intermediate, bulk or finished products which are allowed to be used for processing, packaging or distribution.
Principle ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1.1. The basic concept of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of health supplements. Quality assurance 1.2. Quality Assurance is a wide-ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring the products are of the quality required for their intended use. Quality assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of these guidelines. The system of Quality Assurance appropriate for the manufacture of health supplements shall ensure that: 1.2.1. Health supplements are designed and developed in a way that takes account of the requirements of GMP. 1.2.2. Production and control operations are clearly specified and GMP adopted. 1.2.3. Managerial responsibilities are clearly specified. 1.2.4. Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials. 1.2.5. All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations and validations are carried out. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1.2.7. Health supplements are not sold or supplied before a head of Quality Control has certified that each production batch has been produced and controlled in accordance with the marketing authorization and any other procedures relevant to the production, control and release of health supplements. 1.2.8. Satisfactory arrangements exist to ensure, that the health supplements are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life. 1.2.9. There is a procedure for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Control system. 1.3. Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification. Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that: 1.3.1. All manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing health supplements of the required quality and complying with their specifications. 1.3.2. Critical steps of manufacturing processes and significant changes to the process are verified. 1.3.3. All necessary facilities for GMP are provided including: 1.3.3.1. Sufficient and appropriately qualified and trained personnel; 1.3.3.2. Adequate premises and space; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1.3.3.4. Appropriate materials, containers and labels; 1.3.3.5. Approved procedures and instructions; 1.3.3.6. Suitable storage and transport. 1.3.4. Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided. 1.3.5. Operators are trained to carry out procedures correctly. 1.3.6. Records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the products as expected. Any significant deviations are fully recorded and investigated. 1.3.7. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form. 1.3.8. The proper storage and distribution of the products minimizes any risk to their quality. 1.3.9. A system is available to ensure that any batch of product should be recalled from sale as soon as possible. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Quality control 1.4. Quality Control is the part of Good Manufacturing Practice concerned with: (i) Specifications and testing, (ii) Sampling and (iii) Tests carried out in accordance with regulations, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The basic requirements of Quality Control are that: 1.4.1. Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP. 1.4.2. Samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved of by the quality control department. 1.4.3. Test methods are either internationally accepted or other validated methods (refer to Section 11.1). 1.4.4. Records must be made (manually and/or by recording instruments) demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated; 1.4.5. The finished products must contain ingredients complying with the qualitative and quantitative composition of the product described in the marketing authorization; the ingredients must be of the required purity, in their proper container and correctly labeled. 1.4.6. Records must be made of the results of inspecting and testing the materials and intermediate, bulk and finished products against specifications. Product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1.4.8. Sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained product must be kept in its final pack unless the pack is exceptionally large. Product quality review 1.5. Regular periodic or rolling quality reviews of all health supplements, including export only products, shall be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. Such reviews shall normally be conducted and documented annually, taking into account previous reviews, and shall include at least: 1.5.1. A review of starting materials and packaging materials used for the product, especially those from new sources; 1.5.2. A review of critical in-process controls and finished product results; 1.5.3. A review of all batches that failed to meet established specification(s) and their investigation; 1.5.4. A review of all significant deviations or non -conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken; 1.5.5. A review of all changes carried out to the processes or analytical methods; 1.5.6. A review of product authorization variations (submitted/granted/ refused), including those for third country (export only) dossiers; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1.5.8. A review of all quality-related returns, complaints and recalls and the investigations performed at the time; 1.5.9. A review of adequacy of any other previous product process or equipment corrective actions; 1.5.10. The qualification status of relevant equipment and utilities, e.g. Heating, Ventilation and Air Conditioning (HVAC), water, compressed gases, etc.; 1.5.11. A review of Contractual Agreements to ensure that they are up to date; 1.5.12. A review of post-marketing commitment for new product/variation. 1.6. The manufacturer and manufacturing authorization holder shall evaluate the results of this review and an assessment shall be made whether corrective and preventive action shall be undertaken. Agreed corrective and preventive actions shall be completed in a timely and effective manner. There shall be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self-inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, etc. where scientifically justified. 1.7. Where the product owner is not the manufacturer, there shall be a technical agreement/contract in place between the various parties that defines their respective responsibilities in producing the quality review. The authorised person responsible for final batch certification together with the product owner shall ensure that the quality review is performed in a timely manner and is accurate. II. Personnel Principle ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Staff at all levels should receive initial and continuing training in the principles of GMP and for the tasks and responsibilities assigned to them so that they have the attitudes for achieving the goals of Good Manufacturing Practice. Organization, qualification and responsibilities 2.1. The manufacturer shall have an organization chart. People in responsible positions shall have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. There shall be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice. Key personnel include the head of production department and the head of quality control department (or including the head of production department, head of testing department and head of quality assurance department). Key posts should be occupied by full-time personnel having knowledge, skill and capabilities relevant to their assigned function, and capable of handling their duties properly. The heads of production and quality control departments should be independent of each other. In large organizations, it may be necessary to delegate some of the functions (mentioned in sections 2.2, 2.3 and 2.4 below); however, the responsibility cannot be delegated. 2.2. The head of production department shall have full authority and responsibilities to manage production of products covering operations, equipment, production personnel, production area and records. The head of the production department generally has the following responsibilities: 2.2.1. To ensure those products are manufactured and stored according to the appropriate documentation in order to obtain the required quality; 2.2.2. To approve the instructions relating to production operations, including the in -process controls and to ensure their strict implementation; 2.2.3. To ensure that the production records are evaluated and signed by a designated person before they are made available to the Quality Control Department; 2.2.4. To check the maintenance of the department, premises and equipment; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 2.2.6. To ensure that the required initial and continuing training of production personnel is carried out and adapted according to need. 2.3. The head of Quality Control Department shall have adequate training and practical experience, which can enable the person to perform the functions effectively. He/She shall be given full authority and responsibility in all quality control duties such as establishment, verification and implementation of all quality control procedures. He /She shall have the sole authority to approve starting materials, intermediates, bulk and finished products that meet the specification or to reject those which do not conform to the relevant specification or which were not manufactured in accordance with approved procedures and under the defined conditions. The head of Quality Control shall have the following responsibilities: 2.3.1. To approve or reject starting materials, packaging materials and intermediate, bulk and finished products; 2.3.2. To evaluate batch records; 2.3.3. To ensure that all necessary testing is carried out; 2.3.4. To ensure that the critical processes are appropriately verified; 2.3.5. To approve sampling instructions, specification, test methods, and other quality control procedures; 2.3.6. To approve and monitor tests carried out under contract; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 2.3.8. To establish expiration date and shelf life specifications on the basis of stability test or available stability data related to storage conditions; 2.3.9. To approve those suppliers of raw materials and packaging materials; 2.3.10. To evaluate all complaints received or deficiencies noted about any batch, if necessary in conjunction with other departments, and to take appropriate action accordingly; 2.3.11. To maintain adequate analytical records concerning the examinations of all samples taken; 2.3.12. To recommend contract-manufacturing operations; 2.3.13. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. 2.4. The heads of Production Department and Quality Control Department shall share a joint responsibility: 2.4.1. To authorize written procedures and relevant document including amendments; 2.4.2. To monitor and control the manufacturing environment, sanitation and hygiene; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 2.4.4. To verify critical processes; 2.4.5. To approve and monitor the suppliers of materials and contract manufacturers; 2.4.6. To establish and monitor the storage conditions for materials and products; 2.4.7. To retain records; 2.4.8. To monitor compliance with the requirements of Good Manufacturing Practice; 2.4.9. To inspect, investigate and take samples, in order to monitor factors which may affect product quality. Training 2.5. All personnel shall be trained in the particular operations and in the principles of Good Manufacturing Practice. 2.6. Training in Good Manufacturing Practice shall be on a continuing basis and with adequate frequency to assure that employees remain familiar with Good Manufacturing Practices requirements relevant to their functions. Training in Good Manufacturing Practice shall be in accordance with written programmes approved by the head of Production Department and the head of Quality Control Department. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 2.8. The concept of Quality Assurance and all the measures capable of improving its understanding and implementation shall be fully discussed during the training sessions. III. Premises and equipment Principle Premises and manufacturing equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross -contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. Premises: General 3.1. Premises for manufacturing shall be of suitable size, design, construction and location to facilitate proper operation, cleaning and maintenance. 3.2. Premises shall be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They shall be cleaned and, where applicable, disinfected according to detailed written procedures. 3.3. Steps shall be taken in order to prevent the entry of unauthorized people. Production, storage and quality control areas shall not be used as a right of way by personnel who do not work in them. 3.4. Lighting, temperature, humidity and ventilation shall be appropriate and such that they do not adversely affect, directly or indirectly, either the products during their manufacture and storage, or the accurate functioning of equipment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.6. Premises shall be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products. 3.7. In case the health supplements, herbal medicinal products and traditional medicinal products are manufactured on the same line, appropriate measures must be taken to prevent confusion, contamination and cross-contamination (refer to section 6.19). 3.8. Premises shall be designed, constructed and maintained to protect against access and harboring of vermin, rodents, birds, insects or other animals. 3.9. Design shall consider prevention of mix-up between different products or their components and the possibility of cross contamination by other substances. 3.10. Special attention must be given for processing operations that generate dust. Measures shall be taken to prevent the generation and dissemination of dust. 3.11. Defined areas for the following operations are required: 3.11.1. Receiving and quarantine of incoming material; 3.11.2 (repealed) 3.11.3. Storage of starting and packaging materials; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.11.5. Processing; 3.11.6. Storage of bulk/intermediate products; 3.11.7. Packaging; 3.11.8. Equipment washing; 3.11.9. Storage of quarantine finished products; 3.11.10. Storage of approved finished products; 3.11.11. Designated area for quality control. Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing the physical quarantine shall give equivalent security. Production areas ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.13. Any open channels shall be avoided, but if required they shall be shallow enough to facilitate cleaning and disinfecting. All drainage shall have trapped gullies. 3.14. Buildings shall be effectively ventilated with air control facilities (including temperature, humidity and filtration), appropriate both to the operations undertaken within and to the external environment. 3.15. Production areas shall be well lit, particularly where visual on-line controls are carried out. 3.16. Pipework, light fittings, ventilation points and other services shall be designed and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they shall be accessible from outside the manufacturing areas. 3.17. (repealed) 3.18. In cases where dust is generated (e.g. during sampling, weighing, mixing and processing operations, packaging of dry products), specific provisions shall be taken to avoid cross-contamination and facilitate cleaning. 3.19. Premises for the packaging of health supplements shall be specifically designed and laid out so as to avoid mix-ups or cross-contamination. 3.20. Premises shall preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels. 3.21. Adequacy of working space, which shall allow orderly and logical placement of equipment and materials and to suit the operation, efficient flow of work, effective communication and supervision as well as to avoid crowding and disorders. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.23. Changing rooms into the production areas shall have adequate hand washing and/or sanitizing facilities. Storage areas 3.24. Storage areas shall be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected or recalled. 3.25. Storage areas shall be designed or adapted to ensure good storage conditions. In particular, they shall be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these shall be provided, checked and monitored. 3.26. Segregated and secure areas shall be provided for the storage of rejected, recalled or returned materials or products. Products rejected during a manufacturing process should not be stored in the production facility but marked, entered into a logbook and returned to stock after each production shift to prevent mistakes. 3.27. Highly active materials or products (e.g. flammable, explosive or toxic substances) shall be stored in separate, safe and secure areas. 3.28. Receiving and dispatch bays shall protect materials and products from the weather. Reception areas shall be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage. 3.29. (repealed) 3.30. Printed packaging materials are considered critical to the conformity of the products, and special attention shall be paid to the safe and secure storage of these materials. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.32. Special attention shall be paid to the cleanliness and good maintenance of the storage areas particularly when dust is generated. 3.33. Storage of plant materials, animal materials including parts, microorganisms, extracts, tinctures and other preparations that require special conditions of temperature, humidity or light protection; these conditions shall be provided and monitored. Quality control areas 3.34. If tests are carried out at production facilities, quality control laboratories, especially laboratories where microbiological test methods are employed, should be separated from production areas. 3.35. Control laboratories shall be designed to suit the operations to be carried out in them. Sufficient space shall be given to avoid mix-ups and cross-contamination. There shall be adequate suitable storage space for samples and records. 3.36. Separate rooms may be necessary to protect sensitive instruments from vibrations, electrical interference, humidity, etc. 3.37. Special requirements are needed in laboratories handling particular substances such as microorganism samples. Ancillary areas 3.38. Rest and refreshment rooms and toilets shall be separated from other areas and shall not have direct access to controlled areas (e.g. production and storage areas). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.40. Maintenance workshops shall be separated from production areas. Whenever parts and tools are stored in the production area, they shall be kept in rooms or lockers reserved for that use. 3.41. Animal houses shall be well isolated from other areas, with separate entrance and air handling facilities. Warehouses of explosive and flammable substances, waste storage areas, waste treatment system and boilers (if any) shall be located far away from production, testing and storage areas so as to ensure safety and hygiene. Equipment 3.42. Manufacturing equipment shall be designed, placed and maintained to suit its intended and ensure safety of employees. The maintenance and replacement of accessories shall comply with the approved plan and requirements of the equipment manufacturer. 3.43. Manufacturing equipment shall be installed so as to prevent contamination or minimize the risk of error and, where necessary, tested to ensure the equipment operate appropriately. 3.44. Manufacturing equipment shall be located at a distance from other equipment sufficient to avoid congestion and cross contamination. 3.45. Fixed pipework shall be clearly labelled to indicate the contents and direction of flow. 3.46. Balances and measuring equipment of an appropriate range and precision shall be available for production and control operation. 3.47. Measuring, weighing, recording and control equipment shall be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests shall be maintained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3.49 (repealed) 3.50. Defective equipment shall, if possible, be removed from production and quality control areas, or at least be clearly labelled as defective. 3.51. Repair and maintenance operations shall not present hazard to the quality of the products. Any missing components such as nuts, springs, clips, etc. shall be reported and investigated immediately. 3.52. Production equipment (including transfer pipes and hoses) shall not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard. 3.53. Pipes, hoses, pumps and valves used for treated water, starting materials and the products shall be cleaned and sanitized according to written procedures that detail the action limits for microbiological contamination and the measures to be taken. IV. Sanitation and hygiene Principle A high level of sanitation and hygiene shall be practiced in every aspect of the manufacturing of health supplements. The scope of sanitation and hygiene covers personnel, premises, equipment and utensils; in fact, anything that could become a source of contamination to the product. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Personnel 4.1. All personnel, prior to employment shall undergo health examinations. During the course of their employment they shall also routinely undergo health examinations which shall include relevant examinations appropriate to the tasks that they are required to perform. 4.2. All personnel shall practice good personal hygiene. They shall be trained in the practices of personal hygiene. 4.3. Any person shown at any time to have an apparent illness or open lesions or disease such as active tuberculosis, acute diarrhea, cholera, dysentery, typhoid, acute hepatitis A or E, acute respiratory tract infection or acute dermatitis or skin infection that may adversely affect the quality of products shall not be allowed to handle raw materials, packaging materials, in-process materials, and finished products until the condition is improved. 4.4. Direct contact shall be avoided between the operator's hands and raw materials, intermediate or bulk product. Proper washing of hands and wearing of gloves shall be used if contact with hands is unavoidable. 4.5. To assure protection of the product from contamination as well as the safety of the personnel, appropriate protective garments shall be worn. Soiled uniforms shall be stored in closed containers until properly laundered. 4.6. Only authorised personnel shall be allowed to enter production areas. Visitors or untrained personnel shall, preferably, not be taken into the production and quality control areas. If this is unavoidable, they shall be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They shall be closely supervised. 4.7. Smoking, eating, drinking and chewing or keeping of plants, food, drink, smoking materials and personal medicines shall be restricted to specific areas and not permitted in production, laboratory, storage or other areas where they might adversely influence product quality. 4.8. The wearing of makeup, wrist watches and jewellery shall be prohibited in the production area however for jewellery or objects that cannot be removed; it must be covered by material that is maintained in an intact, clean and sanitary condition. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 4.9. Premises used for the manufacturing of products shall be of suitable design and construction so as to facilitate good sanitation. 4.10. Adequate employee's washing and well ventilated toilet facilities and changing rooms shall be provided at suitable locations. 4.11. Suitable locker facilities shall be provided at appropriate locations for the storage of employees clothing and personal property. 4.12. The preparation, storage and consumption of food and beverages shall be restricted to specific areas, such as meal rooms and canteen. Facilities in such rooms must meet sanitary standards. Meal rooms and canteen rooms shall not have direct access to controlled areas such as production area and areas use to store materials used for production and finished products. 4.13. Waste material shall not be allowed to accumulate. It shall be collected in suitable receptacles for removal to collection points outside the buildings and disposed off safely and in a sanitary manner at regular and frequent intervals. 4.14. Rodenticide, insecticides, fumigating agents and sanitizing materials used must not contaminate equipment, raw materials, packaging materials, in-process materials or finished products. There shall be a pest control programme, documents such as layout, trending and expectations. Contract agreements shall be established, where applicable. 4.15. There shall be written procedures assigning responsibility for sanitation and describing cleaning schedules, methods, equipment, materials to be used and facilities to be cleaned in sufficient detail. Such written procedures shall be followed. 4.16. Pets are not allowed within the vicinity of the manufacturing plant. Equipment and utensil cleaning ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 4.18. Vacuum or wet cleaning methods are to be preferred. Compressed air and brushes shall be used with care or avoided if possible, as they increase the risk of product contamination. 4.19. Cleaning agents, washing and cleaning equipment shall not be a source of contamination. The choice of cleaning method and agents shall be carefully considered and justified. 4.20. Adequate space, preferably separated from processing areas, shall be provided for cleaning and storing mobile equipment and utensils including the storage of cleaning materials. 4.21. Written procedures shall be established and followed for cleaning and sanitising of equipment, utensils and containers used in the manufacture of health supplements. Such written procedures shall be followed. 4.22. These procedures shall be prepared to prevent equipment contamination by cleaning or sanitising agents and shall at least include the following: 4.22.1. Responsibility for cleaning; 4.22.2. Cleaning schedule; 4.22.3. Cleaning methods; 4.22.4. Equipment and materials used in cleaning operations; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 4.22.6. Removal of previous batch identification; 4.22.7. Protection of clean equipment and utensils from contamination prior to use. 4.23. Records of cleaning, including the appropriate sanitizing and inspection conducted prior to use shall be maintained.
Principle Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history of the product, from receiving of starting materials to the distribution of finished products. It shall be able to record executed activities for maintenance, storage, quality control, distribution and other specific matters linked to GMP. For manufacturing activities, a documentation system must be prepared. The system consisting of manufacturing formulae and instructions, specifications, procedures and records must be free from errors and clearly established. General 5.1. The system of documentation shall be able to record the complete history of each batch. It shall be adequate to permit investigation and tracing of any defective products. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.3. Product related records shall be retained for at least one (01) year after the expiry date of the finished product. 5.4. Documents shall be designed, prepared, reviewed and distributed with care. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process. Reproduced documents shall be clear, legible and duly authorized for reproduction. 5.5. Documents shall be approved, signed and dated by appropriate and authorized person. 5.6. Documents shall have unambiguous contents; title, nature and purpose shall be clearly stated. They shall be laid out in an orderly fashion and easy to be checked. 5.7. Documents shall be regularly reviewed and kept up to date. When a document has been revised, systems shall be operated to prevent inadvertent use of superseded documents. 5.8. Documents shall not be hand-written, except in the case where documents require the entry of data. These entries may be made in clear, legible, and indelible handwriting. Sufficient space shall not be provided for data. 5.9. Any alteration made to the entry on a document shall be signed and dated. The reason of the alteration should be recorded. The alteration shall permit the reading of the original information. 5.10. The records shall be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture the product are traceable. 5.11. Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedure relating to the system in use shall be available and the accuracy of the records shall be checked and verified. If documentation is handled by electronic data processing methods, only personnel who have been authorized shall be able to enter or modify data in the computer and there shall be a record of changes and deletions. Access shall be restricted by passwords or other means and the result of entry of critical data shall be independently checked and verified. Batch records electronically stored shall be protected by back-up transfer. It is particularly important that, during the period of retention, the data are readily available. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Quality control documents 5.13. The following shall be readily available from the Quality Control Department: 5.13.1. Specifications; 5.13.2. Sampling procedures; 5.13.3. Testing procedures and records (including analytical worksheets/raw data and/or laboratory notebooks); 5.13.4. Analytical reports and/or certificates; 5.13.5. Data from environmental monitoring, where appropriate; 5.13.6. Procedures for and records of the calibration of instruments and maintenance of equipment; 5.14. Any Quality Control documentation relating to a batch record shall be retained for at least one (01) year after the expiry date of the finished product. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.15. The materials used in the product shall be handled in an appropriate manner and manufactured in an appropriate controlled condition to prevent cross-contamination. Documented traceability of the material and suppliers is fundamental to the quality of the finished products and shall be made available. Specifications for natural materials 5.16. The specifications for natural material shall where appropriate include the following: 5.16.1. Scientific name and if possible with reference to the authors; 5.16.2. Details to the source of the natural material (country or region of origin, and cultivation, time of harvesting, collection procedures, possible pesticides used, etc.); 5.16.3. Whether the whole plant/animal or only a part is used; 5.16.4. When dried plant/animal is purchased, drying system shall be specified; 5.16.5. Pictorial demonstration/description of natural material; macroscopical and/or microscopical examination; 5.16.6. Storage conditions and precautions, when necessary; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.17. Testing procedures shall be available if the following tests are conducted, where appropriate: 5.17.1. Identification tests including, where possible, tests for known active constituents, or markers; 5.17.2. Assay, where possible, of constituents of known therapeutic activity or markers; 5.17.3. Limit tests such as ash value, and presence of essential oils and loss on drying; 5.17.4. Tests for heavy metals and for likely contaminants, foreign materials and adulterants; 5.17.5. Tests for radioactivity, mycotoxin, fungal and microbial contamination; 5.17.6. Test for residual solvents in extracts or finished products, where applicable; 5.17.7. Other tests, as required. Specifications for starting materials and packaging materials ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.18.1. A description of the materials, including: 5.18.1.1. The designated name and the internal code reference; 5.18.1.2. The reference, if any, to a pharmacopoeia monograph; 5.18.1.3. The approved suppliers and, if possible, the original producer of the products; 5.18.1.4. A specimen of printed materials. 5.18.2. Directions for sampling and testing or reference to procedures. 5.18.3. Qualitative and quantitative requirements with acceptance limits. 5.18.4. Storage conditions and precautions. 5.18.5. The maximum period of storage before re-examination. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.19. Specifications for intermediate and bulk products shall be available if these are purchased or transferred, or if data obtained from intermediate products are used for the evaluation of the finished product. The specifications shall be similar to specifications for starting materials or for finished products, as appropriate. Specifications for finished products 5.20. The specifications for finished product where appropriate shall include the following tests: 5.20.1. Microbial limits; 5.20.2. Heavy metals limits; 5.20.3. Uniformity of weight (for tablets and capsules), disintegration (for tablets, capsules and pills), hardness and friability (for tablets), and viscosity (for internal and external liquids); 5.20.4. Physical appearance such as colour, taste, texture, size, etc. 5.20.5. Other tests, as required. 5.21. Other contents: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.21.2. The formula or a reference to; 5.21.3. A description of the dosage form and package details; 5.21.4. Directions for sampling and testing or a reference to procedures, where applicable; 5.21.5. The qualitative and quantitative requirements, with the acceptance limits, where applicable; 5.21.6. The storage condition and any special handling precautions, where applicable; 5.21.7. The shelf life. Production documents (refer to section 11.5) Manufacturing Formula and Processing Instructions Formally authorized Manufacturing Formula and Processing Instructions shall exist for each product and batch size to be manufactured. They are often combined in one document. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.22.1. The name of the product, with a product reference code relating to its specification; 5.22.2. A description of the product dosage form, strength of the product and batch size; 5.22.3. A list of all starting materials to be used, with the amount of each, described using the designated name and a reference which is unique to that material. Mention shall be made of any substance that may disappear in the course of processing; 5.22.4. A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable. 5.23. The Processing Instructions shall include: 5.23.1. A statement of the processing location and the principal equipment to be used; 5.23.2. The methods, or reference to the methods, to be used for setting up the equipment (e.g. Cleaning, assembling, calibrating); 5.23.3. Detailed stepwise processing instruction (e.g. Checks on materials, pre-treatments, sequence for adding materials, mixing times, temperatures); 5.23.4. The instructions for any in-process controls with their limits; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.23.6. Any special precautions to be observed. 5.24. The processing instructions shall describe the different operations carried out upon the crude material such as sorting, cleaning, drying, crushing and sifting, and include drying time and temperatures, and methods used to control fragment or particle size. It shall also describe the sieving process or other methods of removing foreign materials. 5.25. In particular, there shall be written instructions and records, which ensure that each container of the product is carefully examined to detect any adulteration/substitution or presence of foreign matter, such as metal or glass pieces, animal parts or excrement, stones, sand, etc., or rot and signs of decay. 5.26. For product preparation, instructions shall include details of base or solvent, time and temperatures of extraction, details of any concentration stages and methods used. Packaging Instructions 5.27. There shall be formally authorized Packaging Instructions for each product, pack size and type. These shall normally include, or have a reference to the following: 5.27.1. Name of the product; 5.27.2. Description of its product dosage form, and strength where applicable; 5.27.3. The pack size expressed in terms of the n umber, weight or volume of the product in the final container; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.27.5. Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references, and shelf life of the product; 5.27.6. Special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before operations begin; 5.27.7. A description of the packaging operation, including any significant additional operations, and equipment to be used; 5.27.8. Details of in-process controls with instructions for sampling and acceptance limits. Batch processing records 5.28. Batch Processing Record is that part of Batch Manufacturing Record and shall be kept for each batch processed. It shall be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions. The method of preparation of such records shall be designed to avoid transcription errors. The record shall carry the batch number of the product being manufactured. 5.29. Before any processing begins, there shall be recorded verification that the equipment and work station are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use. 5.30. During processing, the following information shall be recorded at the time each action is taken and, after completion, the record shall be dated and signed in agreement by the person responsible for the processing operations: 5.30.1. Name of the product; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.30.3. Name of the person responsible for each stage of production; 5.30.4. Date and the signature of the operator of different significant steps of production and, where appropriate, of the person who checked each of these operations (e.g. weighing); 5.30.5. The batch number and/or analytical control number as well as the quantities of each starting material actually weighed (including the batch number and amount of any recovered or reprocessed materials added); 5.30.6. Any relevant processing operation or event and major equipment used; 5.30.7. A record of the in-process controls and the date and signature of the person(s) carrying them out, and the results obtained; 5.30.8. The product yield obtained at different and pertinent stages of manufacture; 5.30.9. Notes on special problems including details, with signed authorisation for any deviation from the manufacturing formula and processing instructions. Batch packaging records 5.31. A Batch Packaging Record is part of Manufacturing Record and shall be kept for each batch or part of batch processed. It shall be based on the relevant parts of the Packaging Instructions and the method of preparation of such records shall be designed to avoid transcription errors. The record shall carry the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.33. The following information shall be entered at the time each action is taken and, after completion, the record shall be dated and signed in agreement by the person(s) responsible for the packaging operations: 5.33.1. The name of the product; 5.33.2. The date(s) and times of the packaging operations. When there is the risk of contamination, the packaging activity shall be done within the day itself. 5.33.3. The name of the responsible persons carrying out the packaging operation; 5.33.4. The date and signature of the operators of the different significant steps; 5.33.5. Records of verification for identity and conformity with the packaging instructions including the results of in-process controls; 5.33.6. Details of the packaging operations carried out, including references to equipment and the packaging lines used; 5.33.7. Whenever possible, samples of printed packaging materials used, which include the batch/lot number, expiry date and any additional overprinting; 5.33.8. Notes on any special problems or unusual events including details, with date and signed authorization from the manufacturing formula and processing instructions; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Standard Operating Procedures (SOPs) and records 5.34. There shall be written procedures and records for the receipt of each delivery of each starting materials and packaging material. The records of the receipts shall include: 5.34.1. The name of material on the delivery note and the containers; 5.34.2. The “in-house” name and /or code of material (if different from the name of the material on the delivery note and the containers); 5.34.3. Date of receipt, date and signature of the receiving staff; 5.34.4. Supplier’s name and manufacturer’s name; 5.34.5. Manufacturer’s batch or reference number; 5.34.6. Total quantity and number of containers received; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.34.8. Any relevant comment (e.g. State of the containers). 5.35. There shall be written procedures for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate. 5.36. Standard operating procedures shall be available for the operation of each equipment and placed in close proximity to the instrument or equipment. 5.37. There shall be standard operating procedures for sampling, which specify the person(s) authorized to take samples, and the sampling instructions. 5.38. There shall be a standard operating procedure describing the details of the batch/lot numbering system, with the objective of ensuring that each batch of intermediate, bulk, or finished product is identified with a specific batch number. The batch numbering procedures shall assure that the same batch numbers will not be repeatedly used; this applies also to reprocessing. 5.39. Batch number allocation shall be immediately recorded, e.g. in a logbook. The record shall include date of allocation, product identity, and size of batch. 5.40. The standard operating procedures for batch numbering that are applied to the processing stage and to the respective packaging stage shall be related to each other. 5.41. Written procedure for quarantine, release and rejection shall be available for materials and products, and in particular for the release for sale of the finished product by the authorized person. 5.42. Records shall be maintained of the distribution of each batch of a product in order to facilitate the recall of the batch if necessary. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.43.1. Equipment assembly; 5.43.2. Operation of analytical apparatus and calibration; 5.43.3. Maintenance, cleaning, and sanitization of equipment and premises; 5.43.4. Personnel matters including qualification, GMP training, clothing, and hygiene; 5.43.5. Environmental monitoring; 5.43.6. Pest control; 5.43.7. Adverse product reactions, complaints and product recalls; 5.43.8. Returns and recovered products, rejected products/materials; 5.43.9. Disposal and destruction of the rejected products/materials; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5.44. Logbooks shall be kept for major or critical equipment and shall record, as appropriate, any calibrations, maintenance, cleaning, or repair operations, including dates and the identity of the people who carried these operations out. 5.45. Logbooks shall be recorded in chronological order for the use of all equipment and the areas where the products have been processed. 5.46. Several of the above- mentioned procedures, specifications and/or records may be combined together in one specific document. VI. Production Principle With the premises and equipment provided, the processes used in production shall be capable of yielding finished products which conform to their specifications. Defined manufacturing procedures are necessary to ensure that production, quality control and other relevant personnel are instructed on the details of the processes concerned. General 6.1. Production shall be performed and supervised by competent people. 6.2. All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution shall be done in accordance with written procedures or instructions and, where necessary, recorded. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.4. Damage to containers and any other problem, which might adversely affect the quality of a material, shall be investigated, recorded and reported to the Quality Control Department. 6.5. Incoming materials and finished products shall be physically or administratively quarantined immediately after receipt or processing, until they have been released for use or distribution. 6.6. Intermediate and bulk products purchased as such shall be handled on receipt as though they were starting materials. 6.7. All materials and products shall be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation. 6.8. Checks on yields, and reconciliation of quantities, shall be carried out as necessary to ensure that there are no discrepancies outside acceptable limits. 6.9. Operations on different products shall not be carried out simultaneously or consecutively in the same room unless there is no risk of mix-up or cross - contamination. 6.10. At every stage of processing, products and materials shall be protected from microbial and other contamination. Any treatment used to reduce fungal/microbial contamination or other infestation shall be documented. 6.11. When working with dry materials and products, special precautions shall be taken to prevent the generation and dissemination of dust. 6.12. At all times during processing, all materials, bulk containers, major items of equipment and where appropriate, rooms used shall be labelled or otherwise identified with an indication of the product or material being processed, its strength (where applicable) and batch number. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.14. Checks shall be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner. 6.15. Access to production premises shall be restricted to authorized personnel. 6.16. Water used as ingredients or for final rinsing of production equipment shall be treated to minimize microbial contamination Verification 6.17. Verification work that is needed to prove control of critical aspects of particular operations shall be identified and documented. Significant changes to the facilities, equipment and the processes which may affect the quality of the product shall be verified. A risk assessment approach shall be used to determine the scope and extent of verification. (Refer to Section 11.2). Prevention of cross-contamination in production 6.18. Contamination of a starting material or of a product by another material or product shall be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, vapours, sprays or organisms from materials and products in process, from residues on equipment, and from operators’ clothing. The significance of this risk varies with the type of contaminant and of product being contaminated. 6.19. Cross-contamination shall be avoided by appropriate technical or organizational measures, for example: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.19.2. Providing appropriate air-locks and air extraction. 6.19.3. Minimizing the risk of contamination caused by recirculation or re - entry of untreated or insufficiently treated air. 6.19.4. Keeping protective clothing inside areas where products with special risk of cross-contamination are processed. 6.19.5. Using the approved cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination. 6.19.6. Using “closed systems” of production. 6.19.7. Testing for residues and use of cleaning status labels on equipment. 6.19.8. Specific provisions for sampling, weighing, mixing and processing operations of crude plants whenever dust is generated. 6.20. Measures to prevent cross-contamination and their effectiveness shall be checked periodically according to set procedures. Starting materials ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.22. Starting materials shall only be purchased from approved suppliers and, where possible, directly from the producer. It is recommended that the specifications established by the manufacturer for the starting materials are discussed with the suppliers. It is of benefit that all aspects of the production and control of the starting material in question, including handling, labelling and packaging requirements, as well as complaints and rejection procedures are contractually agreed between the manufacturer and the supplier. The supplier of the materials shall be adequately assessed and the assessment shall be recorded. The supplier assessment programme shall include the establishment of an approved supplier list which may include alternative supplier, initial assessment before placing the supplier on the approved supplier list and periodic assessment thereafter, provision for on-site audit of the supplier premises, etc. 6.23. For each delivery, the containers shall be checked for integrity of package and seal and for correspondence between the delivery note and the supplier's labels. 6.24. If one material delivery is made up of different batches, each batch shall be considered as separate for sampling, testing and release. 6.25. Starting materials in the storage areas shall be appropriately labelled. Labels shall bear at least the following information: 6.25.1. The designated name of the product and the internal code reference where applicable; 6.25.2. A batch number given at receipt; 6.25.3. Where appropriate, the status of the contents (e.g. in quarantine, on test, released, rejected); 6.26. There shall be appropriate procedures or measures to assure the identity of the contents of each container of starting material. Bulk containers from which samples have been drawn shall be identified. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.28. Starting materials shall only be dispensed by designated persons, following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers. 6.29. Each dispensed material and its weight or volume shall be independently checked and the check recorded. 6.30. Materials dispensed for each batch shall be kept together and conspicuously labelled as such. Processing operations: Intermediate and bulk products 6.31. Before the introduction of a Master Formula it shall be evaluated sufficiently to determine that it is suitable for routine processing operations, and the ability of the process to be reproducible. 6.32. Production personnel shall follow defined and authorized procedures for every stage of each manufacturing process. 6.33. Any deviation from defined procedures shall be recorded and agreed upon between the head of Production Department and the head of Quality Control Department. 6.34. Before any manufacturing begins, steps shall be taken to ensure that the work area and equipment are free from any materials, products, or documents, not required for the current operation. 6.35. Any necessary in-process controls and environmental controls shall be carried out and recorded. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.37. The final yield of each production stage shall be recorded and checked against the theoretical yield. In the event of a significant variation, steps shall be taken to prevent release or further processing of the batch, until an appropriate investigation is made. 6.38. Storage of materials and bulk products must be under controlled condition. Packaging materials 6.39. The purchase, handling and control of primary and printed packaging material shall be accorded attention similar to that given to starting materials. 6.40. Particular attention shall be paid to printed materials. They shall be stored in adequately secure condition such as to exclude unauthorized access. Cut labels and other loose printed materials shall be stored and transported in separate closed containers so as to avoid mix-ups. Packaging materials shall be issued for use only by authorized personnel following an approved and documented procedure. 6.41. Each delivery or batch of printed or primary packaging material shall be given a specific reference number or identification mark. 6.42. Outdated or obsolete primary packaging material or printed packaging material shall be destroyed and this disposal recorded. Packaging Operations 6.43. When setting up a programme for the packaging operations, particular attention shall be given to minimising the risk of the cross-contamination, mix-ups or substitutions. Different products shall not be packaged in close proximity unless there is physical segregation. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.45. The name and batch number of the product being handled shall be displayed at each packaging station or line. 6.46. All products and packaging materials to be used shall be checked on delivery to the packaging department for quantity, identity and conformity with the Packaging Instructions. 6.47. Primary packaging shall be clean prior to use. Measures shall be taken to prevent any contaminants such as glass fragments and metal particles. 6.48. Normally, filling and sealing shall be followed as quickly as possible by labelling. If it is not the case, appropriate procedure shall be applied to ensure that no mix-ups or mislabelling could occur. 6.49. The correct performance of any printing operation (for example batch/lot numbers, expiry dates) to be done separately or in the course of the packaging shall be checked and recorded. Attention shall be paid to printing by hand which shall be re -checked at regular intervals. 6.50. Special care shall be taken when using cut-labels and when over-printing is carried out off-line. Roll-feed labels are normally preferable to cut-labels, in helping to avoid mix-ups. 6.51. Checks shall be made to ensure that any electronic code readers, label counters or similar devices are operating correctly. 6.52. Printed and embossed information on packaging materials shall be distinct and resistant to fading or erasing. 6.53. On-line control of the product during packaging shall include at least checking the following: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.53.2. Whether the packages are complete; 6.53.3. Whether the correct products and packaging materials are used; 6.53.4. Whether any over-printing is correct; 6.53.5. Correct functioning of line monitors. 6.54. Samples taken away from the packaging line shall not be returned. 6.55. Products which have been involved in an unusual event shall only be reintroduced into the process after special inspection, investigation and approval by authorized personnel. Detailed record shall be kept of this operation. 6.56. Any significant or unusual discrepancy observed during reconciliation of the amount of bulk product and printed packaging materials and the number of units produced shall be investigated and satisfactorily accounted for before release. 6.57. Upon completion of a packaging operation, any unused batch-coded packaging materials shall be destroyed and the destruction recorded. A documented procedure shall be followed if uncoded printed materials are returned to stock. Finished products ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6.59. The evaluation of finished products and documentation which is necessary before release of product for sale is described in Section VII. Quality Control. 6.60. After release, finished products shall be stored as usable stock under conditions established by the manufacturer. Rejected, recovered and returned materials 6.61. Rejected materials and products shall be clearly marked as such and stored separately in restricted areas. They shall either be returned to the suppliers or, where appropriate, reprocessed or destroyed. Whatever action is taken shall be approved and recorded by authorized personnel. 6.62. The reprocessing of rejected products shall be exceptional. It is only permitted if the quality of the final product is not affected, if the specifications are met and if it is done in accordance with a defined and authorized procedure after evaluation of the risks involved. Record shall be kept of the reprocessing. 6.63. The recovery of all or part of earlier batches which conform to the required quality by incorporation into a batch of the same product at the defined stage of manufacture shall be authorized beforehand. This recovery shall be carried out in accordance with a defined procedure after evaluation of the risks involved, including any possible effect on shelf life. The recovery shall be recorded. 6.64. The need for additional testing of any finished product which has been reprocessed, or into which a recovered product has been incorporated, shall be considered by the Quality Control Department. 6.65. Products returned from the market and which have left the control of the manufacturer shall be destroyed unless without doubt their quality is satisfactory. They may be considered for re-sale, re-labelling or recovery in a subsequent batch only after they have been critically assessed by the Quality Control Department in accordance with a written procedure. The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued shall all be taken into account in this assessment. Where any doubt arises over the quality of the product, it shall not be considered suitable for re-issue or re-use, although basic chemical reprocessing to recover active ingredient may be possible. Any action taken shall be appropriately recorded. VII. Quality control ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Every manufacturing establishment shall have a quality control system so designed as to ensure that the products are manufactured in accordance with adequate conditions and procedures and continue to meet the established specifications. Quality control is not confined to laboratory operations, but must involve all decisions which may concern the quality of the product. For this purpose there shall be an appropriate and independent Quality Control Department. General 7.1. Quality control is concerned with sampling, specifications, testing, organization, documentation and release procedures which ensure that the necessary tests are in fact carried out, and that the materials are not released for use, nor products released for sale and supply until their quality has been assessed to be satisfactory. 7.2. The Quality Control Department shall have a designated area with sufficient and well trained staff to perform any required analysis before, during and after manufacture. 7.3. If the in-house Quality Control Department cannot perform certain specific analysis, the services of accredited/ recognised external laboratory can be used to conduct the tests. 7.4. Finished products assessment shall embrace all relevant factors, including production condition, results of in-process testing, a review of manufacturing (including packaging) documentation, compliance with Finished Product Specification and examination of final finished pack. 7.5. Quality Control personnel shall have access to production areas for sampling and investigation as appropriate. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 7.7. The identity and quality of materials and finished products shall be checked/tested. The presence of individual ingredient in pre-mixes shall be confirmed. 7.8. Besides these principal duties, the Quality Control Department as a whole will also have other duties, such as to establish and implement all quality control procedures, keep the reference samples of materials and products, ensure the correct labelling of containers of materials and products, ensure the monitoring of the stability of the products, etc. All these operations shall be carried out in accordance with written procedures and recorded. 7.9. The stability of the finished product shall be monitored according to a continuous appropriate programme that will permit the detection of any stability issue associated with the formulation in the marketed package. Sampling 7.10. Due to the fact that crude material shall be an aggregate of individual natural materials i.e. contain an element of heterogeneity, the sampling has to be carried out with special care by competent personnel. Each batch shall be identified by its own documentation. 7.11. Samples are taken at locations free of from contamination, cross-contamination and mix-ups and following appropriate procedures, including the following: 7.11.1. The method of sampling; 7.11.2. The equipment to be used; 7.11.3. The amount of the sample to be taken; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 7.11.5. The type and condition of the sample container to be used; 7.11.6. The identification of containers sampled; 7.11.7. The storage conditions; 7.11.7. Instructions for the cleaning and the storage of sampling equipment. 7.12. Reference samples shall be representative of the batch of materials or products from which they are taken. Other samples may also be taken to monitor the most stressed part of a process. (e.g. beginning or end of a process). 7.13. Sample containers shall bear a label indicating the contents, with the batch number, the date of sampling and the containers from which samples have been drawn. 7.14. Reference samples from each batch of finished products shall be retained till one year after the expiry date. Finished products shall usually be kept in their final packaging and stored under the recommended conditions. Samples of starting materials (other than solvents, gases and water) shall be retained for at least two (02) years after the release of the product if their stability allows. This period may be shortened if their stability, as mentioned in the relevant specification, is shorter. Reference samples of materials and products shall be of a size sufficient to permit at least a full re-examination. Testing 7.15. All testing operations described in the marketing authorization shall be carried out according to approved methods which shall be internationally accepted (refer to section 11.1). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 7.17. The test performed shall be recorded and the records shall include at least: 7.17.1. Name of the material or product and, where applicable, dosage form; 7.17.2. Batch number and, where appropriate, the manufacturers and/or supplier; 7.17.3. References to the relevant specifications and testing procedures; 7.17.4. Test results, including observations and calculations, and reference to any certificates of analysis; 7.17.5. Dates of testing, the name of the analyst and the name of the external laboratory, if applicable; 7.17.6. Date and signature of the persons who performed the testing; 7.17.6. Date and signature of the persons who verified the testing and the calculations, where appropriate; 7.17.7. A clear statement of release or rejection (or other status decision) and the dated signature of the designated responsible person. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 7.19. Special attention shall be given to the quality of laboratory reagents, volumetric glassware and solutions, reference standards and culture media. They shall be prepared in accordance with written procedures and recorded. 7.20. Laboratory reagents intended for prolonged use shall be marked with the preparation date and the signature of the person who prepared them. The expiry date of unstable reagents and culture media shall be indicated on the label, together with specific storage conditions. In addition, for volumetric solutions, the last date of standardization and the last current factor (F) shall be indicated. 7.21. For some kinds of data (e.g. analytical test results, yields, environmental controls) it is recommended that records in a manner permitting trend evaluation be kept. 7.22. In addition to the information which is part of the batch record, other original data such as laboratory notebooks and/or reports shall be retained and readily available. Ongoing stability programme 7.23. After marketing, the stability of the product shall be monitored according to a continuous appropriate programme that will permit the detection of any stability issue associated with the formulation in the marketed package. 7.24. The purpose of the on-going stability programme is to monitor the product over its shelf life and to determine that the product remains, and can be expected to remain, within specifications under the labelled storage conditions. 7.25. This mainly applies to the product in the package in which it is marketed/sold, but consideration shall also be given to the inclusion in the programme of bulk product. For example, when the bulk product is stored for a long period before being packaged and/or shipped from a manufacturing site to a packaging site, the impact on the stability of the packaged product shall be evaluated and studied under ambient conditions. In addition, consideration shall be given to intermediates that are stored and used over prolonged periods. Stability studies on reconstituted product are performed during product development and need not be monitored on an on-going basis. However, when relevant, the stability of reconstituted product can also be monitored. 7.26. The on-going stability programme shall be described in a written protocol and results formalized as a report. The equipment used for the on-going stability programme (stability chambers among others) shall be qualified and appropriately maintained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 7.27.1. Number of batch(es) per strength and different batch sizes, where applicable; 7.27.2. Relevant physical, chemical, microbiological and biological test methods, stability indicating parameters, where applicable. 7.27.3. Acceptance criteria; 7.27.4. Reference to test methods; 7.27.5. Description of the container closure system(s); 7.27.6. Testing intervals (time points); 7.27.7. Description of the conditions of storage; 7.27.8. Other applicable parameters specific to the finished product. 7.28. The protocol for the on-going stability program can be different from that of the initial long-term stability study as submitted in the marketing authorization dossier provided that this is justified and documented in the protocol. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 7.30. In certain situations, additional batches shall be included in the on-going stability program. For example, an on-going stability study shall be conducted after any significant change or significant deviation to the process or package. Any reworking, reprocessing or recovery operation shall also be considered for inclusion. 7.31. Results of on-going stability studies shall be made available to key personnel and, in particular, to the authorized person(s). Where on-going stability studies are carried out at a site other than the site of manufacture of the bulk or finished product, there shall be a written agreement between the parties concerned. Results of on-going stability studies shall be available at the site of manufacture for review by the competent authority. 7.32. Out of specification or significant atypical trends shall be investigated. Any confirmed out of specification result, or significant negative trend, shall be reported to the relevant competent authorities. The possible impact on batches on the market shall be considered in accordance section IX. Complaints and Product Recalls of the GMP Guide and in consultation with the relevant competent authorities 7.33. A summary of all the data generated, including any interim conclusions on the programme, shall be written and maintained. 7.34. For stability study requirements, reference shall be made to section 11.3. VIII. Contract manufacture and analysis Principle Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties and responsibilities of each party. The contract must clearly state the way in which the authorized person releasing each batch of product for sale exercises his full responsibility. Contract manufacture ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Contract analysis 8.2. Contract analysis must have a written contract agreement between the Contract Giver and the Contract Acceptor which clearly establishes the duties and responsibilities of each party. All arrangements for contract analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the NRA requirements for the product concerned. The contract giver 8.4. The Contract Giver shall be responsible for assessing the competency of the Contract Acceptor in successfully carrying out the work/test required and for ensuring by means of the contract that the principles of GMP described in these guidelines are followed. 8.5. The Contract Giver shall provide the Contract Acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the NRA requirements. The Contract Giver shall ensure that the Contract Acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products. 8.6. The Contract Giver shall ensure that all products and materials delivered by the Contract Acceptor comply with their specifications. The Contract Acceptor 8.7. The Contract Acceptor has adequate premises, equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the Contract Giver. Contract manufacture shall be undertaken only by a manufacturer who is the holder of a manufacturing authorization issued by the NRA. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 8.9. The Contract Acceptor shall not pass to a third party any of the work entrusted to him under the contract without the Contract Giver’s prior to evaluation and approval of the arrangements. Arrangements made between the Contract Acceptor and any third party shall ensure that the manufacturing and the analytical information is made available in the same way as between the original Contract Giver and Contract Acceptor. 8.10. The Contract Acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured/tested for the Contract Giver. The Contract 8.11. A contract shall be drawn up between the Contract Giver and the Contract Acceptor, which specifies their respective responsibilities relating to the manufacture and the control of the product. Technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in traditional medicines and health supplements manufacturing, analysis and GMP. All arrangement for manufacture and analysis must be in accordance with the NRA requirement and agreed by both parties. 8.12. The contract shall specify the way in which the head of Quality Control Department releasing the batch for sale ensures that each batch has been manufactured and checked for compliance with the requirements of the NRAs. 8.13. The contract shall describe clearly who is responsible for purchasing materials, testing and releasing materials, undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis. In case of contract analysis, the contract shall state whether or not the Contract Acceptor shall take samples at the premises of the manufacturer. 8.14. Manufacturing, analytical and distribution records, and reference samples shall be kept by, or be available to, the Contract Giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defect/recall procedures of the Contract Giver. 8.15. The contract shall permit the Contract Giver to visit the facilities of the Contract Acceptor. 8.16. In the case of contract analysis, the Contract Acceptor shall understand that he is subject to inspection by the competent Authorities. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Principle All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. In order to provide for all contingencies, a system shall be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market. Product complaints 9.1. Product complaints are usually concerned with the quality of the product such as its physical properties, or condition of its packaging. Complaints (internal or external) could be made to the manufacturer, verbally or in writing by consumers, distributors or the NRA. 9.2. All complaints shall be investigated and evaluated. Written procedures describing the handling of all written and verbal complaints regarding the product shall be established and followed. Such procedures shall include provisions for review by the Quality Control unit. A written record of each complaint shall be maintained in a file designated for product complaints. 9.3. A person shall be designated responsible for handling the complaints. 9.4. There shall be written procedures describing the action to be taken, including the need to consider a recall, in the case of a complaint concerning a possible product defect. 9.5. Any complaint concerning a product defect shall be recorded with all the original details and thoroughly investigated. The person responsible for Quality Control shall be part of the team. 9.6. Special attention shall be given in establishing whether the product which is the subject of a complaint, genuine or is a counterfeit product. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 9.8. All decisions and measures taken as a result of a complaint shall be recorded and referenced to the corresponding batch records. 9.9. Complaint records shall be reviewed regularly for any indication of specific or recurring problems requiring attention and possibly the recall of marketed products. 9.10. For recurring problem, a trending shall be established in order to identify the possible systemic defects. 9.11. The NRA shall be informed if a manufacturer is considering action following possibly faulty manufacture, product deterioration, or any other serious quality problems with a product. 9.12. The NRA and the complainant shall be furnished with a summary of the action taken. Product recalls 9.13. Responsibility and procedures for recall of the product shall be established by the manufacturer to facilitate the recall of a batch from any link of the distribution chain when this becomes necessary. 9.14. The recall procedures shall take into account the degree and level of recall which in line with the NRA requirement. 9.15. Any action taken to recall a product suspected or known to be defective or hazardous, shall be done immediately and in accordance with a pre-determined plan. The procedures to be followed shall be specified in writing and made known to all that may be concerned. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 9.17. There shall be established written procedures, regularly checked and updated when necessary, in order to organize any recall activity. 9.18. Recall operation shall be capable of being initiated immediately and at any time. 9.19. All NRA of all countries to which products may have been distributed shall be informed immediately if products are intended to be recalled because they are, or are suspected of being defective. 9.20. The distribution records shall be readily available to the person(s) responsible for recalls, and shall contain sufficient information on distributor/retailer/wholesalers and directly supplied customers (with latest and valid addresses, contact number including mobile phone, phone and/or fax numbers inside and outside working hours, batches and amounts delivered), including those for exported products. 9.21. Recalled products shall be identified, recorded and stored separately in a secure area while awaiting a decision on their fate. 9.22. The progress of the recall process shall be recorded and a final report issued, including reconciliation between the delivered and recovered quantities of the products. 9.23. The effectiveness of the arrangements for recalls shall be evaluated regularly. Complaints on adverse product reactions 9.24. Unexpected adverse product reactions resulting from the use of the product must be thoroughly investigated and documented. Reports of serious unexpected adverse reactions shall be immediately forwarded to the NRA. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Principle Self-inspections shall be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures. 10.1. Personnel matters, premises, equipment, documentation, production, quality control, distribution of the products, arrangements for dealing with complaints and recalls, and self-inspection, shall be examined at intervals following a pre-arranged program in order to verify their conformity with the principles of Quality Assurance. 10.2. Self-inspection shall be conducted in an independent and detailed way by designated competent person(s) from the company. The independent audits by external experts may also be useful. 10.3. All self-inspections shall be recorded. Reports shall contain all the observations made during the inspections and, where applicable, proposals for corrective actions and preventive actions, and corresponding time frames. Statements on the actions subsequently taken shall also be recorded. 10.4. Reference shall be made to section 11.4. Self-inspection checklist. XI. Other contents 11.1. List of internationally accepted references for test methods
... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - ISO Standard - ICS 67 - Food Technology; - ISO Standard - ICS 67.050 - General methods of tests and analysis for food products.
http://ods.od.nih.gov/Research/AMRMProgramWebsite.aspx.
... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Note: The use of this list is subject to the consideration, regulations and prerogative of each national regulatory authority. Other references may be considered by national regulatory authority, provided that the test methods are validated against guidelines/parameters defined by ICH/ASEAN Guidelines for Validation of Analytical Procedures. 11.2. Verification Principle 11.2.1. This Appendix describes the principles of verification which are applicable to the manufacture of health supplements. Accordingly, and in this Appendix, verification shall refer to the documented act or conduct of confirmation that the control or procedure required in a particular critical aspect of manufacturing operation has been complied with or satisfactorily implemented by the manufacturer based on risk assessment and risk management. Re-verification shall be performed if there are significant changes to the facilities, systems, processes and equipment that may have impact on the quality of the finished products, and the changes would require regulatory approval. Where there are no significant changes, periodic review shall be performed to show that the facilities, systems, processes and equipment continue to meet the prescribed requirements. Documentation 11.2.2. A verification programme which includes written procedure(s) shall be established to specify how the verification activities will be carried out. The documentation provided will demonstrate the quality assurance systems needed to produce quality health supplements. This includes the QA systems, which consist of elements that address matters such as roles and responsibilities, employee training, document management, equipment calibration and maintenance, manufacturing and laboratory control procedures, and product shelf life evaluation. A report that cross-references the verification programme and procedure shall be prepared, summarizing the results obtained, commenting on any deviations observed, and drawing the necessary conclusions, including the recommending changes necessary to correct the deficiencies. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 11.2.3. Equipment and machinery shall be periodically verified to determine if they are still operating in a valid state. During verification, it is important to use calibrated reference material e.g. NIST traceable calibrated thermometer to verify the temperature of process to determine its valid state. Machinery and equipment to be used shall have been verified prior to the verification of process and staff taking part in verification work shall have been appropriately trained. Verification of process 11.2.4. General Verification of process contributes to assuring product quality and the basic principle of quality assurance is that a product shall be produced under such condition that is fit for its intended use. The basic principle of quality assurance is that a product shall be consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization and product specification. 11.2.5. Verification of process may involve demonstration, testing & analysis and in-process control, or other relevant to confirm that critical processes are kept under control. A process verification report shall be prepared to provide evidence that the process has been verified.
... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Demonstrations can be conducted in actual or simulated environments.
Test is the application of scientific principles and procedures to determine the properties or functional capabilities of items. Test is similar to demonstration, but is more exacting, generally requiring specialized test equipment/configuration/data/procedure in order to verify that the item satisfies the requirement. Analysis is the use of established technical or mathematical models or simulations, algorithms, or other scientific principles and procedures to provide evidence that the item meets its stated requirements.
Critical parameters shall be determined and monitored, checks performed during production in order to monitor and if necessary to adjust the process to ensure that the products conform to its specification. The control of the environment or equipment may also be regarded as a part of in-process control. Change control 11.2.6. Written procedures shall be in place to describe the actions to be taken if a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducibility of the process. Change control procedures shall ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 11.3. Guidelines on stability study and shelf-life of health supplements Introduction Stability is an essential factor of quality in health supplements. It is determined by a series of chemical, physical and microbiological tests conducted, namely to ensure maintenance of the specifications of the finished product stored in the established storage condition within the determined shelf-life. Objective This guideline is intended to provide recommendations on the core stability study required for products. Nevertheless it leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the products being evaluated. Design 11.3.1. General The design of a stability study for the product should be based on the nature of the product. It should take into account of the following: - Selection of batches; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Testing frequency; - Container closure system. 11.3.2. Selection of batches Stability data should be provided for batches of the same formulation and dosage form in the container closure system intended for marketing. - Stability data from at least two batches would be required, derived either from pilot scale, primary scale, production scale or their combination. - The manufacturing process of batches used in stability studies should simulate that of production batches and should be of the same quality as well as meet the same specification as those batches intended for marketing. - Stability studies should be performed on individual strengths of the product and/or type of container closure system in which the finished product is packed unless bracketing/matrixing is applied as in the section “Reduced design”. 11.3.3. Specification and testing parameters A stability study should cover the testing of the physical, chemical and microbiological properties of a finished product that are susceptible to change during storage and are likely to influence quality when changed. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. For a combination product containing multiple active ingredients, although it may not be necessary to assay all the active ingredients. It may be appropriate to assay one, and in some cases, more than one active ingredient, or a surrogate marker that is known to be susceptible to change under storage condition (such as temperature and/or humidity) and is likely to influence the quality of the combination product. A valid justification shall be submitted. For a product containing ingredients without known marker(s), physical parameters may be used as surrogate indicators during storage, when the use of such parameters can be justified. 11.3.4. Testing frequency For accelerated and real time stability studies, frequency of testing should be sufficient to establish the stability profile of the finished product. At the accelerated storage condition, a minimum of three time points, including the initial and final time points, for example, 0, 3, and 6 months for a 6-month study, is recommended. The frequency of testing at real time storage conditions should normally be every 3 months over the first year, every 6 months over the second year and annually thereafter through the proposed shelf-life. Table 1: A typical testing frequency Storage condition Testing frequency Real time 0, 3, 6, 9, 12, 18, 24 months and annually thereafter through the proposed shelf-life ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 0, 3 and 6 months Reduced designs, i.e., matrixing or bracketing, where the testing frequency is reduced or certain factor combinations are not tested at all, can be applied, if justified, as in the section “Reduced design”. Where an expectation exists that outcomes from accelerated studies are likely to approach significant change criteria, i.e. parameters tested are out of the specifications set, it is advised an increased testing should be conducted either adding samples at the final time point or by including a fourth time point in the study design. If the “significant change” occurs within the first 3 months’ testing at the accelerated storage condition, a justification should be provided to address the effect of short term excursions outside the label storage condition, e.g, during shipping or handling. This justification can be supported, if appropriate, by further testing on a single batch of the product for a period shorter than 3 months but with more frequent testing than usual. It is considered unnecessary to continue to test a product through the remaining months when a “significant change” has occurred within the first 3 months, and as such the shelf-life shall be based on real time data. If “significant change” occurs between 3 and 6 months’ testing at the accelerated storage condition, shelf-life shall be based on real time data (often found in preparations such as cream or grease which cannot be tested under accelerated conditions). 11.3.5. Storage conditions In general, HS as a finished product should be evaluated under its storage conditions (with appropriate tolerances) that test its thermal stability under recommended storage conditions and, if applicable, its sensitivity to moisture or potential for solvent loss. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use, for example, after reconstitution or dilution as recommended in the labeling. Specific recommended temperature and relative humidity conditions for storage applied to stability studies and types of container closure system are based on the nature of the products and the type of primary container used, in accordance with recommended storage condition on product label. Common storage conditions are shown in Table 2 below. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Type of container closure system/study Storage condition Products in primary containers permeable to water vapor 30°C±2°C; Relative humidity 75% ±5%. Products in primary containers impermeable to water vapor 30oC±2oC Accelerated studies 40°C±2°C; Relative humidity 75% ±5%. If submitted data is based on conditions that are less stressful (e.g. 30°C/65% RH) than those required, the data should be accompanied by appropriate complementary data which will permit to conduct a proper scientific evaluation under the condition recommended on the label (climate condition in the region/country where the product is expected to be marketed). Factors to be taken into consideration will include: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ● Whether data have also been provided under accelerated conditions; ● The type of container closure system. Other storage conditions are allowable, if justified. Examples would include: ● Heat sensitive products which should be stored under lower temperature condition which will eventually become the designated long term storage temperature. - Products containing less stable active ingredients and formulations not suitable for storage at elevated temperature will need real time stability studies. - When a lower temperature condition is used, the 6 month accelerated testing should be carried out at a temperature at least 150C above the expected actual storage temperature (together with appropriate relative humidity conditions for that temperature). For example, for a product to be stored long term under refrigerated conditions, accelerated testing should be conducted at 25ºC ± 2ºC, 60% RH ± 5% RH. The designated real time testing conditions will be reflected in the labelling and shelf-life (expiration date). Typical storage conditions recommended for stability studies on products intended for storage in a refrigerator as shown in Table 3 below. ● Products which change physically or even chemically at lower storage temperature conditions e.g., suspensions or emulsions. Table 3: Typical storage conditions recommended for products intended in a refrigerator Study ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Real time 5oC±3oC Accelerated studies 25oC±2oC. Relative humidity 60% ±5% Data from the accelerated stability studies can be used to evaluate the effect of short-term excursions outside the label storage conditions such as during shipping. The data from accelerated study and ongoing real time stability study can be used to justify an interim extrapolated shelf-life. However, the actual shelf-life should be based ultimately on the real time stability data at the recommended storage conditions. 11.3.6. Container closure system Stability testing should be conducted on the product packaged in the primary container closure system proposed for marketing including, as appropriate, any secondary packaging. Finished products packed in moisture-impermeable primary containers are not required to be tested under high humidity conditions. Generally considered moisture-impermeable containers include aluminium/aluminium blisters, High Density Polyethylene (HDPE) or glass bottles fitted with metal or HDPE closures. When using moisture-permeable containers for packaging, due to consideration should be given to the stability of the contents under high humidity conditions. Moisture may have an undesirable effect on chemical and physical stability of a finished product. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 11.3.7. Evaluation A systematic approach should be adopted in the presentation and evaluation of the stability information, which should include, as appropriate, results from the physical, chemical and microbiological tests. Any evaluation should consider not only the assay, but also other appropriate test attributes. A recommended presentation of the summary table of stability results appears as in the section “Recommended presentation of the summary table of stability results”. 11.3.8. Labelling The storage conditions that include temperature, light and humidity indicated on the label should be based on the stability evaluation of the product. General precautionary statements, such as “Protect from light” and/or “Store in a dry place”, may be included, but should not be used to conceal stability problems of the finished product. Specific instruction on storage condition should be provided. Terms such as “ambient conditions” or “room temperature” should be avoided. Glossary For the purposes of this Appendix, the terms below shall be construed as follows: 1. Assay: A test procedure for measuring or determining the quantity of active ingredient or marker in a finished product. 2. Batch: A defined quantity of starting material, packaging material or product produced during a given cycle (in a single process or series of processes) and from a specific formulation order, that is uniform in character and quality (the essence of a manufacturing batch is its homogeneity). It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. 3. Pilot scale batch: A batch of substances or product manufactured by procedure fully representative of and simulating that to be applied to a full production scale batch. A pilot scale is generally, at minimum, one tenth that of a full production scale. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 5. Production scale batch: A batch of product manufactured at production scale by using production equipment in a production facility as specified in the application. 6. Specification: A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. Specification is used as the basis for quality assessment. “Conformance to specification” means that the product, when tested according to the listed analytical procedures, will meet the acceptance criteria. The set of criteria to which a substance, product or material at stages of its manufacture should conform to shall be considered acceptable for its intended use. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. 7. Stability study protocol: A document describing rationale, goals, methodology, and statistical methods of the stability study which specifies the terms and conditions under which the stability study must be conducted and managed. 8. Stability studies: Real time and accelerated studies/testing undertaken on primary batches according to a prescribed stability protocol to establish or confirm the re-test period of a substance or shelf-life of a finished product. - Accelerated stability studies: Studies designed to increase the rate of chemical degradation or physical change of a finished product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long-term stability studies, can be used to assess longer term chemical effects at non-accelerated condition and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes. - Real time stability studies: stability studies under the recommended storage condition for the re-test period or shelf-life proposed (or approved) for labeling. 9. Storage condition: condition for intended storage of a finished product defined on the container label based on the stability study. Reduced design A full study design is one in which samples for very combination of all design factors are tested at all time points. A reduced design is one in which samples for every factor combination are not all tested at all time points. A reduced design can be a suitable alternative to a full design when multiple design factors are involved. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. During the course of a reduced design study, a change to full testing or to a less reduced design can be considered if justification is provided and the principles of full designs and reduced design studies are followed. Proper adjustments should be made to the statistical analysis, where applicable, to account for the increase in sample size as a result of the change. Once the design is changed, full testing or less reduced testing shall be carried out through the remaining time points of the stability study. Bracketing Bracketing is the design of a stability schedule such that only samples on the extremes of certain design factors, for example, strength, container size and/or fill, are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Design example An example of a bracketing design is given in Table 4 below. This example is based on a product available in 3 strengths and 3 container sizes. In this example, it demonstrated that the 15 ml and 500 ml high-density polyethylene container sizes truly represent the extremes. The batches for each selected combination should be tested at each time point as in a full design. Table 4: Example of Bracketing Design Strength 50 mg 75 mg ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Batch 1 2 3 1 2 3 1 2 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Container size (ml) 15 T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T 100 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 500 T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T = Sample tested Matrixing Matrixing is the design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations would be tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations would be tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same finished product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and possibly, in some cases, different container closure systems. When a secondary packaging system contributes to the stability of the finished product, matrixing can be performed across the packaging systems. Each storage condition should be treated separately under its own matrixing design. Matrixing should not be performed across test attributes. However, alternative matrixing designs for different test attributes can be applied if justified. Design examples Examples of matrixing designs on time points for a product in two strengths (Sl and S2) are shown in the Table below. The terms “one-half reduction” and “one-third reduction” refer to the reduction strategy initially applied to the full study design. For example, a “one- half reduction” initially eliminates one in every two time points from the full study design and a “one-third reduction” initially removes one in every three. In the examples shown below, the reductions are less than one-third due to the inclusion of full testing of all factor combinations at some time points. These examples include full testing at the initial, final, and 12- month time points as shown in the table below. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Time point (months) 0 3 6 9 12 18 24 36 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. S1 Batch 1 T T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Batch 2 T T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Batch 1 T T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T T T (T = Sample tested) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. At least 4 out of 8 time points ● Example of Matrixing Design on Time Points for a Product with Strengths “One-Third Reduction” Time point (months) 0 3 6 9 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 18 24 36 Strength S1 Batch 1 T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T Batch 2 T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T S2 Batch 1 T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T Batch 2 T T T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T (T = Sample tested) At least 8 out of 12 time points At least 6 out of 8 time points ● Example of Matrixing Design on Time Points for a Product with three Strengths “One-Third Reduction” Time point (months) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3 6 9 12 18 24 36 Strength S1 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T T T T Batch 2 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T T S2 Batch 1 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T T Batch 2 T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T S3 Batch 1 T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T T T Batch 2 T T ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. T T T T (T = Sample tested) At least 12 out of 18 time points At least 8 out of 12 time points ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Recommended presentation of the summary table of stability results: Testing parameters Organoleptic characteristic Assay Hardness/ friability Dissolution/ disintegration Water content Viscosity ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Microbial content Granules/Particle size Resuspendability Health supplement dosage form Oral powder ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Hard capsule ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Soft capsule ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Coated and uncoated tablet ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Coated and uncoated pill/pellet ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Solution ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Emulsion ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Granules ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Recommended presentation of the summary table of stability results Product name: ………. Storage condition: ………. Dosage form: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Batch No. ………. Strength: ………. Manufacturing date: ………. Container: ………. Date of report: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Pack size: ………. Period of the study: ………. Testing parameters (as applicable) Acceptance criteria Testing frequency (months) 0 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6 9 12 18 24 … Organoleptic characteristic ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Strength ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Hardness ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Dissolution ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Humidity ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Microbial content ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. … ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Conclusion: …………………………………………………………………………………… Prepared by Checked by ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 11.4. Self-inspection checklist 11.4.1. Purpose The purpose of self-inspection is to sufficiently determine information and evaluate the compliance with GMP in order to detect any shortcomings and defects in the implementation of GMP and to recommend the necessary corrective actions. The procedure for self-inspection should be documented, including a detailed self-inspection checklist. In case of difference in production lines, dosage form and investment scale, each manufacturer shall produce and promulgate a self-inspection checklist appropriate to its condition. The preparation and application of a selft-inspection checklist shall be relevant to the objective and nature of the inspection (initial or repeated, periodic or unscheduled, general or thematic evaluation). This checklist shall be developed and/or adjusted according to the following self-inspection questionnaire. 11.4.2. Main contents
... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh.
11.4.3. Guidance on response to questionnaires - Regarding open questions: add details to the blank. - Regarding closed-ended questions, place a check mark “√” in the answer box. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 11.4.4. Contents 1. General information about the Company - Name/address: ……………………………………………………………… - Telephone/fax: …………………………………………………………… - Place of manufacturing: …………………………………………….………. - Representative of the company/position: ………………………………………….……. - Total number of employees: ………………………………………………………. - Number of personnel working in production areas: ………………………….… - Authorization of the National Regulatory Authority: ………………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Organization chart: ……………………………………………………………. - Training result: …………………………………………………………. - Diagrams of production areas (geographical premises; line arrangement; class of cleanliness; layout, raw materials, bulk products, semi-finished products): ……………………………………………………………… - Diagram of ancillary systems (air handling system, industrial water supply system, wastewater treatment system, fire fighting system): ..…... - Manufacturing activities: product types, inspection during manufacturing process, supplier evaluation: ………………………………….……….. - Quality assurance system, quality control system: ……………………… - Internal audit: …………………………………………………………... 2. Self-inspection questionnaire No. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Applicable Not applicable Pass Fail Quality management 1 Whether quality policies and commitments are determined, and formally promulgated by competent persons. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 2 Whether a quality management system, including quality manual, procedures, resources and organization structure concerned is established. 3 Whether managerial responsibilities are clearly documented. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 4 Whether arrangements are made for the manufacture, supply and use of the correct starting and packaging materials. 5 Whether in-process controls are established and maintained according to the approved procedures. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6 Whether persons responsible for batch certification are assigned. 7 Whether before release, each batch is reviewed, certified and checked according to procedures and specifications. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 8 Whether a plan for initial or periodic verification of critical steps of a manufacturing process is prepared. 9 Whether critical steps or significant changes that affect product quality during the manufacturing process are verified. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 10 Whether records covering manufacture, which enable the complete history of a batch to be traced are prepared. 11 Whether there are adequate procedures for sampling, inspecting and testing starting materials, intermediate, bulk, and finished products, and for monitoring environmental conditions for GMP and checking measuring equipment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 12 Whether quality control is sufficiently documented. 13 Whether product quality reviews are conducted according to GMP recommendations. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 14 Whether there are self-inspection/internal audit programs.
15 Whether the organization chart is updated (by the time of self-inspection). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 16 Whether the organization chart consists of the following (and the respective quantity): Production department: ………………………………..… persons Quality control department: ………………….… persons ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Other departments (please specify): - …………………………………………………. persons - …………………………………………………. persons. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the head of Production Department and the head of Quality Control Department are independent of each other. 18 Whether these key posts are occupied by full-time personnel. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Information about the head of the production department: - Knowledge (GMP, manufacturing, etc.): …………..…………………. - Qualifications: …………………………. - Skills: …………………………………………………… - Experience (manufacturing, manufacturing management): …….. 20 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Knowledge (GMP, testing, etc.): …………..…………………. - Qualifications: …………………………. - Skills: …………………………………………………… - Experience (testing, testing management): …………………………………………………… …………………………………………………… 21 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Line-based (and the respective quantity on each line): - Line A: …………………………………………………… - Line B: …………………………………………………… Step-based (and the respective quantity required for each step): ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Preliminary processing: …………………………………………………….. - Processing: ………………………………………………….. - Shaping: …………………………………………………. - Primary packaging: …………………………………………… - Secondary packaging: …………………………………………… Combined line and step (and the respective quantity): ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Preliminary processing line A: …………………………………………………… - Processing line B: …………………………………………………… 22 Organization and operation of the Quality Control Department [arranged by tests (chemical, physical, physicochemical or microbiological test); by items (materials, packaging, bulk or finished products); by activities (standard establishment/verification, application registration, testing, stability monitoring, production condition verification/assessment, inspection, supervision), etc.] and respective quantity of each unit: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 23 In-process control personnel belonging to: - Quality Control Department (and quantity): …………….. - Or Production Department (and quantity): …………………….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 24 Job description of: - Head of Production Department: …………………………………. - Head of Quality Control Department: …………………… - Head of another department: ……………………… 25 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Group …: …………………………………………………. - Group …: …………………………………………………. 26 Whether all personnel undergo initial and regular health examinations and medical records are sufficiently retained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 27 Whether all personnel receive training in GMP 28 Whether all personnel receive training in SOPs, relevant professional operations and knowledge. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 29 Whether new personnel training procedures are available. 30 Whether the training is provided according to the approved plan, programme and contents. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 31 Whether trainers have knowledge and experience and have provided training in GMP 32 Whether after each training course, results and effectiveness of training are assessed and all training records are retained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. II. Premises and equipment Premises 33 Whether the establishment manufactures products containing sensitizing materials such as penicillins, hormones or live microorganisms or products intended for external use. 34 Whether dedicated facilities are available for the production of these products. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 35 Whether production, testing, storage and ancillary areas are appropriately located and designed. 36 Premises are well maintained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 37 Whether design drawings (general, detailed) are updated. 38 Whether relevant parameters are verified and assessed again after changes are made. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 39 Whether there are adequate toilets, which are well ventilated and separated from other areas, and do not have direct access to production and storage areas. 40 Whether risk or condition that insects or other animals access and harbor is available. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 41 Whether access to relevant areas is restricted to authorized personnel. Production areas 42 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 43 Whether changing rooms are directly connected to but separated from production areas. 44 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 45 Whether production areas provide adequate space for the installation/maintenance/repair of equipment, production operations and easy cleaning. 46 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 47 Whether pipework, light fittings, ventilation points and other facilities shall be appropriately sited to facilitate cleaning. 48 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. - Information about materials for walls/floors/ceilings: ….…/……/….. - Information about filter classes/pressure difference: ………/….…… 49 Whether there is any peeling paint or crack in these areas. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 50 Whether separate spaces are created for cleaning of production equipment to avoid contaminating clean areas. 51 Whether areas where for containers for waste generated during the manufacturing process and waste routes are appropriately defined to avoid contaminating products and clean areas. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 52 Whether wastewater is collected by anti-syphon traps. 53 Whether open channels are shallow enough to facilitate cleaning. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 54 Whether parameters lighting (a), temperature (b), humidity (c) and ventilation (d) are established, assessed and maintained in a manner that is appropriate to steps of each line:
Area/step ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Toilet and changing clothes for the first time ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Weighing natural raw materials and initiating preliminary processing Changing clothes for the second time ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Weighing raw materials and initiating processing ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Shaping and primary packaging Secondary packaging ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh.
55 Whether the abovementioned parameters are monitored with appropriate frequency to maintain to during the production. Clearly specify control measure: ……………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 56 Whether a limit is imposed on the abovementioned parameters and measures to be taken if such limit is exceeded. 57 Whether the measurement of particles in clean zones is carried out after completing the construction of premise and installation of equipment, and are carried out at regular intervals: - Quantity/m3: … (particles ≥ 0.5 µm); … (particles ≥ 5.0 µm) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 58 Whether special requirements are imposed on controlled areas of facilities manufacturing products at risk of generating microorganisms, such as soft pellets, syrups, preparations extracted from herbal ingredients, etc. - Clearly specify control measure: …………………… - Maximum Colony Forming Units per volume of air and/or surface area of equipment: …/ … /……… - Testing frequency: …………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 59 Specify dust control measures taken in production areas or products that may generate dust: ………………………………………… Storage areas 60 Whether there are separate areas for storage of starting materials, packaging materials and finished products, which provide adequate space and are under appropriate temperature and humidity conditions. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 61 Whether there are separate areas for the receipt, quarantine, storage and release in the abovementioned areas. 62 Whether if special storage conditions are required (temperature, humidity or ventilation), these conditions are monitored using calibrated equipment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 63 Whether there are separate areas for isolation and locks for printed packaging materials, materials/rejected products, residues/scrap, recalled/returned products. 64 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 65 Whether there are separate areas for storage of crude natural materials, materials or flammable substances. Testing areas ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether there are laboratories separated from production areas. 67 Whether there are microbiological laboratories, which meet design requirements. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether working rooms are appropriately located and provide sufficient space. Information about rooms and respective area: ……… 69 Whether there are sufficient equipment and utensils that basically meet requirements for testing of materials, products, assessment/monitoring of environment/production conditions and that undergo assessment prior to use. List main analytical equipment: …………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Ancillary areas 70 Whether ancillary areas are separated from production, testing and storage areas. List ancillary areas: …………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether ancillary areas are located and designed in a safe and sanitary manner. Equipment and utensils 72 Whether there is sufficient production equipment appropriate to current production line(s). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 73 Whether such equipment is designed with appropriate power. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 74 Whether auxiliary parts of production equipment such as exhaust pipe of capsule filling machine, static drying chamber, motor/drive, etc. are appropriately covered and cleaned at regular intervals. 75 Whether surface of equipment, utensils, pipes and filters in direct contact with materials and products is made of inert materials that are not additive and permit easy cleaning. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 76 Whether equipment is installed and located in a space wide enough for the operation, cleaning or maintenance. 77 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 78 Whether fixed pipes are installed inclined to avoid the stagnation of rinsing water. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 79 Whether valves intended for closing/opening flow of materials/liquid products are used. If available, specify microbiological contamination control measure: ………… 80 Whether fixed pipework is clearly labeled to indicate the contents and direction of flow. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 81 Whether equipment is evaluated and tested prior to use and periodic maintenance. 82 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 83 Whether defective equipment is removed from production areas or covered to avoid contamination or clearly labeled as unusable in case of failure to move. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Utility system 84 Whether ancillary utility system is designed and installed in a manner that ensures integrity of materials, in-process products and finished products. List current utilities: …………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether maintenance and cleaning programme is designed for each ancillary system and complied with. 86 Whether there are standards and written procedures for the operation of systems, sampling and monitoring. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 87 Whether defined actions are taken to handle the cases in which the standards are not met. Air handling system ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether air handling and supply system satisfies temperature, humidity and ventilation requirements. 89 Whether system diagram is located at locations that permit easy monitoring and handling in case of incidents. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether pipework is clearly labeled to indicate the direction of air flow. 91 Whether exhaust gas is filtered and/or appropriately handled before being released into the environment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the air supply system is periodically fumigated in areas at high risk of causing microbiological contamination to products. 93 Whether pipework is made of materials impermeable to disinfectants. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the ability to filter air is appropriate to the expected cleanliness level and minimize the effect of contamination and cross-contamination on operations. 95 Specify design value, warning/action limits and recording/monitoring frequency corresponding to the parameters: filter class (a), pressure difference before/after intermediate/final filtration (b), pressure difference between rooms/halls in areas which have various cleanliness levels or require various controls (c) number of air exchanges (d), room temperature/humidity (dd) of the following areas: Warehouses storing materials and packaging that only require air ventilation: …… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Warehouses storing materials and packaging that require temperature/humidity control: …. Preliminary processing areas: ……………………………………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Processing and primary packaging areas (open materials/products): ……………………………………………………………….…… Secondary packaging areas and finished product warehouse: ………………….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Microbiological laboratories and sampling areas: ……………… Physicochemical laboratories and sample retention rooms: ………………….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 96 Whether air handling and supply system is verified prior to use, periodic assessment is carried out, records are made and documents are retained. 97 Is HEPA filter installed for air supplied to rooms/areas presenting high risk to materials and products? ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 98 Whether there are appropriate monitoring and control measures for ensuring integrity of HEPA filters. 99 Whether pre or intermediate filters are periodically cleaned or appropriately replaced. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Water treatment system 100 Whether water treatment and supply system is appropriate to its intended use. 101 Whether water used for cleaning and preliminary processing of natural raw materials satisfies standards for domestic water. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 102 Specify sources of domestic water used by plants (well water, drilled well water, tap water, etc.): ……………………… 103 Whether water used for processing (and rinsing equipment and utensils in clean areas) satisfies standard for drinking water or standard for pure water according to Vietnam’s pharmacopoeia. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 104 Specify the technology for treating such kind of water: ……………………… 105 Whether pipework is clearly labeled to indicate the name and direction of flow. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 106 Whether pipework is made of appropriate materials that are not reactive or additive to such an extent that it will affect the quality of water. 107 Specify materials for producing pipes conveying drinking water or pure water used for producing products at high risk of causing microbiological contamination: ………………………. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 108 Whether there are programmes and plans for sampling and water quality inspection. 109 Whether limit on microbiological and physicochemical criteria are imposed and controlled appropriately and effective measures are taken if such limit is exceeded. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Compressed air system 110 Whether the establishment that uses compressed air for production: Whether the establishment uses compressed air for production, which: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. comes into contact with products (extracting, packing, etc.) and/or clean utensils 111 or only supports production (lifting, etc.) and does not come into contact with products. Oil streaks ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Particles Microbiological limit ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. And humidity, when necessary 112 Whether system diagram is located at locations that permit easy monitoring and handling. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 113 Whether compressed air is handled and filtered through appropriate filters. 114 Whether there are compressed air monitoring and assessment programs. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 115 Whether this system has its safety verified as prescribed Water vapour production system 116 Whether the establishment that uses water vapor for production: comes into contact with product surface or surface of processing utensils in contact with products; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. or only supports production (heating, etc.) and does not come into contact with products. 117 Clearly specify water used for creating water vapour: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. For boilers for heating purpose: ……………………………… 118 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 119 Whether pipes are made of properly treated stainless steel. Wastewater treatment system ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether wastewater treatment system is designed, constructed and operated in a manner that is appropriate to the nature of wastewater and waste generated during production and testing. 121 Whether wastewater treatment system is confirmed by the supervisory environment authority. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 122 Whether fire fighting system is intended for plants. 123 Whether there is a relevant regulatory authority’s effective confirmation of operation of the fire fighting system. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Personnel 124 Whether personnel undergo pre-employment medical examination and examination is done periodically. 125 Personnel are trained in personal hygiene. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 126 Provide sufficient soaps, hand dryers/washers for necessary areas. 127 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 128 Whether personnel in clean areas wear clean clothes, shoes/sandals and hats. 129 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 130 Whether protective garments are appropriately collected and washed in sanitary areas. 131 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 132 Whether any personnel suffering illness or open wound is found still engaging in production at stages that may affect product quality. 133 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 134 Whether visitors are given information about personal hygiene and the prescribed protective clothing, and are closely supervised. 135 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Premises 136 Whether there is a pest control programme. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether there are measures/agents for cleaning/killing insects, which exert adverse effects on products. 138 Whether insects or other animals are found accessing or harboring in production, storage or testing areas. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether there are premise cleaning procedures, which define responsibilities, schedules, methods, cleaning agents, utensils, etc. appropriate to each area (clean, controlled or exterior, etc.) and procedures are complied with. 140 Whether any dust is found in production rooms in clean areas under non-operating conditions. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether cleaning intervals are defined to make sure they are not left unused for an excessive amount of time. 142 Whether wastewater collection and treatment system satisfies sanitary requirements or wastewater treatment contract satisfies applicable regulations on environmental protection. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 143 Whether there are separate rooms for cleaning mobile equipment, removable parts and utensils to avoid contaminating cleaned rooms/equipment/utensils. 144 Whether cleaned equipment and utensils are stored in a clean and dry condition. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 145 Whether vacuum or wet cleaning method with lint-free towel/cloth is to be preferred. 146 Whether compressed air and brushes are used in clean areas. Specify control measures if compressed air and brushes are used: ….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 147 Whether quality of compressed air is controlled in clean areas (particles) and compressed air comes into direct contact with foods in clean areas (oil streaks). Clearly specify measures and implementing frequency: …………………… 148 Whether a list of cleaning agents suitable for cleaning premises and equipment is compiled. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 149 Whether water used for cleaning complies with applicable regulations. 150 Whether there are cleaning procedures intended for each type of production equipment, which define responsibilities, cleaning methods, agents, utensils and intervals, etc. and procedures are complied with. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 151 Whether these procedures permit effective cleaning of equipment and toughest stains. Whether records of assessment of cleaning effectiveness of these procedures are retained. 152 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 153 Whether microbiological limits are imposed on the system (pumps, pipes, couplings, filters, valves, hoses, etc.) for distributing water, materials/liquid products. 154 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Materials, additives and food processing aids 155 Whether materials are purchased from approved suppliers. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the standard to be satisfied by suppliers includes the following: Manufacturer’s quality management system; Specifications for materials (appropriate to expected quantity of final products); ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 157 Whether every material container in warehouses is labeled as quarantined, sampled, released or rejected and put in separate areas. 158 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 159 Specify measures for assuring identity of the contents of each material container, including the container from which samples are not taken: ........................................................... 160 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Specify measures: …………………………………… 161 Whether cut labels and loose materials are stored in separate containers with identification labels. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether appropriate control measures are adopted to avoid mix-ups when dispensing or using printed materials (especially those containing the products with the same name but different contents) or batch numbers and expiry dates are assigned upon packing or inkjet printing (especially the additional amount). 163 Whether material containers are cleaned before being transported to a weighing room. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether materials are divided in clean areas and appropriately labeled. 165 Whether any material that is not approved by QA/QC departments or has reached its expiry or retest date is dispensed. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether materials are dispensed using the FEFO or FIFO method. 167 Whether the weighing and dispensation are controlled in an independent manner. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Specify measures for controlling cross-contamination occurring during the processing of weighing, dispensing or collecting samples of materials: ……………………… 169 Whether materials dispensed for each batch are kept together. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the dispensation of additional materials or receipt of residual products is approved by the head of the Production Department or Quality Control Department and operations are carried out in the same manner as materials are initially dispensed. Documentation Whether the establishment has the following basic documents about 171 Personnel and training. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 172 Premises and results of manufacturing environment monitoring and assessment. 173 Production equipment and results of assessment and testing thereof. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 174 Cleaning and cleaning procedure assessment. 175 Materials and supplier assessment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 176 Receipt, storage and dispensation of materials and finished products. 177 Manufacturing and manufacturing process assessment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 178 Quality control 179 Change control ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 180 Product distribution records 181 Complaint handling and product recalls ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 182 Contract manufacture and analysis 183 Environmental safety assurance and fire fighting ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 184 Self-inspection Documentation 185 Whether documentation is prepared, checked/reviewed, approved, dated and signed by appropriate and authorized person. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 186 Whether document is laid out according to standard design(s) and has clear and unambiguous contents. 187 Whether documentation is updated and reviewed and remains effective. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 188 Whether effective dispensation and recall measures are in place to make sure old versions are not used. Clearly specify such measures: …………………………………………………….. 189 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 190 Whether the recording or entry of data is immediately carried out after performing each activity. 191 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 192 Whether any relevant documentation (production and quality control) is retained for at least 01 year after the expiry date of the finished product. 193 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Quality control documents 194 Whether the Quality Control Department has the following basic documents, including but not limited to: Analyst training records. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Water records. Specifications for starting materials. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Specifications for packaging materials. Specifications for finished products. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Records of verification of analysis procedures (if any) and documents about test methods. Procedures for taking samples of raw materials, natural raw materials, packaging materials and intermediate, bulk and finished products. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Records of sampling and results of monitoring/inspection (packaging and some certain types of materials), analysis (intermediate products), testing (materials, bulk products, finished products): Sample collection form, analyst’s book, analysis report, test report, original test report, etc. Procedures for and records of the calibration/inspection of equipment/measuring instruments and analytical equipment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Records of stability monitoring and evaluation of trends in product quality. Specifications Specifications for natural materials 195 Whether the establish uses natural materials. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Specify such natural materials: ……………………… 196 Whether information about natural materials includes: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Origin (cultivation/harvesting area). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Storage condition and expiry date (if any). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 197 Whether there are sufficient procedures for determining each type of natural material. 198 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Pictorial demonstration/description and identification of active ingredient(s) or marker(s) (if any). Assay of active constituent(s) or marker(s) (if any). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Limit tests: - Impurities, fragmentation or foreign materials. - Loss on drying. - Ash content. - Mycotoxins, microfungi. - Heavy metals. - Radioactivity. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Other tests: ……………………………………………… Specifications for other starting materials and packaging materials 199 Whether specifications are established for other starting materials and packaging materials used in plants. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 200 Whether specifications for materials include: Name, code, reference to a pharmacopoeia monograph or other official documents. Name of the manufacturer and supplier. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Reference to sampling procedures. Qualitative requirements and acceptance limits. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Qualitative requirements and acceptance limits. Residual solvents in extracts or finished products. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Storage condition and expiry date or retest date. A specimen of printed materials. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 201 Whether water used for processing complies with applicable regulations. Specifications for intermediate and bulk products 202 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 203 Whether specifications (tests and acceptance limits) established for these products are appropriate to starting materials or respective finished products. Specifications for finished products ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 204 Whether adequate specifications are established for every finished product. 205 Whether specifications established for each finished product include at least: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Formula or a reference to. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Physical appearance. Uniformity in weight or volume. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Qualitative requirements and acceptance limits. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Bacterial contamination limits. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Limits: Heavy metals, residual solvents (if any) Tests specific to each type of dosage form: Dissolution, hardness, friability, viscosity, pH, etc. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Other tests: …………………………………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Reference to sampling procedures and analysis procedures. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Production documents 206 Whether production documents are designed for each dosage form and each packaging specification in accordance with regulations. List current products (for each specification): …………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether each production procedure is evaluated prior to production to ensure suitability and reproducibility of the procedure. 208 Whether documents are up to date and closed managed to make sure ineffective old versions are not used. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Original formula and processing/packaging instructions 209 Whether there are sufficient original formulas and processing instructions for each finished product batch size. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether processing instructions are stated in a clear, sufficient and stepwise manner. 211 Whether adequate information or requirements for each operation or stage are available: Quantity of each material added; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Name of equipment, code, reference to SOP, parameters required (speed, times, etc.); ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Sampling, product quality inspection (tests, reference to test methods), if any; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Theoretical yields of each step…. Batch processing/packaging records 212 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 213 Whether records are prepared according to original formula and processing/packaging instructions, and standard design for each dosage form and pack size. 214 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Justification: …………………………………………………… 215 Whether records are made after carrying out each operation and completed after the end of each step. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether each result of operations carried out or actual value of each batch is recorded in accordance with the original formula and processing/packaging instructions. 217 Whether a batch record states: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Name, code, content, dosage form, product specification, batch size/number and expiry date. Name, code, number/weight, batch number, number of test report/acceptance report of every material dispensed ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Sufficient about starting/ending time and signature of the person carrying out the activities/inspection. Reconciliation between theoretical/actual yields of residual products/scraps and rate % as requested ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Reconciliation (received, used/defective/returned quantities) and specimen of primary packaging, printed materials Results of inspection carried out before/during/after the manufacturing process of each step ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Report on test of finished products prior to release 218 Whether activities performed differently from standard procedure (batch size, quantity, temperature, moisture content, times, etc.) are accepted by the heads of the Production/Quality Control Departments. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether deviations (moisture content, content, weight, quantity, etc.) listed and used when assessing batch records and monitoring quality trend. Standard Operating Procedures (SOPs) and records 220 Whether SOPs are established for routine activities such as personal hygiene, protective garment changing, operation of production equipment, sampling, etc. Number of SOPs (attached to the List): ………………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 221 Whether training in SOPs is provided to relevant personnel. 222 If a SOP is revised, whether the old SOP is discarded and personnel are re-trained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 223 Whether SOPs are available at locations that permit easy reference. 224 Whether a SOP intended for the receipt includes the following basic receipt requirements: Name, code, batch number, number/quantity of materials. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Supplier’s name and manufacturer’s name. Packaging state and storage conditions upon delivery/receipt. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Check information against invoice/delivery note. Date, signature and name of the person who delivers/receives. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 225 Whether materials and finished products are released by taking the following steps: Receipt, control ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Sampling, check, testing ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 226 Whether the following basic requirements are imposed on release of a finished product batch: Review of records and conformity of results of in-process testing. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Finished product results. Production conditions (rooms, equipment). Other activities and deviations (if any). ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Batches are numbered so that: Whether each batch of materials, in-process products and finished products is identified with a specific batch number and same batch numbers will not be repeatedly used. Whether the traceability of any batches, including those containing residual products or reprocessed products is permitted. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the batch number allocation shall be immediately recorded (in blank documents, material dispensation notes, labels, when inkjet printing, etc.), including batch size.
General 228 Whether all activities related to the manufacturing of a batch of finished products are performed according to procedures, documented and made into a batch record. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 229 Whether the receipt of residual or reprocessed products or activities beyond the procedure are accepted by the heads of the Production/Quality Control Departments. 230 Whether the rate % of receipt, maximum retention period and tests if required are determined. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 231 Whether these activities are documented, batches of these products or these products are assigned a separate batch number for the purposes of monitoring and additional testing. 232 Whether different products are manufactured simultaneously or continuously in a room. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 233 Whether cross-contamination or mix-ups may occur upon performing the abovementioned manufacturing operation. Specify control measures, if available: ............................................... ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 234 Whether there is a record of checks, and the results obtained before an operation begins. 235 Whether a check includes: Status of the room (line clearance performed, cleaned, meeting temperature and humidity requirements, etc.); ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Status of equipment (operational, properly connected, cleaned); Patterns, parts, utensils, sieve cloth, mortars and pestles, etc. (proper type, cleaned); ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Materials, products (packaging, labels, physical appearance). 236 Whether all dispensed materials and packaging, and intermediate and bulk products are closely packaged, labeled and stored under appropriate storage conditions. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 237 Whether labels are attached to all packaging or containers, including at least: name, batch number, number/quantity used for batches of finished products. 238 Whether the name and batch number of the product are displayed using signs at each packaging line. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 239 Whether there is a record of the in-process controls, and the results obtained. 240 Whether in-process controls include, but are not limited to: Manufacturing environment monitoring (temperature, humidity, pressure difference, etc.); ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Personal hygiene control and compliance with manufacturing procedures by personnel. Intermediate products (extracts, granules, solutions, etc.): physical appearance, uniformity, moisture content, viscosity, pH, content, etc.; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Tablet: weight and difference, hardness/friability, disintegration, etc.; Soft capsule: weld edge; moisture content, weight/thickness and difference in capsule size, etc.; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Bags, packs, bottles: proper packaging, batch number, expiry dates, closeness, volume and difference, etc. Boxes: proper packaging, batch number, expiry dates, forms, etc.; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 241 Whether tested samples are collected, labeled and transported to a location awaiting for destruction. 242 Whether there is a record of checks, and the results obtained after each manufacturing step. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 243 The checks include, but are not limited to, the following: Integrity of sieve cloth, mortars and pestles, etc. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 244 Whether residual products, scraps or wastes are removed from premises after each production shift and periodically handled or destroyed or handled under a contract and documented. 245 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 246 Whether final yield and theoretical yield of each production stage and the whole manufacturing process are balanced. 247 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 248 Whether finished products are held in quarantine until their final release under appropriate conditions. Cross-contamination prevention ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the establishment conducts an assessment to determine the appearance or likelihood of, but not limited to the following risks of cross-contamination: Samples are taken during the cleaning or when the cleaning has not been performed; Weighing and dispensation are performed during the cleaning or when the cleaning has not been performed; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Rooms, equipment and utensils intended for producing/weighing/taking samples have not been cleaned; Protective garments are intended for more than 1 product; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. The systems for filtering, supplying/capturing air and controlling pressure difference fail to comply with regulations; Shared activities such as in-process controls (rooms, personnel, utensils), corridors, washing rooms, utensil cleaning rooms, rooms for temporary storage of materials awaiting for processing or intermediate or bulk products, etc. are carried out. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 250 Specify cross-contamination prevention or control measures that have been taken: ……………. II. Testing and control of quality of materials, bulk products and finished products and tests conducted by competent establishments 251 Whether there is a Quality Control Department with sufficient personnel and appropriate equipment. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 252 In order to perform basic tasks, including but not limited to: Approve specifications for materials, packaging and in-process products and finished products; Take samples, conducts necessary checks and tests ; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Assess suppliers and consider deciding to accept materials and packaging ; Calibrate and monitoring the calibration/inspection of necessary equipment and utensils ; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Standardize conditions for production, storage, assessment and monitoring ; Assess (verify) manufacturing process ; ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Assess batch records and decide to release finished products ; Monitor the stability of products and study/determine shelf-life thereof when necessary. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 253 Whether the abovementioned activities are performed according to SOPs, procedures or protocol and sufficiently documented. 254 Whether the establishment conducts all basic tests and conducts them on a frequent basis. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 255 Whether a contract analysis is concluded to do any special test. Specify names of the tests and respective laboratories: …… Sampling ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether samples are taken at locations free from contamination or cross-contamination, by designated persons wearing appropriate clothes and maintaining an appropriate degree of personal hygiene, and according to a procedure. 257 Whether different batches (of a material) are considered as separate for sampling. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether samples are sufficient and representative of the number of material and product containers. 259 Whether material and product containers from which samples have been drawn are identified. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether samples are packaged, labeled and stored under appropriate conditions to make sure their status quo is maintained and they are stored for a given period of time. Check/testing 261 Whether methods for testing parameters of every material, bulk product and finished product are assessed at least in terms of their specificity and accuracy. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 262 Whether methods for testing parameters of every finish product are expected to be submitted in the marketing authorization dossier or have been accepted by the licensing authority as prescribed. 263 Whether all testing operations are carried out according to approved methods. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 264 Whether reagents and standard solutions are prepared, labeled and stored as prescribed. 265 Whether results of operations carried out are documented and retained for a given period of time. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Stability monitoring 266 Whether programmes or protocols are designed, samples are taken and retained, and tests are conducted to monitor the stability of products in order to determine their shelf-life. 267 Whether programmes or protocols are designed, samples are taken and retained, and tests are conducted to monitor the stability of products after being sold on the market. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 268 Whether stability protocols are established in accordance with regulations. 269 Whether results of operations carried out are documented, processed and retained. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. III. Contract manufacture and analysis 270 Whether the establishment undertakes contract manufacture. Specify products and respective manufacturing steps: ……… 271 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 272 Whether the establishment undertakes contract analysis. Specify names of the tests conducted under a contract: …… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the Contract Acceptor has its manufacturing competency assessed and is a laboratory acknowledged to carry out the contracted operations correctly. 274 Whether the contract clearly states the way in which the authorized person releasing each batch of product for sale exercises his full responsibility. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Product complaints and returned products 275 Whether there are SOPs for handling product complaints and returned products. 276 Whether persons are designated to be responsible for transferring, considering, assessing and handling cases of product complaints and returned products. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 277 Whether any complaints on adverse product reactions are received. Please specify: ……………………… 278 Whether quality control and assurance departments are assigned to consider products returned from the market due to complaints, defects, expiration or other reasons that may affect product quality. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 279 Whether if the reason for poor quality of a batch is uncovered, whether other relevant batches are considered. 280 Whether products returned from the market and which have left the control of the manufacturer are destroyed unless without doubt (about origin, labeling, storage conditions, etc.) their quality is satisfactory. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 281 Whether the receipt and handling are documented. Please specify: …………………………… Product recalls ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether there is a recall procedure, which describes the scope and degree of recall according to the degree of poor quality and effects on users. 283 A system is available to ensure that the recall is carried out in a fast and effective manner. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Whether the person responsible for recalls is independent of the sales organization and provided with sufficient information about customers. 285 Whether there is a final record, including a reconciliation between the delivered and recovered quantities and measures to be taken. Please specify: ……………………… ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Self-inspection 286 Whether a self-inspection team is established. Specify names and positions of members: ……………… 287 Whether there are self-inspection programmes and plans and items. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 288 Whether self-inspection items includes: Quality management ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Personnel ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Premises Equipment ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Hygiene and sanitation Documentation ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Manufacturing and in-process controls ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Quality control Contract manufacture and analysis ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Complaints and product recalls Self-inspection ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Results of previous self-inspections and remedial actions taken. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Self-inspection is documented. Whether there is a self-inspection report. 290 Whether self-inspection results are considered to take necessary corrective actions. Whether corrective actions are monitored and assessed. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 11.5. Templates for Manufacturing processes, Batch processing/packaging records and List of finished product batch records The following templates are prepared under the guidance specified in Section 5.22 through Section 5.33 so that health supplement manufacturers can reference to when establishing manufacturing processes and prepare batch records. Manufacturers may develop and/or create their own templates but should comply with GMP and other relevant requirements. Manufacturers may develop and/or create their own forms but should comply with GMP and other relevant requirements. 11.5.1. Template for Manufacturing process 1. General information: - Names, codes, concentration/content and dosage forms of products: ………………… - Theoretical yields of a standard batch and package details: ……………………… - Number of procedure/version and date of issue/entry into force: ………………. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. No. Material Code Amount For smallest unit of finished product For a batch of finished products (standard batch size) Amount Unit Amount ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ………..… …... ……… …... ……… …... ……...…(*) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ……… …... ……… …... Total: ……… …... ……… …... ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 3. Specifications (parameters, limits and reference to test methods): - Materials, packaging: ………………………………………………………..………. - Bulk/intermediate products (if any): ………………………………...…. - Finished products: ………………………………………………………………………... 4. List of main equipment (intended for the process): No. Name of equipment Power Note ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ……………………………….. ……………. ……………. … ……………………………….. ……………. ……………. 5. Manufacturing step diagram: ………………………………………………………………………... 6. Detail description of manufacturing steps: ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. No. Requirement 1 Define sufficient/specific requirements/activities that should be executed according to GMP (Sections 5.22 to 5.33), such as: room/equipment check; order of operations and respective requirements such as equipment, reference SOPs, parameters (times, speed), amount of each material, in-process controls, sampling, testing, acceptance limits; packaging, labeling, quarantine, input quotas, etc. … ………………………………………………………………………………….. 6.2. Processing step: ……………………………………………………………. 6.3. Shaping step: ……………………………………………………………. 6.4. Primary packaging step: ……………………………………………………………. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Prepared by (Date, signature and full name) Checked by (Date, signature and full name) Approved by (Date, signature and full name) 11.5.2. Batch processing/packaging records Product code and number of respective manufacturing process: ………. BATCH PROCESSING/PACKAGING RECORDS Batch number: …………… Expiry date: …….… Name, content and dosage form of product: ….…. Batch size and package details: …………….…….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1. Delivery/receipt of materials: No. Name of material Code Amount required Actual amount For smallest unit of finished product For a batch of finished products (standard batch size) Amount ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Number of material batch Number of test report (3) or acceptance report(4) Amount Unit Amount Unit ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 1 A a0 a1 o0 a2 o1 ….. … ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. ….. … B(1) b0 b1 p0 b2 p1 ….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. … ….. … C(2) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. … … ….. Total: z1 q0 z2 q1 ….. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. (1): Any substance that may disappear in the course of preliminary processing or processing; (2): Residual products from previous batch (if any); (3): Test report of the QC Department (4): Acceptance report of the QC or QA Department. (specify date) ……/……/…… Delivered by (Warehouse keeper) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. (Production personnel) Controlled by (IPC personnel) 2. Preliminary processing: Start at: ….. hour, …../…../…. (specify date) No. Requirement Activity 1 ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. Record the results obtained: amount of materials used, actual parameters, testing results, actual yield, etc. and other activities, deviations or unusual events, if any. End at: ….. hour, …../…../…. (specify date) (specify date) ……/……/…… Performed by (Production personnel) Controlled by (Team leader) 3. Processing: ………………………………………………….. 4. Shaping: …………………………………………………. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. 6. Second-level packaging (secondary packaging) : …………………………………………………………. 7. Batch record review (control of residual products/scraps, reconciliation between yields, other activities, incidents, etc.): ………... 11.5.3. Template for List of finished product batch records LIST OF FINISHED PRODUCT BATCH RECORDS Name of product: …………………………………………………………………………… Manufacturing date: …………… Expiry date: ……………….. Start at: ...………………… End at:……………….… This batch record includes: □ 1. Production order and delivery note ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. □ 2.1. Weighing and dispensation of materials □ 2.1.1. Note indicating status of weighing room and related equipment □ 2.1.2. Main material test report (photocopy) □ 2.1.3. Record of material weighing and dispensation □ 2.2. Preliminary processing □ 2.2.1. Note indicating status of preliminary processing room and main production equipment □ 2.2.2. Labels of material(s) dispensed for preliminary processing and weighing note, if available. □ 2.2.3. In-process control note □ 2.2.4. Record of preliminary processing step ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. □ 2.3.1. Note indicating status of processing room(s) and main production equipment □ 2.3.2. Labels of material(s) dispensed for processing and weighing note, if available. □ 2.3.3. Labels of intermediate products awaiting for processing, where applicable □ 2.3.4. In-process control note □ 2.3.5. Record of processing step □ 2.3. Shaping □ 2.4.1. Note indicating status of shaping room(s) and main production equipment □ 2.4.2. Labels of material(s) dispensed for shaping and weighing note, if available. □ 2.4.3. Labels of intermediate products awaiting for shaping, where applicable ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. □ 2.4.5. Record of shaping step □ 3. Packaging step □ 3.1. Primary packaging □ 3.1.1. Note indicating status of primary packaging room(s) and main equipment □ 3.1.2. Labels of bulk products awaiting for primary packaging (where possible) □ 2.2.3. In-process control note □ 3.1.4. Record of primary packaging □ 3.1.5. Specimen of primary packaging printed/assigned batch number and expiry date □ 3.1.6. Note of dispensation/adjustment/reconciliation (received/used/rejected/returned) of primary packaging ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. □ 3.2.1. Note indicating status of packaging room and secondary packaging equipment, if available □ 3.2.2. Labels of bulk products awaiting for secondary packaging (where possible) □ 3.2.3. Record of batch number/expiry date printing and secondary packaging □ 3.2.4. Specimen of secondary packaging printed/assigned batch number or expiry date □ □ Box □ Instructions for use □ Container label (if available) □ 3.2.5. Note of dispensation/adjustment/reconciliation (received/used/rejected/returned) of secondary packaging □ 4. Batch record review □ 4.1. Reconciliation between yield of each step and yield of the whole manufacturing process □ 4.2. Review of other activities executed, deviations or unusual events (if available) ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. □ 4.4. Finished product release order and receipt note. 1 Prelude to the Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Ministry of Health on amendments to and annulment of certain legislative documents on food safety promulgated by the Minister of Health: “The Law on Promulgation of Legislative Documents No. 80/2-015/QH-13 dated June 22, 2015 and the Law dated June 18, 2020 on Amendments to the Law on Promulgation of Legislative Documents No. 63/2020/QH-14; The Law on Food Safety No. 55/2010/QH10 dated June 17, 2010; The Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of Law on Food Safety; The Government's Decree No. 95/2022/ND-CP dated November 15, 2022 on functions, tasks, powers, and organizational structure of the Ministry of Health; At the request of the Director of the Vietnam Food Administration, ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. This Article is amended by Clause 1 Article 3 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023. Articles 9, 10 and 11 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023, stipulate that: Article 9. Terms of reference In case any of the legislative documents referred to in this Circular are amended, supplemented, or replaced, the new documents shall prevail. Article 10. Effect This Circular comes into force as of November 9, 2023. Article 11. Responsibility for implementation The Chief of Ministry Office; Director of the Food Safety Administration; Ministerial Chief Inspector; Heads of units affiliated to the Ministry of Health; Directors of Health Departments of provinces and cities; Heads of food safety authorities under People's Committees of provinces and centrally-affiliated cities; Heads of health agencies of ministries and central authorities and relevant agencies, organizations and individuals shall implement this Circular./. The ordinal number 32nd is repealed as prescribed in point c Clause 2 Article 7 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023. ... ... ... Hãy đăng nhập hoặc đăng ký Thành viên Pro tại đây để xem toàn bộ văn bản tiếng Anh. This section is repealed as prescribed in point c Clause 2 Article 7 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023. This section is repealed as prescribed in point c Clause 2 Article 7 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023. This section is repealed as prescribed in point c Clause 2 Article 7 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023. Title of this section is changed as prescribed in Clause 2 Article 3 of the Circular No. 17/2023/TT-BYT , which has been effective since November 09, 2023. |
