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1、European Union 药药品生品生产质产质量管理量管理规规范范 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS The rules governing medicinal products in the European Union药品生产质量管理规范药品生产质量管理规范 1 目目 录录 第一章第一章 质质量管理量管理 CHAPTER 1: QUALITY MANAGEMENT 原则 . 5 Principle.5 质量保证. 5 Quality Assurance. 5 药品生产质量管理规范(GMP).7 Goo
2、d Manufacturing Practice for Medicinal Products7 质量控制(QC) .9 Quality Control. .9 产品质量回顾. . 10 第二章人第二章人员员 CHAPTER 2: PERSONNEL 11 原则11 Principle11 通则. 12 General .12 关键人员. 12 Key Personnel.12 培训 12 Training. .15 人员卫生16 Personnel Hygiene.16 第三章厂房和第三章厂房和设备设备 CHAPTER 3: PREMISES AND EQUIPMENT 18 原则18 Pr
3、inciple18 厂房.18 Premises18 通则.18 General18 生产区19 Production Area19 贮存区21 Storage Area.21 The rules governing medicinal products in the European Union药品生产质量管理规范药品生产质量管理规范 2 质量控制区.22 Quality Control Area.22 附助区.22 Ancillary Areas22 设备23 Equipment23 第四章第四章 文件文件 CHAPTER 4: DOCUMENTATION.24 原则24 Principl
4、e.24 通则25 General.25 文件要求.27 Documents Required27 Specifications27 Specifications for starting and packaging materials.27 Specifications for Intermediate and Bulk Products27 Specifications for Finished Products28 Manufacturing Formulae and Processing Instructions.28 Packaging Instructions30 Batch Pr
5、ocessing Records.31 Batch Packaging Records. 32 Procedures and Records .33 Receipt.34 Sampling34 Testing.35 Other35 第五章第五章 生生产产 CHAPTER 5: PRODUCTION. .36 原则 36 Principle.36 通则 36 General.36 生产过程中对交叉污染的预防39 Prevention of Cross-contamination in Production39 The rules governing medicinal products in t
6、he European Union药品生产质量管理规范药品生产质量管理规范 3 验证 40 Validation. 40 原料 41 Starting Materials. 41 生产操作：中间产品和待包装产品42 Processing Operations: Intermediate and Bulk Products42 包装材料 .43 Packaging Materials .43 包装操作 .44 Packaging Operations .44 成品 46 Finished Products. 46 不合格、回收料和退货物料46 Rejected, Recovered and Re
7、turned Materials46 第六章第六章质质量控制量控制 CHAPTER 6: QUALITY CONTROL.48 原则 48 Principle. 48 通则 48 General. 48 质量控制实验室规范49 Good Quality Control Laboratory Practice.49 Documentation49 Sampling. .50 Testing. 52 销售产品的稳定性考察.54 第七章第七章 委托生委托生产产与委托与委托检验检验 CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS55 原则 55 Princip
8、le. 55 通则 56 General. 56 委托方 56 The rules governing medicinal products in the European Union药品生产质量管理规范药品生产质量管理规范 4 The Contract Giver 56 受托方 .57 The Contract Acceptor .57 合同 58 The Contract. .58 第八章第八章 投投诉诉与召回与召回 CHAPTER 8: COMPLAINTS AND PRODUCT RECALL59 原则 59 Principle 59 投诉 59 Complaints 59 召回60
9、Recalls60 第九章自第九章自查查 CHAPTER 9: SELF INSPECTION61 原则.61 Principle61 附件附件8原原辅辅料和包装材料的取料和包装材料的取样样 ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS.63 原则.63 Principle63 人员.63 Personnel.63 原辅料.63 Starting materials.64 包装材料.65 Packaging material.65 The rules governing medicinal products in the Europea
10、n Union药品生产质量管理规范药品生产质量管理规范 5 第一章第一章 质质量管理量管理 CHAPTER 1 QUALITY MANAGEMENT Principle 原则 生产许可证持有厂家只能生产医药产品，以确保药品符合其预期的使用目的， 符合销售许可证的要求，并不因药品安全性、质量或药效方面的问题而给患 者带来风险。达到这一质量目标是高层管理者的责任，同时也需要公司各部 门、各层次的职员以及公司的供应商和销售商的参与并承担义务。为了确保 达到该质量目标，必须全面设计并正确贯彻实施包括 GMP 与质量控制(QC) 在内的质量保证(QA)体系。该体系应用文件明文规定并对其有效性加以监控。
11、质量保证体系的所有部门都必须充分配备胜任的人员，适宜足够的厂房、设 备及设施。与此同时，生产许可证持有者及受权人员具有另外的法律责任。 The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk
12、due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the companys suppliers and by the distribut
13、ors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of the Quality As
14、surance system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s). 1.1.质量保证、GMP 和质量控制的基本概念是内在相互联系的。这里叙述的
15、 主要目的是强调它们之间的关系以及药品生产和控制中的重要性。 1.1.The basic concepts 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 medicinal products. Quali
16、ty Assurance The rules governing medicinal products in the European Union药品生产质量管理规范药品生产质量管理规范 6 质量保证 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 that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outs
