欧盟GMP中英文对照.doc

The rules governing medicinal products in the European Union 药品生产质量管理规范 PAGE PAGE 1 . . WORD.格式整理. . . .专业.知识.分享. . European Union 药品生产质量管理规范 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 目 录 第一章 质量管理 CHAPTER 1: QUALITY MANAGEMENT 原则 5 Principle5 质量保证 5 Quality Assurance 5 药品生产质量管理规范(GMP)7 Good Manufacturing Practice for Medicinal Products7 质量控制(QC) 9 Quality Control 9 产品质量回顾 10 第二章人员 CHAPTER 2: PERSONNEL 11 HYPERLINK \l _To原则11 Principle11 HYPERLINK \l _To通则 12 General 12 关键人员 12 Key Personnel12 培训 12 Training 15 人员卫生16 Personnel Hygiene16 第三章厂房和设备 CHAPTER 3: PREMISES AND EQUIPMENT 18 原则18 Principle18 厂房18 Premises18 通则18 General18 生产区19 Production Area19贮存区21 Storage Area21 质量控制区22 Quality Control Area22 附助区22 Ancillary Areas22 设备23 Equipment23 第四章 文件 CHAPTER 4: DOCUMENTATION24 原则24 Principle24 通则25 General25 文件要求27 Documents Required27 Specifications27 Specifications for starting and packaging materials27 Specifications for Intermediate and Bulk Products27 Specifications for Finished Products28 Manufacturing Formulae and Processing Instructions28 Packaging Instructions30 Batch Processing Records31 Batch Packaging Records. 32 Procedures and Records 33 Receipt34 Sampling34 Testing35 Other35 第五章 生产 CHAPTER 5: PRODUCTION 36 原则 36 Principle36 通则 36 General36 生产过程中对交叉污染的预防39 Prevention of Cross-contamination in Production39 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 Returned Materials46 第六章质量控制 CHAPTER 6: QUALITY CONTROL48 原则 48 Principle 48 通则 48 General... 48 质量控制实验室规范49 Good Quality Control Laboratory Practice49 Documentation49 Sampling 50 Testing... 52 销售产品的稳定性考察54 第七章 委托生产与委托检验 CHAPTER 7: CONTRACT M