欧盟GMP中英文对照.doc

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1、传播优秀Word版文档 ，希望对您有帮助，可双击去除！European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS75 / 100目 录第一章 质量管理CHAPTER 1: QUALITY MANAGEMENT原则. . . .5Principle.5质量保证. . . 5Quality Assurance. 5药品生产质量管理规范(GMP).7Good Manufacturing Practice for Medicinal Products.7质量控制(QC) .9Quality Co

2、ntrol. .9产品质量回顾. . .10第二章人员CHAPTER 2: PERSONNEL. .11原则.11Principle.11通则. 12General. .12 关键人员. .12Key Personnel.12培训. 12Training. .15人员卫生.16Personnel Hygiene.16 第三章厂房和设备CHAPTER 3: PREMISES AND EQUIPMENT. .18 原则.18Principle.18 厂房.18Premises.18通则.18General.18生产区.19Production Area.19贮存区.21Storage Area.2

3、1 质量控制区.22Quality Control Area.22附助区.22Ancillary Areas.22设备.23Equipment.23 第四章 文件CHAPTER 4: DOCUMENTATION.24原则.24Principle.24 通则.25General.25文件要求.27Documents Required.27Specifications.27Specifications for starting and packaging materials.27 Specifications for Intermediate and Bulk Products.27 Specif

4、ications for Finished Products.28Manufacturing Formulae and Processing Instructions.28Packaging Instructions.30Batch Processing Records.31Batch Packaging Records. .32Procedures and Records. .33 Receipt.34 Sampling.34Testing.35 Other.35 第五章 生产CHAPTER 5: PRODUCTION. . .36 原则. .36Principle.36通则. . 36Ge

5、neral.36生产过程中对交叉污染的预防.39Prevention of Cross-contamination in Production.39 验证. .40Validation. .40 原料. .41Starting Materials. .41 生产操作：中间产品和待包装产品.42Processing Operations: Intermediate and Bulk Products.42包装材料. .43Packaging Materials. .43包装操作. .44Packaging Operations. .44成品. .46Finished Products. .46

6、不合格、回收料和退货物料.46Rejected, Recovered and Returned Materials.46第六章质量控制CHAPTER 6: QUALITY CONTROL.48 原则. .48Principle. .48通则. .48General. .48质量控制实验室规范.49Good Quality Control Laboratory Practice.49Documentation.49Sampling. .50Testing. .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 MANUFACTURE AND ANALYSIS.55 原则. .55Principle. .55 通则. .56General. .56委托方. .56The Contract Giver. .56 受托方. .57The Contract Acceptor. .57合同. .58The Contract. .58第八章 投诉与召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL.59原则. .59Principle. .59投诉. .59Complaints. .59召回.60Recalls.60第九章自查CHAPTER 9: SELF INSPECTION.61原则.