欧盟GMP中英文对照.docx

1、欧盟GMP中英文对照European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS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 Control. .9产品质量回顾. . .10第二章人员C

2、HAPTER 2: PERSONNEL. .11Principle.11General. .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.21 质量控制区.22Quality Control Area.22附助区.22

3、Ancillary 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 Specifications for Finished Products.28Manufa

4、cturing 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. . 36General.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. .