欧盟GMP中英文对照.docx

1、欧盟GMP中英文对照European Union欧阳光明（2021.03.07）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: QUALITYMANAGEMENT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CHAP

2、TER 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.22Ancillary Areas.22设

3、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.27Specifications for Intermediate and Bulk Products.27Specifications for Finished Products.28Manufacturing Formulae and Pr

4、ocessing Instructions.28Packaging Instructions.30Batch Processing Records.31Batch Packaging Records.32Procedures and Records.33Receipt.34Sampling.34Testing.35Other.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.