European Union 药品生产质量管理规范 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS The rules governing medicinal products in the European Union 目 药品生产质量管理规范 录 第一章 质量管理 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 Good Manufacturing Practice for Medicinal Products..............................................................................7 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 原则......................................................................................................................................11 Principle..................................................................................................................................11 通则................................................................................................................................... 12 General...................................................................................................................... .............12 关键人员................................................................................................................... ............................12 Key Personnel...........................................................................................................................................12 1 The rules governing medicinal products in the European Union 药品生产质量管理规范 培训.......................................................................................................................................................... 12 Training..................................................................................................................... .............15 人员卫生................................................................................................................................................16 Personnel Hygiene...................................................................................................................................16 第三章厂房和设备 CHAPTER 3: PREMISES AND EQUIPMENT................................................................ ..............18 原则........................................................................................................................................18 Principle....................................................................................................................................18 厂房.........................................................................................................................................18 Premises....................................................................................................................................18 通则.........................................................................................................................................18 General......................................................................................................................................18 生产区....................................................................................................................................19 Production Area........................................................................................................................19 贮存区............................................

doc文档 欧盟GMP中英文对照

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