Eu ropean 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 药品生产质量管理规范 1 目 录 第 一章 质量管理 CHAPTER 1: QUALITY MANAGEMENT 原 则 ............................................................ ..................................................... ............ ........................5 Principle.....................................................................................................................................................5 质 量 保 证 ................................................................... .............. .......................................................... 5 Qu ality Assu rance..................................................................................................................................... 5 药 品 生 产质 量 管理规范(GMP).................................................................................................7 Good Manu factu ring Practice for Medicinal Produ cts..............................................................................7 质 量 控制(QC) ...................................................................................................................................9 Qu ality Control....................... ...................................................................................................................9 产品 质 量 回顾....................... ....................... ....................................................................................10 第 二章人员 CHAPTER 2: PERSONNEL...................................................................................... ........11 原 则 ......................................................................................................................................11 Principle........................................
