PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME药品检验公约药品检验合作计划GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I药用产品良好生产规范指南第一部分目录第一章 质量管理............................................................................................................................2第二章人员....................................................................................................................................11第三章 厂房设施..........................................................................................................................17第四章 文件..................................................................................................................................25第五章 生产..................................................................................................................................41第六章质量控制............................................................................................................................53第七章 委托生产与委托检验......................................................................................................62第八章 产品投诉和召回..............................................................................................................66第九章 自检..................................................................................................................................69CHAPTER 1 第一章 质量管理QUALITY MANAGEMENTPRINCIPLE 原则The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the particip...
