美国FDA灭菌药品工艺检查1990年药品质量保证..................................................................................................................................3I．背景.........................................................................................................................................3II.施行..........................................................................................................................................4目的..........................................................................................................................................4项目管理指导..........................................................................................................................4III．检查......................................................................................................................................5指导..........................................................................................................................................7样品收集..................................................................................................................................8样品的量..................................................................................................................................8报告..........................................................................................................................................8.Ⅳ分析........................................................................................................................................9分析实验室..............................................................................................................................9分析........................................................................................................................................10V．管制／行政措施......................................................................................................................10Ⅵ．参考文献、附件及项目联系人.............................................................................................12参考文献或帮助....................................................................................................................12附件........................................................................................................................................13VII．主要责任...............................................................................................................................14无菌工艺检查评价指南................................................................................................................14组件的贮存及准备........................................................................................................................14评价系统................................................................................................................................15主要系统和加工过程............................................................................................................16环境监测................................................................................................................................16设施的清洁、消毒...........................................................................................
