2023-GAMP5及计算机化系统验证相关知识课件.pptVIP

GAMP5及计算机化系统验证相关知识GAMP5(Good Automated Manufacturing Practice)良好自动化生产实践指南A Risk Based Approach to Compliant GxP ComputerisedSystem遵从GxP计算机化系统监管的风险管理方法 Different Terminology不同的术语?????Computerised Systems计算机系统Automation Systems自动化系统Control Systems控制系统Control Equipment控制设备Data Management systems 数据管理系统Computerised System: A system including the input of data, electronicprocessing and the output of information to be used either for reporting orautomatic control计算机系统:系统中包括数据输入，电子化处理和用于报告或自控的信息输出SFDA: Good Manufacturing Practice for pharmaceutical products(Draft for comment)SFDA：药品生产质量管理标准〔征求意见稿〕