简称 URS SOP GMP cGMP UPS HSE ICH Q7 PIC/S FDA CFR FRA IQ OQ PQ
全称 User Requirement Specification 用户需求标准 Standard Operating Procedure 标准操作规程 Good Manufacture Practice 药品生产质量管理规范 current Good Manufacture Practice 现行药品生产质量管理规范 uninterrupted power supply 不间断电力供应 health, safety, environment 健康、安全、环保 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 人用药物注册技术要求国际协调会议 GMP Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Cooperation Scheme药品生产检查相互承认公约/药品生产检查合作计划 Food and Drug Administration (美国)食品药品管理局 Code of Federal Regulation (美国)联邦法规 Functional Risk Assessment 功能风险分析 Installation Qualification 安装确认 Operation Qualification 运行确认 Performance Qualification 性能确认
