GMP常见英文缩写.pdfVIP

GMP 常见英文缩写 AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备 API(Active Pharmaceutical Ingredient):活性药物物质,即原料药 ANDA (Abbreviated New Drug Application):简化新药申请 ADR(Adverse Drug Reaction):不良反应 BSE(Bovine Spongiform Encephalopathy):疯牛病 BPCS(Business Planning and Control System):业务计划及控制系统 BIA(Business impact assessment): 商业影响评估 cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范 CCCD(China Certification Committee for Drugs): 中国药品认证委员会 CIP(Cleaning In Place):在线清洁 CV(Concurrent Validation): 同步验证 CDER( Center for Drug Evaluation and Research): 药品研究与评价中心 COA(Certificate Of Analysis):分析报告单 CFR(Code of Federal Regulation):(美国)联邦法规 CDC(Centers for Disease Control and Prevention):疾病预防控制中心 COS/ CEP( Certificate of Suitability for European Pharmacopeia ):欧洲药典适用性证书 CCD (Certification Committee for Drugs):药品认证管理中心 CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会 CTD(Common Technical Document):通用技术文件 CDC( Centers for Disease Control and Prevention): 疾病预防控制中心 GMP(Good Manufacturing Practice):药品生产质量管理规范 ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use):人用药品注册技术要求国际协调会 EU(European Union):欧洲联盟 EFPIA(European Federation of Pharmaceutical Industries Associations):欧洲制药工业协会 联合会 MHW(Ministry of Health and Welfare,Japan): 日本厚生省 JPMA(Japan Pharmaceutical Manufacturers Association): 日本制药工业协会 FDA(US Food and Drug Adminiistration):美国食品与药品管理局 PRMA(Pharmaceutical Research and Manufacturers of America): 美国药物研究和生产联 合会 WHO(World Health Organization):世界卫生组织 IFPMA(International Federation of Pharmaceutical Manufacturers Associations): 国际制药工业协会联合会 TQC(Total Quality Control),TQM(Total Quality Management): 全面质量管理 PDCA(Plan,Do,Check,Action):计划,执行,检查,处理 QA(Quality Assurance):质量保证 QC (Quality Control):质量控制 QS(Quality System):质量体系 QM(Quality Management): 质量管理 SOP(Standard Operating Procedure): 标准操作规程 SMP(Standard Management Procedure):标准管理程序 SOR(Standar