GMP英文缩写由刀豆文库小编整理，希望给你工作、学习、生活带来方便，猜你可能喜欢“gmp常见英文缩写”。
1.AQAI(Automated Quality Aurance Inspection Equipment):在线自动质量保证检查设备 2.API(Active Pharmaceutical Ingredient):活性药物物质 即原料药 3.ANDA(Abbreviated New Drug Application):简化新药申请 4.ADR(Adverse Drug Reaction):不良反应
5.BSE(Bovine Spongiform Encephalopathy):疯牛病
6.BPCS(Busine Planning and Control System):业务计划及控制系统 7.BIA(Busine impact aement): 商业影响评估
8.cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范 9.CCCD(China Certification Committee for Drugs):中国药品认证委员会 10.CIP(Cleaning In Place):在线清洁 11.CV(Concurrent Validation):同步验证
12.CDER(Center for Drug Evaluation and Research): 药品研究与评价中心 13.COA(Certificate Of Analysis):分析报告单 14.CFR(Code of Federal Regulation):(美国)联邦法规
15.CDC(Centers for Disease Control and Prevention):疾病预防控制中心
16.COS / CEP(Certificate of Suitability for European Pharmacopeia):欧洲药典适用性证书 17.CCD(Certification Committee for Drugs):药品认证管理中心
18.CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会 19.CTD(Common Technical Document):通用技术文件
20.CDC(Centers for Disease Control and Prevention): 疾病预防控制中心 21.GMP(Good Manufacturing Practice):药品生产质量管理规范 22.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 23.EU(European Union):欧洲联盟
24.EFPIA(European Federation of Pharmaceutical Industries Aociations):
欧洲制药工业协会联合会 25.MHW(Ministry of Health and Welfare,Japan):日本厚生省
26.JPMA(Japan Pharmaceutical Manufacturers Aociation):日本制药工业协会 27.FDA(US Food and Drug Adminiistration):美国食品与药品管理局
28.PRMA(Pharmaceutical Research and Manufacturers of America):美国药物研究和生产联会 29.WHO(World Health Organization):世界卫生组织
30.IFPMA(International Federation of Pharmaceutical Manufacturers Aociations):
国际制药工业协会联合会 31.TQC(Tota lQuality Control),TQM(Total Quality Management): 全面质量管理 32.PDCA(Plan,Do,Check,Action):计划 执行 检查 处理 33.QA(Quality Aurance):质量保证 34.QC(Quality Control):质量控制 35.QS(Quality System):质量体系
36.QM(Quality Management): 质量管理
37.SOP(Standard Operating Procedure): 标准操作规程 38.SMP(Standard Management Procedure):标准管理程序 39.SOR(Standard Operating Record): 标准操作记录 40.GEP(Good Engineering Practice):工程设计规范
41.HVAC(Heating Ventilation and Air Conditioning):空调净化系统 42.DQ(Design Qualification):设计确认 43.IQ(Installation Qualification):安装确认 44.OQ(Operational Qualification):运行确认 45.PQ(Performance Qualification):性能确认
46.OOS(Out-Of-Specification):检验结果偏差，有别于偏差 47.PFDS(Proce Flow Diagrams):工艺流程图
48.MRA(cMutual Reognition Agreements): 现场检查多边认同协议 49.DMF(Drug Master File):药物主文件
50.EDMF(European Drug Master File)欧盟药物主文件
51.EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局 52.ORA(Office of Regulatory Affairs):药政事务办公室 53.GGPs(Good Guidance Practices): 优良指南规范 54.MOA(Method Of Analysis):分析方法 55.VMP(Validation Master Plan):验证主计划 56.VP(Validation Protocol):验证方案
57.MSDS(Material Safety Data Sheet):物料安全技术说明书 58.NDA(New Drug Application):新药申请 59.OTC(Over-the-counter):非处方
60.INN(International Nonproprietary Name):国际非专有名称.61.USP(the united state pharmacopeia): 美国药典 62.NF(National Formulary):(美国)国家药品集
63.GAP(Good Agricultural Practice):中药材种植管理规范 64.GCP(Good Clinical Practice):药物临床试验质量管理规范 65.GLP(Good Laboratory Practice):药物实验室管理规范 66.GSP(Good Supply Practice):药品经营质量管理规范 67.GUP(Good Use Practice):药品使用质量管理规范 68.SM(Starting Material):起始物料
69.PMF(Plant Master File);SMF(Site Master File):工厂主文件 70.EDL(List of Eential Drugs): 基本药物目录 71.PI(Package Insert):说明书
72.PCT(Patent Cooperation Treaty): 专利合作条约
73.PPAC(Patent Protection Aociation of China):中国专利保护协会 74.PIC(Person In Charge):负责人
75.PDS(Pharmaceutical Development Services):整体新药研发机构 76.SPC(Summary of Product Characteristics):产品特性摘要
