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(Standard Operating Record): 标准操作记录 GEP(Good Engineering Practice):工程设计规范

HVAC(Heating Ventilation and Air Conditioning):空调净化系统 DQ(Design Qualification):设计确认 IQ(Installation Qualification):安装确认

OQ(Operational Qualification):运行确认 PQ(Performance Qualification):性能确认 OOS(Out-Of-Specification):检验不合格;超标 PFDS(Process Flow Diagrams):工艺流程图

MRA(cMutual Reognition Agreements): 现场检查多边认同协议 DMF( Drug Master File):

EDMF(European Drug Master File）欧盟药物主文件

EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局 ORA(Office of Regulatory Affairs):药政事务办公室 GGPs( Good Guidance Practices): 优良指南规范 MOA(Method Of Analysis):分析方法 VMP(Validation Master Plan):验证主计划 VP(Validation Protocol):验证方案

MSDS(Material Safety Data Sheet):物料安全技术说明书 NDA (New Drug Application):新药申请 OTC(Over-the-counter):非处方

INN(International Nonproprietary Name)国际非专有名称 USP(the united state pharmacopeia): 美国药典 NF(National Formulary):(美国)国家药品集

GAP(Good Agricultural Practice):中药材种植管理规范 GCP(Good Clinical Practice):药物临床试验质量管理规范 GLP(Good Laboratory Practice):药物实验室管理规范 GSP(Good Supply Practice):药品经营质量管理规范 GUP(Good Use Practice):药品使用质量管理规范

SM(Starting Material):起始物料

PMF(Plant Master File); SMF(Site Master File):工厂主文件 EDL(List of Essential Drugs ) : 基本药物目录 PI(Package Insert):说明书

PCT( Patent Cooperation Treaty): 专利合作条约

PPAC(Patent Protection Association of China):中国专利保护协会 PIC( Person In Charge) :负责人

PDS(Pharmaceutical Development Services): 整体新药研发机构 SPC(Summary of Product Characteristics):产品特性摘要