GMP常见英文缩写

1、GMP常见英文缩写AQAI(Automated Quality Assura nee In spection Equipme nt):在线自动质量保证检查设备API (Active Pharmaceuticallngredient):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(BusinessPlanning and Control System)业务计划及控制系统BIA(B

2、us in ess impact assessme nt)商业影响评估cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范CCCD(Chi na Certificate n Committee for Drugs):中国药品认证委员会CIP(Cleaning In Place)在线清洁CV(Co ncurre nt Validatio n):同步验证CDER( Centerfor Drug Evaluation andResearch):药品研究与评价中心COA(Certificate Of Analysis):分析报告单CFR(Code

3、of FederalRegulation):(美国)联邦法规CDC(Ce ntersfor DiseaseCo ntrol a nd Preve ntio n):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(Committeefor Proprietary Medicinal Products):欧洲专利药品委员会CTD(Common Technical Document):

4、通用技术文件CDC( Centersfor Diseasecontrol andPrevention):疾病预防控制中心GMP(Good Manufacturing Practice):药品生产质量管理规范ICH(International ConferenceonHarmonizationof TechnicalRequirementsfor Registration ofPharmaceuticalsfor Human Use):人用药品注册技术要求国际协调会EU(Europea nlln io n):欧洲联盟EFPIA(European Federationof Pharmaceutic

5、al Industries Associations):欧洲儒(J药工业协会联合会MHW(Ministry of Health and Welfare,Japan) H本厚生省JPMA(Japan PharmaceuticalMa nu facturers Associati on)：H本制药工业协会FDA(US FoodandDrug Adminiistration):美国食品与药品管理局PRMA(Pharmaceutical Researchand Manufacturers of America):美国药物研究和生产联 合会WHO(World Health Organization):世

6、界卫生组织IFPMA(lnternational Federation of Pharmaceutical ManufacturersAssociations):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 Assuranee)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(Sta

7、ndardOperat in g Procedure):标准操作规程SMP(Sta ndardMa nageme ntProcedure)标准管理程序SOR(Sta ndardOperat ing Record):标准操作记录GEP(Good Engineering Practice)：X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(lnstallation Qualification):安装确认OQ(Operational Qualification):运行确

8、认PQ(PerformanceQualification):性能确认OOS(Out-Of-Specification):检验不合格；超标PFDS(ProcessFlow Diagrams):工艺流程图MRA(cMutual Reognition Agreements):现场检查多边认同协议DMF( Drug MasterFile):EDMF(European Drug Master File)欧盟药物主文件EDQM(EuropeanDirectoratefor Quality Medicines):欧洲药品质量管理局ORA(Office of Regulatory Affairs):药政事务办

9、公室GGPs(Good Guida nee 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-cou nter):非处方INN( In ternatio nal Non proprietary Name)国际非专有名称USP(theu nited statepharm

10、acopeia):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(GoodSupply 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 ofEssentialDrugs ):基本药物目录PI(Packagel nsert):说明书PCT( PatentCooperation Treaty):专利合作条约PPAC(Paten