GMP常见英文缩写

1、.GMP常见英文缩写AQAI(AutomatedQualityAssuranceInspectionEquipment):在线自动质量保证检查设备API(ActivePharmaceuticalIngredient):活性药物物质,即原料药ANDA(AbbreviatedNewDrugApplication):简化新药申请ADR(AdverseDrugReaction):不良反应BSE(BovineSpongiformEncephalopathy):疯牛病BPCS(BusinessPlanningandControlSystem):业务计划及控制系统BIA(Businessimpactasse

2、ssment):商业影响评估cGMP(currentGoodManufacturingPractice):现行药品生产质量管理规范CCCD(ChinaCertificationCommitteeforDrugs):中国药品认证委员会CIP(CleaningInPlace):在线清洁CV(ConcurrentValidation):同步验证CDER(CenterforDrugEvaluationandResearch):药品研究与评价中心COA(CertificateOfAnalysis):分析报告单CFR(CodeofFederalRegulation):(美国)联邦法规 CDC(Center

3、sforDiseaseControlandPrevention):疾病预防控制中心COS/CEP(CertificateofSuitabilityforEuropeanPharmacopeia):欧洲药典适用性证书CCD(CertificationCommitteeforDrugs):药品认证管理中心CPMP(CommitteeforProprietaryMedicinalProducts):欧洲专利药品委员会CTD(CommonTechnicalDocument):通用技术文件CDC(CentersforDiseaseControlandPrevention):疾病预防控制中心GMP(Goo

4、dManufacturingPractice):药品生产质量管理规范ICH(InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse):人用药品注册技术要求国际协调会EU(EuropeanUnion):欧洲联盟EFPIA(EuropeanFederationofPharmaceutical IndustriesAssociations):欧洲制药工业协会联合会MHW(MinistryofHealthandWelfare,Japan):日本厚生省

5、JPMA(JapanPharmaceuticalManufacturersAssociation):日本制药工业协会FDA(USFoodandDrugAdminiistration):美国食品与药品管理局PRMA(PharmaceuticalResearchandManufacturersofAmerica):美国药物研究和生产联合会WHO(WorldHealthOrganization):世界卫生组织IFPMA(International Federation of Pharmaceutical ManufacturersAssociations):国际制药工业协会联合会TQC(TotalQ

6、ualityControl),TQM(TotalQualityManagement):全面质量管理PDCA(Plan,Do,Check,Action):计划,执行,检查,处理QA(QualityAssurance):质量保证QC(QualityControl):质量控制QS(QualitySystem):质量体系QM(QualityManagement):质量管理SOP(StandardOperatingProcedure):标准操作规程SMP(StandardManagementProcedure):标准管理程序SOR(StandardOperatingRecord):标准操作记录GEP(G

7、oodEngineeringPractice):工程设计规范HVAC(HeatingVentilationandAirConditioning):空调净化系统DQ(DesignQualification):设计确认IQ(InstallationQualification):安装确认OQ(OperationalQualification):运行确认PQ(PerformanceQualification):性能确认OOS(Out-Of-Specification):检验不合格;超标PFDS(ProcessFlowDiagrams):工艺流程图MRA(cMutualReognitionAgreeme

8、nts):现场检查多边认同协议DMF(DrugMasterFile):EDMF(EuropeanDrugMasterFile）欧盟药物主文件EDQM（EuropeanDirectorateforQualityMedicines）:欧洲药品质量管理局ORA(OfficeofRegulatoryAffairs):药政事务办公室GGPs(GoodGuidancePractices):优良指南规范MOA(MethodOfAnalysis):分析方法VMP(ValidationMasterPlan):验证主计划VP(ValidationProtocol):验证方案MSDS(MaterialSafetyD

9、ataSheet):物料安全技术说明书NDA(NewDrugApplication):新药申请OTC(Over-the-counter):非处方INN(InternationalNonproprietaryName)国际非专有名称USP(theunitedstatepharmacopeia):美国药典NF(NationalFormulary):(美国)国家药品集GAP(GoodAgriculturalPractice):中药材种植管理规范GCP(GoodClinicalPractice):药物临床试验质量管理规范GLP(GoodLaboratoryPractice):药物实验室管理规范GSP(GoodSupplyPractice):药品经营质量管理规范GUP(GoodUsePractice):药品使用质量管理规范SM(StartingMaterial):起始物料PMF(PlantMasterFile);SMF(SiteMasterFile):工厂主文件EDL(ListofEssentialDrugs):基本药物目录PI(PackageInsert):说明书PCT(PatentCooperationTreaty):专利合作条约PPAC(Patent Protecti