GMP常見英文縮寫[互聯(lián)網(wǎng)+]

1、GMP常見英文縮寫AQAI(AutomatedQualityAssuranceInspectionEquipment):在線自動質(zhì)量保證檢查設備API(ActivePharmaceuticalIngredient):活性藥物物質(zhì),即原料藥ANDA(AbbreviatedNewDrugApplication):簡化新藥申請ADR(AdverseDrugReaction):不良反應BSE(BovineSpongiformEncephalopathy):瘋牛病BPCS(BusinessPlanningandControlSystem):業(yè)務計劃及控制系統(tǒng)BIA(Businessimpactasses

2、sment):商業(yè)影響評估cGMP(currentGoodManufacturingPractice):現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范CCCD(ChinaCertificationCommitteeforDrugs):中國藥品認證委員會CIP(CleaningInPlace):在線清潔CV(ConcurrentValidation):同步驗證CDER(CenterforDrugEvaluationandResearch):藥品研究與評價中心COA(CertificateOfAnalysis):分析報告單CFR(CodeofFederalRegulation):(美國)聯(lián)邦法規(guī) CDC(Centers

3、forDiseaseControlandPrevention):疾病預防控制中心COS/CEP(CertificateofSuitabilityforEuropeanPharmacopeia):歐洲藥典適用性證書CCD(CertificationCommitteeforDrugs):藥品認證管理中心CPMP(CommitteeforProprietaryMedicinalProducts):歐洲專利藥品委員會CTD(CommonTechnicalDocument):通用技術(shù)文件CDC(CentersforDiseaseControlandPrevention):疾病預防控制中心GMP(Good

4、ManufacturingPractice):藥品生產(chǎn)質(zhì)量管理規(guī)范ICH(InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse):人用藥品注冊技術(shù)要求國際協(xié)調(diào)會EU(EuropeanUnion):歐洲聯(lián)盟EFPIA(EuropeanFederationofPharmaceutical IndustriesAssociations):歐洲制藥工業(yè)協(xié)會聯(lián)合會MHW(MinistryofHealthandWelfare,Japan):日本厚生省J

5、PMA(JapanPharmaceuticalManufacturersAssociation):日本制藥工業(yè)協(xié)會FDA(USFoodandDrugAdminiistration):美國食品與藥品管理局PRMA(PharmaceuticalResearchandManufacturersofAmerica):美國藥物研究和生產(chǎn)聯(lián)合會WHO(WorldHealthOrganization):世界衛(wèi)生組織IFPMA(International Federation of Pharmaceutical ManufacturersAssociations):國際制藥工業(yè)協(xié)會聯(lián)合會TQC(TotalQu

6、alityControl),TQM(TotalQualityManagement):全面質(zhì)量管理PDCA(Plan,Do,Check,Action):計劃,執(zhí)行,檢查,處理QA(QualityAssurance):質(zhì)量保證QC(QualityControl):質(zhì)量控制QS(QualitySystem):質(zhì)量體系QM(QualityManagement):質(zhì)量管理SOP(StandardOperatingProcedure):標準操作規(guī)程SMP(StandardManagementProcedure):標準管理程序SOR(StandardOperatingRecord):標準操作記錄GEP(Go

7、odEngineeringPractice):工程設計規(guī)范HVAC(HeatingVentilationandAirConditioning):空調(diào)凈化系統(tǒng)DQ(DesignQualification):設計確認IQ(InstallationQualification):安裝確認OQ(OperationalQualification):運行確認PQ(PerformanceQualification):性能確認OOS(Out-Of-Specification):檢驗不合格;超標PFDS(ProcessFlowDiagrams):工藝流程圖MRA(cMutualReognitionAgreemen

8、ts):現(xiàn)場檢查多邊認同協(xié)議DMF(DrugMasterFile):EDMF(EuropeanDrugMasterFile）歐盟藥物主文件EDQM（EuropeanDirectorateforQualityMedicines）:歐洲藥品質(zhì)量管理局ORA(OfficeofRegulatoryAffairs):藥政事務辦公室GGPs(GoodGuidancePractices):優(yōu)良指南規(guī)范MOA(MethodOfAnalysis):分析方法VMP(ValidationMasterPlan):驗證主計劃VP(ValidationProtocol):驗證方案MSDS(MaterialSafetyDa

9、taSheet):物料安全技術(shù)說明書NDA(NewDrugApplication):新藥申請OTC(Over-the-counter):非處方INN(InternationalNonproprietaryName)國際非專有名稱USP(theunitedstatepharmacopeia):美國藥典NF(NationalFormulary):(美國)國家藥品集GAP(GoodAgriculturalPractice):中藥材種植管理規(guī)范GCP(GoodClinicalPractice):藥物臨床試驗質(zhì)量管理規(guī)范GLP(GoodLaboratoryPractice):藥物實驗室管理規(guī)范GSP(GoodSupplyPractice):藥品經(jīng)營質(zhì)量管理規(guī)范GUP(GoodUsePractice):藥品使用質(zhì)量管理規(guī)范SM(StartingMaterial):起始物料PMF(PlantMasterFile);SMF(SiteMasterFile):工廠主文件EDL(ListofEssentialDrugs):基本藥物目錄PI(PackageInsert):說明書PCT(PatentCooperationTreaty):專利合作條約PPAC(Patent Protection A