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GMP英语词汇翻译学习该文章转载自医学全在线:的全称为:PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,PIC/S(制药检查草案),药品检查协会(PIC/S),也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(ActivePharmaceuticalIngredient)原料药又称:活性药物组分AirLock气闸AuthorizedPerson授权人Batch/Lot批次BatchNumber/Lot-Number批号;BatchNumberingSystem批次编码系统;BatchRecords批记录;BulkProduct待包装品;Calibration校正;Cleanarea洁净区;Consignment(Delivery)托销药品。FDA(FOODANDDRUGADMINISTRATION):(美国)食品药品管理局IND(INVESTIGATIONALNEWDRUG):临床研究申请(指申报阶段,相对于NDA而言);研究中的新药(指新药开发阶段,相对于新药而言,即临床前研究结束)NDA(NEWDRUGAPPLICATION):新药申请ANDA(ABBREVIATEDNEWDRUGAPPLICATION):简化新药申请TREATMENTIND:研究中的新药用于治疗ABBREVIATED(NEW)DRUG:简化申请的新药DMF(DRUGMASTERFILE):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER:DMF持有者CFR(CODEOFFEDERALREGULATION):(美国)联邦法规PANEL:专家小组BATCHPRODUCTION:批量生产;分批生产BATCHPRODUCTIONRECORDS:生产批号记录POST-ORPRE-MARKETSURVEILLANCE:销售前或销售后监督INFORMEDCONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)PRESCRIPTIONDRUG:处方药OTCDRUG(OVER—THE—COUNTERDRUG):非处方药GMP文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberStateCMS每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicinalProductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganizationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBranch(DR,ProductEvaluation&RegistrationDivision,CPAEDQM(EuropeanDirectoratefortheQualityofMedicines)欧洲联盟药品质量指导委员会EEA欧洲经济地区EGMAEuropeanGenericsMedicineAssociationELAEstablishedLicenseApplicationEMEAEuropeanMedicinesEvaluationAgencyEMEA(EuropeanAgencyfortheEvaluationofMedicinalProducts)欧洲联盟药品评价机构EPEuropeanPharmacopoeiaEPAREuropeanPublicAssessmentReportsESRAEuropeanSocietyofRegulatoryAffairsEuropeanPharmacopoeiaCommission欧洲药典委员会FDAFDAFoodandDrugAdministrationFinalEvaluationReport(FER)FreeSaleCertificates(FSCs)GCPGoodClinicalPracticeGCP药品临床研究管理规范医学全在线(HSA)HSA’sMedicinesAdvisoryCommittee(MAC)IBInvestigatorsBrochureICHInternationalConferenceforHarmonizationIDMCIndependentData-MonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNon-proprietaryNameInternationalConferenceonHarmonization(ICH)IPCInProcessControlIRBInstitutionalReviewBoardLICENCEHOLDERMAMarketingAuthorizationMAAMarketingAuthorizationApplicationMAA上市申请MAHMarketingAuthorizationHolderMAH销售许可持有者MCAMedicinesControlAgencyMHWMinistryofHealthandWelfare(Japan)MRMutualRecognitionMRA美国与欧盟的互认协议MRAs(MutualRecognitionAgreements)互相認證同意MRFGMutualRecognitionFacilitationGroupMRPMutualRecognitionProcedureNASNewActiveSubstanceNCENewChemicalEntityNDANewDrugApplicationNewChemicalEntities(NCEs)NewDrugApplications(NDAs)NSAIDNonSteroidalAntiInflammatoryDrugNTANoticeToApplicantsOOSOutofSpecificationOTCOvertheCounterPAGBProprietaryAssociationofGreatBritainPhEurEuropeanPharmacopoeiaPILPatientInformationLeafletPLProductLicensePOMPrescriptionOnlyMedicinePRODUCTOWNERPSUPeriodicSafetyUpdatesQAQualityAssuranceQCQualityControlRAJRegulatoryAffairsJournalRMSReferenceMemberStateRMS相互认可另一成员国RSDRelativeStandardDeviationRxPrescriptionOnlySAESeriousAdverseEventSMFSiteMasterFileSOPStandardOperatingProcedureSOP(STANDARDOPERATIONPROCEDURE)标准运作程序SPCSummaryofProductCharacteristicsTherapeuticGoodsAdministration(TGA)USPUSPharmacopoeiaVMFVeterinaryMasterFileVPCVeterinaryProductsCommitteeA.A.AAdditionandAmendments增补和修订ACAirConditioner空调器ADRAdverseDrugReaction药物不良反应AFDOAssociationofFoodandDrugOfficials食品与药品官员协会(美国)ACCAccept接受AQLAcceptableQualityLevel合格质量标准ADNAAbbreviatedNewDrugApplication简化的新药申请BOMBillofMaterial物料清单BPCBulkpharmaceuticalChemicals原料药CBERCenterforBiologicsEvaluationResearch生物制品评价与研究中心CFUColonyFormingUnit菌落形成单位DMFDrugMasterFile药品管理档案CDERCenterforDrugEvaluationandResearch药物评价与研究中心CICorporateIdentity(Image)企业识别(形象)CIPCleaninginPlace在线清洗CSIConsumerSafetyInspector消费者安全调查员CLPCleaningLineProcedure在线清洗程序DALDefectActionLevel缺陷作用水平DEADrugEnforcementAdministration管制药品管理DSDocumentationSystem文件系统FDAFoodandDrugAdministration食品与药品管理局(美国)GATTGeneralAgreementonTariffsandTrade关贸总协会GMPGoodManufacturingPractice药品生产质量管理规范GCPGoodClinicalPractice药品临床实验管理规范GLPGoodLaboratoryPractice实验室管理规范GSPGoodSupplyPractice药品商业质量规范GRPGoodRetailPractice药品零售业质量管理规范GAPGoodAgriculturePractice药材生产管理规范GVPG
本文标题:GMP英语词汇翻译学习
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