GMP文件常见缩写

GMP英语1.ABBREVIATED（NEW）DRUG：简化申请的新药2.AirLock气闸3.ANDA（ABBREVIATEDNEWDRUGAPPLICATION）：简化新药申请4.API(ActivePharmaceuticalIngrediet)原料药又称：活性药物组分5.AuthorizedPerson授权人6.BatchNumber/Lot-Number批号7.BatchNumberingSystem批次编码系统8.BATCHPRODUCTIONRECORDS：生产批号记录9.BATCHPRODUCTION：批量生产；分批生产10.BatchRecords批记录11.Batch/Lot批次12.BulkProduct待包装品13.Calibration校正14.CFR（CODEOFFEDERALREGULATION）：（美国）联邦法规15.Cleanarea净区16.Consignmecnt（Delivery）托销药品17.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）18.FDA（FOODANDDRUGADMINISTRATION）：（美国）食品药品管理局19.HOLDER：DMF持有者20.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）21.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）22.NDA（NEWDRUGAPPLICATION）：新药申请23.OTCDRUG（OVER—THE—COUNTERDRUG）：非处方药24.PANEL：专家小组25.PIC/S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）26.PIC的权威翻译：药品生产检查相互承认公约27.POST-ORPRE-MARKETSURVEILLANCE：销售前或销售后监督28.PRESCRIPTIONDRUG：处方药29.TREATMENTIND：研究中的新药用于治疗GMP文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberState每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicinalProductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganisationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBranch(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EGMAEuropeanGenericsMedicineAssociationELAEstablishedLicenceApplicationEMEAEuropeanMedicinesEvaluationAgencyEMEA（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GLPGoodLaboratoryPracticeGLP药品临床前安全性研究质量管理规范GMPGoodManufacturingPracticeGMP药品生产质量管理规范GSP药品销售管理规范HealthSciencesAuthority(HSA)HSA’sMedicinesAdvisoryCommittee(MAC)IBInvestigatorsBrochureICHInternationalConferenceforHarmonisationIDMCIndependentData-MonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNon-proprietaryNameInternationalConferenceonHarmonisation(ICH)IPCInProcessControlIRBInstitutionalReviewBoardLICENCEHOLDERMAMarketingAuthorisationMAAMarketingAuthorisationApplicationMAA上市申请MAHMarketingAuthorisationHolderMAH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)NSAIDNonSteroidalAntiInflammatoryDrugNTANoticeToApplicantsOOSOutofSpecificationOTCOverTheCounterPAGBProprietaryAssociationofGreatBritainPhEurEuropeanPharmacopoeiaPILPatientInformationLeafletPLProductLicencePOMPrescriptionOnlyMedicinePRODUCTOWNERPSUPeriodicSafetyUpdatesQAQualityAssuranceQCQualityControlRAJRegulatoryAffairsJournalRMSReferenceMemberStateRMS相互认可另一成员国RSDRelativeStandardDeviationRxPrescriptionOnlySAESeriousAdverseEventSMFSiteMasterFileSOPStandardOperatingProcedureSOP（STANDARDOPERATIONPROCEDURE）标准运作程序SPC/SmPCSummaryofProductCharacteristicssummaryofproductcharacteristics(SPC)TherapeuticGoodsAdministration(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BPCBulkpharmaceuticalChemiclls原料药CBERCenterforBiologicsEvaluationResearch生物制品评价与研究中心CFUColonyFormingUnet菌落形成单位DMFDrugMasterFile药品管理档案CDERCemterforDrugEvaluationamdResearch药物评价与研究中心CICorporateIdentity(Image)企业识别（形象）CIPCleaninginPlace在线清洗CSIConsumerSafetyInsepctor消费者安全调查员CLPCleaningLineProcedure在线清洗程序DALDefectActionLevel缺陷作用水平DEADrugEnforcementAdminestration管制药品管理DSDocumentationSystim文件系统FDAFoodandDrugAdministration食品与药品管理局（美国）GATTGeneralAgreemerntonTariffsandTrade关贸总协会GMPGoodManufacturingPracticeGvp药品生质量管理规范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GRPGookRaTAILPractice药品零业质量管理规范GAPGoodAgr