ICH要求的质量部分CTD格式介绍

INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINETHECOMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:QUALITY–M4Q(R1)QUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITYCurrentStep4versiondated12September2002ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.M4Q(R1)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005M4QApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.20July2000M4QM4QApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000M4QCurrentStep4versionM4QApprovalbytheSteeringCommitteeofNumberingandSectionHeaderschangesforconsistencydirectlyunderStep4withoutfurtherpublicconsultation.12September2002M4Q(R1)InordertofacilitatetheimplementationoftheM4Qguideline,theICHExpertshavedevelopedaseriesofQ&AswhichcanbedownloadedfromtheICHwebsite:(R1)THECOMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:QUALITYQUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITYICHHARMONISEDTRIPARTITEGUIDELINEHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)TABLEOFCONTENTSMODULE2:COMMONTECHNICALDOCUMENTSUMMARIES................................12.3:QUALITYOVERALLSUMMARY(QOS).......................................................................1INTRODUCTION.........................................................................................................................12.3.SDRUGSUBSTANCE(NAME,MANUFACTURER).....................................................12.3.S.1GeneralInformation(name,manufacturer)....................................................12.3.S.2Manufacture(name,manufacturer).................................................................12.3.S.3Characterisation(name,manufacturer)...........................................................22.3.S.4ControlofDrugSubstance(name,manufacturer)...........................................22.3.S.5ReferenceStandardsorMaterials(name,manufacturer)...............................22.3.S.6ContainerClosureSystem(name,manufacturer)...........................................22.3.S.7Stability(name,manufacturer)........................................................................22.3.PDRUGPRODUCT(NAME,DOSAGEFORM).............................................................32.3.P.1DescriptionandCompositionoftheDrugProduct(name,dosageform).......32.3.P.2PharmaceuticalDevelopment(name,dosageform)........................................32.3.P.3Manufacture(name,dosageform)....................................................................32.3.P.4ControlofExcipients(name,dosageform).......................................................32.3.P.5ControlofDrugProduct(name,dosageform)..................................................32.3.P.6ReferenceStandardsorMaterials(name,dosageform).................................32.3.P.7ContainerClosureSystem(name,dosageform)..............................................32.3.P.8Stability(name,dosageform)...........................................................................32.3.AAPPENDICES....................................................................................................................42.3.A.1FacilitiesandEquipment(name,manufacturer)............................................42.3.A.2AdventitiousAgentsSafetyEvaluation(name,dosageform,manufacturer)..................................................................42.3.A.3Excipients...........................................................................................................42.3.RREGIONALINFORMATION.........................................................................................4iTheCommonTechnicalDocument-QualityMODULE3:QUALITY.....................................................................................................53.1.TABLEOFCONTENTSOFMODULE3..........................................................................53.2.BODYOFDATA...................................................................................................................53.2.SDRUGSUBSTANCE(NAME,MANUFACTURER)....................................................53.2.S.1GeneralInformation(name,manufacturer).....................................................53.2.S.1.1Nomenclature(name,manufacturer)..............................