CTD质量部分中英文指南

INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE人用药物注册技术要求国际协调会议ICHHARMONISEDTRIPARTITEGUIDELINEICH三方协调指南THECOMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:人用药物注册通用技术文件QUALITY质量QUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITY模块2：质量概要模块3：质量HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHICH指导委员会会议ICH进程第4步2000年11月9日该指南建议三方法规处采用ICH(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)2002年9月11-12日华盛顿会议一致通过采用统一编号和标题并在e-CTD中使用ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.该指南已经合格的专家工作组研究并按照ICH程序经法规部协商。进程第4步最终草案已被欧盟、日本和美国采纳iTHECOMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:人用药物注册通用技术文件QUALITY质量QUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITY模块2：质量概要模块3：质量ICHHARMONISEDTRIPARTITEGUIDELINEICH三方协调指南HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)ICH指导委员会会议ICH进程第4步2000年11月9日该指南建议三方法规处采用ICH2002年9月11-12日华盛顿会议一致通过采用统一编号和标题并在e-CTD中使用TheCommonTechnicalDocument-QualityiiTABLEOFCONTENTS目录MODULE2:COMMONTECHNICALDOCUMENTSUMMARIES................................62.3:QUALITYOVERALLSUMMARY(QOS)......................................................................6INTRODUCTION.........................................................................................................................62.3.SDRUGSUBSTANCE(NAME,MANUFACTURER)....................................................62.3.S.1GeneralInformation(name,manufacturer)...........................................62.3.S.2Manufacture(name,manufacturer)......................................................72.3.S.3Characterisation(name,manufacturer)................................................72.3.S.4ControlofDrugSubstance(name,manufacturer).................................82.3.S.5ReferenceStandardsorMaterials(name,manufacturer)......................92.3.S.6ContainerClosureSystem(name,manufacturer).................................92.3.S.7Stability(name,manufacturer).............................................................92.3.PDRUGPRODUCT(NAME,DOSAGEFORM).............................................................92.3.P.1DescriptionandCompositionoftheDrugProduct(name,dosageform)92.3.P.2PharmaceuticalDevelopment(name,dosageform)...............................92.3.P.3Manufacture(name,dosageform).......................................................102.3.P.4ControlofExcipients(name,dosageform)..........................................102.3.P.5ControlofDrugProduct(name,dosageform).....................................102.3.P.6ReferenceStandardsorMaterials(name,dosageform).......................102.3.P.7ContainerClosureSystem(name,dosageform)..................................112.3.P.8Stability(name,dosageform)..............................................................112.3.AAPPENDICES..................................................................................................................122.3.A.1FacilitiesandEquipment(name,manufacturer).................................122.3.A.2AdventitiousAgentsSafetyEvaluation(name,dosageform,manufacturer)....................................................122.3.A.3Excipients...........................................................................................122.3.RREGIONALINFORMATION.......................................................................................12MODULE3:QUALITY...................................................................................................133.1.TABLEOFCONTENTSOFMODULE3........................................................................133.2.BODYOFDATA.................................................................................................................133.2.SDRUGSUBSTANCE(NAME,MANUFACTURER)..................................................133.2.S.1GeneralInformation(name,manufacturer).........................................133.2.S.1.1Nomenclature(name,manufacturer)............................................14TheCommonTechnicalDocument–Qualityiii3.2.S.1.2Structure(name,manufacturer)...................................................153.2.S.1.3GeneralProperties(name,manufacturer).....................................153.2.S.2Manufacture(name,manufacturer)....................................................153.2.S.2.1Manufacturer(s)(name,manufacturer).........................................153.2.S.2.2DescriptionofManufacturingProcessandProcessControls(name,manufacturer)............