M4Q-质量

GuidanceforIndustryM4Q:TheCTD—QualityU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)August2001ICHGuidanceforIndustryM4Q:CTD—QualityAdditionalcopiesareavailablefrom:OfficeofTrainingandCommunicationsDivisionofDrugInformationHFD-2405600FishersLaneRockville,MD20857(Tel)301-827-4573(Internet)::1-888-CBERFAXor301-827-3844Mail:theVoiceInformationSystemat800-835-4709or301-827-1800.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)August2001ICHTABLEOFCONTENTSBACKGROUND...........................................................................................................................2TheCTD.......................................................................................................................................2PreparingandOrganizingtheCTD..............................................................................................2Module4.NonclinicalStudyReports...........................................................................................3OrganizationandFormatoftheICHGuidancesforIndustry......................................................6Numbering....................................................................................................................................6MODULE2QUALITYOVERALLSUMMARY.....................................................................72.3INTRODUCTIONTOTHEQUALITYOVERALLSUMMARY..................................72.3.SDRUGSUBSTANCE[NAME,MANUFACTURER].....................................................72.3.S.1GeneralInformation[name,manufacturer].....................................................................72.3.S.2Manufacture[name,manufacturer].................................................................................72.3.S.3Characterization[name,manufacturer]...........................................................................82.3.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............................................................92.3.P.2PharmaceuticalDevelopment[name,dosageform]...........................................................92.3.P.3Manufacture[name,dosageform].....................................................................................92.3.P.4ControlofExcipients[name,dosageform]......................................................................102.3.P.5ControlofDrugProduct[name,dosageform].................................................................102.3.P.6ReferenceStandardsorMaterials[name,dosageform]..................................................102.3.P.7ContainerClosureSystem[name,dosageform]..............................................................102.3.P.8Stability[name,dosageform]..........................................................................................102.3.AAPPENDICES..................................................................................................................112.3.A.1FacilitiesandEquipment.................................................................................................112.3.A.2.AdventitiousAgentsSafetyEvaluation...........................................................................112.3.A.3NovelExcipients.............................................................................................................112.3.RREGIONALINFORMATION........................................................................................11MODULE3:FORMATOFTHEQUALITYSECTIONOFTHECTD.............................123.1MODULE3TABLEOFCONTENTS...............................................................................133.2BODYOFDATA.................................................................................................................133.2.SDRUGSUBSTANCE[NAME,MANUFACTURER]..................................................133.2.S.1GeneralInformation[name,manufacturer]....................................................................133.2.S.1.1Nomenclature[name,manufacturer].............................................................................133.2.S.1.2Structure[name,manufacturer]....................................................