工业界指南--CGMP的质量体系-英文

GuidanceforIndustryQualitySystemsApproachtoPharmaceuticalCGMPRegulationsU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)OfficeofRegulatoryAffairs(ORA)September2006PharmaceuticalCGMPsGuidanceforIndustryQualitySystemsApproachtoPharmaceuticalCGMPRegulationsAdditionalcopiesareavailablefrom:OfficeofTrainingandCommunicationDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573://(Tel)800-835-4709or301-827-1800orCommunicationsStaff,HFV-12CenterforVeterinaryMedicineFoodandDrugAdministration7519StandishPlace,Rockville,MD20855(Tel)301-827-3800(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)OfficeofRegulatoryAffairs(ORA)September2006PharmaceuticalCGMPRegulationsContainsNonbindingRecommendationsTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUNDANDPURPOSE..................................................................................1A.Background....................................................................................................................................1B.GoaloftheGuidance.....................................................................................................................2C.ScopeoftheGuidance...................................................................................................................3D.OrganizationofthisGuidance......................................................................................................4III.CGMPSANDTHECONCEPTSOFMODERNQUALITYSYSTEMS...................4A.Quality.............................................................................................................................................4B.QualitybyDesignandProductDevelopment.............................................................................4C.QualityRiskManagement............................................................................................................5D.CAPA(CorrectiveandPreventiveAction)..................................................................................5E.ChangeControl..............................................................................................................................5F.TheQualityUnit............................................................................................................................5G.Six-systemInspectionModel.........................................................................................................6IV.THEQUALITYSYSTEMSMODEL.............................................................................8A.ManagementResponsibilities.......................................................................................................81.ProvideLeadership..........................................................................................................................82.StructuretheOrganization..............................................................................................................93.BuildYourQualitySystemtoMeetRequirements...........................................................................94.EstablishPolicies,Objectives,andPlans.....................................................................................105.ReviewtheSystem..........................................................................................................................10B.Resources......................................................................................................................................121.GeneralArrangements...................................................................................................................122.PersonnelDevelopment.................................................................................................................133.FacilitiesandEquipment...............................................................................................................134.ControlOutsourcedOperations....................................................................................................14C.Manufacturing.............................................................................................................................151.Design,Develop,andDocumentProductandProcesses..............................................................152.ExamineInputs.............