ICH-Q3D培训PPT

1PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0Overview1Module0OverviewofTrainingModulesICHQ3DElementalImpuritiesInternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUseDisclaimer:Thispresentationincludestheauthors’viewsonElementalImpuritiestheoryandpractice.Thepresentationdoesnotrepresentofficialguidanceorpolicyofauthoritiesorindustry.2PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0Overview2LegalNoticeThispresentationisprotectedbycopyrightandmaybeused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICH'scopyrightinthepresentationisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthepresentation,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginalpresentation.Anyimpressionthattheadaption,modificationortranslationoftheoriginalpresentationisendorsedorsponsoredbytheICHmustbeavoided.Thepresentationisprovidedasiswithoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginalpresentationbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthepresentation.Theabove-mentionedpermissionsdonotapplytocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeobtainedfromthiscopyrightholder.3PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewPrinciplesfordevelopingtrainingmaterials•IntendedtoprovideclarityonkeyaspectsoftheguidelineinordertofacilitateaharmonizedinterpretationandimplementationbyindustryandregulatorsintheICHandnon-ICHregions•Modularapproach:oOverview(Module0)oModules1-7onkeysafetyandqualitytopicsoModule8:ThreecasestudiesillustratinganapproachtopresentingtheriskassessmentoModule9:FrequentlyAskedQuestions•Elaborateonkeyprinciplesoftheguideline•NotintendedtoprovidetemplatesforaddressingtheQ3Drecommendations.•TrainingmaterialdoesnotprovideadditionalguidancebeyondQ3D34PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewOverviewoftheGuideline•Mainbody,referencesandglossary(pages1-17)•Appendix1:MethodforEstablishingExposureLimits(pages18-20)•Appendix2:EstablishedPermitteddailyexposures(PDEs)forElementalImpuritiesbyoral,parenteralandinhalationroutesofadministration(pages21-22)•Appendix3:IndividualSafetyAssessmentsfor24elements(pages23-67)•Appendix4:IllustrativeExamples(pages68-73)45PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewTableofContents1.Introduction2.Scope3.SafetyAssessmentofPotentialElementalImpurities3.1PrinciplesoftheSafetyAssessment…3.2OtherRoutesofAdministration3.3JustificationforElementalImpurityLevelsHigherthananEstablishedPDE3.4ParenteralProducts4.ElementClassificationModule1Module2Module4:LargeVolumeParenterals6PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewTableofContents5.RiskAssessmentandControlofElementalImpurities6.ControlofElementalImpurities7.ConvertingbetweenPDEsandConcentrationLimits8.SpeciationandotherConsiderations9.AnalyticalProcedures10.LifecycleManagementAppendix1:MethodforEstablishingExposureLimits6Module5Module6Module7Module3:AcceptableexposuresforelementswithoutaPDEModule8:CaseStudiesModule9:FrequentlyAskedQuestions7PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewTrainingModules1.HowtoApplyQ3DConceptstoRoutesofAdministration,notaddressedinQ3D2.JustificationforElementalImpurityLevelsHigherthananEstablishedPDE3.ApplicationofQ3DconceptstodeterminingsafelevelsofelementsnotincludedinQ3D4.LargeVolumeParenterals5.RiskAssessment6.ControlofElementalImpurities7.ConvertingbetweenPDEsandConcentrations8.CaseStudies9.FAQs78PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewTrainingModules1.HowtoApplyQ3DConceptstoRoutesofAdministration,notaddressedinQ3D2.JustificationforElementalImpurityLevelsHigherthananEstablishedPDE3.ApplicationofQ3DconceptstodeterminingsafelevelsofelementsnotincludedinQ3D4.LargeVolumeParenterals5.RiskAssessment6.ControlofElementalImpurities7.ConvertingbetweenPDEsandConcentrations8.CaseStudies9.FAQs8ToxicologyChemistry9PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0OverviewConsolidatedWorkflow910PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0Overview10ControlStrategyWorkflow11PreparedbytheQ3DImplementationWorkingGroupforexampleonly;notanofficialpolicy/guidance©ICH2015Q3Dtrainingmodule0Overview11ControlStrategyWorkflow12PreparedbytheQ3DImplementationWorkingGroupforexample