ICH发布统一的Q8 Q9 Q10培训材料ppt课件

HowICHQ8,Q9,Q10guidelinesareworkingtogetherthroughouttheproductlifecycle,ICH,November2010,Disclaimer,TheinformationwithinthispresentationisbasedontheICHQ-IWGmembersexpertiseandexperience,andrepresentstheviewsoftheICHQ-IWGmembersforthepurposesofatrainingworkshop.,ICH,November2010,Outline,WorkshopGoalsandObjectivesICHQ8,Q9&Q10HowtheguidelinesareworkingtogetherthroughouttheproductlifecycleUtilityofICHQ8,Q9&Q10KeymessagesConclusion,ICH,November2010,WorkshopGoalsandObjectives,ThispresentationisintendedtooutlinethelinkagebetweenQ8,9&10andhowtheguidelinesareworkingtogetherThispresentationisNOTintendedtooutlineregulatoryexpectations(assessmentand/orinspection)Thisworkshopwill:ProvidetrainingontheintegratedimplementationofQ8,Q9andQ10AllowparticipantstoshareimplementationstrategiesandexperiencesSeekparticipantsinputandidentifyimplementationissueandconcerns,ICH,November2010,Nov2005&Nov2008,November2005,June2008,ICHQ8,Q9andQ10,Highlevelguidances(notprescriptive)Scienceandrisk-basedEncouragessystematicapproachesApplicableoverentireproductlifecycleIntendedtoworktogethertoenhancepharmaceuticalproductquality,ICH,November2010,PharmaceuticalDevelopment-Q8(R2),Describesscienceandrisk-basedapproachesforpharmaceuticalproductandmanufacturingprocessdevelopmentIntroducedconceptsofdesignspaceandflexibleregulatoryapproachesIntroducedconceptsofQualitybyDesign(QbD)andprovidedexamplesofQbDdevelopmentapproachesanddesignspace,ICH,November2010,Q8(R2)-ExampleQbDApproach,QualityTargetProductProfile(QTPP)Determine“potential”criticalqualityattributes(CQAs)LinkrawmaterialattributesandprocessparameterstoCQAsandperformriskassessmentDevelopadesignspace(optionalandnotrequired)DesignandimplementacontrolstrategyManageproductlifecycle,includingcontinualimprovement,ICH,November2010,QualityRiskManagementQ9,Describessystematicprocessesfortheassessment,control,communicationandreviewofqualityrisksAppliesoverproductlifecycle:development,manufacturinganddistributionIncludesprinciples,methodologiesandexamplesoftoolsforqualityriskmanagementAssessmentofrisktoqualityshould:BebasedonscientificknowledgeLinktotheprotectionofthepatientExtendoverthelifecycleoftheproduct,ICH,November2010,QualityRiskManagementProcess-Q9,ICH,November2010,PharmaceuticalQualitySystem-Q10,DescribeskeysystemsthatfacilitateestablishmentandmaintenanceofastateofcontrolforprocessperformanceandproductqualityFacilitatescontinualimprovementAppliestodrugsubstanceanddrugproductthroughoutproductlifecycleSoundpharmaceuticaldevelopment(Q8R(2)incombinationwitharobustPQS(Q10)provideopportunitiesforflexibleregulatoryapproaches.RelevantPQSelementsincludesystemsfor:TrackandtrendproductqualityMaintainandupdatemodelsasneededInternallyverifythatprocesschangesaresuccessful,ICH,November2010,PharmaceuticalQualitySystem-Q10,ICH,November2010,ICHQ8,Q9andQ10WorkingTogether,FormulationActivities:QTPPDefinitionPre-FormulationStudiesFormulationScreeningOptimization&Selection,ProcessDevelopmentActivities:ProcessScreeningLabScaleDevelopmentScale-UpStudies,ManufacturingActivities:CommercialScaleManufacturingBatchReleaseContinualVerification&Improvement,Q8PharmaceuticalDevelopment,Q9QualityRiskManagement,Q10PharmaceuticalQualitySystems,ICH,November2010,Howcanthethreeguidelinesworktogether,Thefollowingfourslides(slides14-17)areintendedtoshowhowQ8,Q9,Q10canworktogetheratdifferentstagesoftheproductlifecycleItisimportanttonotethattheyareNOTintendedtoshowcompleteactivitiesateachstageNORtoshowtheexacttiming(stage)forthoseactivities,ICH,November2010,FormulationDevelopmentActivities,ICH,November2010,ProcessDevelopmentActivities,ICH,November2010,TechnologyTransfer,ICH,November2010,CommercialManufacturingActivities,ICH,November2010,TheUtilityofICHQ8,9&10,TheimplementationofQ8,9&10isvaluableforalldrugproducts,pharmaceuticaldevelopmentapproachesandregulatorysystemsNew/innovator,marketed/legacyandgenericsSimpleandcomplexdosageformsSmallmoleculeandbiotechTraditionaldevelopmentandQbDWithinandoutsideICHregionsGoodscientificdevelopment(Q8)incombinationwithQRM(Q9)andPQS(Q10)willimprovedrugqualityandefficiencyofpharmaceuticalmanufacturingQualityisimportantforalldrugproductsthroughoutproductlifecycle(new,legacyandgenerics),ICH,November2010,KeyMessages,ICHQ8,Q9andQ10arelinkedtogethertoprovideasystematic,modernrisk-andscience-basedapproachtopharmaceuticalmanufacturinganddevelopmentComprehensiveimplementationofthethreeguidelinestogetherisessentialtoachieveICHQualityVisionGuidelinesareapplicableoverentireproductlifecycleGuidelinescanbeutilizedbyallstakeholdersIndustryandregulatorsAssessorsandinspectorsareexpectedtoincorporateQRMduringregulatoryprocesses,ICH,November2010,KeyMessages,Traditionaldevelopmentapproaches,asoutlinedinICHQ8(R2)partI,areacceptableEnhancedapproaches(QbD)providehigherassuranceofproductqualityandadditionalopportunitiesformanufacturingefficiencyandflexibilityTheuseofqualityriskmanagementprocess,methodologiesandtools(Q9)isbeneficialregardlessofdevelopmentormanufacturingapproachesusedPharmaceuticalQualitySystems(Q10)appliestodrugsubstanceanddrugproductthroughoutproductlifecycleandprovidetoolstofacilitatescontinualimprovement,ICH,November2010,Conclusions,Workshopmaterials,plenarypresentations,andbreakoutdiscussionswillprovideusefulinformationtofacilitatepharmaceuticaldevelopmentandmanufacturing,andrelatedregulatoryaspectsTrainingmaterialsprovideonlyillustrativeexamplesTrainingmaterialsarenotintendedtoserveastemplatesforpharmaceuticaldevelopment,manufacturing,regulatoryassessmentorinspectionDependingofthepharmaceuticalproduct,otherapproachesmightbeappropriate,ICH,November2010,Conclusions,ThemaingoalofthisworkshopistoprovidetrainingonthecomprehensiveimplementationofQ8,Q9andQ10WorkshopfeedbackwillbeutilizedbyIWGtofurtherimprovetheimplementationfor