ICH发布统一的Q8 Q9 Q10培训材料

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 Q9andQ10AllowparticipantstoshareimplementationstrategiesandexperiencesSeekparticipants inputandidentifyimplementationissueandconcerns 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 QualityRiskManagement Q9 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 Q9andQ10WorkshopfeedbackwillbeutilizedbyIWGtofurtherimprovetheimplementationforth