文档介绍：HowICHQ8,Q9,Q10guidelinesareworkingtogetherthroughouttheproductlifecycleDisclaimerTheinformationwithinthispresentationisbasedontheICHQ-IWGmembersexpertiseandexperience,andrepresentstheviewsoftheICHQ-IWGmembersforthepurposesofatrainingworkshop.©ICH,November2010OutlineWorkshopGoalsandObjectivesICHQ8,Q9&Q10HowtheguidelinesareworkingtogetherthroughouttheproductlifecycleUtilityofICHQ8,Q9&Q10KeymessagesConclusion©ICH,helinkagebetweenQ8,9&10andhowtheguidelinesareworkingtogetherThispresentationisNOTintendedtooutlineregulatoryexpectations(assessmentand/orinspection)Thisworkshopwill:ProvidetrainingontheintegratedimplementationofQ8,Q9andQ10AllowparticipantstoshareimplementationstrategiesandexperiencesSeekparticipants’inputandidentifyimplementationissueandconcerns©ICH,November2010Nov2005&Nov2008November2005June2008ICHQ8,Q9andQ10Highlevelguidances (notprescriptive)Scienceandrisk-basedEncouragessystematicapproachesApplicableoverentireproductlifecycleIntendedtoworktogethertoenhancepharmaceuticalproductquality©ICH,November2010PharmaceuticalDevelopment-Q8(R2)Describesscienceandrisk-basedapproachesforpharmaceuticalproductandmanufacturingprocessdevelopmentIntroducedconceptsofdesignspaceandflexibleregulatoryapproachesIntroducedconceptsofQualitybyDesign(QbD)andprovidedexamplesofQbDdevelopmentapproachesanddesignspace©ICH,November2010Q8(R2)-ExampleQbDApproachQualityTargetProductProfile(QTPP) Determine“potential”criticalqualityattributes(CQAs) LinkrawmaterialattributesandprocessparameterstoCQAsandperformriskassessmentDevelopadesignspace(optionalandnotrequired) Designandimplementacontrolstrategy Manageproductlifecycle,includingcontinualimprovement©ICH,November2010QualityRiskManagement–Q9Describessystematicprocessesfortheassessment,municationandreviewofqualityrisksAppliesoverproductlifecycle:development,manufacturinganddistributionIncludesprinciples,methodologiesandexamplesoftoolsforqualityriskmanagementAssessmentofrisktoqualityshould:BebasedonscientificknowledgeLinktotheprotectionofthepatie