罗氏-生物产品的生命周期管理.pdf

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1、ProductMonitoring&Post-ApprovalLifecycleManagementofBiotechProductsRonTaticek,Ph.DSr.Director,ProductQualityManagementPharmaTechnicalQualityBiologicsGenentech,SouthSanFrancisco,CAPresentationOutline•Background–Needforintegratedproductqualitymanagement•ProcessMoni

2、toringandDataTrending–Roche/GenentechApproach•Post-ApprovalLifecycleManagement•CommercialProductQualityStewardrole–Productqualityoversightbylinkingsystem,data,andpeopleNeedforIntegratedProductQualityManagementICHQ10PharmaceuticalQualitySystem,ProcessPerformancean

3、dProductQualityMonitoringSystem3.2.1:•Pharmaceuticalcompaniesshouldplanandexecuteasystemforthemonitoringofprocessperformanceandproductqualitytoensureastateofcontrolismaintained.•Usequalityriskmanagementtoestablishthecontrolstrategy.•Providethetools(e.g.,datamanag

4、ementandstatisticaltools)formeasurementandanalysisofparametersandattributesidentifiedinthecontrolstrategy•Verifycontinuedoperationwithinastateofcontrol•Identifysourcesofvariationaffectingprocessperformanceandproductqualityforpotentialcontinualimprovementactivitie

5、s.•IncludefeedbackonproductqualityfrombothinternalandexternalsourcesProductQualityManagementatRoche&Genentech•AnEndtoEndviewofproductqualitythroughouttheproductandprocesslifecycle•Strongscientificrigorandtechnicalexpertiseusedtoevaluateproductperformanceandconsis

6、tencyacrosssites•Afocusoninnovationandcontinualimprovement•Ensuresthesafety,efficacyandpurityofproductsproducedandsuppliedtoourpatientsProductQualityManagement:FundamentalElementsProductComplaints•EarlywarningsignalsofproductqualityissuesinthefieldProductAssessme

7、nt&Trending•ProactiveassessmentofproductqualityattributesacrossthemanufacturingprocessProductQualityStewards•SinglepointofContactforQualitytokeystakeholders•Routinehealthassessmentofproducttoaddresstrends•PlanningprovidesforesightandproactiveapproachQCtestingnetw

8、orksupport•Harmonizedapproachtotestmethodexecution&support•Scalability&flexibilitytobalancetestworkloadacrossnetworkAnalyticalmethodsmanagementScientificrigor