QbD implementation in Generic Industry-Overview and Case-Study.pdf

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1、QbDimplementationinGenericIndustry:IFPACOverviewandCase-StudyJAN2013R&DInnaInnaBenBen-AnatAnatQbDStrategyLeaderTevaPharmaceuticals,QbDStrategyLeader,TevaPharmaceuticalsThreeCoreComponentsofQbDandGenericIndustry:HowDoTheyOverlapQualitybyDesignGeneri

2、cIndustry1.Clearldfiilydefiningthiheintendddedpurposeof1.RRdieproduciblblyMMakkii“ng“AAddrugprodtductthefuturedevelopedproductanddesignthatiscomparabletobrand/referencethisproducttofititspurposelisteddrugproductindosageform,nisclearstrengthrouteofadmin

3、istrationqualityostrength,routeofadministration,quality2.Understandingwhatattributesofthisandperformancecharacteristics,andproductarecriticalsoit(product)willkeepintendeduse"servinggpitsintendedpurpposeheconnectiT2.Providinguninterruptedsupplyofhigh3.E

4、nhancedunderstanding‘what’impactingqualityandaffordablemedicationtoourthecriticalqualityattributesand‘how’patients(materials,process,packagingetc);definecontrolstrategiessothattheintended3.EfficiencyandSpeedpurposeoftheproductwillreproduciblymaitiititi

5、tintainitsintegrityQbDforGenerics:FindingtherightbalancebetweenSpeed,EfficiencyandExcellenceOverviewofQbD(GPhA,May2012)QbDGuideforGenerics:Step1-ProductDesignRLDCharacterizationQualityTargetProductProfileCriticalQualityAttributesCriticalQualit

6、yAttributesGPhA/FDACMCWorkshop,May2012QbDGuideforGenerics:Step2-WhatarethepotentialRisksRiskAssessmentDefinestheDevelopmentStrategyWhataretheRisks?...APIExcipientsFormulationandProcessHowdowestayefficientEquipmentEffectivePriorKnowledgeutilizati

7、onTestingandmanagementPackagingGenericIndustryhasalotofGenericIndustryhasalotof…informationandin-houseknowledgeavailableDatabasesofpreDatabasesofpre-createdIshikawadiagramsinordertoharmonizeandstreamlinetheRiskAssessmentprocessHistoricaldata-mini

8、ngHistoricalDataMining:DrugLayeringofPelletsExampleExample:Previouslydevelopedproduct,multiplybatchesareavailableforDataMining:In-ProcessPelletsAssayvs.FinesCorrelationBasedonthefoundrelationshipAssayBasedonthefoundrelationship,Assayd