上海cmc培训 building a master plan for pharmaceutical compliance

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1、CompliancebyDesignBuildingaMasterPlanforPharmaceuticalComplianceRichard.Poska@Abbott.comGlobalPharmaceuticalRegulatoryAffairsCMCRequirementsandStrategiesWorkshop29June20101PoskaCbD/CMP062910UltimateRiskofNon-complianceDeath/AEWhenGMPSystemsFail1999KCllabelmix-up2000AlbuterolDose2006,200

2、8GlycerinsubstitutedwithDEG2007Viraceptgenotoxiccontaminant2007Methotrexate/cytarabinecontamination2008Heparinadulterated2009Infantformulamelamineadulteration2009Tylenolcontamination2PoskaCbD/CMP062910PresentationGoalsProposeconceptofapplyingdevelopmentapproachestocomplianceStimulatedis

3、cussiononuniqueapproachwithsupportinginformationUsecase-studiestoexploreapplicationofconceptsExplorefutureopportunities3PoskaCbD/CMP0629101.ConceptLeverageexistingqualityapproachestoenableenhancedcompliance.Specifically:CompliancebyDesign(CbD)BasedonQualitybyDesign(QbD)ComplianceMasterP

4、lan(CMP)BasedonValidationMasterPlans(VMP)4PoskaCbD/CMP0629102a.SupportingInformationGreatachievementsinprocesscontrolPATRapiddevelopmentofmodernconcepts&understandingQbDPharmaceuticalcomplianceismulti-facetedBUT…5PoskaCbD/CMP062910SupportingInformationPeoplediefromnon-complianceGreatac

5、hievementsinprocesscontrolPATRapiddevelopmentofmodernconceptsQbDPharmaceuticalcomplianceismulti-facetedDeathsandadverseeventsstilloccurringPATandQbDdonotaddresscomplianceBusinesspressuresarefinancial&global6PoskaCbD/CMP062910FDAComplianceInitiativesareMulti-faceted7PoskaCbD/CMP062910Opp

6、ortunitiesandThreatsofGlobalizationJanetWoodcockMarch2009OpportunitiesIndustry:costsavings,globalopportunitiesforoutsourcingingredientsRegulators:Sciencebasedregs,collaborationwithindustryandotherregulators,harmonizedstandardsThreatsInabilitytoforecastvulnerabilitiesUnabletoforeseegaps

7、throughoutproductlifecycleRegulators&IndustrycannotinspectqualityinComplacencyinrapidlychangingenvironment8PoskaCbD/CMP062910HastheQualityIconTrippedorFallen:LessonsLearnedfromanAutoGiantIsLEANcompatiblewithquality?Corporategainsvs.developpeopleWhatimpacthascorporate“rightsizi