基于风险管理模式的项目执行方法和合作理念,在系统验证需求的制药工程中的应用

ISPE-CCPIECHINACONFERENCE2008Nov11-122008BeijingTrack2–GAMP5,(_)ISPE-CCPIECHINACONFERENCE2008WhyisthePharmaceuticalIndustrysomuchregulated?•1941:taintedSulfadrug=300deaths300•1955:Polioscandal=149deaths149•1962:Thalidomidescandal=10000infantdeformities20021•2006_6:=11•2006_6:””=432,11•2006_12:””=,12•2008:Heparincontamination:55death55•2008_10:WandashanCiwujiaInjection:Foodscandals:2008_9:Moredeaths=MoreRegulations=ISPE-CCPIECHINACONFERENCE2008„„„:„:„„ISPE-CCPIECHINACONFERENCE2008EffectsonAutomatedSystemsinPharmaceuticalOperations„Ö„„Ö„„.Leveragesupplierknowledgeanddocumentation!ISPE-CCPIECHINACONFERENCE2008PLCPLCISPE-CCPIECHINACONFERENCE2008„„„„„„Leveragesupplierknowledgeanddocumentation!ISPE-CCPIECHINACONFERENCE2008GMP,GAMP,V-Model,21CFRPart11,etc.21CFRPart11GMPGAMP521CFRPart1121CFRPart11-V------URS,FS,DS,--.-Part11-Part11--.-Part11-ISPE-CCPIECHINACONFERENCE2008GAMP5TraceabilityMatrixVPQPQPPRiskAnalysis21CFRPart11AssessmentDeviationManagementChangeControlURSFATDSFSPQModuleTestingModuleDevelopmentApplicationDevelopmentImplementationVRLifeCycleofAutomatedProductionPlantLifeCycleofAutomationSystemIQSAT-IQOQSAT-OQGAMP4GAMP5ISPE-CCPIECHINACONFERENCE2008GAMP5-Patientsafety,productquality,dataintegrityƒƒ•••()ISPE-CCPIECHINACONFERENCE2008GAMP5MainBody–QualityRiskManagement(QRM)„ICHQ9ISPEQRM„„¾¾¾„,ISPE-CCPIECHINACONFERENCE2008-FDA,Part11,;—;FDA,2003„,“••/••ISPE-CCPIECHINACONFERENCE2008–„?„?„?„?„?„?„¾?¾?ISPE-CCPIECHINACONFERENCE2008–„Q:?„A:.„Q:?„A:„...,„Q:?„A:„Q:?„A:.;.ISPE-CCPIECHINACONFERENCE2008-•/••••••••/ISPE-CCPIECHINACONFERENCE2008-„„„„„&&ISPE-CCPIECHINACONFERENCE2008HighLowMedium211312323LowMediumHighRiskLikelihoodBusinessImpact312HighPriorityLowPriorityLowMediumHighProbabilityofDetectionRiskClassificationActivityWhoWhenISPE-CCPIECHINACONFERENCE2008Vs.(SDLC)SDLC:¾¾¾:¾¾¾¾:¾¾¾¾/¾¾¾SDLC:¾//¾¾¾¾¾ISPE-CCPIECHINACONFERENCE2008Vs.(SDLC)FoodandDrugAdministration(FDA)HACCPHACCPScopeManagementQualityManagementTimeManagementCostManagementHumanResourceManagement/Contractor/ProcurementManagementCommunicationsManagementIntegrationManagementRiskManagementRiskManagementBaselineBuildingaTeamBuildingaProjectBuildingSuccessBuildingSuccessISPE-CCPIECHINACONFERENCE2008Cooperation/ManagementModelbetweenCustomerandSupplierISPE-CCPIECHINACONFERENCE2008RiskAnalysis–Methods:ExamplePM•ThereareseveralmethodsavailableISPE-CCPIECHINACONFERENCE2008RiskAnalysis–Methods:Example•ThereareseveralmethodsavailableISPE-CCPIECHINACONFERENCE2008RiskAnalysis–Methods:ExampleFMEA•ThereareseveralmethodsavailableRiskAnalysisMethod:FMEA(FailureModeandEffectsAnalysis)NoAnalysisAssessment1PotentialFailure/RiskPotentialConsequence(s)(Effect)PotentialCauseProtectiontargetABERPZP:Protectiontargetproductqualityandintegrity/patientsafetylowrisk:1111M:Protectiontargetoperatorprotection1112U:ProtectiontargetenvironmentalsafetyA:Likelihoodmidrisk:3V:ProtectiontargetplantavailabilityB:Consequence2228A:ProtectiontargetyieldE:Detectabilityhighrisk:933327A.1BurstofcartireLossofdriving/trackingstabilityInterruptedtravel-pressuretohigh-materialfatigueM,V1313A.2BrokenexhaustpipeNoiseexposureLostofefficiency-materialfatigueU,A2112A.3.1FuelemptyInterruptedtravel-fueltankemptyV,A3216A.3.2-ignoredwarning2214A.3.3-malfunctionoffuelgauge-fuelhosebroken223122021111:FMEA()///ISPE-CCPIECHINACONFERENCE2008TemplatesGuideline+1x4x10x50x-200xISPE-CCPIECHINACONFERENCE2008ReduceProjectRisk,RealizeQuickExtension,ByusingitsuniqueapproachRiskbasedapproachaddressesthePharmachallengesEfficiency&Flexibility„Optimizedproductionefficiency„Improvedresourceutilization„Reduceddowntime„KPIReal-timeKPIanalysis/Product/ConsumerPreferences„Consistentquality„Fasttime-to-marketQuality&drugSafety„Sustainableregulatorycompliance„Increasedprocessvisibility„IntegratedQuality„ImprovedtraceabilityGlobalMarkets&DistributedProduction„Corporateproductspecificationmanagement„BrandprotectionagainstgenericsCEO/CIOPlantManagerWorkshopDirectorHistorianHDDHistorianHDDModelerModelerUnilabUnilabReportManagerReportManagerStep11Step22Step33Step4:OverallOptimization4:ISPE-CCPIECHINACONFERENCE2008Question?„Equality„Legality„Trust„Investmentforvalueaddedpart„Confidentiality„,Sharing&coordination„---Manager–thebridgeofcooperation„ChangeControl