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1.0INTRODUCTION..................................................11.1PurposeandScope........................................11.2Background...................................................12.0GLOSSARYOFTERMS........................................62.1Acronyms......................................................93.0BUILDINGANDCAPTURINGPROCESSKNOWLEDGE(STAGE1—PROCESSDESIGN)103.1DeliverablesfromStage1ProcessValidation.......................................123.2QualityTargetProductProfile(QTPP)...........123.3CriticalQualityAttributes.............................133.4DefinetheManufacturingProcess..............143.5AnalyticalMethods......................................203.6RiskAssessmentandParameterCriticalityDesignation..................................................203.7ProcessCharacterization.............................233.8ProductCharacterizationTestingPlan..........233.9ControlStrategy...........................................243.10ClinicalManufacturingExperience–BatchRecordsandProductionData.......................253.11ProcessDesignReport.................................263.12ProcessValidationMasterPlan...................263.13Stage1ManufacturingandTechnologyConsiderations.............................................264.0PROCESSQUALIFICATION(STAGE2)...............284.1StrategiesforSystemDesignandQualification.................................................284.1.1EngineeringandDesign..........................294.1.1.1RiskAssessment...............................294.1.2Installation..............................................294.1.3QualificationPlan....................................294.1.3.1TestFunctionsandAcceptanceCriteria...........................304.1.4MaintainingSystemsinaStateofControl......................................304.2ProcessPerformanceQualification.............314.2.1PPQReadiness.......................................314.3DesignStrategyforProcessPerformanceQualification(PPQ).......................................334.3.1UseofPriorKnowledgeandStage1DatatoSupportPPQ...............................334.3.2PPQStudyDesign..................................344.3.2.1NumberofBatches............................354.3.2.2PPQatNormalOperatingConditions.354.3.2.3PPQUsingIndividualUnitOperationStudies..............................................364.3.2.4PPQUsingBracketing,Matrix,andFamilyApproaches....................364.3.2.5BracketingApproach.........................364.3.2.6MatrixApproach..............................364.3.2.7Family(Grouping)Approach..............374.3.2.8ProcessAnalyticalTechnology.........384.3.2.9SamplingStrategy.............................394.3.2.10SettingPPQAcceptanceCriteria....394.4PPQProtocol...............................................404.5PPQReport..................................................424.6TransitiontoContinuedProcessVerification435.0CONTINUEDPROCESSVERIFICATION(STAGE3)..........................................................445.1EstablishingaMonitoringProgram..............445.1.1PurposeandStrategy.............................445.1.2DocumentingtheCPVProgram..............445.1.3LegacyProductsandContinuedProcessVerification..............................................465.1.4DemonstratingContinuedProcessVerification..............................................475.1.5CPVMonitoringPlan...............................485.1.6DataAnalysisandTrending....................485.2IncorporationofFeedbackfromCPVMonitoring............................................495.2.1QualitySystemsandCPV.......................495.3CPVDataReviewandReporting..................506.0PROCESSVALIDATIONENABLINGSYSTEMSANDTECHNOLOGY............................................516.1ApplicationofRiskManagement..................516.1.1RiskManagementinStage1–ProcessDesign.......................................526.1.2RiskManagementinStage2–ProcessQualification..............................536.1.3RiskManagementinStage3–ContinuedProcessVerification...............546.1.4RawMaterialRiskManagementConsiderations.......................................546.2StatisticalAnalysisTools............................556.2.1DesignofExperiments(DoE)..................576.2.2StatisticalProcessControlandProcessCapability................................................596.2.2.1StatisticalProcessControlCharts.....606.2.2.1.1FactorstoConsiderinDesigningaControlChart..................................626.2.2.1.2TypesofControlCharts..................626.2.2.1.3ProcessCapability..........................626.2.3StatisticalAcceptanceSampling.............64TableofContents6.2.4NumberofLotsforStage2ProcessPerformanceQualification(PPQ).............666.3ProcessAnalyticalTechnology(PAT)...........666.3.1SelectionofPATSystem.........................676.3.2ProcessValidationConsiderationsDuringthePATSystemDesignStage.....696.3.2.1RiskAssessment...............................696.3.2.2In-ProcessApplicationandMethodDevelopment........................696.3.3ProcessQualificationConsiderationsforPAT............................696.3.4Continue