FDA培训——连续制造的多变量统计过程控制.pdf

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1、PATfortheOn-lineCharacterizationofContinuousManufacturingSystemsThomasO’Connor,Ph.D.OfficeofPharmaceuticalScienceFDA/PQRIConference:InnovationinManufacturingandRegulatoryAssessmentSeptember16th,20141DisclaimerThispresentationreflectstheviewsoftheauthorandshouldnotbeconstruedtor

2、epresentFDA’sviewsorpolicies2ObjectivesandOutline•Objectives–TodelineatewhyPATiscriticalforthemonitoringandcontrolofacontinuousprocess–Toillustratetheroleofprocessmonitoringinthecontrolstrategyforacontinuousprocessandtheadvantagesofmultivariatetools•Outline–RoleofPATforContinuo

3、usManufacturing–ProcessMonitoringandControl–MultivariateStatisticalProcessControl(MSPC)–ConsiderationsfortheImplementationofMSPC–ConcludingRemarks3ProcessAnalyticalTechnology•Processanalyticaltechnology(PAT)is“asystemfordesigning,analyzing,andcontrollingmanufacturingthroughtime

4、lymeasurements(i.e.,duringprocessing)ofcriticalqualityandperformanceattributesofrawandin-processmaterialsandprocesses,withthegoalofensuringfinalproductquality”PATGuidance•PATtools–Multivariatetoolsfordesign,dataacquisition,andanalysis–Processanalyzers–Processcontroltools–Contin

5、uousimprovementandknowledgemanagementtools4AConceptualExampleofControlStrategyinContinuousManufacturingGranulationReceivingFeederBlendingDryingMillingBlendingParticlesizedistributionConcentration&UniformityMoisturecontent(Multi-component)ChemometricmodelAt-lineSurrogateChemical

6、PropertiesFeedFrameDissolution&PhysicalPropertiesTabletPressModelforRawMaterialsCoating(release)Real-TimeOnlineAssayDigitalImagingReleaseTestingChemometricmodelWeight&HardnessRawmaterialcharacterization,processdata,&chemometricmodeloutputsintegratedintoasupervisorycontrolanddat

7、aacquisition(SCADA)system5RoleofPATforContinuousProcesses•NecessaryforProcessMonitoring–Assuredesiredproductqualityisbeingconsistentlymanufactured–Identifynon-conformingmaterial•SupportsRealTimeRelease(RTR)–Evaluatethequalityoffinalproductbasedacombinationofmeasuredmaterialattr

8、ibutesandprocesscontrols,ICHQ8R(2)–RTRfacilitatedbyon-