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1、QualitySystemRegulationQualitySystemRegulation21CFR82021CFR820BasicIntroductionBasicIntroductionKimberlyA.TrautmanFDA’sMedicalDeviceQualitySystemsExpertOverviewOverviewòBackgroundòDefinitionsòSubsystems•Management•DesignandDevelopmentControls•ProductionandProcessControls•Corre
2、ctiveandPreventiveActionsòResources2BackgroundBackgroundEffectiveJune1,1997,replacingthe1978GMPformedicaldevicesPreambletothe1997regulation-VERYImportantRequirementsarenotprescriptiveProvidesframeworkofbasicrequirementsformanufacturerstofollow3QualityManagementSystemQualityMan
3、agementSystemAmanufacturermustdevelopaQualityManagementSystem(QMS)commensuratewith:•riskpresentedbythedevice•complexityofdeviceandmanufacturingprocesses•sizeandcomplexityoforganization4QualitySystemRegulationQualitySystemRegulation820.3DefinitionsEstablishmeansdefine,document(
4、inwritingorelectronically),andimplement.5QualitySystemRegulationQualitySystemRegulation820.3DefinitionsFinisheddevicemeansanydeviceoraccessorytoanydevicethatissuitableforuseorcapableoffunctioning,whetherornotitispackaged,labeled,orsterilized.6QualitySystemRegulationQualitySyst
5、emRegulation820.3DefinitionsManufacturermeansanypersonwhodesigns,manufactures,fabricates,assembles,orprocessesafinisheddevice.Manufacturerincludesbutisnotlimitedtothosewhoperformthefunctionsofcontractsterilization,installation,relabeling,remanufacturing,repacking,orspecificati
6、ondevelopment,andinitialdistributorsofforeignentitiesperformingthesefunctions.7QualityManagementQualityManagementSubsystemsSubsystemsCorrective&PreventiveActionsProduction&DesignControlsProcessControlsManagementMaterialMaterialEquipment&ControlsFacilityControlsRecords,Records,
7、Documents,ChangeControls8ManagementSubsystemManagementSubsystem820.20ManagementResponsibility820.22QualityAudits820.25Training9820.20Management820.20ManagementResponsibilityResponsibilityQualityPolicy.òMustbeestablishedbymanagementwithexecutiveresponsibility.òMustbeunderstood,
8、implemented,andmaintainedatalllevelsoftheorganization.10820.2
