fda.IQ,OQ,PQ工艺验证指南

:2004(Edition2)FINALDOCUMENTTitle:QualityManagementSystems-ProcessValidationGuidanceAuthoringGroup:SG3Endorsedby:TheGlobalHarmonizationTaskForceDate:Edition2-January2004TaisukeHojo,GHTFChairThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidancetoregulatoryauthoritiesforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.–January2004Page2ProcessValidationGuidanceContents0Introduction1Purposeandscope1.1Purpose1.2Scope2Definitions3Processesthatshouldbevalidated3.1Specialprocesses3.2Processvalidationwithinthequalitymanagementsystem3.3Processvalidationdecision3.4Examples4Statisticalmethodsandtoolsforprocessvalidation5Conductofavalidation5.1Gettingstarted5.2Protocoldevelopment5.3Installationqualification(IQ)5.4Operationalqualification(OQ)5.5Performancequalification(PQ)6Maintainingastateofvalidation6.1Monitorandcontrol6.2Changesinprocessand/orproduct6.3Continuedstateofcontrol6.4Examplesofreasonsforrevalidation7Useofhistoricaldatainprocessvalidation8SummaryofactivitiesAnnexesAStatisticalmethodsandtoolsforprocessvalidationBExamplevalidation–January2004Page30Introduction“QualityManagementSystems–ProcessValidationGuidance”,originallyfinalizedin1999,isbeingrepublishedas“GHTF/SG3/N99-10:2004(Edition2)”afterrevisionsduetothechangesinISO13485:2003,whichisutilizedinsomeregulatorysystems.TheProcessValidationGuidancehasbeenrevisedinsections0through3.4,Figure1andAnnexB.Therevisionscanbegeneralizedintwocategories:1.)EditorialrevisionofterminologytobeconsistentwithISO13485:2003(i.e.,“qualitysystem”to“qualitymanagementsystem”and“designcontrols”to“designanddevelopmentcontrols”),and;2.)ChangestoFigure1andthecorrespondingtexttoreflectthenewprocessvalidationrequirementsfoundinclause7.5.2ofISO13485:2003.Thisprocessvalidationguidanceisintendedtoassistmanufacturersinunderstandingqualitymanagementsystemrequirementsconcerningprocessvalidationandhasgeneralapplicabilitytomanufacturing(includingservicingandinstallation)processesformedicaldevices.Theguidanceprovidesgeneralsuggestionsonwaysmanufacturersmayprepareforandcarryoutprocessvalidations.Processvalidationisatermusedinthemedicaldeviceindustrytoindicatethataprocesshasbeensubjecttosuchscrutinythattheresultoftheprocess(aproduct,aserviceorotheroutcome)canbepracticallyguaranteed.Thisisvitallyimportantifthepredeterminedrequirementsoftheproductcanonlybeassuredbydestructivetesting.Processingdeficienciesmayonlybecomeapparentafteranintermediatecomponentisfurtherprocessedorthefinishedproductisinuse.Validationofaprocessentailsdemonstratingthat,whenaprocessisoperatedwithinspecifiedlimits,itwillconsistentlyproduceproductcomplyingwithpredetermined(designanddevelopment)requirements.Themedicaldeviceindustryencompassesawiderangeoftechnologiesandapplications,rangingfromsimplehandtoolstocomplexcomputer-controlledsurgicalmachines,fromimplantablescrewstoartificialorgans,fromblood-glucoseteststripstodiagnosticimagingsystemsandlaboratorytestequipment.Thesedevicesaremanufacturedbycompaniesofvariedsize,structure,volumeofproduction,manufacturingprocessesandmanagementmethods.Thesefactors,especiallyproductionvolumeandnumberofmanufacturingstepsperunit(e.g.solderingorweldingsteps)significantlyinfluencehowprocessvalidationisactuallyapplied.Giventhisdiversity,thisguidancedoesnotsuggestparticularmethodsofimplementation,andtherefore,mustnotbeusedtoassesscompliancewithqualitymanagementsystemrequirements.Rathertheintentistoexpandonqualitymanagementsystemrequirementswithpracticalexplanationsandexamplesofprocessvalidationprinciples.Manufacturerscanandshouldseekout/selecttechnology-specificguidanceonapplyingprocessvalidationtotheirparticularsituation.Thisguidanceprovidesgeneralsuggestionsonwaysmanufacturersmayprepareforandcarryoutprocessvalidations.Otherwaysmaybeequallyacceptable;someregulatoryrequirementsplacetheresponsibilityonthemanufacturertospecifythoseprocesseswhichrequirevalidationandthequalificationofpersonnelwhooperatevalidatedprocesses.Regardlessofthemethodusedtovalidatetheprocess,recordsofallvalidationsactivitiesshouldbekeptandthefinaloutcomedocumented.Whilethecompletionofprocessvalidationisaregulatoryrequirement,amanufacturermaydecidetovalidateaprocesstoimproveoverallquality,eliminatescrap,reducecosts,improvecustomersatisfaction,orotherreasons.Coupledwithproperlycontrolleddesignanddevelopmentactivities;avalidatedprocessmaywellresultinareduc