process validation guide line

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1、GHTF/SG3/N99-10:2004(Edition2)FINALDOCUMENTTitle:QualityManagementSystems-ProcessValidationGuidanceAuthoringGroup:SG3Endorsedby:TheGlobalHarmonizationTaskForceDate:Edition2-January2004TaisukeHojo,GHTFChairThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avo

2、luntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidancetoregulatoryauthoritiesforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestri

3、ctionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.GHTFStudyGroup3

4、-QualityManagementSystemsProcessValidationGuidance–January2004Page2ProcessValidationGuidanceContents0Introduction1Purposeandscope1.1Purpose1.2Scope2Definitions3Processesthatshouldbevalidated3.1Specialprocesses3.2Processvalidationwithinthequalitymanagementsystem3.3Proces

5、svalidationdecision3.4Examples4Statisticalmethodsandtoolsforprocessvalidation5Conductofavalidation5.1Gettingstarted5.2Protocoldevelopment5.3Installationqualification(IQ)5.4Operationalqualification(OQ)5.5Performancequalification(PQ)6Maintainingastateofvalidation6.1Monito

6、randcontrol6.2Changesinprocessand/orproduct6.3Continuedstateofcontrol6.4Examplesofreasonsforrevalidation7Useofhistoricaldatainprocessvalidation8SummaryofactivitiesAnnexesAStatisticalmethodsandtoolsforprocessvalidationBExamplevalidationGHTFStudyGroup3-QualityManagementSy

7、stemsProcessValidationGuidance–January2004Page30Introduction“QualityManagementSystems–ProcessValidationGuidance”,originallyfinalizedin1999,isbeingrepublishedas“GHTF/SG3/N99-10:2004(Edition2)”afterrevisionsduetothechangesinISO13485:2003,whichisutilizedinsomeregulatorysys

8、tems.TheProcessValidationGuidancehasbeenrevisedinsections0through3.4,Figure1andAnnexB.Therevisionscanbegeneral