GHTF-SG3-N99-10-2004 Process Validation Guidance

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

2、kForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidancetoregulatoryauthoritiesforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopm

3、ent.Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmoniz

4、ationTaskForce.GHTFStudyGroup3-QualityManagementSystemsProcessValidationGuidance–January2004Page2ProcessValidationGuidanceContents0Introduction1Purposeandscope1.1Purpose1.2Scope2Definitions3Processesthatshouldbevalidated3.1Specialprocesses3.2Processvalidationw

5、ithinthequalitymanagementsystem3.3Processvalidationdecision3.4Examples4Statisticalmethodsandtoolsforprocessvalidation5Conductofavalidation5.1Gettingstarted5.2Protocoldevelopment5.3Installationqualification(IQ)5.4Operationalqualification(OQ)5.5Performancequalif

6、ication(PQ)6Maintainingastateofvalidation6.1Monitorandcontrol6.2Changesinprocessand/orproduct6.3Continuedstateofcontrol6.4Examplesofreasonsforrevalidation7Useofhistoricaldatainprocessvalidation8SummaryofactivitiesAnnexesAStatisticalmethodsandtoolsforprocessval

7、idationBExamplevalidationGHTFStudyGroup3-QualityManagementSystemsProcessValidationGuidance–January2004Page30Introduction“QualityManagementSystems–ProcessValidationGuidance”,originallyfinalizedin1999,isbeingrepublishedas“GHTF/SG3/N99-10:2004(Edition2)”afterrevi

8、sionsduetothechangesinISO13485:2003,whichisutilizedinsomeregulatorysystems.TheProcessValidationGuidancehasbeenrevisedinsections0through3.4,Figure1andAnnexB.Therevisionscanbegeneral