Process Validation Guidance GHTFSG3N99-102004

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1、ProcessValidationGuidanceGHTF/SG3/N99-10:2004StudyGroup3Introduction¾Purpose&ScopeofSG3/N99¾Whatisprocessvalidation?¾Howareprocessesvalidated?¾Whatprocessesmustbevalidated?¾Howtomaintainstateofvalidation¾RevalidationGHTFSG3Training:TorontoMay14-16,20092SG3/N99SG3/N99--10(Edition2)Quali

2、ty10(Edition2)QualityManagementSystemsManagementSystems--ProcessValidationGuidance.ProcessValidationGuidance.1.1Purpose¾ToassistmanufacturersinunderstandingqualitymanagementsystemrequirementsconcerningprocessvalidationGHTFSG3Training:TorontoMay14-16,20093SG3/N99SG3/N99--10(Edition2)Qua

3、lity10(Edition2)QualityManagementSystemsManagementSystems--ProcessValidationGuidance.ProcessValidationGuidance.1.2Scope¾Applicabletomanufacturing,servicingandinstallationprocessesformedicaldevices¾DoesnotcoververificationofdesignoutputordesignvalidationGHTFSG3Training:TorontoMay14-16,2

4、0094SG3/N99SG3/N99--10(Edition2)Quality10(Edition2)QualityManagementSystemsManagementSystems--ProcessValidationGuidance.ProcessValidationGuidance.2.4ProcessValidation(Definition)¾Establishingbyobjectiveevidencethataprocessconsistentlyproducesaresultorproductmeetingitspredeterminedrequi

5、rements.GHTFSG3Training:TorontoMay14-16,20095SG3/N99SG3/N99--10(Edition2)Quality10(Edition2)QualityManagementSystemsManagementSystems--ProcessValidationGuidance.ProcessValidationGuidance.2.6Verification(Definition)¾Confirmationbyexaminationandprovisionofobjectiveevidencethatthespecifie

6、drequirementshavebeenfulfilled.GHTFSG3Training:TorontoMay14-16,20096SG3/N99SG3/N99--10(Edition2)Quality10(Edition2)QualityManagementSystemsManagementSystems--ProcessValidationGuidance.ProcessValidationGuidance.ThreeElementsofProcessValidationôVerifythatequipmentisinstalledandoperatingp

7、roperly(InstallationQualification-IQ)ôDevelopprocessthatcanproduceproductorresultthatmeetsallspecifications(OperationalQualification-OQ)ôVerifythatprocesscanproduceproductorresultthatmeetsallspecificationsconsistentlyovertime(PerformanceQualification-PQ)GHTFSG3Training:TorontoMay14-1