制药企业过程自控系统GMP验证探讨

Extention8220062B10030492(2006)01008202TP273GMPDiscussionabouttheGMPValidationofProcessAutomationSysteminPharmaceuticalCorporation31250020051018GMP21CFRPart11V-ModelV-ModelCSVPAS21CFRPart11Abstract:ThispaperintroducestheextentrelatingtothecomputerizedsystemvalidationoftheGMPplantinpharmaceuticalcorporation,providestheconditionsoftherelevantassessmentfor21CFRPart11,analysestheapplicationofthenewvalidationmodelnamed¡¯V-Model¡¯duringvalidation,anddescribesthedetailedprocessandthespecificrequirementsofthecriticalvalidationactivities.Keywords:V-Model;CSV;PAS;21CFRPart111PASProcessAutomationSystemCSVComputerizedSystemValidationFDAEUTGAFDACSVCSVFDAISPECSVPASFDA21CFRPart11LifeCycleModelV-ModelPAS2CSVGMPGMPValidationQualificationFDAGxPsGCPGLPGMPFDAGxPPASQAGxPHighLevelGxPRiskAssessmentFRAFunctionalRiskAssessment19978FDA21CFRPart11DCSPLC1975GMPExtention832006221CFRPart11Part1121CFRPart11FDATGA1CSV-V-Model3V-ModelGAMP4PLC//PCPLCSCADASupervisoryControlandDataAcquisitionDCSBMSSLC1V-Model1V-ModelV4PAS2URSUserRe-quirementsSpecificationURSPQOQFRAFRAPQPAS25GMPGxPV-ModelIT[1]ElectronicRecords;ElectronicSignatures21CFRPart11,March1997.[2]GuidanceforIndustry,21CFRPart11;ElectronicRecords;ElectronicSigna-turesValidation,August2001.[3]GuidanceforIndustry,Part11,ElectronicRecords;ElectronicSignatures-ScopeandApplication,August2003.060122