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1、外文翻译原文ManagingstafftrainingandGMPcomplianceMaterialSource:ManagingtrainingandcomplianceAuthor:MonikaBrunnHoffmanLaRocheAcasestudyispresentedthatdescribeshowasoftwarecontrolsystemcaneasethecomplextaskofmanagingtrainingneedsacrossaninternationalcompany,andimproveGMPco
2、mpliancebyensuringthatemployeesareaptlyqualifiedtoperformtheirassignedtasks.WhatarethethreemostimportantreasonsforGMPdeviations?AlackofGMPtraining,alackofGMPtrainingandalackofGMPtraining!TherootcauseforGMPdeviationsmostfrequentlylistedininspectionreportsisthepersonn
3、elinvolvedinAPImanufactureandqualityassurance.GMPtrainingformanufacturingpersonnelisessential,asdefinedinChapter2Paragraph2.9oftheEUGMPGuideandin211.25oftheFDAcGMPGuide;however,GMPcontrolisnotalwaysasgoodasitshouldbe—asdemonstratedbytheincreasingnumberofwarninglette
4、rs,importstopsandotherprovisionsbyregulatoryauthoritiesinpastyears.Well-qualifiedemployeesareanessentialpartofGMP,andtrainingconceptsandthecompliancestatusofpersonnelarealwayswithinthescopeofinspections.Assuch,requirementsforqualifications,traininganddevelopmentofal
5、lemployeesinvolvedinGxPrelevantoperationsmustbemettoensurethatemployeescanaptlyperformtheirassignedtasksaccordingtotheirposition.Thebestwaytoaccomplishthisisthroughtrainingprogrammestailoredtoeachemployee'sjob.Thisshouldnotjustendwithaninductionprogramme,butcontinue
6、withannualtrainingplansandperiodicretrainingtoensurethatanemployee'sknowledgeandbehaviourismaintainedattherequiredlevel.Trainingshouldbeplanned,scheduled,conductedanddocumentedusingaverysystematicapproach,particularlyinlargecompanies.In2006,apublicationbySchaffer/Sc
7、hmidtdescribedhowapharmaceuticalcompanyestablishedkeyperformanceindicators(KPis)tocalculatetheratiobetweenthetotalnumberoftrainingsplanned/needed,andthetotaltrainingsconducted,whichhelpedmanagementtoassessandassignthenecessaryresources.Theoverallconclusionofthispubl
8、icationwasthatacompany-widetrainingmanagementsystemisneededtomanagethetrainingneedsinapharmaceuticalcompany.Theadministrationofresources,a
