国外供应商审计qclaboratoryduediligence韩国

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1、DueDiligenceProcessTheme–Laboratory/TestingFacilityQualityAssuranceQualityOrganization·Organizationchart·ListofrolesandresponsibilitiesLaboratory/TestingFacility·Touroffacility/Laboratoryfootprint·Equipmentlist/Typesofanalysisperformed·People/Testrequest/Samples/Analysis/Data–Flow·Approp

2、riateUtilities(Water,Steam,Gases,Solvents,Waste,HVAC)QualitySystems·Changecontrol·Datadocumentation·Testresultrelease·Referencestandards·Equipment·Samplehandling·Methodvalidation·Methodcertification·Training·Retest/resample·Deviations·Notificationtomanagement·SystemssecurityInspectionHis

3、tory·Regulatoryagencyvisit(s)andobservations·Statusofresponse(s)QualityAssuranceDueDiligenceThemesPage5of5BNeelyrevised6/05/03DueDiligenceProcessTheme–Laboratory/TestingFacility(DetailedReviewQuestions)QualityAssuranceQualityOrganization·OrganizationchartØArealllabsinvolvedbeenidentified

4、?ØAreallpersonsrelatedtolaboratoryresponsibilitieslisted?ØHowdoesthelaboratorycomponentfitintotheotherqualityareas?(e.g.Manufacturing,technicalservices,etc.)·ListofrolesandresponsibilitiesØHowisthispersonqualified?ØArethesequalificationsstatedlistedanywhere?(e.g.Training,SOP,guideline)ØH

5、aveexternallaboratoriesinvolvedwithtestingsbeenidentified/approvedforuse?Laboratory/TestingFacility·Touroffacility/LaboratoryfootprintØTypesofLaboratories(e.g.Analytical,Microbiological,Pyrogen/Endotoxin,Particulates,Radiation)·Equipmentlist/Typesofanalysisperformed·People/Testrequest/Sa

6、mples/Analysis/Data–Flow·AppropriateUtilitiesØWaterØSteamØGasesØSolventsØWasteØHVACØElectricalØMonitoring§Temperature§Humidity§Airflow§Refrigeration§Ovens§Instrumentation–Dissolution,sampleprep,etc.§Solvent§Environment§WaterconductivityQualityAssuranceDueDiligenceThemesPage5of5BNeelyrevi

7、sed6/05/03DueDiligenceProcessTheme–Laboratory/TestingFacility(DetailedReviewQuestions)(Continued)QualitySystems·ChangecontrolØWhatprocedureorsystemisusedtodocumentproposedmethodchanges?ØChangestolaboratoryprocesses?·DatadocumentationØWhatsystemsareusedtorecordrawdataandre