OECD-principles-of-GLP

UnclassifiedENV/MC/CHEM(98)17OrganisationdeCoopérationetdeDéveloppementEconomiquesOLIS:21-Jan-1998OrganisationforEconomicCo-operationandDevelopmentDist.:26-Jan-1998__________________________________________________________________________________________Or.Eng.ENVIRONMENTDIRECTORATECHEMICALSGROUPANDMANAGEMENTCOMMITTEEOECDSERIESONPRINCIPLESOFGOODLABORATORYPRACTICEANDCOMPLIANCEMONITORINGNumber1OECDPrinciplesonGoodLaboratoryPractice(asrevisedin1997)61011DocumentcompletdisponiblesurOLISdanssonformatd’origineCompletedocumentavailableonOLISinitsoriginalformatUnclassifiedENV/MC/CHEM(98)17Or.Eng.ENV/MC/CHEM(98)172ENV/MC/CHEM(98)173OECDEnvironmentalHealthandSafetyPublicationsSeriesonPrinciplesofGoodLaboratoryPracticeandComplianceMonitoringNo.1OECDPrinciplesofGoodLaboratoryPractice(asrevisedin1997)EnvironmentDirectorateOrganisationforEconomicCo-operationandDevelopmentParis1998ENV/MC/CHEM(98)174AlsopublishedintheSeriesonPrinciplesofGoodLaboratoryPracticeandComplianceMonitoringNo.2,RevisedGuidesforComplianceMonitoringProceduresforGoodLaboratoryPractice(1995)No.3,RevisedGuidancefortheConductofLaboratoryInspectionsandStudyAudits(1995)No.4,QualityAssuranceandGLP(1992)No.5,ComplianceofLaboratorySupplierswithGLPPrinciples(1992)No.6,TheApplicationoftheGLPPrinciplestoFieldStudies(1992)No.7,TheApplicationoftheGLPPrinciplestoShort-termStudies(1993)No.8,TheRoleandResponsibilitiesoftheStudyDirectorinGLPStudies(1993)No.9,GuidanceforthePreparationofGLPInspectionReports(1995)No.10,TheApplicationofthePrinciplesofGLPtoComputerisedSystems(1995)No.11,TheRoleandResponsibilitiesoftheSponsorintheApplicationofthePrinciplesofGLP©OECD1998Applicationsforpermissiontoreproduceortranslateallorpartofthismaterialshouldbemadeto:HeadofPublicationsService,OECD,2rueAndré-Pascal,75775ParisCedex16,France.ENV/MC/CHEM(98)175AbouttheOECDTheOrganisationforEconomicCo-operationandDevelopment(OECD)isanintergovernmentalorganisationinwhichrepresentativesof29industrialisedcountriesinNorthAmerica,EuropeandthePacific,aswellastheEuropeanCommission,meettoco-ordinateandharmonizepolicies,discussissuesofmutualconcern,andworktogethertorespondtointernationalproblems.MostoftheOECD’sworkiscarriedoutbymorethan200specialisedCommitteesandsubsidiarygroupscomposedofMembercountrydelegates.ObserversfromseveralcountrieswithspecialstatusattheOECD,andfrominterestedinternationalorganisations,attendmanyoftheOECD’sWorkshopsandothermeetings.CommitteesandsubsidiarygroupsareservedbytheOECDSecretariat,locatedinParis,France,whichisorganisedintoDirectoratesandDivisions.TheworkoftheOECDrelatedtochemicalsafetyiscarriedoutintheEnvironmentalHealthandSafetyDivision.TheEnvironmentalHealthandSafetyDivisionpublishesfree-of-chargedocumentsinsixdifferentseries:TestingandAssessment;PrinciplesonGoodLaboratoryPracticeandComplianceMonitoring;Pesticides;RiskManagement;ChemicalAccidentsandHarmonizationofRegulatoryOversightinBiotechnology.MoreinformationabouttheEnvironmentalHealthandSafetyProgrammeandEHSpublicationsisavailableonOECD’sWorldWideWebsite(seenextpage).ThispublicationwasproducedwithintheframeworkoftheInter-OrganizationProgrammefortheSoundManagementofChemicals(IOMC).TheInter-OrganizationProgrammefortheSoundManagementofChemicals(IOMC)wasestablishedin1995byUNEP,ILO,FAO,WHO,UNIDOandtheOECD(theParticipatingOrganizations),followingrecommendationsmadebythe1992UNConferenceonEnvironmentandDevelopmenttostrengthenco-operationandincreaseinternationalco-ordinationinthefieldofchemicalsafety.UNITARjoinedtheIOMCin1997tobecometheseventhParticipatingOrganization.ThepurposeoftheIOMCistopromoteco-ordinationofthepoliciesandactivitiespursuedbytheParticipatingOrganizations,jointlyorseparately,toachievethesoundmanagementofchemicalsinrelationtohumanhealthandtheenvironment.ENV/MC/CHEM(98)176Thispublicationisavailableelectronically,atnocharge.ForthecompletetextofthisandmanyotherEnvironmentalHealthandSafetypublications,consulttheOECD’sWorldWideWebsite()orcontact:OECDEnvironmentDirectorate,EnvironmentalHealthandSafetyDivision2rueAndré-Pascal75775ParisCedex16FranceFax:(33-1)45241675E-mail:[e-mail]/MC/CHEM(98)177FOREWORDChemicalscontrollegislationinOECDMembercountriesisfoundedinaproactivephilosophyofpreventingriskbytestingandassessingchemicalstodeterminetheirpotentialhazards.Therequirementthatevaluationsofchemicalsbebasedonsafetytestdataofsufficientquality,rigourandreproducibilityisabasicprincipleinthislegislation.ThePrinciplesofGoodLaboratoryPractice(GLP)havebeendevelopedtopromotethequalityandvalidityoftestdatausedfordeterminingthesafetyofchemicalsandchemicalsproducts.Itisamanagerialconceptcoveringtheorganisationalprocessandtheconditionsunderwhichlaboratorystudiesareplanned,performed,monitored,recordedandreported.Itsprinciplesarerequiredtobefollowedbytestfacilitiescarryingoutstudiestobesubmittedtonationalauthoritiesforthepurposesofassessmentofchemicalsandotherusesrelatingtotheprotectionofmanandtheenvironment.Theissueofdataqualityhasanimportantinternationaldimension.Ifregulatoryauthoritiesincoun