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1、ComparisonChartofFDAandEPAGoodLaboratoryPractice(GLP)RegulationsandtheOECDPrinciplesofGLP Documentissuedon:June2004U.S.DepartmentofHealthandHumanServicesFoodAndDrugAdministrationOfficeofRegulatoryAffairs(ORA)TableofContents ·Preface1·ScopeandAuthority2·Definitions3·Organizat
2、ionandPersonnel4·Facilities5·Equipment6·FacilityOperation7·Articles8·ProtocolandConduct9·RecordsandReports10·Disqualification11Page65of65Preface PublicCommentCommentsandsuggestionsmaybesubmittedatanytimetotheDivisionofCompliancePolicy(HFC-230),OfficeofEnforcement,OfficeofRegu
3、latoryAffairs(ORA),FoodandDrugAdministration,5600FishersLane,Rockville,MD20857.Pleaserefertotheexacttitleofthisdocumentwhensubmittingcommentsorsuggestions.ForquestionsregardingtheuseorinterpretationofthischartcontactChrisAndersat(240)632-6853,ore-mailChristopher.Anders@fda.hh
4、s.gov.AdditionalCopiesAdditionalcopiesareavailablefromtheInternetat: http://www.fda.gov/ora/compliance_ref/bimo/fda_epa_oecd.html.Submitwrittenrequestsforsinglecopiesoftheguidanceentitled"ComparisonChartofFDAandEPAGoodLaboratoryPractice(GLP)RegulationsandtheOECDPrinciplesofGL
5、P"totheDivisionofCompliancePolicy(HFC-230),OfficeofEnforcement,OfficeofRegulatoryAffairs(ORA),FoodandDrugAdministration,5600FishersLane,Rockville,MD20857.Sendoneself-addressedadhesivelabeltoassisttheofficeinprocessingyourrequests.Page65of65ScopeandAuthorityComparisonofFDA,EPA
6、,OECDGLPScopeandAuthorityTopicFDAEPAOECDScopeSec.58.1(a)ThispartprescribesgoodlaboratorypracticesforconductingnonclinicallaboratorystudiesthatsupportorareintendedtosupportapplicationsforresearchormarketingpermitsforproductsregulatedbytheFoodandDrugAdministration,includingfood
7、andcoloradditives,animalfoodadditives,humanandanimaldrugs,medicaldevicesforhumanuse,biologicalproducts,andelectronicproducts.Compliancewiththispartisintendedtoassurethequalityandintegrityofthesafetydatafiledpursuanttosections406,408,409,502,503,505,506,507,510,512-516,518-520
8、,706,and801oftheFederalFood,Drug,andCosmeticActandsections351and354-
