美国GLP完整版

1FoodandDrugAdministration,HHS§SOURCE:43FR60013,Dec.22,1978,unlessotherwisenoted.SubpartA—GeneralProvisionsA部分——一般规定§58.1Scope.58.1范围(a)Thispartprescribesgoodlaboratorypracticesforconductingnonclinicallaboratorystudies本部分描述了适用于非临床化验室研究的GLP，thatsupportorareintendedtosupportapplicationsforresearchormarketingpermitsfor其支持或将会支持拟通过FDA批准的药品申请。productsregulatedbytheFoodandDrugAdministration,includingfoodandcoloradditives,包括食品和色素添加剂animalfoodadditives,humanandanimaldrugs,medicaldevicesforhumanuse,biological动物食品和添加剂，人用和兽用药品，人用医疗器械products,andelectronicproducts.Compliancewiththispartisintendedtoassurethequalityand生物制剂和电子产品。符合本部分将会确保质量和安全数据的完整性integrityofthesafetydatafiledpursuanttosections406,408,409,502,503,505,506,510,512–516,518–520,721,and801oftheFederalFood,Drug,andCosmeticActandsections351and354–360FofthePublicHealthServiceAct.(b)ReferencesinthisparttoregulatorysectionsoftheCodeofFederalRegulationsaretochapterIoftitle21,unlessotherwisenoted.[43FR60013,Dec.22,1978,asamendedat52FR33779,Sept.4,1987;64FR399,Jan.5,1999]本部分参考21CFRI部分。§58.3Definitions.58.3定义Asusedinthispart,thefollowingtermsshallhavethemeaningsspecified:本部分用到的术语以下定义：(a)ActmeanstheFederalFood,Drug,andCosmeticAct,asamended(secs.201–902,52Stat.1040etseq.,asamended(21U.S.C.321–392)).（a）行动意思是联邦食品、药品和化妆品行动(b)Testarticlemeansanyfoodadditive,coloradditive,drug,biologicalproduct,electronic（b）检验规章意思是任何食品添加剂、色素添加剂、药品、生物制剂、电子产品、product,medicaldeviceforhumanuse,oranyotherarticlesubjecttoregulationundertheactor人用医疗器械或其他任何用于符合公共健康服务的要求或符合公共健康服务行动351和354-360部分的规定。undersections351and354–360FofthePublicHealthServiceAct.(c)Controlarticlemeansanyfoodadditive,coloradditive,drug,biologicalproduct,electronic(c)控制规章意思是任何食品添加剂、色素添加剂、药品、生物制剂、电子产品、product,medicaldeviceforhumanuse,oranyarticleotherthanatestarticle,feed,orwaterthatis人用医疗器械、或其他任何不同于检验的规章，种子、或水用于非临床化验室研究阶段的检验体系，目的是建立一个可以和检验规章相比较的基础。administeredtothetestsysteminthecourseofanonclinicallaboratorystudyforthepurposeof2establishingabasisforcomparisonwiththetestarticle.(d)Nonclinicallaboratorystudymeansinvivoorinvitroexperimentsinwhichtestarticlesare(d)非临床实验室研究预先在实验室条件下进行体外或体内试验研究来确定他们的安全性。studiedprospectivelyintestsystemsunderlaboratoryconditionstodeterminetheirsafety.Thetermdoesnotincludestudiesutilizinghumansubjectsorclinicalstudiesorfieldtrialsinanimals.这个阶段并不包括对人或临床或动物研究。Thetermdoesnotincludebasicexploratorystudiescarriedouttodeterminewhetheratestarticlehasanypotentialutilityortodeterminephysicalorchemicalcharacteristicsofatestarticle.这个阶段不包括对试验规章是否有潜在的功效或确定其物理或化学特性的基础探索研究。(e)Applicationforresearchormarketingpermitincludes:（e）销售或研究允许申请包括：(1)Acoloradditivepetition,describedinpart71.（1）色素添加剂申请，71部分有描述。(2)Afoodadditivepetition,describedinparts171and571.（2）食品添加剂申请，171和571部分有描述。(3)Dataandinformationregardingasubstancesubmittedaspartoftheproceduresforestablishingthatasubstanceisgenerallyrecognizedassafeforuse,原料药的有关数据和信息，作为提交程序的一部分，为了建立原料药的安全使用证明，whichuseresultsormayreasonablybeexpectedtoresult,directlyorindirectly,initsbecominga这些使用数据或将用建立的数据，直接或间接影响其所组成的食物的特性，在170.35和570.35有描述。componentorotherwiseaffectingthecharacteristicsofanyfood,describedin§§170.35and570.35.(4)Dataandinformationregardingafoodadditivesubmittedaspartoftheproceduresregardingfoodadditivespermittedtobeusedonaninterimbasispendingadditionalstudy,describedin§180.1.食品添加剂可以作为一部分使用的研究在180.1有描述。(5)Aninvestigationalnewdrugapplication,describedinpart312ofthischapter.IND申请在312部分有描述。(6)Anewdrugapplication,describedinpart314.ND申请在314部分有描述。(7)Dataandinformationregardinganover-the-counterdrugforhumanuse,submittedaspartoftheproceduresforclassifyingsuchdrugsasgenerallyrecognizedassafeandeffectiveandnotmisbranded,describedinpart330.OTC药品在330部分有描述。(8)Dataandinformationaboutasubstancesubmittedaspartoftheproceduresforestablishingatoleranceforunavoidablecontaminantsinfoodandfood-packagingmaterials,describedinparts109and509.原料药在109和509部分有描述。(9)[Reserved]（9）保留(10)ANoticeofClaimedInvestigationalExemptionforaNewAnimalDrug,describedinpart511.3(11)Anewanimaldrugapplication,describedinpart514.(12)[Reserved](13)Anapplicationforabiologicslicense,describedinpart601ofthischapter.(14)Anapplicationforaninvestigationaldeviceexemption,describedinpart812.(15)AnApplicationforPremarketApprovalofaMedicalDevice,describedinsection515oftheact.(16)AProductDevelopmentProtocolforaMedicalDevice,describedinsection515oftheact.(17)Dataandinformationregardingamedicaldevicesubmittedaspartoftheproceduresforclassifyingsuchdevices,describedinpart860.(18)Dataandinformationregardingamedicaldevicesubmittedaspartoftheproceduresforestablishing,amending,orrepealingaperformancestandardforsuchdevices,describedinpart861.(19)Dataandinformationregardinganelectronicproductsubmittedaspartoftheproceduresforobtaininganexemptionfromnotificationofaradiationsafetydefectorfailureofcompliancewitharadiationsafetyperformancestandard,describedinsubpartDofpart1003.(20)Dataandinformationregardinganelectronicproductsubmittedaspartoftheproceduresforestablishing,amending,orrepealingastandardforsuchproduct,describedinsection358ofthePubli