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1、药品研究中GLP实验室实验原始记录审核技术要求龚兆龙博士资深副总裁兼首席技术官昭衍新药研究中心1新药研发过程2新药研发过程质量规范GLP历史沿革遵从GLP的意义GLP规范基本要求原始数据核查要点非临床实验室常见错误法规对GLP或非GLP的要求案例分析内容提要4GLP历史–美国WhatpromptedUSFDAtoissueGLPregulations?Inthe1960sand1970s,inadditiontothe“Thalidomide”story,FDAfound:Selectivelysubmittedfindi
2、ngsFabricateddataFalsifieddataDiscrepanciesinreporting(e.g.,betweenindividualandsummarydata)Poorlaboratoryrecordkeeping(resultingininabilitytoreconstructstudyperformance)GLP历史–美国Inthe1960sand1970s,FDAalsofound:Noprotocols,protocolswrittenafterstudyperformance,stud
3、ynotperformedaccordingtoprotocolNooneinchargeofstudiesSloppylaboratorypracticesUSFDAGLP法规1976CongressionalhearingsGLPsproposed1978GLPsfinalized1979GLPsbecomeeffectiveUSFDAGLP法规21CFR:CodeofFederalRegulations,Food&DrugAdministration.21CFRPart58:GoodLaboratoryPractic
4、esforNonclinicalLaboratoryStudies21CFRPart11:ElectronicRecords;ElectronicSignaturesUSFDAGLPPart58要求DescribesrequirementsforconductingandreportingnonclinicallaboratorystudiesIntent:providesaframeworkforconductingwell-controlledstudiesassuresqualityandintegrityofthe
5、datafacilitatesstudyreconstructionprovidesoverallaccountabilityNonclinicalstudiesthatevaluatesafetymustbeGLPcompliantUSFDAGLP检查FDAGLP检查过的美国国内实验室200余家,CRO,药厂USFDAGLP检查FDAGLP检查过的美国境外实验室40余家,CRO,药厂USFDAGLP检查：MOU8个国家日本法国德国加拿大意大利瑞典瑞士荷兰USFDAGLP检查：中国GLP实验室2009年7月检查了三家GLP
6、实验室国家安评中心(NCSED)昭衍（JOINN)Bridge(康龙化成)昭衍提交的试验报告获得美国FDA认可,用于支持美国的临床试验。OECDGLP规范Developedin1978USFDAGLPprovidedthebasisforOECDRevisedOECDprinciplesadoptedin1997PrimaryobjectivesimilartoUSFDAToensurethegenerationofhighqualityandreliabletestdatarelatedtothesafetyofindu
7、strialchemicalsubstancesandpreparationsintheframeworkofharmonisingtestingproceduresforthemutualacceptanceofdata(MAD)OECDMAD（数据互认）DatageneratedinthetestingofchemicalsinanOECDmembercountryinaccordancewithOECDTestGuidelinesandOECDPrinciplesofGLPshallbeacceptedinother
8、MembercountriesforpurposesofassessmentandotherusesrelatingtotheprotectionofmanandtheenvironmentOECDMemberCountriesAustralia,Austria,Belgium,Canada,Czech
