OECD Good laboratory practice (GLP)中英文对照PPT版.ppt

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1、OECDGLPPrinciples经济合作与发展组织GLP原则SuzhouResearch-LeoLiu西山中科-刘振超1.1TestFacilityManagement’sResponsibilities机构负责人的职责1.1.1EachtestfacilitymanagementshouldensurethatthesePrinciplesofGoodLaboratoryPracticearecompliedwith,initstestfacility.1.1.1机构负责人应对确保机构的运行遵从GLP原则。1.1TestFacilityManageme

2、nt’sResponsibilities机构负责人的职责1.1.2a)ensurethatastatementexistswhichidentifiestheindividual(s)withinatestfacilitywhofulfilltheresponsibilitiesofmanagementasdefinedbythesePrinciplesofGoodLaboratoryPractice;1.1.2a)确保存在一个声明（委任状）授权某个（些）人成为机构负责人；1.1TestFacilityManagement’sResponsibilitie

3、s机构负责人的职责1.1.2b)ensurethatasufficientnumberofqualifiedpersonnel,appropriatefacilities,equipment,andmaterialsareavailableforthetimelyandproperconductofthestudy;1.1.2b)确保存在足够数量的合格人员、设施、设备和物品以便于专题及时准确的实施；1.1TestFacilityManagement’sResponsibilities机构负责人的职责1.1.2c)ensurethemaintenanceof

4、arecordofthequalifications,training,experienceandjobdescriptionforeachprofessionalandtechnicalindividual;1.1.2c)确保专家和技术人员的资质、培训、经历和工作描述的记录得到维护和保留；1.1TestFacilityManagement’sResponsibilities机构负责人的职责1.1.2d)ensurethatpersonnelclearlyunderstandthefunctionstheyaretoperformand,wherenece

5、ssary,providetrainingforthesefunctions;1.1.2d)确保人员清楚的理解他们所要执行的工作，必要时，提供培训。1.1TestFacilityManagement’sResponsibilities机构负责人的职责1.1.2e)ensurethatappropriateandtechnicallyvalidStandardOperatingProceduresareestablishedandfollowed,andapprovealloriginalandrevisedStandardOperatingProcedur

6、es;1.1.2e)确保有效的SOP体系得到建立和遵从，批准新起草的和修订的SOP。1.1TestFacilityManagement’sResponsibilities机构负责人的职责1.1.2f)ensurethatthereisaQualityAssuranceProgrammewithdesignatedpersonnelandassurethatthequalityassuranceresponsibilityisbeingperformedinaccordancewiththesePrinciplesofGoodLaboratoryPracti

7、ce;1.1.2f)确保带有指定人员的质量保证计划的存在，确保质量保证职责符合本GLP指南的要求。1.1TestFacilityManagement’sResponsibilities机构负责人的职责1.1.2g)ensurethatforeachstudyanindividualwiththeappropriatequalifications,training,andexperienceisdesignatedbythemanagementastheStudyDirectorbeforethestudyisinitiated.Replacementofa

8、StudyDirectorshouldbedoneaccordin