1、OECD GLP Principles经济合作与发展组织GLP 原则Suzhou Research-LeoLiu-2、Definitions of Terms术语定义术语定义 2.1GLP:Good Laboratory Practice(GLP)is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned,performed,monitore
2、d,recorded,archived and reported.2.1GLP是一种涉及组织过程和非临床健康和环境安全专题实施条件的质量系统。在这些条件下，专题经历计划（试验方案）、实施、监督（各种检查）、记录、存档和报告。2、Definitions of Terms术语定义术语定义 2.1.1Quality system质量系统：ISO9001,GMP,HACCP等等。2.1.2The organizational process and the conditions组织过程和实施条件：Personnel,Premise,Material,Method and condition.人（资质、
3、培训和分工组织）、机（检定、验证、维护）、物（合格、按条件储存和使用）、法（SOP经过审核和批准）、环（可控、达到试验要求）。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.1 Test facility means the persons,premises and operational unit(s)that are necessary for conducting the non-clinical health and environmental safety study.2.2.1 测试机构
4、指执行非临床健康和环境安全专题所必须的人员、设施和设备以及其他运作单元。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.2 Test site means the location(s)at which a phase(s)of a study is conducted.2.2.2 测试场所指专题的某个（某些）阶段执行的场所，例如动物房、水生测试室、环境行为测试室等。2.2.3 Test facility management means the person(s)who has the autho
5、rity and formal responsibility for the organisation and functioning of the test facility according to these Principles of Good Laboratory Practice.2.2.3机构负责人：得到正式授权负责机构按照GLP原则组织和运行的一个或几个人。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.4 Sponsor means an entity which commissi
6、ons,supports and/or submits a non-clinical health and environmental safety study.2.2.4委托方指委托、赞助和把非临床健康和环境专题结果呈递（注册机构）注册的团体（法人）。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.5Study Director means the individual responsible for the overall conduct of the nonclinical health an
7、d environmental safety study.2.2.5总体上负责专题实施的个人-专题的唯一控制点。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.6Principal Investigator means an individual who,for a multi-site study,acts on behalf of the Study Director and has defined responsibility for delegated phases of the study
8、.2.2.6主研究员指多场所执行的专题中，代表SD负责专题某个（某些）阶段实施的个人。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.7Quality Assurance Programme means a defined system,including personnel,which is independent of study conduct and is designed to assure test facility management of compliance with these
9、 Principles of Good Laboratory Practice.2.2.7质量保证项目指包括其人员在内，独立于专题实施之外的有明确定义的系统，其主要任务是确保机构的管理符合GLP原则。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.8 Standard Operating Procedures(SOPs)means documented procedures which describe how to perform tests or activities normally not
10、specified in detail in study plans or test guidelines.2.2.8标准操作程序指描述如何执行测试或执行某些活动的书面程序。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语 2.2.9 Master schedule means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facili
11、ty.2.2.9用于评估测试机构负载能力和追踪专题状态的信息汇编。2.2 Terms Concerning the Organisation of a Test Facility有关测试机构组织的术语2.3 Terms Concerning Study与专题相关的术语 2.3.1 Non-clinical health and environmental safety study,henceforth referred to simply as study,means an experiment or set of experiments in which a test item is exa
12、mined under laboratory conditions or in the environment to obtain data on its properties and/or its safety,intended for submission to appropriate regulatory authorities.2.3.1非临床健康和环境安全专题，简称“专题”，指在实验室或自然环境状态下对一个供试品进行的一个或一系列试验，以得到这个供试品的属性和（或）安全数据，目的是向注册机构提交这些数据。2.3 Terms Concerning Study与专题相关的术语 2.3.2
13、 Study plan means a document which defines the objectives and experimental design for the conduct of the study,and includes any amendments.2.3.2试验方案指描述专题试验目的和试验设计的文件，也包括对其进行的变更文件。2.3 Terms Concerning Study与专题相关的术语 2.3.3Study plan amendment means an intended change to the study plan after the study i
14、nitiation date.2.3.3试验方案变更指专题启动（日期）后对试验方案进行的有计划的变更。2.3.4 Study plan deviation means an unintended departure from the study plan after the study initiation date.2.3.4对试验方案的偏离指专题启动（日期）后发生的对试验方案意外的不符合。2.3 Terms Concerning Study与专题相关的术语 2.3.5Test system means any biological,chemical or physical system o
15、r a combination thereof used in a study.2.3.5试验/测试系统指专题中使用的任何生物、化学的或物理的系统，或者是它们的组合。例如动物、植物、微生物、水、土壤、光等等。2.3 Terms Concerning Study与专题相关的术语 2.3.5 Raw data means all original test facility records and documentation,or verified copies thereof,which are the result of the original observations and activi
16、ties in a study.2.3.5原始数据指机构内产生的原始记录和文件，或者是它们的真实复印件，原始数据是观察或从事某（个）些活动的直接结果。2.3 Terms Concerning Study与专题相关的术语 2.3.6 Study initiation date means the date the Study Director signs the study plan.2.3.6专题启动日期指SD签署试验方案的日期（2号令第二十七条里是机构负责人）。2.3.7 Study completion date means the date the Study Director sign
17、s the final report.2.3.7专题完成日期指SD签署最终报告的日期（2号令第三十三条里是机构负责人）。2.3 Terms Concerning Study与专题相关的术语 2.3.8Experimental starting date means the date on which the first study specific data are collected.2.3.8试验开始日期指得到第一个（组）试验数据的日期。2.3.9Experimental completion date means the last date on which data are colle
18、cted from the study.2.3.9试验结束日期指得到最后一个（组）试验数据的日期。2.4 Terms Concerning the Test Item有关供试品的术语 2.4.1Test item means an article that is the subject of a study.2.4.1供试品指专题研究的主题。2.4.2Reference item(“control item”)means any article used to provide a basis for comparison with the test item.参照品/参照物（“质控品”）为供试品提供对比基础的物品。为更好满足学习和使用需求，课件在下载后自由编辑，请根据实际情况进行调整Thank you for watching and listening.I hope you can make great progress
