GLP组织机构和管理体系的建立与运行

发布时间：2018-01-15 15:23

  本文关键词：GLP组织机构和管理体系的建立与运行　出处：《中国药理学与毒理学杂志》2013年03期 　论文类型：期刊论文

  更多相关文章： GLP 管理体系 组织机构

【摘要】：我国药物非临床研究质量管理规范(GLP)制定的目的是提高药物非临床研究的质量,确保实验资料的真实性、完整性和可靠性。与其它国家(美国、欧洲等)同样,我国的规范包括了组织机构和人员、实验设施、仪器设备和实验材料、标准操作规程、研究工作的实施、资料档案等内容。其中,组织机构和管理体系的建立是其他各项内容运行或实施的基础和载体,是一个GLP机构保证GLP规范复合性的最重要的软件核心和实力象征。本文以国家药物安全评价监测中心组织机构模式的建立和发展为例,交流GLP管理体系运行中的心得体会,希望业界同行取长补短,完善各自机构的管理,最大限度保证非临床研究的规范符合性。本中心目前的组织机构包括机构负责人全权负责下的质量保证室、实验动物技术室、一般毒理室、生殖遗传毒理室、安全药理室、临床检验与病理室、药物代谢动力学室、综合办公室8个部门科室。共同担当着GLP体制下研究项目管理和质量体系管理的各项功能及分工。SOP/文书档案/、设备/试剂管理由综合办公室管理,供试品管理由药物代谢动力学室负责、动物管理和动物在体操作由实验动物技术室负责、标本档案由临床检验与病理室负责,一般毒理室、生殖遗传毒理室、安全药理室主要由专题负责人(SD)构成,负责研究项目的设计、执行和报告。质量保证部门负责对质量体系和研究项目进行检查和核查,并向各相关负责人以及机构负责人报告检查情况、督促整改。为了解决管理上的共性问题,设置了四个专门委员会来协调跨部门工作。包括GLP委员会、伦理(IACUC)委员会、环境健康安全(EHS)委员会和学术委员会,分别负责GLP法规事务、动物使用和福利、安全健康、学术和科研活动。上述组织机构看似更接近一种行政体系,但是在一个符合GLP规范的专题研究进行过程中,上述组织机构的行政属性将依从于其功能属性,在运行过程中,上述大的组织框架又包含着各自小的运行结构。将以实例介绍在上述组织机构下,研究专题进行时研究方案制定、研究实施、总结报告的各个阶段GLP符合性的保证。上述组织机构的发展变化、优缺点,并与国内外同行机构的组织机构对比;任何形式的GLP组织结构,基本要素均为GLP规范要求的人员(机构负责人、质量保证部门负责人和相应的工作人员)、资源(设施、仪器设备和实验材料)和管理文件(标准操作规程)。在满足上述要素的基础上,可以建立适合本机构的合理的组织管理框架,以便使上述要素合理配置、充分沟通和配合,达到使非临床研究资料真实、完整、可靠的目的。
[Abstract]:Specification for quality management of clinical research in China (GLP) the purpose is to improve the quality of non clinical drug research, experimental data to ensure the authenticity, integrity and reliability. And other countries (America, Europe) as experimental facilities in our specification includes organization and personnel, equipment, and the experimental materials, standard operating procedures, the implementation of the research work, archives and so on. Among them, the establishment of the organization and management system is the foundation and carrier of the operation or implementation of other content, is a GLP mechanism to ensure the GLP specification of the compound of the most important software and core strength symbol. The establishment and development of the National Center for safety evaluation of drugs organization mode as an example, operation experience of GLP management system in the exchange of experience, I hope the colleagues learn from each other, improve their management mechanism, ensure the maximum non pro Study on the bed specification. The quality of the center at the organization including institutions responsible solely responsible for the experimental animal room, technical room, general toxicology, reproductive and genetic toxicology, safety pharmacology, clinical examination and pathology, pharmacokinetics room, 8 Department of General Office jointly with GLP department. Under the system of project management and quality management system and functions of the division of.SOP/ documents / equipment / reagent management from the integrated office management, sample management by pharmacokinetics lab is responsible for the management and responsible for animal, animal by animal technical room in gymnastics, specimens of archives by clinical inspection and pathology department responsible for the general toxicology room, reproductive and genetic toxicology, safety pharmacology is mainly composed of a special person in charge (SD), responsible for the design of research projects, implementation and report the quality assurance department responsible for quality. System and research projects for examination and verification, and to the relevant responsible person and organization responsible for the inspection, supervision and rectification report. In order to solve the common problems in management, four special committees set up to coordinate the inter departmental working committee. Including GLP (IACUC), ethics committee, environmental health and safety committee (EHS) and the academic committee, responsible for GLP regulatory affairs, and the use of animal welfare, health and safety, academic and research activities. The organization seems closer to a kind of administrative system, but in a research topic conforming to the GLP process, the administrative attribute of the organization will depend on its functional properties in the running process in the large organizational framework and contains their small operation structure. This paper introduces with examples in the organization, research topics of research scheme, implementation research, summary Each stage of the report of GLP compliance assurance. The organization development and change, the advantages and disadvantages, and compare the organization of domestic and foreign counterparts of the organization; organizational structure of GLP in any form, the basic elements are the requirements of GLP personnel (responsible person, the quality assurance department responsible person and relevant staff). Resources (facilities, equipment and materials) and file management (SOP). Based on satisfying the above elements, can establish the mechanism of the rational management framework, in order to make reasonable allocation of the elements of the full communication and coordination, to make non clinical research data is true, complete and reliable purpose.

【作者单位】： 中国食品药品检定研究院食品药品安全评价研究所;
【分类号】：R95
【正文快照】： GLP组织机构和管理体系的建立与运行@霍艳$中国食品药品检定研究院食品药品安全评价研究所!北京100176 @谢寅$中国食品药品检定研究院食品药品安全评价研究所!北京100176 @汪巨峰$中国食品药品检定研究院食品药品安全评价研究所!北京100176我国药物非临床研究质量管理规范(G，

本文编号：1428935