姚洪伟2,
周芳丽2
1. 上海化工院检测有限公司, 上海 200062;
2. 上海化工研究院有限公司, 上海 200062
作者简介: 汪丹(1986-),女,硕士,工程师,研究方向为GLP体系管理与计算机化系统验证,E-mail:wd@ghs.cn.
基金项目: 上海化工研究院科研计划项目（N307-2016jczx-01）中图分类号: X171.5
SOP Schedule Design and Compliance Management of GLP Laboratory in Ecotoxicology Study
Wang Dan1,Yao Hongwei2,
Zhou Fangli2
1. Shanghai Institute of Chemical Industry Testing Co. Ltd, Shanghai 200062, China;
2. Shanghai Research Institute of Chemical Industry Co. Ltd., Shanghai 200062, China
CLC number: X171.5
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摘要:良好实验室规范（GLP）要求所有研究必须制定研究计划，这能够确保研究的实施有据可依，有利于人员、时间和资源的统一调度和安排，保证研究有序开展。而研究计划的核心之一就是在时间上分解活动和任务，规定试验进度，确定目标实现的方式。但是，目前GLP实验室在时间点概念以及具体日程管理方面缺乏具有实际操作意义的指导，所以需要各个机构自行定义，但是如果不能结合实际研究领域来理解GLP规范，那么就会导致机构内管理与实践脱节，严重时还会遭到监管部门对机构管理水平的质疑。因此，结合生态毒理测试领域，调研了经济合作与发展组织（OECD）、美国食品药品监督管理局（US FDA）、美国环境保护局（US EPA）、日本环境省、德国联邦风险评估研究所（Bundesinstitut für Risikobewertung，BFR）和瑞士等多个国家、地区或组织的GLP规范和指南，理顺了研究计划时间点的历史规定、定义和逻辑关系，确认监管机构在实施合规性检查时的关注点，获取了具有官方指导意义的做法。同时，结合生态毒理GLP实验室中具体研究的工作流程，采用活动属性划分方式对研究实施过程进行剖析和再建，识别出生态毒理研究的核心为生产性活动，应该以此为依据设立日程。最后以快速生物降解和藻类生长抑制试验为例，给出了实际研究中具体时间点和日程安排的建议，并且对建立独立实验日程进度表的盲区和关键点展开讨论。
关键词: GLP合规管理/
生态毒理/
日程设计
Abstract:The principles of Good Laboratory Practice (GLP) are intended to assure data quality and integrity, and a well thought-out study plan is a key controlling document for a GLP study. The presence of a written study plan is to assist with proper execution of the study by providing all participants with clear instructions and sufficient resources. The cornerstone of study plan is to break down activities based on time, design the schedule of experiment, and determine the means to achieve the goal. However, the principles of GLP are very flexible so that an accurate and practical interpretation on time points is required in application phase. The schedule planning method to be used and the experimental date definition are at the discretion of the test organization. A balance has to be achieved between specified testing area and regulation aspects, if not, a disjointing problem would arise, and more seriously, the organization management ability may be questioned about by the monitoring agency. In this paper, a guiding approach to schedule design and management is illustrated with reference to GLP standards and guidance of several countries, areas and organizations in the field of ecotoxicology study, including Organization for Economic Co-operation and Development (OECD), United States Food and Drug Administration (US FDA), United States Environmental Protection Agency (US EPA), Ministry of the Government in Japan, Bundesinstitut für Risikobewertung (BFR) in Germany and Switzerland. Furthermore, the specified definition of time points in the GLP principles, historical rules about them, and logical connections between them are described, and potential caveats from a regulatory standpoint are indicated. At the meanwhile, by combining the working flow of specified study in GLP laboratory, it adopts the method of activity categorization to analyze and reconstruct the implementation process of research, and it recognizes that essentially ecotoxicology studies are productive activity, so that a schedule should be built up on the basis of it. Finally, taking ready biodegradation and alga growth inhibition test as examples, it puts forward the advice on specific time points and schedule in actual research, and discusses on the blind area and key point in the establishment of schedule of independent experiment.
Key words:GLP compliance management/
ecotoxicology test/
schedule design.
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