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[职业卫生领域的良好实验室规范]

[Good laboratory practice in occupational hygiene].

作者信息

Stetkiewicz Jan

机构信息

Zakładu Patomorfologii Instytut Medycyny Pracy im. prof. J. Nofera w Łodzi.

出版信息

Med Pr. 2004;55(1):27-9.

Abstract

Good laboratory practice (GLP) is the system that ensures quality assessment, defines the organization rules of institutions performing non-clinical studies in the area of human and environmental safety in general, and of chemicals and chemical preparations in particular as well as sets the conditions of planning, performing and monitoring of studies, the outcome of which is recorded, stored and reported. Occupational hygiene is an area of activities that involves anticipation, assessment and surveillance of health hazards in the work environment aimed at protecting health of workers and the population at large (IOHA). Assessment and control of harmful agents, which occur in the work environment, technological processes or methods of work should be carried out by research units (laboratories) with well documented competencies in the environment and/or biological monitoring, and those granted accreditation according to EN/ISO 17025. Anticipated risks should be based on analyses of physical, chemical and toxic properties of harmful agents, performed in line with the rules of good laboratory practice. Accredited laboratories and the quality of their tests are monitored by governmental agencies. The application of the GLP system provides: the opportunity to investigate analytical procedures and data (the documentation concerning each stage of a given analysis should ensure a complete reconstruction of the whole analytical process); the confirmed reliability of the results; the recognition of the results in European Union member states and by the Organization for Economic Cooperation and Development (OECD); the opportunity to avoid repetition of analyses and studies; a better care of the human health and environment.

摘要

良好实验室规范(GLP)是一种确保质量评估的体系,它总体上定义了在人类与环境安全领域,特别是化学品和化学制剂领域进行非临床研究的机构的组织规则,并规定了研究的规划、实施和监测条件,研究结果需进行记录、存储和报告。职业卫生是一个活动领域,涉及对工作环境中的健康危害进行预测、评估和监测,旨在保护工人及广大民众的健康(国际职业卫生协会)。对工作环境、工艺流程或工作方法中出现的有害因素的评估和控制,应由在环境和/或生物监测方面具备充分文件证明能力且根据EN/ISO 17025获得认可的研究单位(实验室)进行。预期风险应基于按照良好实验室规范的规则对有害因素的物理、化学和毒性特性进行的分析。认可实验室及其测试质量由政府机构进行监测。GLP体系的应用提供了以下几点:调查分析程序和数据的机会(关于给定分析每个阶段的文件应确保能够完整重建整个分析过程);结果的可靠性得到确认;在欧盟成员国以及经济合作与发展组织(经合组织)获得结果认可;避免重复分析和研究的机会;对人类健康和环境的更好保护。

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