CNAS-CL06体系良好运行对动物实验数据科学性的积极作用
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中国食品药品检定研究院

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The positive effect of the good operation of the CNAS-CL06 system on the scientific nature of animal experimental
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1.National Institutes for Food Drug Control;2.National Institutes for Food and Drug Control;3.GUO Meng

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    摘要:

    药品生物制品检验检测机构的动物实验室承担着检测和科研工作的重要基础支撑任务。本文梳理了本机构CNAS-CL06质量管理体系在运行中积累的管理经验,为同类机构在运行中提供借鉴,以保障动物实验数据的科学性。本为确保动物实验数据的科学性,实验动物机构顺利通过了CNAS实验动物机构认可,并在现场监督评审中按时完成了整改,同时依据《实验动物饲养和使用机构质量和能力认可准则》(CNAS-CL06)开展体系定期自查。在自查过程中一边检查问题一边完善体系内容,从动物采购、职业健康安全、动物疾病治疗与护理、设施运行突发事件演练等几方面着手,充实了质量管理体系内容,确保体系持续有效运行,保障了动物实验数据的有效性和标准化,同时在动物实验平台共享方面贡献了本机构的管理思路,为动物实验的云平台建设提供硬件和软件支撑。 本文旨在根据工作实际探索形成实验动物行业质量管理模式, 为制定和执行国家标准、行业/团体标准、认可认证标准等机构提供基础数据,为开展动物实验的机构提供可供探讨的管理模式,也为推动整个动物实验的规范化、科学化发展水平夯实基础。

    Abstract:

    The animal laboratory of pharmaceutical and biological product inspection and testing institutions undertakes important basic support tasks for testing and scientific research work. This article summarizes the management experience accumulated in the operation of our institution's CNAS-CL06 quality management system, providing reference for similar institutions in operation to ensure the scientific nature of animal experimental data. In order to ensure the scientific nature of animal experimental data, the experimental animal institution has successfully passed the CNAS accreditation of the experimental animal institution, and has completed rectification on time during on-site supervision and evaluation. At the same time, regular self inspections of the system have been carried out in accordance with the "Quality and Capability Accreditation Guidelines for Experimental Animal Breeding and Use Institutions" (CNAS-CL06). During the self inspection process, we examined issues while improving the content of the system. Starting from animal procurement, occupational health and safety, animal disease treatment and care, and facility operation emergency drills, we enriched the content of the quality management system, ensured the continuous and effective operation of the system, and ensured the effectiveness and standardization of animal experiment data. At the same time, we contributed to the management ideas of our institution in sharing animal experiment platforms, Provide hardware and software support for the construction of cloud platforms for animal experiments. This article aims to explore and form a quality management model for the experimental animal industry based on practical work, Being focused in the standardization strategy, continue to deepen the reform of standardization work, and give full play to the basic and strategic role of standardization in the modernization of the animal experiments system.

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  • 收稿日期:2023-07-27
  • 最后修改日期:2024-02-20
  • 录用日期:2024-06-28
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