我国工业化学品测试GLP发展的历程、特点和挑战

GLP Development,Characteristics and Challenges for Testing of Industrial Chemicals in China

回顾了我国工业化学品测试GLP发展的历程,分别介绍我国环境保护部和国家认证认可监督管理委员会的2个工业化学品测试GLP体系的概况,及其与OECD的GLP之间的异同。介绍了环境保护部采用的GLP中文译法所考虑的因素。指出环境保护部的GLP体系是为保证环境管理所需数据的质量,在管理体系方面涵盖OECD的GLP准则的全部内容;同时关注技术能力,增加了技术考核的要求。分析了我国工业化学品测试机构在建立、理解和执行GLP体系方面存在的问题和面临的挑战。建议加强人员培训,强调注重培训质量;加强国际交流,培养一批高水平的GLP专家,完善我国化学品测试GLP考评体系;通过实验室间技术比对,严格督促实验室认真执行GLP规范的各项规定,提高实验室的技术能力和管理水平。

The Good Laboratory Practice （GLP） development for testing of industrial chemicals in China was reviewed and the outlines of MEP and CNCA GLP systems introduced. Comparing the two GLP systems with OECD GLP Principles, the similarities and differences were discussed. The Chinese term of GLP by MEP and its issues were also interpreted. In order to improve the data quality and integrity for environmental management of chemicals, the MEP GLP system covers all contents of OECD GLP Principles in management system. Additionally, MEP GLP emphasizes the laboratory＇s technical capacity, and inserts the technical assessment requirements into its GLP. The problems and challenges on establishment, understanding and implementation of GLP in test facilities of industrial chemicals were analyzed. It is suggested to accentuate laboratory training and its efficiency, increase international communication and bring up a fine set of GLP experts, and improve GLP monitoring systems. It is also proposed to improve laboratory＇s technical capacity and management level by inter-laboratory competency comparison and laboratory suoervision in comoliance with the GLP reaulations.