GLP原则在体外毒理学评价实验室的应用

在动物福利运动的推动下,以减少、优化和替代动物试验为核心内容的体外试验系统已成为安全评价不可或缺的组成部分,在药品、化学品、化妆品毒理学评价中起到重要作用。体外试验系统不同于体内动物实验,体外毒理学实验室GLP原则的建立和运行应充分考虑体外试验系统的特殊性。目前我国专业的体外安全评价实验室的建设刚刚起步,还没有可供借鉴的成熟经验。本文从实验室组织、试验系统维护、人员职责、质量管理和运行几个方面,介绍了GLP原则在化妆品体外毒理学检验和评价实验室的应用。

The Application of GLP Principle in Toxiciology Evaluation Laboratory In vitro

Under the promoting of animal welfare movement, the in vitro testing system with the core content of 3R principle has been an indispensable part of health safety evaluation, and play a important role in toxicity assessment of drugs, chemical, cosmetics, etc. Testing system in vitro was different from animal test in vivo, the establishment and management of GLP principle in vitro toxicity laboratory need conform to the specialty itself. Up to now in our country, it was lack the successful GLP experience for reference during the construct of safety evaluation lab in vitro. The effort and application of GLP practice in cosmetics inspection and toxicology study, including the laboratory organizing, testing system maintains, personnel responsibilities, quality assurance and performance ware expatiated in this article.