国内外质量保证部门的差异分析

Analysis for differences in QAU between China and abroad

质量保证部门(QAU)指非临床研究机构内负责保证其各项工作符合药物非临床研究质量管理规范(GLP)要求的重要部门或组织,是GLP建设的关键,随着国外众多知名医药研发中心及CRO的涌入,对我国GLP实施和QAU执行带来了挑战。文中对国内外QAU的差异及如何使国内QAU的发展跟上国外的步伐,切实保证非临床研究符合相关的GLP等问题进行了阐述。

As the key on GLP construction, QAU is an important department which assures all activities to be compliant with the principles of GLP. With the mushroom of many foreign famous pharmaceutical research centers and CRO in China, we face a lot of challenges in Good Laboratory Practice （GLP） and Quality Assurance Unit （QAU） conduct. What is the difference between China and abroad？ How to make QAU development to keep up with abroad level, and to assure the compliance of non-clinical studies to GLP？ These issues will be described in this paper.