Tian Shaolei
Center for Drug Certification, State Food and Drug Administration, Beijing 100061.
Zhongguo Yi Liao Qi Xie Za Zhi. 2010 Mar;34(2):129-32.
In this paper, the procedures, logos, methods, essentials as well as notable problems for inspecting the qualification management system of in vitro diagnostic regent manufactures are discussed, with aims of promoting inspector's practical level and consequentially ensuring the quality, standard and efficacy of the inspection.
本文探讨了体外诊断试剂生产企业资质管理体系检查的程序、标识、方法、要点以及值得注意的问题，旨在提高检查人员的实践水平，从而确保检查工作的质量、规范性和有效性。
