[Site inspection procedures and methods for evaluation of the quality management system of in vitro diagnostic regents].
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.
Tian
Shaolei
S
Center for Drug Certification, State Food and Drug Administration, Beijing 100061. sltian1@yahoo.com.cn
D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation*; D007202:Indicators and Reagents / Q000592:standards*; D011785:Quality Assurance, Health Care; D011786:Quality Control
D007202:Indicators and Reagents