Abstract：OBJECTIVE To evaluate the ability level of drug detection in laboratories nationwide, so that the regulatory agencies can get the proficiency status of drug inspection laboratories and the laboratories can improve the detection ability level through the analysis and study on the capability results of NIFDC-PT-139 and NIFDC-PT-182. METHODS Statistical analysis and summary were made on the satisfaction rate of results, problems found,key technical points, the laboratory types and capability results of the two proficiency testing projects. RESULTS The result satisfaction rates of provincial drug control institutions were 100.0% (NIFDC-PT-139) and 93.5% (NIFDC-PT-182), the rates of municipal drug control institutions were 71.3% (NIFDC-PT-139) and 81.9% (NIFDC-PT-182), the rates of enterprise laboratories were 75.0% (NIFDC-PT-139) and 79.3% (NIFDC-PT-182), the rates of other laboratories were 55.6% (NIFDC-PT-139) and 58.3% (NIFDC-PT-182). CONCLUSION The successful implementation of the two plans has provided the laboratories with effective external quality control means, as well as the first-hand reference for regulatory authorities on the capacity of nationwide drug laboratories. The detection abilities of drug testing laboratories are basically good, and the management and technical capacity of some laboratories need to be improved.
陆继伟, 陈祝康, 杨美成, 项新华. 两项国家药品监督管理局理化检测能力验证结果分析[J]. 中国药学杂志, 2020, 55(23): 1913-1918.
LU Ji-wei, CHEN Zhu-kang, YANG Mei-cheng, XIANG Xin-hua. Proficiency Results of Two NMPA's Physical and Chemical Proficiency Testing Programs. Chinese Pharmaceutical Journal, 2020, 55(23): 1913-1918.