Analysis of the Requirements for Inspection Work in the Newly Revised “Regulations for Drug Quality Sampling and Testing”
ZHU Jia-liang1, LIU Wen1, WANG Ju-cai2, HU Jun3, LI Zhe-yuan4, YANG Yue5, ZHU Jiong1*, CHEN Lei6*
1. National Institutes for Food and Drug Control, Beijing 102629, China; 2. Hainan Institute for Drug Control, Haikou 570216, China; 3. Shanghai Institute for Food and Drug Safety, Shanghai 200233, China; 4. Yunnan Institute for Food and Drug Control, Kunming 650106, China; 5. Institute of Drug Regulatory Sciences, Shenyang Pharmaceutical University,Shenyang 110016, China; 6. Chinese Pharmacopoeia Commission, Beijing 100061, China
Abstract：OBJECTIVE To propose feasible measures and suggestions through analysis and discussion of the newly revised “Regulations for Drug Quality Sampling and Testing” to promote the innovation of the management mode of drug spot inspection. METHODS Combined with the practical problems in drug sampling test, the requirements of drug test and retest related to the “Regulations for Drug Quality Sampling and Testing” were analyzed and discussed, and clear requirements were put forward for strengthening internal quality management of inspection institutions from the inside out, and improving service supervision from the outside, focusing on the six essentials of "human-machine material method environmental testing" 5M1E in the theory of total quality management (TQM). Based on the laboratory quality management, this paper discussed the inspectors, inspection samples, inspection items, inspection time limit and other factors that affect the quality during the formation of inspection reports. Suggestions and measures were put forward on how to perform high quality drug inspection work in the new period. RESULTS AND CONCLUSION Drug sampling is an important part of drug sampling as well as the starting point of drug supervision work. Drug inspection institutions should strengthen the overall quality management internally to ensure the accuracy and reliability of the inspection results. At the same time, they should realize the basic purpose of technical support and service supervision, externally through the forms of risk pre-warning, such as exploratory research. It is helpful for inspection institutions to improve the quality management system, strengthen the management of inspection personnel, inspection samples, inspection items, inspection time limit and other elements, to ensure the accuracy and reliability of inspection results, and provide technical support for strengthening drug supervision.
朱嘉亮, 刘文, 王巨才, 胡骏, 李哲媛, 杨悦, 朱炯, 陈蕾. 浅析新修订《药品质量抽查检验管理办法》对检验工作的要求[J]. 中国药学杂志, 2020, 55(23): 1926-1931.
ZHU Jia-liang, LIU Wen, WANG Ju-cai, HU Jun, LI Zhe-yuan, YANG Yue, ZHU Jiong, CHEN Lei. Analysis of the Requirements for Inspection Work in the Newly Revised “Regulations for Drug Quality Sampling and Testing”. Chinese Pharmaceutical Journal, 2020, 55(23): 1926-1931.
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2020, Vol. 55 
