摘要
目的 本研究旨在通过对新修订《药品质量抽查检验管理办法》的分析和探讨,提出可行的应对举措和建议,推动药品抽检管理模式的创新。方法 结合药品抽检工作中的实际问题,对《药品质量抽查检验管理办法》中检验和复验相关条款的要求进行分析和梳理,由内而外对检验机构强化内部质量管理,以及对外提升服务监管提出了明确要求,围绕全面质量管理(TQM)理论中“人机料法环测”5M1E 6大要素,以实验室质量管理为基础,对检验报告形成过程中的检验人员,检验样品、检验项目及检验时限等要素进行讨论。就如何做好新时期的药品检验工作提出建议和对策。结果与结论 药品质量抽查检验是上市后药品监管的重要手段之一,各级药品检验机构对内部要强化全面质量管理,确保检验结果准确可靠,同时要通过探索性研究等风险预警形式,对外实现技术支撑,服务监管的根本目的。有助于检验机构进一步健全质量管理体系,加强对检验人员,检验样品、检验项目及检验时限等要素的管理,确保检验结果准确可靠,为加强药品监管提供技术支持。
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.
关键词
药品 /
质量抽查检验 /
检验 /
工作模式
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Key words
drug /
quality sampling and testing /
test /
working mode
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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 https://doi.org/10.11669/cpj.2020.23.004
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”[J]. Chinese Pharmaceutical Journal, 2020, 55(23): 1926-1931 https://doi.org/10.11669/cpj.2020.23.004
中图分类号：
R917
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参考文献
[1] NMPA. Notice of NMPA on printing and distributing the Regulations For Drug Quality Sampling and Testing ( No. 34 of 2019) [EB/OL]. (2019-08-19). http://www.nmpa.gov.cn/WS04/CL2196/357543.html.
[2] SAMSON D, TERZIOVSKI M. The relationship between total quality management practices and operational performance[J]. J Operations Manag, 1999, 17:393-409.
[3] KAYNAK H. The relationship between total quality management practices and their effects on firm performance[J]. J Operations Manag, 2003, 21:405-435.
[4] NIFDC. Annual Report of Medicine Post Market Quality Surveillance(2016)[EB/OL]. (2017-10-09). https://www.nifdc.org.cn/nifdc/fwzn/ypchytsxyj/gjypcynb/9872.html.
[5] NIFDC. Annual Report of Medicine Post Market Quality Surveillance(2017)[EB/OL]. (2018-06-05). https://www.nifdc.org.cn/nifdc/fwzn/ypchytsxyj/11119.html.
[6] NIFDC. Annual Report of Medicine Post Market Quality Surveillance(2018)[EB/OL]. [2019-08-07]. https://www. nifdc. org. cn/nifdc/fwzn/ypchytsxyj/20190807101035. html.
[7] NIFDC. Annual Report of Medicine Post Market Quality Surveillance(2019)[EB/OL]. (2020-03-23).https://www. nifdc. org. cn/nifdc/fwzn/ypchytsxyj/gjypcynb/20200323142400. html.
[8] Notice of the State Food and Drug Administration on Issuing the Guidelines for Quality Analysis of the National Drug Sampling Inspection[EB/OL]. [2014-07-09]. http://samr.cfda.gov.cn/WS01/CL0844/102814. Html.
[9] HAN L, NICHOLAS B, ZHENG Q, et al. US FDA's regulatory system for drug manufacturing quality [J]. Chin J New Drugs(中国新药杂志),2012, 21(18):2128-2135.
[10] DAVID F, JACQ K, SANDRA P, et al. Analysis of potential genotoxic impurities in pharmaceuticals by two dimensional gas chromatography with Deans switching and independent column temperature control using a low-thermal-mass oven module [J]. Anal Bioanal Chem, 2010, 396:1291-1300.
[11] FREDERICK G V, ALIREZA S K. Development of quality-by-design analytical methods [J]. J Pharm Sci, 2011, 100:797-812.
[12] KOCHLING J, BRIDGEWATER J, NAJI R. Introducing a science-based quality by design concept to analytical methods development. Biotechnology: Pharmaceutical Aspects (Pharmaceutical Stability Testing to Support Global Markets)[M]. Vol 12. New York: Springer, 2010: 169-179.
[13] PUERTOLLANO M, CARTWRIGHT T, AYLOTT M, et al. Assessing an analytical method for the dissolution profile of an extended-release tablet in accordance with QbD [J]. Tablets Capsules, 2009, 7:30-39.
[14] ZHU J L, YANG X, LI Z Y, et al. Development and prospect on the marketed drug sampling and testing for quality evaluation[J]. Chin J New Drugs(中国新药杂志),2015,24(16): 1810-1815.
[15] HU C Q. Strategy on quality evaluation of post-marketing antibiotics in China [J]. Chin J Antibiot(中国抗生素杂志),2013, 38(1):1-10.
[16] State Council. Regulations for the implementation of the drug administration law of the people's Republic of China [EB/OL]. (2005-08-02). http://www.gov.cn/banshi/2005-08/02/content_19275.htm.
[17] WANG J C. On the construction of "national defense system" of post marketing drug supervision [N]. China Pharm News(中国医药报),2019-05-27(003).
[18] Notice of the State Food and Drug Administration on Issuing the Supplementary Inspection Methods for 3 Drugs including Auramine O Inspection Items in Gongyankang Granules[EB/OL]. (2018-01-17). http://www.nmpa.gov.cn/WS04/CL2138/300488.html.
[19] NMPA. Notice of NMPA on five supplementary inspection methods including the inspection items of toddalolactone in Jinji pills[EB/OL]. (2020-02-10). http://www. nmpa. gov. cn/WS04/CL2138/374672. html.
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