On Quality Management of Traditional Chinese Medicine Production Based on Drug Flight Inspection

Cao Changying, Wen Zhanquan, Zhang Yanzhao, Jiang Xiaoqing, Liu Chuanxu

Chinese Pharmaceutical Affairs ›› 2018, Vol. 32 ›› Issue (11) : 1511-1514.

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Chinese Pharmaceutical Affairs ›› 2018, Vol. 32 ›› Issue (11) : 1511-1514. DOI: 10.16153/j.1002-7777.2018.11.010
Quality Management

On Quality Management of Traditional Chinese Medicine Production Based on Drug Flight Inspection

  • Cao Changying, Wen Zhanquan, Zhang Yanzhao, Jiang Xiaoqing, Liu Chuanxu
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Abstract

Objective: To analyze and summarize the reasons affecting the quality of traditional Chinese medicine production and to put forward suggestions for improvement in order to promote the safety and reliability of traditional Chinese medicine production and to ensure the medication safety for patients. Methods: Flight inspection results of enterprises producing traditional Chinese medicine from March 2015 to March 2017 issued by the former China Food and Drug Administration were analyzed statistically. The flight inspection results between 2015 and 2016 were compared and studied and the problems of production quality found in the flight inspection in 2016 were analyzed in particular. Results: There were some problems in the production of Chinese patent medicines, such as unauthorized change of production technology, improper management of Chinese medicinal materials and Chinese herbal pieces and the incomplete drug inspection, and so on. Similar problems also existed in the enterprises producing Chinese herbal pieces and artificial bezoar. Conclusion: The enterprises of producing traditional Chinese medicines should bear the social responsibilities for the construction of production system in order to promote standardization, industrialization and large-scale production. The supervision department should change the concept of supervision, enrich the means of supervision, change the way of supervision, adhere to problem orientation and risk prevention and control, promote the flight inspections into key enterprises, weak segments and problem clues, and thoroughly find out the risks and hidden problems in order to ensure the quality of traditional Chinese medicine production.

Key words

traditional Chinese medicine production;Chinese medicinal materials and Chinese herbal pieces;good manufacturing practice;flight inspection

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Cao Changying, Wen Zhanquan, Zhang Yanzhao, Jiang Xiaoqing, Liu Chuanxu. On Quality Management of Traditional Chinese Medicine Production Based on Drug Flight Inspection[J]. Chinese Pharmaceutical Affairs, 2018, 32(11): 1511-1514 https://doi.org/10.16153/j.1002-7777.2018.11.010

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