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Application of quality risk control in the production of traditional Chinese medicine preparations
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Zhen WANG1, Xin CUI2, Yi LIANG1, *
Chinese Journal of New Drugs | 2025, 34(17) : 1793 - 1801
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Chinese Journal of New Drugs | 2025, 34(17): 1793-1801
Application of quality risk control in the production of traditional Chinese medicine preparations
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Zhen WANG1, Xin CUI2, Yi LIANG1, *
Affiliations
  • 1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
  • 2Market Supervision and Administration Bureau of Wuzhong, Suzhou 215128, China
Published: 2025-09-15 doi: 10.20251/j.cnki.1003-3734.2025.17.001
Outline
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Objective:

To introduce the concepts and tools of risk management in the production process of traditional Chinese medicine preparations.

Methods:

The differences between the productions of traditional Chinese medicine preparations and chemical drugs were studied. Combined with the characteristics of risk management and control, a match was made. Quality risk management tools such as fishbone diagrams, hazard analysis and critical control points (HACCP), as well as failure mode and effects analysis (FMEA) were used. Taking a certain traditional Chinese medicine preparation production enterprise as an example, quality risk management was carried out on the traditional Chinese medicine preparations it produced.

Results:

Through the introduction of the risk management model, the quality control of the entire production process of traditional Chinese medicine preparations has become clearer, enabling the identification of potential hazards in various aspects on a wide scale, thus improving the quality and safety level of traditional Chinese medicine preparations.

Conclusion:

The production and quality control of traditional Chinese medicine preparations with the concept and tools of risk management has comparative advantages and is worth popularizing.

quality risk management  /  Chinese medicine preparations  /  failure mode and effects analysis  /  hazard analysis and critical control points  /  fishbone diagram
Zhen WANG, Xin CUI, Yi LIANG. Application of quality risk control in the production of traditional Chinese medicine preparations[J]. Chinese Journal of New Drugs, 2025 , 34 (17) : 1793 -1801 . DOI: 10.20251/j.cnki.1003-3734.2025.17.001
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Year 2025 volume 34 Issue 17
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Article Info
doi: 10.20251/j.cnki.1003-3734.2025.17.001
  • Online Date：2026-03-06
  • Published：2025-09-15
Article Data
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History
  • Accepted：2025-03-03
Affiliations
    1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
    2Market Supervision and Administration Bureau of Wuzhong, Suzhou 215128, China
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https://castjournals.cast.org.cn/joweb/zgxyzz/EN/10.20251/j.cnki.1003-3734.2025.17.001
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多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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