Application of quality risk control in the production of traditional Chinese medicine preparations
WANG Zhen
CUI Xin
LIANG Yi
Abstract：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.
Keywords：quality risk managementChinese medicine preparationsfailure mode and effects analysishazard analysis and critical control pointsfishbone diagram
Publication Date：2025-09-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 1793-1801 )