【摘要】 目的:在中药制剂生产过程中引入风险管理的理念和工具。方法:研究中药制剂生产与化学药品生产的差异，结合风险管控的特点进行匹配，使用鱼骨图、危害分析和关键控制点(hazard analysis and critical control points,HACCP)、失效模式与影响分析(failure mode and effects analysis,FMEA)等质量风险管理工具，并以某中药制剂生产企业为例，对其生产的中药制剂开展质量风险管理。结果:通过风险管控模式的引入，使整个中药制剂生产过程质量管控更加清晰，能够广泛识别不同方面的潜在危害，提高中药制剂的质量安全水平。结论:运用风险管理的理念和工具进行中药制剂生产与质量管控具有优势，值得推广应用。更多还原

【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.更多还原