中药饮片生产企业在质量管理方面的问题及建议

Problems and suggestions on quality management of the production enterprises of Chinese herbal pieces

目的研究中药饮片生产企业在药品GMP符合性检查中发现的检查缺陷,探讨中药饮片生产企业在质量管理方面存在的问题,为企业提升质量管理,确保产品质量提供借鉴和参考。方法以2020年82家次中药饮片生产企业GMP符合性检查中存在的缺陷为研究对象,采用分析归纳的方法对缺陷项目进行分析。结果与结论中药饮片生产企业在质量管理方面发现的严重缺陷所占比例最高,饮片生产企业应牢固树立质量主体责任意识,开展有针对性的改进措施,切实提升质量管理水平,确保中药饮片质量符合用药要求。

Objective To study the defects that found in GMP compliance inspection of Chinese herbal pieces and explore the problems of quality management,in order to provide reference for ensuring product quality.Methods The defects in the GMP compliance inspection of 82 Chinese herbal pieces production enterprises in 2020 were taken as the research object,and the defects were analyzed by the method of analysis and induction.Results and Conclusion The proportion of serious defects found in the quality management of Chinese herbal pieces production enterprises is the highest.Chinese herbal pieces production enterprises should firmly establish the sense of quality responsibility,carry out targeted improvement measures,effectively improve the quality management level,and ensure that the quality of Chinese herbal pieces meets the requirements of medication.