中国药业2024，Vol.33Issue(13)：34-37,4.DOI:10.3969/j.issn.1006-4931.2024.13.009
中药生产企业检查中存在问题及监管建议
Problems in the Inspection of Traditional Chinese Medicine Production Enterprises and Suggestions for Supervision
吕谦 1黄玉兰1
作者信息
- 1. 四川省泸州市市场检验检测中心,四川 泸州 646000
- 折叠
摘要
Abstract
Objective To provide a reference for the drug administration departments to strengthen supervision of traditional Chinese medicine(TCM)production enterprises.Methods The problems existing in the inspection of TCM production enterprises were summarized,and the targeted suggestions for supervision were put forward.Results Due to inadequate understanding of the Good Manufacturing Practice of Medical Products(GMP),there were some problems such as differences in drying methods that affected the quality of TCM decoction pieces,risks in the production management of toxic TCM decoction pieces for medical use,difficulties in processing cutting fresh TCM decoction pieces in planting area,and a lack of a dedicated and unified quality evaluation system for the process of TCM decoction pieces during the inspection of TCM production enterprises.Conclusion It is recommended that drug administration departments develop exclusive quality evaluation methods and standards,and establish standardized production lines for TCM decoction pieces;remove the restrictions on the varieties of cutting fresh TCM decoction pieces and ensure that the quality of the products can be traced and supervised throughout the entire process;improve the categories and scope of drug production licenses to prevent risks in the production of toxic TCM decoction pieces;strengthen research on common problems and improve the inspection ability of supervision personnel;utilize intelligent supervision measures to improve the efficiency of supervision and inspection.关键词
中药生产企业/药品检查/药品/监管Key words
traditional Chinese medicine production enterprises/drug inspection/drug/supervision分类
医药卫生引用本文复制引用
吕谦,黄玉兰..中药生产企业检查中存在问题及监管建议[J].中国药业,2024,33(13):34-37,4.
