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

作　　者：吕谦 黄玉兰 LYU Qian;HUANG Yulan(Luzhou Market Inspection and Testing Center,Luzhou,Sichuan,China 646000)

机构地区：[1]四川省泸州市市场检验检测中心,四川泸州646000

出　　处：《中国药业》2024年第13期34-37,共4页China Pharmaceuticals

摘　　要：目的为药品监督管理部门加强对中药生产企业的监管提供参考。方法总结中药生产企业检查中存在的问题,并提出有针对性的监管建议。结果由于对《药品生产质量管理规范》等理解不到位,中药生产企业检查中存在干燥方法差异影响饮片质量,医疗用毒性中药饮片生产管理风险,趁鲜切制类中药饮片产地加工困境,中药饮片缺乏专属、统一的炮制质量评价体系等问题。结论建议药品监管部门制订专属性强的质量评价方法及标准,建立规范化的中药饮片生产线;放开趁鲜加工品种限制,实现质量全程可追溯监管;完善药品生产许可证类别和范围,防范毒性饮片生产风险;加强共性问题研究,提高监管人员的检查能力;运用智慧监管手段,提升监督检查效能。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 

分 类 号：R932[医药卫生—生药学] R288[医药卫生—药学]