基于药品飞行检查探析中药生产质量管理

目的：分析总结影响中药生产质量的原因，提出改进意见，促进中药生产质量的安全可靠，进一步保证患者用药安全。方法：对原国家食品药品监督管理总局发布的2015年3月至2017年3月关于中药类生产企业飞行检查的情况进行统计，分析对比2015年与2016年飞行检查的结果，着重分析2016年飞行检查发现的生产质量问题。结果：中成药生产企业存在擅自改变生产工艺，中药材、中药饮片物料管理混乱，做不到药品全检等问题。且中药饮片和人工牛黄生产企业也存在类似问题。结论：中药生产企业必须承担起社会责任，加强生产制度建设；要推进中药材生产标准化、产业化、规模化；监管部门应转变监管理念，丰富监管手段，变革监管方式，坚持问题导向和风险防控，加大对重点企业、薄弱环节、问题线索的飞行检查，深挖风险隐患，为中药生产质量管理保驾护航。

On Quality Management of Traditional Chinese Medicine Production Based on Drug Flight Inspection

Objective: To analyze and summarize the reasons affecting the quality of traditional Chinese medicine production and to put forward suggestions for improvement in order to promote the safety and reliability of traditional Chinese medicine production and to ensure the medication safety for patients. Methods: Flight inspection results of enterprises producing traditional Chinese medicine from March 2015 to March 2017 issued by the former China Food and Drug Administration were analyzed statistically. The flight inspection results between 2015 and 2016 were compared and studied and the problems of production quality found in the flight inspection in 2016 were analyzed in particular. Results: There were some problems in the production of Chinese patent medicines, such as unauthorized change of production technology, improper management of Chinese medicinal materials and Chinese herbal pieces and the incomplete drug inspection, and so on. Similar problems also existed in the enterprises producing Chinese herbal pieces and artificial bezoar. Conclusion: The enterprises of producing traditional Chinese medicines should bear the social responsibilities for the construction of production system in order to promote standardization, industrialization and large-scale production. The supervision department should change the concept of supervision, enrich the means of supervision, change the way of supervision, adhere to problem orientation and risk prevention and control, promote the flight inspections into key enterprises, weak segments and problem clues, and thoroughly find out the risks and hidden problems in order to ensure the quality of traditional Chinese medicine production.