中药材生产质量管理规范延伸检查的实践与思考  

Practice and Reflection on Extended Inspection Under Good Agricultural Practice for Chinese Crude Drugs

作　　者：徐贻权 莫结丽 严振 曾祥卫 欧阳蒲月[3] 赖盼 郑聪敏 XU Yi-quan;MO Jie-li;YAN Zhen;ZENG Xiang-wei;OUYANG Pu-yue;LAI Pan;ZHENG Cong-min(Evaluation and Inspection Center of Guangdong Medical Products Administration;Guangdong Medical Products Administration;Guangdong Food and Drug Vocational College)

机构地区：[1]广东省药品监督管理局审评认证中心 [2]广东省药品监督管理局 [3]广东食品药品职业学院

出　　处：《中国食品药品监管》2025年第2期118-127,共10页China Food & Drug Administration Magazine

摘　　要：坚持“六统一”,控制中药材生产和质量的各种影响因素,规范中药材生产全过程,中药材全产业链质量可追溯,是中药材生产质量管理规范(GAP)的核心。本文通过对广东省中药材GAP延伸检查情况进行统计与分析,聚焦延伸检查的内容与流程,探讨了中药材GAP基地建设工作中的亮点、普遍存在的问题和需要重视的问题,并对中药材GAP实施与基地建设工作提出了思考。中药材GAP基地投入恰当合理、运作模式规范适用,中药材品质稳定可控、安全、有效,中药材产业才能可持续发展,进而加强中药全产业链质量管理,推动中药产业高质量发展,促进中医药传承创新发展。Ensuring the"six unifications",controlling key factors affecting the production and quality of Chinese medicinal materials,standardizing the entire production process,and achieving full traceability across the supply chain are core principles of good agricultural practice(GAP)for traditional Chinese medicine(TCM).This paper presents an analysis of GAP extended inspections conducted in Guangdong Province,focusing on key inspection aspects and processes.It highlights best practices,common challenges,and critical issues in GAP base construction and offers recommendations for improvement.A wellstructured and appropriately invested GAP base,supported by a standardized operating model,is essential to ensuring stable,controllable,safe,and effective TCM quality.Strengthening GAP implementation and base development is crucial for sustainable industry growth,improving supply chain quality management,and promoting the high-quality development of the TCM industry.

关 键 词：中药材 生产质量管理规范 延伸检查 广东省 工作思考 

分 类 号：R95[医药卫生—药学]