兽用中化药生产企业GMP监督检查情况分析与思考  

Analysis and Reflection of GMP Inspections in Veterinary Chemical Pharmaceutical Enterprises and Chinese Traditional Medicine Enterprises

作　　者：陈莎莎[1] 张珩[1] 周晓翠 安洪泽[1] 吴涛[1] CHEN Sha-sha;ZHANG Heng;ZHOU Xiao-cui;AN Hong-ze;WU Tao(China Institute of Veterinary Drug Control,Beijing 100081,China)

机构地区：[1]中国兽医药品监察所(农业农村部兽药评审中心),北京100081

出　　处：《中国兽药杂志》2024年第11期39-42,共4页Chinese Journal of Veterinary Drug

摘　　要：对近年来中国兽医药品监察所组织实施的兽用中化药企业GMP监督检查发现的缺陷项目进行统计和分析,研究企业在生产质量管理中存在的主要问题并提出建议,以期帮助兽药生产企业提高自身GMP执行水平,确保产品质量,并为兽药监管部门提供参考。This paper analyzes the defects found in GMP inspection of veterinary drug manufacturing enterprises organized by China Institute of Veterinary Drug Control in recent years,studies the problems existing in the quality management of enterprises,and proposes suggestions,aiming to help enterprises improve GMP implementation level and provide reference for regulatory agencies.

关 键 词：兽药GMP 飞行检查 监督检查 缺陷 

分 类 号：S859.79[农业科学—临床兽医学]