PIC/S体系对我国兽药GMP检查员队伍建设的启示OA
Implications of the PIC/S System for Building a Veterinary Drug GMP Inspector Team in China
本文系统梳理了药品检查合作计划(PIC/S)检查员培训体系及其审计清单中关于检查员管理的要求,结合我国兽药 GMP 检查员的管理现状,提出通过拓宽多元化培训方式、推进检查员分级分类管理、加快专业化检查员队伍建设进程等举措,不断提升检查员专业化水平和监管效能,为兽药产业高质量发展提供有力支撑.
This paper systematically reviews the Pharmaceutical Inspection Co-operation Scheme(PIC/S)inspector training system and the requirements for inspector management as outlined in its audit checklist.In light of the current management practices for veterinary drug GMP inspectors in China,it proposes measures such as diversifying training methods,promoting tiered and categorized management of inspectors,and accelerating the development of a professional inspector workforce.These initiatives aim to continuously enhance the expertise of inspectors and improve regulatory efficiency,thereby providing strong support for the high-quality development of the veterinary drug industry.
宫爱艳;周晓翠;张欣玉;陈莎莎;张珩;范强
中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
农业科技
药品检查合作计划(PIC/S)兽药GMP检查员培训体系队伍建设
PIC/Sveterinary drug GMPtraining systemteam building
《中国兽药杂志》 2026 (5)
59-65,7
中国兽医药品监察所兽药行业公益性重点专项"药品检查合作计划组织(PIC/S)技术标准和指南研究"与"国内外兽药创新和前沿技术研究"(GY202415)
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