加入PIC/S对我国职业化专业化药品检查员队伍建设的思考  

Reflection on the Construction of China's Professional and Specialized Team of Drug Inspectors by Joining PIC/S

作　　者：李海山 刘莹莹 杨宇 Li Haishan;Liu Yingying;Yang Yu(Center for Food and Drug Inspection of Yunnan Province,Kunming 650500,China)

机构地区：[1]云南省食品药品审核查验中心,昆明650500

出　　处：《中国药事》2024年第8期869-875,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:对我国职业化专业化药品检查员队伍建设进行深入思考,以期为早日加入PIC/S国际组织,实现我国药品检查国际化,促进我国医药行业走向世界提供参考与借鉴。方法:对照PIC/S审计清单中对检查员要求的模块,概述PIC/S对检查员的要求,对我国检查员队伍现状进行分析,对我国职业化专业化药品检查员队伍建设进行深入思考。结果与结论:为加快建立职业化专业化药品检查员队伍,以满足PIC/S对药品检查员的要求,应扩大职业化专职化检查员的规模,深入推进检查员的分级分类管理。同时,需要建立高素质的检查员培养模式,以提升其检查能力。此外,还应建立具有职业特点的职称评审体系,并完善检查员的薪酬待遇保障机制和激励机制,以充分调动检查员提升能力的积极性和主动性,为我国早日加入PIC/S提供坚实保证。Objective:Through in-depth thinking on the construction of professional and specialized team of drug inspectors in China,to provide reference and inspiration for joining the PIC/S international organization as soon as possible,realizing the internationalization of drug inspection in China,and promoting the internationalization of China's pharmaceutical industry.Methods:By comparing the modules required for inspectors in the PIC/S audit checklist,the requirements of PIC/S for inspectors were summarized,the current situation of the team for inspectors in China was analyzed,and the construction of China's professional and specialized team of drug inspectors was deeply considered.Results and Conclusion:In order to accelerate the establishment of a professional and specialized team of drug inspectors to meet the requirements of PIC/S,the scale of professional and full-time inspectors should be expanded,and the hierarchical and classified management of inspectors should be deeply promoted.At the same time,a high-quality inspector training model to enhance their inspection capabilities should be establishsd.In addition,a professional title evaluation system with professional characteristics should be established,with improving the salary guarantee mechanism and incentive mechanism for inspectors to fully mobilize their enthusiasm and initiative to improve their abilities.These measures will provide a solid guarantee for China's early accession to PIC/S.

关 键 词：药品检查合作计划 职业化专业化 药品检查员 队伍建设 

分 类 号：R95[医药卫生—药学]