我国药品领域能力验证活动的现状研究及建议  

Study on Proficiency Testing Development in Chinese Pharmaceutical Sector

作　　者：刘雅丹[1] 王菲菲[1] 赵萌 项新华[1] 于欣[1] Liu Yadan;Wang Feifei;Zhao Meng;Xiang Xinhua;Yu Xin(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2021年第8期899-907,共9页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院中青年发展基金(编号2019G)。

摘　　要：目的:为药品领域能力验证活动现状中存在的问题提出建议。方法:梳理2015年以来国内7家能力验证提供者能力验证活动的组织情况。结果与结论:我国现阶段经认可的能力验证提供者提供的能力验证计划数目逐年增加,基本可以解决能力验证活动可获得性的问题。但是能力验证的参加者和组织方在参与或组织能力验证活动过程中仍反映出一些问题。例如:参加者在参加能力验证活动时主动参与意识较弱、倾向于参加难度较低的能力验证计划及对不满意结果的认识不足等;能力验证提供者在组织过程中提供的项目存在聚堆、连续性不足以及评价标准不一的情况等。本文针对能力验证的现状中出现的问题给出合理化建议。Objective:To analyze the progress and discover problems on Proficiency Testing(PT)in Chinese drug testing sector.Method:The implementation of PT activities by 7 proficiency testing providers since 2015 was sorted and summarized.Results and Conclusion:The number of proficiency testing plans provided by accredited proficiency testing providers in China is increasing year by year.These PTs guarantee the availability of PT activities.However,some problems were found during the participation or organization of PT activities.For example,participants are still lack of initiative,tend to take part in simple schemes,and are short of adequate knowledge of PT activities.Proficiency Testing Providers may provide similar schemes at the same time,organize the schemes without continuity or evaluate the results with different criteria etc.This paper gives reasonable suggestions for the problems found in the current situation of proficiency testing.

关 键 词：能力验证 药品领域 现状 问题 

分 类 号：R95[医药卫生—药学]