基于内外审结果对比的药品领域能力验证体系内审有效性评价探析  

Evaluation of Internal Audit Effectiveness of Proficiency Testing System in the Pharmaceutical Field Based on the Comparison of Internal and External Audit Results

作　　者：刘雅丹[1] 王迪 赵萌 乔涵 高晓明 项新华[1] Liu Yadan;Wang Di;Zhao Meng;Qiao Han;Gao Xiaoming;Xiang Xinhua(National Institutes for Food and Drug Control,Beijing 102629,China;Jiangsu Food and Drug Inspection and Research Institute,Nanjing 210019,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]江苏食品药品监督检验研究院,南京210019

出　　处：《中国药事》2025年第3期293-299,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:为提高药品领域能力验证内审活动的有效性,通过比较内审与外审结果,探索一种新的内审有效性评估方法。方法:采用描述性统计和比较分析方法,分析2020-2024年中国食品药品检定研究院能力验证提供者体系内审的相关发现,并与外审结果进行对比研究。结果与结论:2020-2024年内审发现的48个不符合项分布于13个要素,外审的39个不符合项涉及6个要素,其中报告和文件控制在内外审关键要素中重合。研究发现内审在日常管理环节作用显著,但能力验证计划设计审核存在不足,外审结果有力验证了内审在部分要素改进的有效性,且内外审互补性强,为后续优化内审工作提供了重要方向。Objective:To boost the effectiveness of internal audits in proficiency testing(PT)within the pharmaceutical field by exploring a new method for evaluating internal audit effectiveness by contrasting the results of internal and external audits.Methods:Descriptive statistics and comparative analysis methods were utilized to thoroughly dissect the relevant discoveries from the internal audits of the proficiency testing provider(PTP)system at the National Institutes for Food and Drug Control during 2020-2024,and a detailed comparison was made with the external audit findings.Results and Conclusion:From 2020 to 2024,48 nonconformities were unearthed in the internal audits,spreading across 13 elements,while 39 nonconformities were spotted in the external audits,covering 6 elements.Significantly,report and document control are the two prominent overlapping elements in the distribution of nonconformities between the internal and external audits.It is found that the internal audit plays a substantial role in daily management;yet,there are shortcomings in the audit of proficiency testing scheme design.The external audit results convincingly confirm the effectiveness of the internal audit in enhancing some elements,and a strong complementarity exists between the internal and external audits,thus offering vital directions for the subsequent optimization of internal audit work.

关 键 词：能力验证 体系 内审 有效性 

分 类 号：R95[医药卫生—药学]