国家药品抽检检验机构实验室管理风险点分析及对策  

Risk Analysis and Countermeasures of Laboratory Management of National Drug Sampling and Testing Institutions

作　　者：朱嘉亮[1] 郗昊 冯磊[1] 徐苗[1] 顾颂青 李睿 孙婷 陈蕾[5] ZHU Jialiang;XI Hao;FENG Lei;XU Miao;GU Songqing;LI Rui;SUN Ting;CHEN Lei(National Institutes for Food and Drug Control,Beijing 102629,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Jiangsu Institute for Food and Drug Control,Nanjing 210019,China;Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050200,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]上海市食品药品检验研究院,上海201203 [3]江苏省食品药品监督检验研究院,南京210019 [4]河北省药品医疗器械检验研究院,石家庄050200 [5]国家药典委员会,北京100061

出　　处：《医药导报》2025年第1期68-72,共5页Herald of Medicine

基　　金：中国药品监管研究会课题(2024-Y-Y-014);国家药品监督管理局药品监管科学体系建设重点项目(RS2024Z006-106)。

摘　　要：目的通过梳理近年来国家药品抽检检验流程中潜在风险因素,针对质量管理体系运行情况,对检验机构如何在新的药品监管模式下做好抽检工作提出建议。方法以考察数据完整性、真实性为重点,重点围绕试剂管理、标准物质管理、仪器设施管理、电子数据管理等风险点进行分析,对质量管理体系运行的有效性等进行全面核查。结果国家药品抽检检验机构应强化全面质量管理,根据本实验室运行情况,结合各自风险特点,在试剂管理、标准物质管理、仪器设施管理、电子数据管理等方面的风险进行系统梳理并建立风险提示功能,制定风险警示清单,实施相应的风险控制策略。结论检验机构应继续加强对运行过程中影响因素的有效控制,重视各项检测工作的关键控制点,持续规范和完善检验过程的质量体系,确保各项质量活动处于受控状态。Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.

关 键 词：国家药品抽检 实验室管理 风险点分析 

分 类 号：R95[医药卫生—药学] R927.11