药品质量控制实验室WHO-PQ中仪器设备管理经验探讨  

Discussion on the equipment management experience in WHO-PQ of pharmaceutical quality control laboratory

作　　者：王冠杰[1] 刘博[1] 洪婧 张中天 韩冬晴 张嘉澍 季士委[1] 王岩[1] WANG Guanjie;LIU Bo;HONG Jing;ZHANG Zhongtian;HAN Dongqing;ZHANG Jiashu;JI Shiwei;WANG Yan(National Institute for Food and Drug Control,Beijing102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国医药导报》2025年第9期172-175,共4页China Medical Herald

摘　　要：世界卫生组织预认证(WHO-PQ)体系是药品检测机构能力评价和提升的有效手段,仪器设备是WHO-PQ的重要构成因素。通过分析2012—2024年WHO-PQ中仪器设备不符合项,发现主要存在管理文件不齐全,验证频次、参数或范围不全,安全管理不规范,标识不规范,软件验证不完善等方面问题,分析原因并归纳WHO-PQ对仪器设备评审要素要求,总结了预认证前期准备、现场检查、后续整改等在仪器设备方面经验,为药品检测机构申请WHO-PQ提供参考。World Health Organization prequalification(WHO-PQ)system is an effective means of evaluating and enhancing the capabilities of drug testing institutions,and equipment is important components of WHO-PQ.By analyzing the non-conformance items of equipment in the WHO-PQ from 2012 to 2024,it was found that the main problems were incomplete management documents,incomplete verification frequency,parameters or scope,non-standard safety management,non-standard labeling,and incomplete software verification.The reasons were analyzed and the requirements for equipment review elements in WHO-PQ were summarized.The experience in equipment preparation,on-site inspection,and subsequent rectification in precertification was summarized,providing reference for drug testing institutions to apply for WHO-PQ.

关 键 词：世界卫生组织预认证 实验室 仪器设备 质量管理 

分 类 号：R951[医药卫生—药学]