基于WHO疫苗国家监管体系评估等标准和指南要求对OOS分析工作的思考  

Consideration on OOS Analysis Work Based on the Requirements of WHO Benchmarking of the Assessment of the National Regulatory Authority for Vaccines

作　　者：张姮婕 刘雅丹[2] 马晶 李炎 蒋佳兴 秦力 林涛 杨蕾 崔学文 徐苗[2] 项新华[2] ZHANG Heng-jie;LIU Ya-dan;MA Jing;LI Yan;JIANG Jia-xing;QIN Li;LIN Tao;YANG Lei;CUI Xue-wen;XU Miao;XIANG Xin-hua(Sichuan Institute for Drug Control,NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products,SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products;National Institutes for Food and Drug Control)

机构地区：[1]四川省药品检验研究院,国家药品监督管理局疫苗及生物制品质量控制与评价重点实验室,四川省药品监督管理局生物制品质量监测与风险评估重点实验室 [2]中国食品药品检定研究院

出　　处：《中国食品药品监管》2024年第5期70-77,共8页China Food & Drug Administration Magazine

摘　　要：随着我国通过世界卫生组织(WHO)疫苗国家监管体系(NRA)评估,以及疫苗批签发能力建设的不断推进,越来越多的省级药品检验机构陆续加入疫苗批签发体系。本文基于WHO疫苗NRA评估要求,结合国际上疫苗相关主要法规或指南,探讨疫苗及药品检验结果超标(OOS)分析工作中需要重点关注和易混淆的内容,以期对相关人员开展工作有所启示。As China has passed the WHO assessment of the National Regulatory Authority(NRA)for vaccines and has advanced in building national lot release capacity,an increasing number of provincial drug control laboratories are joining the vaccine lot release system.This article aims to discuss the key areas of focus and potential confusion in out-of-specification(OOS)analysis work based on the requirements of WHO benchmarking of the assessment of NRA for vaccines and other major international regulations or guidelines,in order to provide insights for relevant personnel.

关 键 词：疫苗 世界卫生组织 国家监管体系 检验结果超标 法规 指南 

分 类 号：R95[医药卫生—药学]