构建满足WHO-NRA评估要求的疫苗质量控制实验室质量管理体系的研究  

Study on the Construction of Quality Management System of Vaccine Quality Control Laboratory Meeting the Evaluation Requirements of WHO-NRA

作　　者：陆明[1] 顾颂青[1] 项新华[2] Lu Ming;Gu Songqing;Xiang Xinhua(Shanghai Institute for Food and Drug Control,Shanghai 201203,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]上海市食品药品检验所,上海201203 [2]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2020年第12期1378-1383,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:通过对比ISO/IEC 17025与世界卫生组织疫苗国家监管体系评估(WHO-NRA)采用的全球基准评估工具(GBT)中实验室板块(LT)的差异,为我国疫苗检测实验室建立质量管理体系提供理论依据,构建既符合ISO/IEC 17025,又满足WHO-NRA要求的质量管理体系。方法:对ISO/IEC 17025:2017中的8项大条款28项小条款和GBT-LT中的10项大指标28项亚指标进行比较研究。结果:GBT-LT有20项亚指标基本与ISO 17025对应,主要涉及组织机构、分析程序、参考标准、人力资源、设备设施、监管流程、能力验证、健康与安全、分包;有8个亚指标是全新的要求,即疫苗国家批签发机构(LT0101)、支持疫苗监管的文件化程序(LT0202)、基于风险控制原则的产品检验策略(LT0301)、OOS(LT0304)、透明度(LT0701)、医疗产品数据库(LT0801)、绩效指标KPI(LT0804)和免疫监测(LT0903)。结论:我国疫苗检验实验室可以以ISO/IEC17025:2017为基础建立实验室质量管理体系,纳入GBT-LT板块中的新要求,实现在现有基础之上满足WHO-NRA要求的质量管理体系。Objective: To compare the differences of Laboratory Testing(LT) between ISO/IEC 17025 and the World Health Organization(WHO) Global Benchmarking Tool(GBT), so as to provide theoretical basis for the establishment of quality management system for vaccine testing laboratories in China, and to construct a quality management system that meets the requirements of ISO/IEC 17025 and WHO-NRA. Methods: A comparative study was conducted among 8 major clauses and 28 sub clauses in ISO/IEC 17025: 2017 and 10 major clauses and 28 sub clauses in GBT-LT. Results: There were 20 sub indexes in GBT-LT, which were similar according to ISO 17025(mainly involving organization, analysis procedures, reference standards, human resources, equipment and facilities, regulatory process, proficiency testing, health and safety, and subcontracting). The 8 sub indicators were new requirements, namely the National Vaccine approval authority(LT0101), documented procedures supporting vaccine supervision(LT0202), product inspection strategy based on risk control principle(LT0301), OOS(LT0304), transparency(LT0701), medical products database(LT0801), performance indicators KPI(LT0804) and immune monitoring(LT0903). Conclusion: China’s vaccine testing laboratories could establish a laboratory quality management system based on ISO/IEC 17025:2017 and incorporate the new requirements in GBT-LT to achieve a quality management system that meets the requirements of WHO-NRA on the existing basis.

关 键 词：疫苗检验实验室 全球基准评估工具 ISO/IEC 17025 质量管理体系 

分 类 号：R95[医药卫生—药学] R155.51