疫苗生产场地变更质量可比性研究的总体思考  

Comments and recommendations on comparability of vaccines related to manufacturing site changes: quality issues

作　　者：李敏[1] 高恩明[1] 罗建辉[1] 尹红章[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国生物制品学杂志》2013年第2期289-291,296,共4页Chinese Journal of Biologicals

摘　　要：由于疫苗生产产业化和法规升级等因素的要求,疫苗生产场地需要进行变更。可比性研究有利于控制场地变更对疫苗安全性、有效性带来的风险,是变更成功的桥梁。本文结合国内外技术指导原则的解读和疫苗产品的特点,对我国疫苗场地变更的质量可比性研究作一综述。Increase in product yield and complementation of the requirement of national regulatory agency are driving to site changes of vaccines. Comparability exercise is the bridge to a successful change, which would ascertain that introduction of the manufacturing site change did not alter the safety and efficacy profile of the product, This paper introduced the core element of the international guideline, and put forwards considerations on designing and fulfilling comparability study regards to vaccine quality assessment.

关 键 词：疫苗 场地变更 可比性 

分 类 号：R392.33[医药卫生—免疫学]