浅谈疫苗批签发资料审核关键点  

Discussion on the key points of review of summary protocols in vaccine lot release

作　　者：徐宏山[1] 刘欣玉[1] 岳广智[1] 杨立宏[1] 李玉华[1] 叶强[1] XU Hongshan;LIU Xinyu;YUE Guangzhi;YANG Lihong;LI Yuhua;YE Qiang(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药品标准》2023年第5期556-560,共5页Drug Standards of China

摘　　要：目的:践行疫苗全生命周期最严格监管和质量控制,总结批签发资料审核的重点和关键点,为疫苗批签发资料审核工作和省级药品检验机构疫苗批签发能力巩固和提升提供借鉴。方法:围绕《生物制品批签发管理办法》中资料审核相关法规的内容,结合多年积累的疫苗批签发资料审核经验,对批签发资料审核过程中的重点和关键点进行总结、分析和研究。从批签发实施和能力提升角度,对资料审核的实施依据、资料审核的重点、关键点和资料审核常见问题举例等方面深入阐述。结果和结论:批签发资料审核过程中应将工艺参数、质量标准、检验结果和趋势分析等信息作为审核重点和关键点。资料审核能够发现和解决疫苗生产和检验过程中出现的问题,可作为疫苗上市前生产验证和质量控制的手段。本文可为其他生物制品资料审核提供参考。Objective:To practice the strictest supervision and quality control throughout the entire life cycle of vaccines,summarize the key points of summary protocols review in order to provide reference for the review in vaccine lot release and consolidation and improvement of the capacity of provincial drug inspection institutions.Methods:Focusing on the content of relevant laws and regulations on summary protocols review in the Management of Lot Release of Biological Products,combining with the year′s of experience in the review of vaccine lot release,the points of vaccine lot release review were summarized,analyzed and studied.From the perspective of implementation and capability improvement in lot release,the implementation basis,key points and examples of common problems in review were discussed in detail.Results and Conclusion:In the process of summary protocols reviewing,the information of process parameters,quality standards,test results,and trend analysis should be taken as key points.The review of summary protocols can find and solve problems in vaccine production and testing,and can be used as a means of vaccine production validation and quality control before marketing by National Regulatory Authority or National Central Laboratory.This study can provide reference for the summary protocols review of other varieties of biological products.

关 键 词：批签发 资料审核 重点和关键点 疫苗 

分 类 号：R921.2[医药卫生—药学]