疫苗类批签发检验流程中的风险点控制分析  

Analysis of Risk Point Control in the Batch Issuance and Inspection Process for Vaccines

作　　者：丁文静 顾颂青 陆明 沈漪 伍恒 Ding Wenjing;Gu Songqing;Lu Ming;Shen Yi;Wu Heng(Shanghai Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验研究院,上海201203

出　　处：《中国药事》2024年第2期143-146,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:在疫苗类批签发实验室建立风险点控制,保证最终检验数据和结果准确、合规。方法:依据批签发检验流程中各个环节及涉及的因素,结合实验室一线的实践操作,通过监督检查的方式,发现风险点,从而提出风险点的控制措施。结果与结论:随着批签发机构的扩容和批签发品种目录的扩大,批签发检验中的风险也随之增加。本文总结了疫苗类批签发检验流程中的风险点控制,为同行提供参考,保证上市的疫苗质量,助力我国疫苗产品在国际社会发挥更大的作用。Objective:To establish a risk point control in the vaccine batch issuance laboratory,so as to ensure the accuracy and compliance of the fi nal test data and results.Methods:Based on the various links and factors involved in the batch issuance and inspection process,combined with the practical operation of the laboratory frontline,by the method of supervision and inspection,risk points were found,and control measures for risk points were proposed.Results and Conclusion:With the expansion of batch issuance of institutes and the expansion of the variety catalogs of batch issuance,the risk in batch issuance and inspection also increased.This article summarizes the risk points control in the vaccine batch issuance and inspection process,to provide references for peers,in order to ensure the quality of vaccines on the market and assist China's vaccine products in playing a greater role in the international community.

关 键 词：疫苗 批签发实验室 批签发检验 流程风险点控制 监督检查 

分 类 号：R95[医药卫生—药学]