我国人用疫苗GMP管理中生物安全要求

Biosafety requirements in GMP management of human vaccine in China

安全有效、质量可靠是疫苗生产严格执行《药品生产质量管理规范》的充分条件。然而,利用病原微生物进行疫苗生产,具有一定的生物安全风险。因此,须在保证疫苗质量的同时确保生产活动的生物安全。本文通过梳理我国《药品生产质量管理规范》及生物安全管理的相关要求,分析了疫苗生产管理中可能存在的生物安全风险及问题,并提出相关建议。

Safety,effectiveness and reliable quality are sufficient conditions for the strict implementation of Good Manufacturing Practice for Drugs in human vaccine production.However,the use of pathogenic microorganisms for vaccine production carries certain biosafety risks.Therefore,it is necessary to ensure the biosafety of production activities while ensuring the quality of vaccines.The possible biosafety risks and problems in human vaccine production are analyzed by sorting out the relevant requirements of China’s Good Manufacturing Practice for Drugs and the biosafety management and the relevant suggestions are proposed.