随着近几年医药问题的频发、医患矛盾的增多,生物制药以及药品监督管理部门等相关概念开始逐渐被人们提起,渐渐来到了大众的面前。作为国家生物制药的监管部门,其发布的各项条例都是需要各个相关的制药部门严格遵守的,只有这样才可以保证最终药品的质量,让人们买到放心药;并在此基础上提高社会各界对药品监督的意识。在本文中,我们就以生物制品《药品生产质量管理规范》(GMP)管理中的生物安全问题进行相关的研究与分析。 With the frequent medical problems in recent years, the contradiction between doctors and patients increased, biopharmaceuticals and drug regulatory authorities and other related concepts began to be gradually lifted, and gradually came to the public. As the national regulatory authorities of biopharmaceuticals, the regulations promulgated by them all require strict compliance with the relevant pharmaceutical departments. Only in this way can the quality of the final drugs be guaranteed so that people can buy safe medicines. On the basis of this, the society will be promoted All walks of life awareness of drug supervision. In this article, we conduct a related research and analysis on biosafety in the management of biopharmaceutical Good Manufacturing Practice (GMP).