药品GMP法规逻辑的数字化探索  

Exploration on digitalization of good manufacturing practice regulation logics

作　　者：王涛 朱馨 曹萌 WANG Tao;ZHU Xin;CAO Meng(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《上海医药》2021年第15期61-64,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：随着药品新法落地,药品相关数据真实、充分、可靠的要求更加严格。药品生产全链条过程和记录的合规性研究迫切需要聚焦现代化手段提升技术水平。信息化引领药品管理现代化,特别是药品生产数字化质量保证理念近些年受到越来越多的关注。本文从药品生产的数字化管理角度出发,介绍了数字化质量保证技术在监督和促进生产过程合规的应用思路,分析了GMP法规的数字化实施方法,讨论了在药品质量保证领域自动化监督、预防和提醒的一些探索,并对相关研究的推进意义以及相关新技术应遵循的标准规范进行了展望。With the implementation of new legislation,more stringent requirements have been put forward for drugrelated data integrity.The compliance research of the entire chain of drug production processes and records urgently needs to focus on modern means to improve the technical level.In recent years,informatization leads the modernization of drug management,especially the concept of digital quality assurance in drug production has drawn more and more attention.This paper introduced the thoughts on applications of digital quality assurance technology in supervision and promote the process compliance from drug management perspective,demonstrated digital implementation method for GMP rules,discussed some explorations of the automation,prevention and warning in the field of drug quality supervision,and also gave an insight on the significant advance of pilot projects applying related technical innovations and the possible standards that should be followed.

关 键 词：数字化质量保证 药品生产 药品生产质量管理规范 

分 类 号：R951[医药卫生—药学]