摘要
药品生产检验记录与数据是相关企业合规生产的重要凭证,是保证药品全程可追溯的关键源头。2020年7月国家药监局发布的《药品记录与数据管理要求(试行)》明确,采用计算机(化)系统生成记录或数据的,应当采取相应的管理措施与技术手段,确保生成的信息真实、准确、完整和可追溯。本文通过分析电子记录与数据在《药品生产质量管理规范》(GMP)管理中的控制特点,围绕GMP电子记录与数据的管理要求,通过对药品生产实际工作中电子记录与数据管理的思考和总结,探讨药品生产企业如何更好地维护数据完整性和提升信息化管理水平。
Inspection records and data in drug production are important certificates for relevant enterprises to comply with the production and ensure the traceability of drugs throughout the process.In July 2020,the National Medical Products Administration issued the Requirements for Drug Records and Data Management(Trial)to clarify that when records or data are generated using a computer(computerized)system,corresponding management measures and technical means should be implemented to ensure the authenticity,accuracy,completeness,and traceability of the generated information.This paper analyzes the control characteristics of electronic records and data in the Good Manufacturing Practice(GMP)management,focusing on the management requirements of GMP for electronic records and data.It explores how pharmaceutical manufacturing companies can enhance data integrity and improve their information management by reflecting on and summarizing the management of electronic records and data in drug production.
作者
梁惠仪
刘洁萍
林文森
LIANG Hui-yi;LIU Jie-ping;LIN Wen-sen(Guangzhou Baiyunshan Biological Products Co.,Ltd.)
出处
《中国食品药品监管》
2023年第8期102-109,共8页
China Food & Drug Administration Magazine
