摘要
中国《药品生产质量管理规范》(Good Manufacturing Practice,GMP)生物制品附录第59条要求疫苗生产企业采用信息化手段记录生产及检验数据,确保全过程符合法定要求,旨在解决传统纸质记录存在的易丢失、易篡改问题,提升数据完整性和可追溯性,本文对该条款进行了详细解析。通过构建制造执行系统(Manufacturing Execution System,MES)及实验室信息管理系统(Laboratory Information Management System,LIMS),疫苗生产企业可实现生产与检验数据的实时监控、自动存档及权限控制,强化疫苗生产关键工艺参数和关键质量属性的信息化管理。本文还探讨了MES、LIMS系统建设难点与解决策略,包括数据采集、完整性保障、业务流程重构等,并提出了现场检查关注重点,如数据完整性、系统验证等,以期为疫苗企业信息化建设提供指导。
The Article 59 stipulated in the appendix for Biological Products in China's Good Manufacturing Practice(GMP)mandates that vaccine manufacturers adopt information technology systems for the recording of all production and quality control data,thereby ensuring comprehensive traceability and compliance throughout the entire manufacturing lifecycle.The regulation is designed to mitigate the significant risks inherent in traditional paper-based documentation systems,including their susceptibility to loss,inadvertent damage,and deliberate tampering,with the ultimate goal of ensuring robust data integrity.This paper provides a critical analysis of this regulatory provision The implementation of Manufacturing Execution System(MES)and Laboratory Information Management System(LIMS)serves as the foundational approach to facilitate real-time monitoring,enforce automated data capture and archiving,and implement stringent access controls.Such technological infrastructure is essential for enhancing the management of Critical Process Parameters(CPPs)and Critical Quality Attributes(CQAs).This paper further examines the principal implementation challenges and proposes corresponding solutions for MES and LIMS deployment,with a focus on data acquisition interoperability,cryptographic assurance of data integrity,and necessary business process re-engineering.Additionally,the paper delineates key focus areas for regulatory inspections,including data integrity and validation of computerized systems.The findings offer a systematic framework to guide vaccine manufacturers in achieving regulatory compliance and advancing their digital maturity.
作者
康鹰
许秦
马岩松
KANG Ying;XU Qin;MA Yansong(Center for Food and Drug Inspection of NMPA,Beijing 100076,China;不详)
出处
《中国生物制品学杂志》
2026年第3期374-384,共11页
Chinese Journal of Biologicals
关键词
《药品生产质量管理规范》生物制品附录
信息化手段
制造执行系统
实验室信息管理系统
数据完整性
Good Manufacturing Practice appendix for biological products
Information technology
Manufacturing Execution System(MES)
Laboratory Information Management System(LIMS)
Data integrity
