摘要
疫苗安全关乎国家公共卫生与民生福祉,生产检验数据作为药品质量管理体系的核心要素,是保证药品质量的基石。为强化疫苗监管,推进疫苗生产企业数字化转型,促进产业高质量发展,2022年6月,国家药品监督管理局信息中心、国家药品监督管理局食品药品审核查验中心联合发布《疫苗生产检验电子化记录技术指南(试行)》,为疫苗生产企业开展生产检验过程电子化记录、数字化管理的设计等提供技术指导。该技术指南正式实施已3年多。本研究以我国在产疫苗生产企业为研究对象,围绕数字化转型升级实施路径展开探析,通过调查研究,系统梳理当前疫苗生产企业信息化建设与运行现状,结合数字化转型趋势,分析当前疫苗生产数字化转型中存在的问题,进一步提出疫苗生产企业实现全生命周期质量管理的数字化转型优化策略,为企业规划、完善信息化建设路线图提供参考,以期依托信息化手段提升疫苗生产企业质量管理体系,实现由“合规驱动”向“数字赋能”的跃迁,进而推动疫苗产业高质量发展。
Vaccine safety is crucial for national public health and social well-being.Production and testing data,as core elements of the pharmaceutical quality management system,serve as the cornerstone for ensuring drug quality.To strengthen vaccine regulation,advance the digital transformation of vaccine manufacturers,and promote high-quality development within the industry,the Center for Information and the Center for Food and Drug Inspection of the National Medical Products Administration(NMPA)jointly issued the Technical Guidelines for Electronic Records of Vaccine Production and Testing(Trial)in June 2022,which provide technical direction for vaccine manufacturers in implementing electronic recording and digital management of production and testing processes,and has been formally implemented for over three years.This study takes the vaccine manufacturers in China as the research objects to analyze the implementation pathways for their digital transformation and upgrading.Through investigative research,this study systematically reviews the current status of informatization construction and operational practices within these enterprises.Aligned with digital transformation trends,it identifies existing challenges in this process.Subsequently,the study proposes optimization strategies for digital transformation of vaccine manufacturing enterprises to achieve full life cycle quality management,and to provide reference for enterprises in planning and refining their digital transformation development roadmaps.The transition to digital-enabled and data-driven operations is expected to elevate quality management systems beyond mere compliance,driving the vaccine industry into high-quality development.
作者
都艳茹
陆颖
曹明
李南
DU Yanru;LU Ying;CAO Ming;LI Nan(Center for Information,NMPA,Beijing 100076,China)
出处
《中国医药导刊》
2025年第12期1354-1357,共4页
Chinese Journal of Medicinal Guide
基金
国家药品监督管理局药品监管科学体系建设重点项目(RS2024S007)。
关键词
疫苗生产
数字化转型
数据价值
药品监管
Vaccine production
Digital transformation
Data value
Drug administration
