CHINESE JOURNAL OF MEDICINAL GUIDE >
Research on the Application of Digital Supervision Technology for Vaccine and Blood Product Production
Received date: 2026-01-22
Revised date: 2026-06-05
Accepted date: 2026-06-28
Online published: 2026-08-17
Vaccines and blood products, as high-risk products, their proudction processes are directly related to the life safety and health of the people. In recent years, with the rapid development of information technology, the application of digital supervision technology in the field of drug production has become increasingly widespread, and digital supervision technology has gradually become an important means to enhance drug supervision capabilities. The drug regulatory authorities have utilized technologies such as industrial Internet of Things, big data, and artificial intelligence to achieve comprehensive monitoring and intelligent analysis of key production processes for vaccines and blood products, effectively improving regulatory efficiency and accuracy. However, the lack of unified industry standards makes it difficult for enterprises to achieve expected digital transformation, and there is a lack of risk regulation, which brings many challenges to the digital supervision of vaccine and blood product production. In response to these challenges, this study proposes measures: ① developing industry authoritative data standards; ② clarify the boundaries of responsibilities between regulatory authorities and enterprises, and establish a technical system framework for two-level distributed collaborative supervision; ③ to ensure the legal and compliant use and retrieval of vaccine and blood production testing data, a data collaboration contract mechanism should be established based on regulatory requirements. Subsequently, artificial intelligence, risk warning, and risk analysis models should be used to ensure the safety and stability of vaccine and blood product production, thus establishing a comprehensive and intelligent digital supervision system for drug production.
TIAN Yaxuan, LU Ying, CAO Ming, DU Yanru
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Research on the Application of Digital Supervision
Technology for Vaccine and Blood Product Production
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