Construction of a quality management system for entire life cycle of vaccine pharmaceutical development and analysis of key inspection points
10.13200/j.cnki.cjb.004621
- VernacularTitle:疫苗药学研发全生命周期质量管理体系的构建与核查要点分析
- Author:
Yansong MA
1
Author Information
1. Center for Food and Drug Inspection of NMPA, Beijing 100076, China
- Publication Type:Journal Article
- Keywords:
Vaccine pharmaceutical development;
Quality management system;
Key inspection points
- From:
Chinese Journal of Biologicals
2025;38(12):1530-1536
- CountryChina
- Language:Chinese
-
Abstract:
Pharmaceutical research and development of vaccines is the core link to ensure their successful transition from laboratory research to commercial stable production. In view of the fact that my country's current vaccine development still mostly draws on traditional processes, the construction of the quality management system(QMS) for the entire life cycle of pharmaceutical development is not yet perfect, and there are challenges such as data reliability management, it is very important to establish a scientific and effective quality management strategy. Based on a systematic analysis of international and domestic regulatory guidelines, this paper proposes to establish a phased and differentiated quality management system, and emphasizes the concept of Quality by Design(QbD) as the core guide. The application of this system in the entire life cycle of vaccine development is systematically expounded, covering the key control points such as seed lot management for bacterial and viral strains, manufacturing process development and optimization, and quality research, as well as quality management strategies at each stage, in order to provide systematic reference for improving the compliance and reliability of vaccine development and meeting the regulatory expectations, so as to ultimately ensure the quality and safety of marketed vaccines.
