隨著信使核糖核酸（mRNA）疫苗相繼獲批上市，對其生產現(xiàn)場檢查更加重視。生產現(xiàn)場檢查包括人員、廠房設施和設備、物料管理、確認與驗證、質量控制和質量保證檢查。對mRNA疫苗生產現(xiàn)場檢查要點進行分析，并對生產企業(yè)檢查的典型缺陷，如確認與驗證、生產管理和廠房設施設備、質量控制和質量保證、物料管理、機構人員和文件管理進行分析和舉例，以便提升生產質量管理水平，保障藥品安全。

With the successive approval of messenger ribonucleic acid (mRNA) vaccines for market, more attention is being paid to their production site inspections. Production site inspection includes personnel, plant facilities and equipment, material management, confirmation and verification, quality control, and quality assurance inspections. This article analyzes the key points of on-site inspection for mRNA vaccine production, and provides examples of typical defects in inspection by production enterprises, such as confirmation and verification, production management and factory facilities and equipment, quality control and quality assurance, material management, institutional personnel and document management, in order to improve the level of production quality management and ensure drug safety.

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