隨著信使核糖核酸（mRNA）疫苗相繼獲批上市，對(duì)其生產(chǎn)現(xiàn)場(chǎng)檢查更加重視。生產(chǎn)現(xiàn)場(chǎng)檢查包括人員、廠(chǎng)房設(shè)施和設(shè)備、物料管理、確認(rèn)與驗(yàn)證、質(zhì)量控制和質(zhì)量保證檢查。對(duì)mRNA疫苗生產(chǎn)現(xiàn)場(chǎng)檢查要點(diǎn)進(jìn)行分析，并對(duì)生產(chǎn)企業(yè)檢查的典型缺陷，如確認(rèn)與驗(yàn)證、生產(chǎn)管理和廠(chǎng)房設(shè)施設(shè)備、質(zhì)量控制和質(zhì)量保證、物料管理、機(jī)構(gòu)人員和文件管理進(jìn)行分析和舉例，以便提升生產(chǎn)質(zhì)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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