随着信使核糖核酸（mRNA）疫苗相继获批上市，对其生产现场检查更加重视。生产现场检查包括人员、厂房设施和设备、物料管理、确认与验证、质量控制和质量保证检查。对mRNA疫苗生产现场检查要点进行分析，并对生产企业检查的典型缺陷，如确认与验证、生产管理和厂房设施设备、质量控制和质量保证、物料管理、机构人员和文件管理进行分析和举例，以便提升生产质量管理水平，保障药品安全。

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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