目的: 进一步加强我国化学药品生产企业对世界卫生组织（WHO）检查的理解,促进药品生产质量管理水平提升。方法: 对WHO资格预审进行介绍,对WHO资格预审清单和WHO对我国化学药品生产企业检查情况及缺陷进行统计分析。结果及结论: WHO资格预审旨在使世界上每个人都能获得安全、有效和质量可靠的药品,我国化学原料药和制剂通过WHO资格预审的数量均能位列前三。WHO检查以申报的产品为核心,覆盖GMP各要素,2023年WHO对我国药品企业的检查均为常规检查,共提出206 项缺陷,平均每次检查提出缺陷约17 项,无严重缺陷,高频缺陷主要分布于质量控制和质量保证、确认和验证、文件管理等方面,对照WHO药品检查的情况,建议药品生产企业结合自身产品及实际情况,持续提升生产质量管理水平。
Objective: In order to strengthen the understanding of World Health Organization (WHO) inspections in China’s drug manufacturing enterprises and promote the improvement of quality management level of drug production. Methods: Introduced the prequalification of the WHO, provided a statistical analysis of the WHO prequalification list and inspections and deficiencies of the WHO on chemical drugs in China. Results and Conclusion: WHO prequalification aims to ensure that everyone in the world has access to safe, effective and reliable medicines. The number of chemical raw materials and preparations in China that have passed WHO prequalification can rank among the top three. WHO inspection takes the declared products as the core and covers all GMP elements. In 2023, WHO did not propose serious defects for the inspection of pharmaceutical enterprises in China, and proposed about 17 defects each time. The high-frequency defects are mainly distributed in quality control and quality assurance, confirmation and verification, document management, etc. Against the WHO drug inspection, it is suggested that pharmaceutical manufacturers should continuously improve the production quality management level in combination with their own products and actual conditions.
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