我国疫苗批签发检验机构实验室质量体系建设研究

Analysis of the Construction of Quality Management System in Lot Release Institutions for Vaccines in China

目的分析我国疫苗批签发检验机构质量管理体系,识别改进的内容,以便完善疫苗批签发机构实验室质量管理体系,满足世界卫生组织(WHO)-疫苗国家监管体系评估要求。方法用差距分析方法对照WHO-医疗产品国家监管体系评估全球基准工具(GBT)实验室检查(LT)板块和WHO-药品质量控制实验室质量管理规范(GPCL),分析我国疫苗检验机构质量体系。结果我国疫苗批签发机构已建立比较完善的质量体系框架,但实验室管理水平仍待提高。结论疫苗批签发检验实验室质量体系建设工作取得了长足进展,还需要从组织机构、人员培训、文件记录、样品管理、设施设备、审核体系等方面不断完善和提高。

OBJECTIVE To analyze the quality management system of lot release institutions for vaccines, and identify the issues that still need to be improved, so as to improve the quality management system of lot release institutions and meet the evaluation requirements of WHO-NRA. METHODS Gap analysis was used to analyze the quality management system of lot release institutions in China, comparing with WHO-GBT LT and WHO-GPCL. RESULTS The framework of quality management system for biological products lot release had been built in some drug control institutions in China, but there was still much needing to be improved in laboratory management. CONCLUSION Although some progress has been made in the construction of the quality management system for the lot release system in China, it still needs to be improved from the aspects of organization, personnel training, records, sample management, facilities and equipment, audit systems, etc.