| 高晓明,项新华,陈国庆,杨美成,郭洪祝,彭文兵,李长贵,于欣.疫苗批签发网络实验室质量体系的构建[J].中国药事,2021,35(8):908-914 |
| 疫苗批签发网络实验室质量体系的构建 |
| Construction of a Quality System of Vaccine Lot Release Network Laboratory |
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| DOI：10.16153/j.1002-7777.2021.08.009 |
| 中文关键词: 疫苗国家监管体系 批签发 网络实验室 实验室板块 质量管理体系 ISO/IEC 17025: 2017 |
| 英文关键词: NRA lot release network Laboratory LT sector quality management system ISO/IEC 17025: 2017 |
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| 摘要点击次数: 635 |
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| 中文摘要: |
| 目的：以ISO/IEC 17025的要求为基础，结合实验室检测(LT)板块指标条款的要求，针对新批签发机构构建网络实验室，以满足世界卫生组织(WHO)疫苗国家监管体系(NRA)评估要求，保证新冠疫苗批签发网络实验室技术和质量管理的一致性，确保批签发质量。方法：依据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《中华人民共和国药品管理法实施条例》《生物制品批签发管理办法》，参考ISO/IEC 17025：2017、药品质量控制实验室良好操作规范(GPCL)、WHO全球基准评估工具(GBT)的要求，结合批签发实际工作中的解决方案，从组织构架、人员、环境设施、设备、溯源、实验方法、样品、文件和记录、检验能力的质量保证及风险控制、报告、数据控制和信息管理、批签发检验策略和检验频率的制修订和执行、超出质量标准的处理、绩效考核、免疫监测15个方面建立批签发网络实验室质量体系专家共识。结果与结论：我国批签发网络实验室可以以ISO/IEC 17025： 2017为核心，适当纳入WHO全球基准评估工具实验室板块要求(LT)，建立批签发网络实验室质量管理体系，保证批签发网络实验室质量管理体系的一致性，实现满足WHO-NRA评估、新冠疫苗批签发及批签发网络实验室建设需求。 |
| 英文摘要: |
| Objective: Based on the requirements of ISO/IEC 17025, combining the requirements of LT sector indexes, according to a new batch of issuing institution, to construct a network laboratory, so as to meet the assessment requirements of the National Regulatory Authority (NRA) of WHO. Moreover, to ensure the consistency of network laboratory technology and quality management in the COVID-19 vaccine lot release agencies, and ultimately guarantee the quality of lot release. Methods: In accordance with the Pharmaceutical Administration Law of the People's Republic of China, Vaccine Administration Law of the People's Republic ofChina, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, and Measures for the Administration of Lot Release of Biological Products, together with reference to the requirements of ISO/ IEC 17025, GPCL and WHO-GBT, and further combined with the solutions in the actual work of lot release, the expert consensus on the quality system of its network laboratory from 15 aspects was established, including the organizational structure, personnel, environmental facilities, equipment, traceability, experimental methods, samples, documents and records, quality assurance and risk control of inspection ability, reports, data control and information management, revision and implementation of lot release strategy and frequency, OOS, performance appraisal and immune monitoring. Results and Conclusion: ISO / IEC 17025：2017 could be adopted as the core guide for lot release network laboratory in China, and the requirements of the WHO global benchmarking tool laboratory testing (LT) sector should be appropriately included, to established the quality management system of lot release network laboratory in China, ensure the consistency of the quality management system of lot release network laboratory, and meet the needs of WHO-NRA evaluation, COVID-19 vaccine lot releasing and the construction of a lot release network laboratory. |
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