【摘要】 国际药品认证合作组织于2021年更新了《血站和医院血库良好实践指南》,旨在促进血液和血液成分高质量的采集、加工、检验、储存、供应等，并为血站和医院血库制订个性化需求提供参考。《血站质量管理规范》是我国血站质量管理的基本准则，对促进我国血站建设与发展、确保血液安全等发挥了重要作用。但与《指南》比较，《规范》在架构、质量管理条线、质量管理理念等方面存在不足。将二者进行比较，认为我国《规范》需调整架构，使之与国际标准保持一致，并细化质量管理内容，力求与世界先进的血站质量管理水平同步。更多还原

【Abstract】 The Good Practice Guideline for Blood Establishments and Hospital Blood Banks were updated by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation(PIC/S) in 2021 to promote high-quality collection, processing, testing, storage, supply of blood and blood components, and to provide a reference for the personalized needs of blood establishments and hospital blood banks. The Quality Management Standard of Blood Station is the basic principle of blood station quality management, which plays an important role in promoting the construction and development of blood stations, and ensuring blood safety. However, compared with the guideline, the standard still has some shortcomings in terms of structure, quality management lines and quality management concepts. Comparing the two, it is considered that our "standard" needs to adjust the framework to keep consistent with international standards, and refine the content of quality management, and strive to synchronize with the advanced blood station quality management level in the world.更多还原