质量安全是血液制品的最关键的内容，亦是最基本的要求。药品生产六大系统实际上已涵盖了影响药品质量的各要素。对国内外药品监管和检查机构针对全球血液制品生产企业检查缺陷的收集、梳理与分析，结合血液制品生产质量管理的特点，对血液制品生产质量管理中质量管理系统、设施设备系统、物料系统、生产系统、包装和标签系统、实验室控制系统的管理要点和常见问题进行分析，为血液制品监督检查、企业持续提升质量管理水平提供建议和参考。

The quality and safety represent the most crucial aspect and fundamental requirement of blood products. The six major systems of drug production actually covered various elements that affected drug quality. This article collects, sorts out, and analyzes the inspection defects of global blood product production enterprises by domestic and foreign drug regulatory and inspection agencies. Combining with the characteristics of blood product production quality management, it analyzes the management points and common problems of quality management system, facility and equipment system, material system, production system, packaging and labeling system, and laboratory control system in blood product production quality management. The aim is to provide suggestions and references for blood product supervision and inspection, as well as for enterprises to continuously enhance their quality management standards.

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