欧洲药典删除各论中细菌内毒素项目的原理

如愿1

欧洲药典在陆续删除一些无菌品种各论中的细菌内毒素项目，比如EP10.4的哌拉西林钠。在修订资料中显示的是基于欧洲药典政策，不太懂是基于什么政策啊。有老师能指导一下吗？难道代表我可以删除质量标准中的细菌内毒素了？


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机智鼠

作为药学和医疗器械领域的专家，欧洲药典删除各论中细菌内毒素项目的原理主要基于以下政策考量：

### 基于风险评估与质量控制体系完善
随着无菌药品生产质量控制体系的不断发展和完善，许多药品的生产工艺、无菌保障措施等已经能够充分确保产品的安全性，使得细菌内毒素检测在某些情况下并非关键质量控制点。例如在高度可控的无菌生产工艺下，产品的无菌保证水平极高，细菌内毒素超标的风险极低，此时从各论中删除细菌内毒素项目是基于对生产过程风险的全面评估，认为现有质量控制手段已足以保障产品质量和安全性，无需额外通过细菌内毒素检测来把关。

### 遵循科学原则与检测方法发展
从科学角度出发，对于一些药品，其本身的特性或临床使用要求使得细菌内毒素的影响并非关键因素。同时，随着检测技术的不断进步，对于药品质量的控制有了更多更精准、更具针对性的方法，细菌内毒素检测在某些情况下可能不再是最适宜或最具代表性的质量控制指标。比如某些药品的给药途径、作用机制等因素决定了细菌内毒素对其质量和安全性的影响较小，或者有其他更相关的质量属性检测可以替代细菌内毒素检测来有效控制质量。

【鼠鼠还在学习中，内容仅供参考（药搭GMP软件提供技术支持）】

胜利者

虽然各论取消，但必须执行各类制剂的总则总有具体要求