中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 857-862.
DOI: 10.19803/j.1672-8629.20240421

• 细菌内毒素检测技术与实践专栏 • 上一篇    下一篇

美国食品药品监督管理局警告信中细菌内毒素问题探讨

陆德1, 许文艳1, 刘瑾欣2, 裴宇盛3,*   

  1. 1国家药品监督管理局药品审评检查长三角分中心,上海 201203;
    2国家药品监督管理局食品药品审核查验中心,北京 100050;
    3中国食品药品检定研究院化学药品检定所,北京 100050
  • 收稿日期:2024-06-21 出版日期:2024-08-15 发布日期:2024-08-21
  • 通讯作者: *裴宇盛,男,硕士,副研究员,药品质量控制。E-mail: pysh@nifdc.org.cn
  • 作者简介:陆德,女,硕士,主管药师,药品监管科学与检查研究。
  • 基金资助:
    国家重点研发计划（2019YFC1200704）

Discussion and analysis of bacterial endotoxin problems in FDA warning letters

LU De1, XU Wenyan1, LIU Jinxin2, PEI Yusheng3,*   

  1. 1Yangtze River Delta Center for Drug Evaluation and Inspection, National Medical Products Administration, Shanghai 201203, China;
    2Center For Food and Drug Inspection, National Medical Products Administration, Beijing 100050, China;
    3Institute for Chemical Drug Control , National Institutes for Food and Drug Control, Beijing 100050, China
  • Received:2024-06-21 Online:2024-08-15 Published:2024-08-21

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摘要： 目的 研究美国食品药品监督管理局（FDA）警告信中药品细菌内毒素控制的常见问题,为行业提供参考。方法 对FDA近年来细菌内毒素控制缺陷的警告信进行梳理,并对其细菌内毒素控制方面存在缺陷进行分类总结。结果 无菌药品生产中控制细菌内毒素污染至关重要,尽管FDA相关法规及指南提出了明确要求,但生产企业实际执行中在原料、辅料及包材,过程控制以及质量控制等方面存在不足。结论 细菌内毒素控制是药品质量管理的重点和难点,生产企业应重点关注并持续优化,以保证药品的安全性和有效性。

关键词: 细菌内毒素, 警告信, 药品生产质量管理规范, 质量控制, 偏差调查, 原料, 辅料, 美国食品药品监督管理局

Abstract: Objective Study the common problems of drug bacterial endotoxin control in FDA warning letters to provide reference for the industry. Methods The warning letters of the deficiencies in bacterial endotoxin control of FDA in recent years were sorted out, and the deficiencies in bacterial endotoxin control were classified and summarized. Results It is very critical to control bacterial endotoxin contamination in drug production. Although the relevant regulations and guidelines of FDA put forward clear requirements, there were still shortcomings in the actual implementation of active pharmaceutical ingredients/excipient /packaging materials,process control and quality control. Conclusion Bacterial endotoxin control is the key and difficult point of drug quality control. Enterprises should focus on and continuously optimize to ensure the safety and effectiveness of drugs.

Key words: bacterial endotoxin, warning letter, good manufacturing practice for drugs, quality control, deviation investigation, active pharmaceutical ingredients, excipient, FDA

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