关键词: 细菌内毒素, 能力验证, 质量管理, 药品质量, 监督, 管理, 注射剂

Abstract: Objective To improve the quality control of bacterial endotoxin detection in laboratories by comparing and analyzing domestic and international bacterial endotoxin proficiency testing schemes and results, and summarizing the experience in designing proficiency testing schemes. Methods Introduce the contents and characteristics of the bacterial endotoxin proficiency testing program organized by the EDQM, Charles River and NIFDC, the correlation between the source of the sample to be tested and the satisfaction rates and result evaluation methods were analyzed. Results Each organization's proficiency testing has its own characteristics and it was found that the satisfaction rates of proficiency testing using real samples and multiple test samples were significantly lower than those using standard samples. Conclusion It is suggested that multiple modes of proficiency testing should be adopted for bacterial endotoxin detection. Proficiency testing schemes should emphasize the use of real samples and strengthen research on the uncertainty of bacterial endotoxin detection. This will further improve the level of domestic bacterial endotoxin detection proficiency testing and ensure the quality and safety of injectable drugs.

Key words: bacterial endotoxin, proficiency testing, quality management, drug quality, supervision, management, injection