内毒素检测结果超过质量标准规定（OOS）的情况在日常检测中不可避免。通过风险因素分析法，结合大量实际工作经验，对产生OOS的原因进行了逐项分析和研究，包括质量标准与计算、实验操作、材料与仪器等因素。针对内毒素检查的特性，设计决策流程图确定验证OOS方案。确定了所有类型的风险因素产生原因和解决方法，建立了用于回顾细菌内毒素OOS的风险因素鱼骨图和用于验证OOS结果的决策流程图。按建立的方法进行验证处理OOS，能够使内毒素检测结果更加科学严谨。
A series of scientific methods are established to confirm the out of specification (OOS) result which is inevitable in daily detection for bacterial endotoxin test. According to the risk factor analysis and work experience, the causes of OOS results are analyzed and details of quality standard and calculation, experimental operation, materials, instruments, etc. are studied. Based on the characteristics of bacterial endotoxin test, a decision flow chart is designed to determine the validation scheme for OOS. All types of causes and solutions for risk factors are determined, and the risk factor fishbone diagram to review OOS and a decision-making flowchart to verify OOS results are established. This work makes the endotoxin test results more scientific and rigorous by using the fish bone diagram of risk factors to review and analyze the causes of OOS and by following the decision-making flow chart to confirm the result.
[1] The European Pharmacopoeia Commission. Europe pharmacopoeia 7.0[S]. France:European Directorate for the Quality of Medicines & HealthCare of the Council of Europe, 2010.
[2] The United States Pharmacopeial Convention. United States pharmaco-poeia[S]. The United States of America:The United States Pharmaco-peial Convention, 2013.
[3] Pei Y, Cai T, Gao H, et al. Comparison of result judgment algorithm of test for interfering factors in the bacterial endotoxins test among Chi-nese, Japanese, European, American, and Indian pharmacopeias[J]. Chi-nese Medical Journal, 2013, 127(15):2784-2788.
[4] 国家药典委员会. 中国药典2010年版2部[M]. 北京:中国医药科技出版社, 2010. The Chinese Pharmacopoeia Commission. China Pharmacopoeia 2010 Vol Ⅱ[M]. Beijing:China Medical Science Press, 2010.
[5] Pei Y, Cai T, Gao H, et al. Application of WHO GPCL quality manage-ment concept in laboratories for bacerial endotoxin detection[J]. Chin Pharm Affairs, 2013, 27(7):693-699.
