EP5.1.10细菌内毒素测试使用指南(中英文2)要点解析.docVIP

EP 5.1.10 细菌内毒素测试使用指南（中英文2/2）?? 2015-12-28 23:00:31|??分类：?EP For routine tests on this product, it may be expedient to dilute 1 mL of the solution to be examined to 20 mL (MVD/2 rounded to the next lower whole number). However, if this test result is positive the analyst will have to dilute 1 mL to 41.67mL and repeat the test. A dilution to 41.67 mL is also necessary when the test is performed to settle a dispute. 对于此药品的日常检查，可以取1ml供试液稀释至20ml（MVD/2四舍五入至最接近的整数）。但是，如果该测试结果为阳性，则化验室要稀释1ml至41.67ml，重复测试。如果有争议，仲裁测试也必须使用41.67ml的稀释。 3. RISK ASSESSMENT?风险评估 As stated in section 1 of this general chapter, the conclusion is generally justified that the absence of bacterial endotoxins in a substance or product implies the absence of pyrogenic components, provided the presence of non-endotoxin pyrogenic substances can be ruled out. To rule out the presence of non-endotoxin pyrogens in substance or products, the use of the monocyte-activation test (2.6.30) is recommended at release or during development of the production process; if any changes are made to the production process that could influence the quality of the product regarding pyrogenicity, the monocyte-activation test is repeated. Examples of such changes include the use of different raw materials, a different production site and different process parameters. 正如本通论第1部分所述，如果可以排除非内毒素热源物质的存在，则原料药或制剂中不存在细菌内毒素通常可以论述得到结论不存在热源成分。为了排除原料药或制剂中存在非内内毒素热源，推荐在放行或生产工艺研发时使用单核细胞激活测试（2.6.30）。如果对生产工艺进行了变更，可能会影响产品热源方面的质量，则需要重新进行单核细胞激活测试。这类变更的例子包括使用了不同的原料、不同的生产场所和不同的工艺参数。 The decision to use the test for bacterial endotoxins as the sole pyrogenicity test is to be made after careful evaluation of the risk of the substance or product containing non-endotoxin pyrogens. The risk assessment is made with consideration given to any factor that could result in the inclusion of pyrogens not detected by the test for bacterial endotoxins. The items below constitute a non-exhaustive list of factors to be considered in the risk assessment. 使用细菌内毒素测试作为单一热