EMA修订清洁验证的限度标准P2.pdfVIP

We should have more thinking……… 1 EMA works on Recalculation of Limits for Cleaning Validation EMA 将重新计算清洁验证的限度标准 EMAs Inspector Working Group will get together at the end of February. According to the Concept Paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities published in October 2011, the question of Dedicated Facilities and the determination of limits for cleaning validation will be addressed. EMAs 检查员工作团队将在2 月底聚会，处理关于专用设施及确定清洁验证的限度标准，此次聚会是根据2011 年10 月出版的“发展毒理学指南用于风险识别在公用设施中生产不同产品” Yet, a first internal draft for a guideline has been announced which is elaborated together with a specialists team of EMAs Safety Working Party (SWP). 第一份内部的草案已经发布了，他是由专家团队和SWP 共同完成的。 The key question which should be answered in this paper concerns the maximal acceptable carry over between products manufactured in the same facility or plant. 在这份文章中需要回答的主要问题就是公用工厂或车间的产品在生产过程中最大可以接受的转移量。 Limits which have been frequently used until now for cleaning validation (namely the 1/1000 dose and the 10ppm criterion) are being questioned by the inspectorate expert group as they do not take into account the available pharmacological/ toxicological data. For instance, the so-called lead effect of a substance is not taken into consideration. This is the first effect which occurs when increasing doses of a medicinal product. 现在被经常使用的清洁验证的标准是日常剂量的千分之一和10ppm 的标准，这两种标准同样被专家检查员所质疑，因 为他们没有考虑药理学及毒理学的数据。更进一步的说，这个所谓的能够引起作用或反应的成分没有考虑在内。这个效 果最有可能发生，当你增加治疗的剂量的时候。 This may be the pharmacologically desired therapy effect (actually the basis for calculating) or undesired adverse effects like, for example, teratogenicity in case of a drug for cancer. 也许药物的治疗效果是我们最想得到的（实际上是我们计算的基础）而药物的不良反应是我们不想看到的，如癌症药物 的致畸性有可能。 One of the possibilities to take into account these effects is to use the ADE (acceptable daily exposure) value. The