EMA公布分析方法验证文件

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北京-丹丹 发表于 2014-8-19 07:05:45 | 只看该作者回帖奖励

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EMA公布分析方法验证文件2014-08-19 转载蒲公英

On 26 June 2014, the European Medicines Agency (EMA) published the concept paper "Transferring quality control methods validated in collaborative trials to a product/laboratory specific context".2014年6月26日，EMA公布了“合作试验阶段产品或化验室专用质量控制方法的转移”的概念文件。

To accept a method an authority always requires a scientific validation. The same applies when existing methods are to be replaced, reduced or to be optimized (3R = replacement, reduction, refinement). Many of these new methods principally represent an improvement compared to the old "standard" methods and therefore are acceptable from a regulatory perspective. 药监当局一直要求对接收的检验方法进行科学的验证，这也同样适用于对已有方法的替换、简化或优化（即3R= replacement, reduction, refinement）。这些新方法与老的“标准”方法相比，通常是一种改进，因此从法规角度来说是可以接受的。

The scientific proof of validation also includes the evidence of the concept and the possibility to transfer a method between different laboratories as well as large scale collaborative studies indicating that a method is suitable for the intended purpose. After completing these steps successfully, it can ultimately result in a monograph of the European Pharmacopoeia (Ph. Eur.) or also in a guidance document for the WHO or the EMA. 验证中的科学证明也包括对概念的证明、对不同化验室之间转移的可能性的证明，以及大规模合作研究中对方法适用于其既定用途的证明。在成功完成这些步骤后，最终成为欧洲药典各论的一部分，或成为WHO或EMA指南文件的一部分。

This method's validity has to be proven by the laboratory that proposes the new method. Moreover, this validation also needs to be proven specifically for the medicinal products it is supposed to be used for. Laboratories that participated in large scale collaborative studies before, usually already created plenty of data telling something about the function of this method. 方法的有效性必须由拟定该新方法的化验室进行证明。另外，该验证还要证明其对所测定的药品的专属性。之前参与或大型合作研究的化验室一般已经建立了大量的数据，可以提供关于该方法功能的一些信息。

This EMA concept paper now suggests that more guidance documents should be developed on this subject: how can these data from large scale collaborative studies be used to easier implement the laboratory- and product-specific validation of 3R methods (3R - see above)? The concrete specifications for this are currently still missing. 该EMA概念文件现在建议制订关于该主题的更多指南性文件：大型合作研究中所获得的数据如何应用于化验室的简单实施，以及3R方法的产品专属性验证。目前还没有建立这些具体的指标。

The issue is also to introduce an alternative method without necessarily having to show that the new method correlates with the existing Pharmacopoeia method.另外还引入了一个问题，即在使用替代方法时，不必要说明该新方法与已有药典方法的相关性。

想了解更多内容，请链接： Transferring quality control methods validated in collaborative trials to a product/laboratory specific context.

The deadline for submission of comments is on 31 October 2014.递交建议的最后期限为2014年10月31日。

http://www.gmp-compliance.org/eca_news_4415_8430,8360,8369,Z-QCM.html