20140827 ECA新闻：在欧洲如何处理OOS结果

20140827 ECA新闻：在欧洲如何处理OOS结果  

2014-09-01 13:22:50|  分类： ECA新闻 |

原文网址http://www.gmp-compliance.org/enews_04461_Handling-of-OOS-Results-in-Europe.html   

GMP News
27/08/2014

Handling of OOS Results in Europe

在欧洲如何处理OOS结果

For some time now, information about the handling of OOS results has been put on the website of the MHRA. There, you can find a Guidance document entitled "Out of Specification Investigations". This document was updated last year to add microbiological aspects.

MHRA将其关于OOS结果处理的资料放在网上已有一段时间了。在其中，你能找到一份题为“OOS调查”的指南性文件，该文件在去年进行了更新，增加了微生物方面的内容。

It is easier to understand than the FDA Guideline on the same topic. The different Flow Charts are also helpful.

该指南比FDA同样的指南更易于理解，其不同的流程图也对公司非常有帮助。

A definition of all terms - both Out-of-Specification (OOS) Results and Out of Trend (OOT) Results - is provided at the beginning as well as atypical / aberrant / anomalous results. A definition of the term "Reportable Result" is also provided as follows: "is the final analytical result. This result is appropriately defined in the written approved test method and derived from one full execution of that method, starting from the original sample."

一开始，它就给出了所有术语----OOS结果和OOT结果----的解释，以及非典型、非常规、异常结果的定义。关于“可报告的结果”也有定义如下“……是指最终的分析结果。该结果基于书面批准的适当的检验方法，通过实施完整的一套方法从原始样品中获得。”

Regarding averaging, it is explicitly said that it "must be specified by the test method". Moreover, the 95% Confidence Limit must be taken into consideration when averaging is used.

关于平均值计算，其中明确说道“必须在检验方法中指明”。另外，在计算平均值时必须考虑95%置信限。

Retesting may be performed if no assignable cause can be found to explain a deviating result. Retesting should be performed on the original sample not on a different sample. Regarding the number of retests required, the MHRA refers to other publications suggesting 5, 7 or 9 retests. Retest results shouldn't be averaged with the original results which triggered the OOS investigation.

如果没有发现可归结的原因来解释偏差结果，可以进行复测。应采用原样而不是另一样品进行复测。关于复测的次数有要求，MHRA引用了其它出版物，建议进行5、7或9次复测。复测不应与引发OOS调查的初始检测结果进行平均。

Like in the FDA Guidance, an outlier test solely can't be considered as sufficient to justify the rejection of data.

和FDA指南一样，该指南认为仅有逸出值检验是不足以作出拒绝某数据的断定的。

Also the aspect of OOS and OOT results for stability testing is addressed.

其中还说明了稳定性测试中的OOS和OOT结果的处理。

For quite a long time, Germany has been using the ZLG Aide Mémoire (Zentralstelle der L?nder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten) on the monitoring of manufacturers of medicinal products; section 6.8 also addresses the handling of OOS results. With regard to retesting, the Aide Mémoire defines that the number of retests should be set in advance in an SOP based on sound scientific judgement and should be statistically valid.

在很长一段时间里，德国一直在对药品生产商进行监控时使用ZLG备忘。其中第6.8部分说的是对OOS结果的处理。关于复测，备忘说复测次数应在一个SOP中预先规定，并根据科学合理的判定，且在统计学角度来说是有效的。

The ZLG Aide Mémoire also states that averaging is allowed: the average value must correspond to the specification, but single results must not. However, it is a condition that acceptance criteria should be defined for the variability of the single values and that these provisions are described in an SOP.

ZLG备忘也声明了计算平均值是被允许的：平均值必须符合质量标准，但单个结果则不一定。但是，前提是可接受标准中必须对单个结果的变化范围进行定义，并在一个SOP中描述这些条款。

You can find more information in the MHRA Guidance Document Out-of-Specification Investigations here as well as in the ZLG Aide Mémoire on the monitoring of manufacturers of medicinal products.

更多信息，参见MHRA OOS调查指南性文件和药品生产企业监控ZLG备忘。

楼主我加一句，该资料来自新浪博客一个朋友信息

对于我这个照猫画虎的，深入理解OOS和处理流程是很关键的。