Handling of OOS Results in Europe

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.

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

A definition of all terms – both Out-of-Specification (OOS) Results and Out of Trend (OOT) Results – is provided at the beginning as…