Live Online Training - Handling OOT Results

This new online Training Course participants will get practical advice on how to identify OOT Results. You will get to know how to use the statistical tool box for detecting OOT data. During the training the following aspects will be discussed:

Participants will get a worksheet document and a preparation document for pre-reading upfront. During the training feedback related to the worksheet is requested which will be discussed by the speaker. Possible solutions will be suggested and recommendations will be provided.

Laboratory tests are performed on active pharmaceutical ingredients, excipients and other components, inprocess materials, and finished drug product. In these tests a trend can occur and a trend analysis has to be performed by applying techniques for detecting an underlying pattern of behaviour in a time or batch sequence which would otherwise be partly or nearly completely hidden by noise.

There are two distinct types of trend situations:

There is a fundamental difference between these two situations in that the variance increases with time in the second Situation.

Trend analysis is of regulatory relevance and a key aspect in both in EU guidelines (e.g. Annex 15, EU GMP-Guide) and FDA Guidances (e.g. Guidance for Industry, Process Validation: General Principles and Practices).

The ECA Working Group on Analytical Quality Control decided to address these aspects and developed a harmonised guideline SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. It encourages the application of  a consistent and scientifically sound approach to trend analysis as part of a QMS. The current Version 2 is available for all ECA members on the ECA members area.