Background

The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results.  Version 2 of the ECA OOS SOP has been available for all ECA members since 2013.

Given the complexity of the topic, it was decided that the handling of OOT and OOE results should be addressed in a separate guideline SOP, since there is both a lack of knowledge in the industry and a lack of guidance for trend analysis from the regulators in spite of increased regulatory interest in this area.  

In 2013 the ECA’s QC Working Group decided to address these issues by developing a new guideline aimed at QC and other quality groups to encourage the application of  a consistent and scientifically sound approach to trend analysis as part of a QMS for assuring data integrity.

There were initially three core components:

• Recommended approaches for detecting out of expectation (OOE) data within an analytical sequence which are based on the known process capability of the analytical procedure used.
• Recommended approaches to detecting out of trend (OOT) data between analytical sequences where no trend is expected.  These are based on standard Statistical Process Control methodology and
• Recommended approaches for detecting out of trend (OOT) data between analytical sequences where a trend is expected as is the case for Stability Testing.

From this foundation the current OOE/OOT Laboratory Data Management Guidance  was developed by an international team to provide a harmonised approach to trending.

The ECA Analytical QC Group’s goal is to have a basic global framework for OOT/OOE within R&D, production and QC laboratories which is acceptable to the authorities and adaptable for individual companies.

At this ECA OOE/OOT Training Course version 01 of the OOE/OOT Laboratory Data Management Guidance will be presented and participants will have the opportunity to review and discuss the contents and technical aspects of the guidance document as well as looking at the scope and application of the proposed methods within industry.