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FDA’s final Guidance for Industry titled “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production” was published in 2006. It covers many points that are relevant to the investigations to be started in pharmaceutical laboratories once OOS results have occured. However, the incorrect handling and investigation of OOS results is still a continuing source of 483 citations and Warning Letters since 2006. And the investigation of OOS results is still a hot topic in FDA inspections.

There was no intent to write a European version within the authorities as they found the FDA Guidance generally acceptable. However there were problems with individual companies QA departments how to interpret the FDA guideline. Therefore the MHRA published a response in UK in 2010 to problems of interpretation that they had seen in order to issue Guidance.

With this Forum the ECA Foundation is launching the SOP “Out of expectation (OOE), Out of Trend (OOT) and Out of Specification (OOS) Results”.

The New OOS SOP

The ECA Working Group on Analytical Quality Control was set up in 2010 in attempt to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results.

More than 100 ECA members were registered as OOS Review Team Members and approx. 80 members provided their feed-back, first to the general OOS Flowchart and second to the draft OOS SOP. The result was a framework SOP Version 1 which will be launched at the OOS Forum as a basis for broader discussion. The majority of comments of the Review Team Members were favourable although a number of companies wanted consideration of alternative approaches.
The purpose of the OOS Forum is to discuss that document and other inputs as well as consider debate these alternative approaches in order to provide a broader basis of discussion which should/will allow a version 2 to be produced.
ECA’s ultimate goal is to have one basic global framework for OOS within QC laboratories acceptable by the authorities which individual companies may adapt to fit their particular Quality Management System.