Receive your Guidance Document for the Handling of OOE/OOT Results

11 November 2015

The first project of the ECA Working Group "Analytical Quality Control" was the development of a SOP for the handling of Out of Specification (OOS) results.  This OOS SOP is available as a free download in the ECA members' area.

The second project is the development of a SOP for the handling of Out of Expectation (OOE) and Out of Trend (OOT) results. This SOP will address the following aspects:

1. Methods and approaches for detecting out of expectation (OOE) data within an analytical se-quence which could be based on the process capability of the analytical procedure.

2. Methods and approaches for detecting out of trend (OOT) data between analytical sequences where no trend is expected - for example a variety of statistical process control approaches.

3. Methods and approaches for detecting out of trend (OOT) data between analytical sequences where a trend is expected as is the case for stability testing.

Version 1 of this SOP will be presented during the OOT Forum 2015 from 2-3 December 2015 in Barcelona, Spain. Following the presentations of the basic proposals for the three issues mentioned above there will be discussions, allowing delegates to get actively involved in the development of this SOP.

Directly after the OOT Forum follows the ECA Post Conference OOS Workshop on 4 December 2015 focusing on regulatory expectations on OOS Results (Europe and U.S) and the OOS SOP Version 2 of ECA's Analytical QC Working Group.

For more details please take a look at the OOT Forum Website.

 

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