ANALYTICA l QUALITY CONTROL: ECA WORKING GROUP DEVELOPS SOP ON OOE AND OOT
In the context of the analytical quality control, there are a number of issues that were not addressed adequately until a few years ago. Some of these points were discussed during the Advisory Board meeting of the ECA Foundation in 2010. Following a new Working Group Analytical Quality Control was set up with the goal to address these issues.
The development of a uniform SOP for dealing with analytical deviations within the laboratory including OOS, OOE-, and OOT results was the first project on the agenda of the new group. This project was controlled by two project coordinators (Dr Christopher Burgess and Dr Bernd Renger) and an "OOS Review Team".
In the first step of this project, an SOP Flowchart was defined and evaluated by nearly 80 members of the OOS Review Team. The second step involved the development of the OOS SOP itself. A draft of this SOP - based on the jointly developed OOS Flow Chart - was first presented and discussed during the ECA Course Out-of-Specification Results in Munich, Germany, in June 2011. It was then also forwarded to all members the OOS Review Team. Beside the OOS SOP there were some questions about specific details of the OOS SOP to which the OOS Review Team was asked to provide their evaluation.
The preliminary draft version of this OOS SOP was presented in June 2012 at the OOS Forum in Prague and introduced to a wider audience. At the same time alternative approaches of the GMP-compliant handling of OOS results were discussed with representatives from various pharmaceutical companies.
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Contrary to the original intention to also cover the handling of Out-of-Trend results (OOT ), it was decided during the ECA OOS Forum to focus on Out-of-Specification results with this first ECA OOS SOP. The final version 2.0 of the ECA OOS SOP became effective on 14 August 2012. In the meantime, version 2.1 of this SOP is available as a final document. ECA members can download this version from the ECA members' area for free.
During the development phase of the OOS SOP it had showed that the handling of Out of Expectation (OOE) and Out of Trend (OOT ) results can not be covered in the same document as the subjects OOE and OOT are much too complex to address all relevant aspects in one SOP. Therefore, the ECA QC Working Group is planning the creation of a separate SOP on OOE and OOT . This SOP will have the following priorities and will thus be structured accordingly:
- 1. Methods and approaches for detecting Out of Expectation (OOE) results within an analytical sequence which can be traced back to the process capability of the analytical procedure.
- 2. Methods and approaches for detecting Out of Trend (OOT ) results between analytical sequences where no trend would be expected - for example a variety of statistical process control approaches.
- 3. Methods and approaches for detecting Out of Trend (OOT ) results between analytical sequences where a trend can be expected - as is the case for stability testing.
The first draft of this SOP was just presented these days during the OOT Forum in Prague, Czech Republic. Following the presentations of the basic proposals for the three issues mentioned above there were discussions which allowed delegates to get actively involved and to define what regulations with regard to OOE and OOT especially need to be considered from their perspective.
More detailed information is available on the Working Group's site at www.gmp-compliance.org.
Author:
Dr. Günter Brendelberger
CONCEPT HEIDELBERG
