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Speakers
Dr Tony Bennett, GSK, UK
Dr Christopher Burgess, Chairman of the Analytical Quality Control Group
Margarida Mesquita Carvalho, Bluepharma Industria Farmaceutica S.A., Portugal
Dr Matthias Heuermann, European GMP Inspector, NRW Centre for Health (LZG.NRW), Germany
Dr Elin Jensen, Novo Nordisk , Denmark
Dr Olaf Kunze, CSL Behring GmbH, Germany
Dr Peter Rauenbuehler, Roche, USA
Dr Bernd Renger, European QP Association, Germany
Dr Ulrich Rose, EDQM, France
Dr Dawn Toronto, CMC & Analytical Consultant, Germany
Objective
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”. | |
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