Back The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!

EDQM Strasbourg, France 25/01/2024
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A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024.

The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives detailed guidance on how to address each eCTD section with a particular emphasis on the overall control strategy applied.

Quality overall summary (QOS) template for CEP

Guidance for the optimal use of the template (certification/new applications/submit a new information/important information).