The Quality Overall Summary (QOS) plays a crucial role in the Certificate of Suitability to the European Pharmacopoeia monographs (CEP) procedure. It serves as a concise overview of the comprehensive Technical Dossier, highlighting the control strategy applied and how regulatory requirements are met to ensure the quality of the active substance and providing assessors with a clear understanding of the product’s quality specifications and manufacturing processes.

The QOS is a mandatory component of the CEP application and should be treated with utmost importance. A poorly crafted or incomplete QOS can hinder the assessment process and lead to delays, potentially jeopardising the overall certification timeline. A high-quality QOS is essential because:

  • it allows assessors to quickly grasp the key aspects of the product’s quality profile in the initial review, enabling them to focus their evaluation efforts effectively;
  • it minimises the need for assessors to seek clarification or additional information from the applicant, greatly impacting the speed and efficiency of the assessment process;
  • it helps the applicants better target some key information to be retained from the Technical Dossier and summarise it.

The template provides detailed instructions to be followed.

Here are the main things to keep in mind when filling in the Quality Overall Summary:

By following these essential practices, applicants can ensure that their QOS is comprehensive, accurate and well-structured, contributing to a more efficient and streamlined CEP process.

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