Place it in the CTD
The QOS is Module 2.3 of the Common Technical Document (CTD), alongside the broader summaries in Module 2 and detailed quality information in Module 3.
NARRATIVA · REGULATORY
Introduction to the Summary of Quality
A clear guide to the Quality Overall Summary (QOS)—what CTD Module 2.3 covers, how it connects to the detailed quality information in Module 3, and why it.
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QUALITY OVERALL SUMMARY · CTD MODULE 2.3
Understand the detail.
See the whole picture.
The QOS gives reviewers a concise, organized view of a product’s quality story. It summarizes key evidence while pointing to the detailed data and explanations in the rest of the submission.
Follow the section structure
Its organization commonly includes drug substance (2.3.S), drug product (2.3.P), appendices (2.3.A), and regional information (2.3.R), as applicable.
Summarize the drug substance
Depending on the product, this section brings together relevant information about the active substance, its manufacture, characterization, controls, and stability.
Summarize the drug product
This part describes the finished dosage form and summarizes relevant development, manufacturing, control, container-closure, and stability information.
Connect summary and evidence
Module 2.3 presents key quality conclusions in context; the underlying methods, data, and supporting explanations are provided in the corresponding Module 3 sections.
Keep expert judgment central
Authors and reviewers confirm that the summary accurately reflects the supporting dossier and applicable submission requirements.
THE QUALITY OVERALL SUMMARY · AN INTRODUCTION
A concise view of the product’s quality story.
The Quality Overall Summary (QOS) is CTD Module 2.3. It provides a high-level overview of the quality information for a medicinal product, drawing on the detailed data and explanations presented in Module 3. It helps reviewers understand the quality approach and locate supporting information in the dossier.
The content follows the applicable CTD organization and requirements. Sections typically address the drug substance and drug product, with appendices and regional information included where relevant. The QOS is a summary of the underlying evidence—not a replacement for the detailed Module 3 information or expert assessment.
INTRODUCTION TO THE QOS · FAQ
Quality summaries, explained.
Key points about the purpose, content, and place of the QOS in a regulatory submission.
What is the Summary of Quality?
The Quality Overall Summary (QOS) is CTD Module 2.3. It summarizes the quality information for a medicinal product and directs readers to supporting detail in Module 3.
What is the purpose of the QOS?
It gives reviewers an organized, high-level account of the product’s quality attributes, development, manufacture, controls, and stability, as applicable, while keeping the detailed evidence available in the dossier.
How does Module 2.3 relate to Module 3?
Module 2.3 is the summary; Module 3 contains the detailed quality data and explanations. The QOS should be consistent with its supporting sections and make the evidence straightforward to follow.
What topics are usually included?
Content is organized around the drug substance, drug product, appendices, and applicable regional information. The specific topics and level of detail depend on the product and relevant regulatory requirements.
Is the QOS a substitute for detailed quality data?
No. It provides a structured overview of the quality story. The technical data, methods, and full supporting explanations remain in the applicable Module 3 sections.
Who prepares and reviews the QOS?
Qualified CMC, regulatory, and subject-matter experts contribute to authoring and review. They confirm that statements are accurate, supported by the dossier, and appropriate for the submission.