Note!
This section is OPTIONAL at the IND stage as many sponsors are still in the early stages of CMC development. Should you still wish to include a QOS, consider the recommendations in the section below to understand what key information to present.
The overall goal of the QOS section is to provide the FDA with a summary of the scope and outline of the body of data you are showing in Module 3. A summary of the type of information you should consider including and not including within the QOS is shown in the table below:
Information you should consider including in the QOS:
QOS should include | QOS should NOT include |
|---|---|
✅ Sufficient information to provide the Quality Reviewer with an overview of Module 3: Quality ✅ Emphasis on critical key parameters of the Drug Substance and Drug Product – refer to Module 3 for further definition of DS and DP ✅ Justification for cases where guidances were not followed ✅ Discussion of key issues that integrate information from other modules, particularly Module 3 ✅ Cross-reference supporting information in other modules | ❌ Information, data, or justification that was not already included in Module 3 or in other parts of the CTD |
Pro Tip
Please make sure that the QOS is no longer than 40 pages of text, excluding tables and figures. Biotech products such as gene therapies have more complex manufacturing processes, so the document can be longer (but should not exceed 80 pages of text). Most of the information in QOS can be imported from Module 3: Quality (including tables, figures, or other items)