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Blog & Resources Camargo Blog October 5th, 2010

Why have a Quality Overall Summary for the Quality Module?

The Quality Module (Module 3 or Chemistry, Manufacturing and, Controls section (CMC)) in the eCTD format serves as the backbone of any regulatory submission, an IND or NDA. We have discussed this in a previous blog posting. There is debate about the usefulness of the Quality Overall Summary (QOS or Module 2.3 of eCTD) with respect to the Quality Module. Is there really any value to this component? Often during the preparation of the quality component of Module 2.3, entire sections of Module 3 are repeated.

The best way to understand the value of this section is to think of it from the reviewers’ perspective. Every reviewer will not be a CMC expert, therefore when the preclinical or clinical reviewer has a question about the dosage form or batch of drug product, that individual may choose to look at the QOS for information. This allows the non-CMC expert to have a high level overview of the critical information that they will need to complete the review of their specific components. The M4Q Guidance for Industry does a great job of walking the writer through which details should be included in the QOS. The value of the QOS should be to point reviewers at the most important information to support the quality of your final drug product in the most transparent presentation possible.


Categories: CMC / Regulatory

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