CRED Getting the CMC Dossier Right 2024

29/08/2024

Module 2: Quality Overall Summary (QOS)

⚫ What makes a good QOS:

● Follows scope/outline of body of data in Module 3

● Short, concise

● No new data/information

● Aim to provide Quality Assessor with a critique of M3: – Rather than a ‘cut and paste’ version of M3 – Emphasize critical key parameters of drug substance/product – Provide justification where guidelines not followed – Discuss key issues which integrate information from Quality module and supporting information from other Modules e.g. qualification of impurities via toxicological studies included in Module 4 ● Make it worth reading! – User friendly structure? Links to M3?

– See NtA Volume 2B and ICH M4 (Quality) for advice on content – Consider to include word copy in working documents folder

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3.2.S in the MA dossier / CTD

Module 3 Quality

3.1 Table of content

3.2 Body of data

3.3 Literature references

3.2.S Substance

3.2.P Drug product

3.2.A Appendices

3.2.R Regional Info

and 3.2.P.2!

⚫ Practical issues – data provision

● Location of information – ICH M4 (www.ich.org/products/ctd.html) – Notice to Applicants, Vol 2B

● Quality vs. quantity of data – Focus on key topics?

– Are data not included readily available – Non-essential data may trigger questions – May increase need for variations

(https://ec.europa.eu/health/documents/eudralex/vol 2_en)

● Index/hyperlinks/bookmarks etc

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