How to Complete CTD Module 3: CMC Regulatory Q&A for Pharma & Biotech This presentation highlights attendees' questions from the free module 1 training session for the full course "Completing the Quality/CMC Module of the CTD" delivered by Educo Life Sciences. You can read the full Q&A article here - https://educolifesciences.com/cmc-regulatory-qa-for-pharma-biotech/

1. How to Complete CTD
Module 3: CMC Regulatory
Q&A for Pharma & Biotech
Insights from Free Module 1 Training Sessions

2. Introduction
• The Chemistry, Manufacturing, and Controls (CMC) section of a regulatory
dossier is critical in ensuring product quality and regulatory compliance.
• Educo delivers the course
“Completing the Quality/CMC Module of the CTD”which includes a
free-to-attend module 1 training session.
• This presentation answers key questions raised in those free-to-attend
module 1 training sessions.

3. Want to Read the Detailed Q&A Article?
• This presentation provides highlights from the original article. The
answers in the original are more comprehensive.
• To read the full article – follow the link.

4. General Questions on CMC and CTD
Q: What is the most common mistake seen in CMC dossiers?
A: Lack of clear linkage between sections; ensuring consistency is critical.
Q: How much flexibility is there in CMC submissions across different regions?
A: CTD format is harmonised, but regional variations exist (e.g., FDA vs EMA
expectations).
Q: How can we best approach writing the Quality Overall Summary (QOS)?
A: It should summarise, not introduce new data; ensure alignment with
Module 3.

5. Q: How do you justify the analytical methods used in the dossier?
A: Based on suitability and validation per ICH Q2 (R1) and upcoming ICH
Q14.
Q: What is the importance of control strategy in the CTD?
A: Links CPPs, CQAs, and analytical methods to ensure product
consistency.
Q: How should nitrosamines and elemental impurities be handled in
CMC submissions?
Analytical Methods and Specifications

6. Regulatory Considerations and Global Submissions
Q: How should changes post-submission be managed?
A: Implement ICH Q12 principles to minimise unnecessary variations.
Q: When is the new CTD format expected?
A: It may take 2–5 years; companies should prepare in advance.
Q: What challenges do small molecule CMC managers face with future
CTD changes?
A: Increasing expectations for detailed control strategies and
justifications.

7. Practical Considerations for CTD Compilation
Q: Who should be involved in writing and reviewing Module 3?
A: A cross-functional team including regulatory, analytical, and
manufacturing experts.
Q: How can CMC dossiers be simplified while maintaining compliance?
A: Focus on justifications rather than excessive raw data.
Q: How can regulatory communication be improved during CMC review?
A: Engage with agencies proactively via scientific advice meetings and pre-
submission discussions.

8. Special Considerations for Gene Therapy and Advanced
Products
Q: What level of detail is expected in Module 3 for gene therapy
products?
A: Extensive documentation required, covering plasmids, viral seeds,
and control of materials.

9. Conclusions
Key Takeaways
• CMC dossier success depends on consistency, scientific justification, and
strategic preparation.
• Regional variations exist; a global dossier approach is beneficial.
• Engagement with regulatory authorities facilitates approvals.
Next Steps
• Attend the full Educo Life Sciences CMC training programme.
>>Click Here<<
• Register for the free Module 1 training session. >>Click Here<<

10. Thank You!
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