CRED Getting the CMC Dossier Right 2024

28/08/2024

Role of the Quality section

• Quality topics located in two sub-sections of ICH M4:

• Module 3 Quality & Module 2.3 Quality Overall Summary

• ICH M4Q gives detailed breakdown of heading for both these

• Format applies to New Chemical Entities and Biotech drug substances and corresponding finished products

• The purpose of the Quality information is to:

• Provide assurance of the identity, purity, potency and other standards of quality in the drug substance and drug product (ICH Q6A and Q6B)

• To ensure the critical quality attributes are met using critical manufacturing parameters (ICH Q8)

• Provide science – and risk-based assessments of the quality of the pharmaceutical (ICH Q9)

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CTD Quality Structure of Module 3

3.1 Table of Contents

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3.2 Body of Data

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3.2.S Drug Substance Data

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3.2.P Drug Product Data

3.2.A Appendices

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• 3.2.A.1 Facilities and Equipment (Biotech)

• 3.2 A.2 Adventitious Agents Safety Evaluation

• 3.2.A.3 Novel Excipients (as per 3.2.S headings)

3.2.R Regional Information

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3.3 Literature References

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