CRED Getting the CMC Dossier Right 2024

28/08/2024

Analytical Methodology - Early Development

Molecular characterisation of the drug substance and related substances:

• Structure [NMR, IR, MS, X-ray crystallography]

• Assay [HPLC, GC, UV/Vis]

• Impurities [HPLC, GC]

• Solvents, catalysts [GC, AAS, ICP]

Control of DS and intermediates

Method and validation summaries presented in the clinical application – not for all territories.

• Increasing detail as progress through development phases.

Important to gather valid data throughout development

• understand CQAs and control strategy

The Organisation for Professionals in Regulatory Affairs

27

Analytical Methodology – Regulatory Validation (ICH Q2A / Q2B)

Data submitted in MAA/NDA

The Organisation for Professionals in Regulatory Affairs

28

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