CRED Getting the CMC Dossier Right 2024

28/08/2024

Assay/potency ● Validated method specific for drug substance ● Controls purity level (upper and lower limits) ● Stability indicating ● Non-specific methods can be justified if combined with other specific methods for impurities Drug Substance – Quality Attributes

The Organisation for Professionals in Regulatory Affairs

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Drug Substance – Quality Attributes

Impurities (ICH Q3A) ● From synthetic route; – starting materials

– intermediates/by-products – enantiomers (chiral compounds) – elemental impurities (ICH Q3D) – residual solvents (ICH Q3C) ● Degradation products ● Mutagenic impurities (ICH M7)

The Organisation for Professionals in Regulatory Affairs

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