CRED Getting the CMC Dossier Right 2024

28/08/2024

Drug Substance – Quality Attributes

Polymorphic forms ● Different crystalline forms? ● Solvation or hydration products? ● Amorphous forms? ● Transformation between forms

Do forms have different properties? ● Solubility? ● Stability?

● Decision Trees in ICH Q6A very useful to define impact and guide development

The Organisation for Professionals in Regulatory Affairs

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Drug Substance – Quality Attributes

Chiral compounds

● Ensure have correct enantiomer – Different biological properties therefore different/undesired performance ● Can control – in specification by chiral specific assay/impurity limit – during manufacture by testing starting material/intermediate and no further racemisation or change ● ID test must prove have correct enantiomer

● Stability studies to prove no change during storage of chirality ● Atropisomerism – planar chirality/racemisation by bond rotation

● Decision Trees in ICH Q6A very useful to define impact and guide development

The Organisation for Professionals in Regulatory Affairs

24

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