CRED Getting the CMC Dossier Right 2024

28/08/2024

Drug Substance – Quality Attributes

Specification should address

• Each specified identified impurity

• Each specified unidentified impurity

• A clause to capture any unspecified impurity with potential to be present

• Total impurities

Typical Early specification

Typical Late/commercial specification

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Drug Substance – Quality Attributes

Impurities (ICH Q3A)

Specified impurities should be limited based on understanding of safety i.e., Impurities should be suitably qualified

Qualification

The process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified.’

Thresholds

ICH Q6A Decision trees give guidance on acceptance criteria

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