CRED Getting the CMC Dossier Right 2024

28/08/2024

Sources of Active Drug Substances

Sources of Active Drug Substances are many and varied: ● Chemical (organic and inorganic) ● Plants (herbal products and herbal extracts) ● Homeopathic Stocks ● Animals and Humans (tissues, fluids, extracts) ● Fermentation (antibiotics, vaccines) ● Biotechnology (proteins)

Wide range of different complexities - some can present a significant challenge to analyse, fully characterise and establish a specification

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Critical Quality Attributes – ICH Q11

● A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. ● CQAs can be modified as drug substance knowledge and process understanding increase. ● CQAs typically include those properties or characteristics that affect identity, purity, biological activity and stability. – Impurities are an important class of potential DS CQAs; potential to direct impact on drug product safety ● When physical properties are important with respect to in vivo performance or drug product manufacture, these can be designated as CQAs.

● Biotechnological/biological products, most of the CQAs of the drug product are associated with the drug substance ... are a direct result of the design of the drug substance or its manufacturing process.

The identification of CQAs is vital for all active drug substances

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