CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Universal Tests / Criteria – Biological

• Appearance and description • A qualitative description of the dosage form should be provided (e.g., physical state and color). • Identification • Establish identity of drug substance – one or more orthogonal methods • Purity and impurities • Process-related impurities e.g. cell culture media, HCP, DNA, mAbs, chromatographic media, solvents, buffer • Product-related impurities, e.g. molecular variants and breakdown products • Potency / specific activity • A relevant, validated potency/activity assay method • Quantity • Protein content

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ICH Specific Tests: Tablets, capsules, granules (1)

Dissolution •

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Release of drug substance from the drug product • Single-point measurements for IR dosage forms • Two-stage testing for DR dosage forms • Three or more time-points for PR/ER dosage forms • Acceptance limits in line with clinical batches and available batch data • Disintegration: • Hardness/friability • Only if considered a CQA, e.g., chewable tablets, otherwise monitored in-process For rapidly dissolving products containing high-solubility drugs in lieu of dissolution •

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