CRED Getting the CMC Dossier Right 2024

29/08/2024

Common deficiencies: Impurities

⚫ Key Guidance on Impurities

• Control of impurities of pharmacopoeial substances

• ICH Q3A (R2) Impurities in new drug substances

• ICH Q3B (R2) Impurities in new drug products

• ICH Q3C (R5) Residual solvents

• ICH Q3D Elemental impurities

• ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

• Setting specifications for related impurities in antibiotics

• Nitrosamines (CMDh, EMA, MHRA)

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Common deficiencies: Impurities

⚫ How to apply guidance on Impurities

● Essential to read and fully digest the guidance documents

● Know your drug substance

● Potential impurities – Justification for tests/limits; control strategy – sound, supported, validated methods, mass balance, gaps? – where and when to test

● Still not sure? Seek scientific advice before submission

The Organisation for Professionals in Regulatory Affairs

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