CRED Getting the CMC Dossier Right 2024

29/08/2024

Common deficiencies: Particle size

⚫ How to consider particle size

● Know your drug substance – Poorly soluble? – impact on the drug product? – particle size reduction needed? - method; site involved

– control of particle size needed? – adequate method; multi-point – supported by batch data – supported by stability data

● Often linked to 3.2.P

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Common deficiencies: Polymorphism

⚫ The issue:

● Assessors on the ‘look out’ for: Drug substances exhibiting polymorphism

● The issue – Polymorphism - Critical Quality Attribute – Impact on the drug product – dissolution, – bioavailability, pharmaceutical equivalence – Stability ● Information inadequate – no discussion – lack of control in drug substance specification – Stability implications

– Stability in the finished product? ● May also be raised in 3.2.P.2!

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