CRED Getting the CMC Dossier Right 2024

28/08/2024

Carcinogenicity Potency Categorisation approach

The Organisation for Professionals in Regulatory Affairs

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Pharmacopoeial Drug Substance

Dir 2001/83/EC (Annex 1, Part 2, C) states:

“The monographs of the PhEur shall be applicable to all substances appearing in it”. – Hierarchy is PhEur > other MS pharmacopoeia

Is compliance with the bare monograph enough?

● Different residual solvents

● Impurities from different syntheses/purification

● Tests for special uses (microbial limits, endotoxins)

Different territorial monographs are not necessarily aligned.

The Organisation for Professionals in Regulatory Affairs

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