CRED Getting the CMC Dossier Right 2024

28/08/2024

Considerations for writing a CMC dossier [1]

Narrative descriptions in “cooking - book” style are key to implement flexibility, e.g.

➢ Equipment:

by type, not by tradenames

➢ Materials:

by quality grade (“or equivalent”), no article numbers

➢ Operations: end-point-oriented, details adequate to criticality: “do xx until yy is achieved”/ “operate at least for xx” (otherwise a CQA will not be met)

➢ Specifications: Just the CQA in context of the intended purpose

➢ Avoid scans of manufacturing/ analytical procedure instruction

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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Considerations for writing a CMC dossier [2]

Is the dossier clear and complete? ➢ Does the lay-out ease readability of data (scans!!)? Is the text understandable? ➢ Are data in the correct CTD section? No empty CTD sections without explanation? ➢ Requirements of (local) guidelines considered?

Is the dossier consistent and compliant?

➢ Within 3.2.P, e.g. composition & batch formula, process validation & batch size, analytical method validation & specifications; specifications & CoAs … ➢ Does 3.2.P fit to: - GMP source documents (manufacturing/ test instructions...) - AF/ annexes to AF, SmPC, and module 2.3 (QOS)

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

22

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