CRED Getting the CMC Dossier Right 2024

28/08/2024

The Quality Overall Summary (CTD 2.3)

Your summary discussion of the product’s quality profile

➢ Consolidated narrative presentation and justification of the critical quality attribute es/ process parameters and summary of the data that support them ➢ Show specifications, but refer to 3.2.S/P/A/R for data (exception: active substance/ drug product batch analysis results to show that the targeted quality profile is met)

➢ Do not include new data that are not in module 3

➢ Updates not obligatory in case of type IA/ IB variations

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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Thank you for your attention

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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