CRED Getting the CMC Dossier Right 2024

28/08/2024

Purpose of “Quality”/ CMC info in regulatory dossiers

Efficacy

„Quality“ means information about a medicine‘s :

- physico- C hemical characteristics: that can deliver an intended efficacy/ safety profile

Quality

Safety

- M anufacturing settings:

to reliably generate a product with these characteristics

- C ontrol tools:

quality attributes and procedures to verify whether an actual batch has these characteristics

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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The challenge of writing a CMC dossier:

Compile masses of diverse information about a medicine to a consolidated presentation that

➢ explains its quality profile and how it complies with standards to regulatory assessors,

➢ with adequate flexibility for the daily real-life business to produce, control, and release/ deliver it to markets .

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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