CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2 Pharmaceutical Development [1]

Explanation of the quality profile of your medicine:

➢ Presentation style: Summary of its evolution from concept to the final design that delivers the intended performance

➢ Key content:

How were C ritical Q uality A ttributes (CQA) and P rocess P arameters (CPP) identified and established

➢ Note: 3.2.P.2 is a product knowledge repository for lifecycle management

Guidance: ICH Q8 (R2), EMA NtA Vol 2B

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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3.2.P.2 Pharmaceutical Development [2]

Components:

Which physico-chemical characteristics contribute to the performance/ manufacturability of the drug product? - Active substance: e.g. polymorphism, solubility, particle size… - Excipients: function in formulation, quality grade… How is the active substance maintained, transported and released at the site of action (e.g. tablet films, rheological properties…..)? Support the evolution of test/ clinical/ final formulations by data for comparability (e.g. dissolution profiles for oral solids)

Formulation:

Guidance: ICH Q8, EMA NtA Vol 2B

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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