CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2 Pharmaceutical Development

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

9

3.2.P.2 Pharmaceutical Development

Components of the Drug Product:

Discussion on PSD & polymorphism

EXAMPLE

• Two different active substance polymorphs

may have different solubility, water content,

bioavailability …

• This has to be discussed and supported by

data (3 batches DS; PSD justified by test biobatch)

• Effect of manufacturing on properties?

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

10