CRED Getting the CMC Dossier Right 2024

05/09/2024

Validation for non-standard processes

Require validation on commercial scale in the dossier:

• Specialised pharmaceutical dosage forms: low unit dose (2% or below), Modified Release products, Inhalers, Sterile Suspensions and Emulsions, Liposomes, Nanoparticles, Micelles

• New Technology

• Specialised or complex Processes (eg lyophilisation, scale-up difficulties or stability problems, aseptic processing)

• Non-standard methods of sterilisation

Different approaches can be based on company or site experience, comparable processes of already registered products

Agency meeting is recommended

The Organisation for Professionals in Regulatory Affairs

23

Stability Programmes and Data Requirements - for New Applications Q1 - for existing substances and related finished products (CPMP/QWP/122/02)

The Organisation for Professionals in Regulatory Affairs

24

12