CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.3 Manufacture

● Description of the manufacturing process (P.3.3) – enough details.

● Process parameters (mixing time & speeds, filter details, temperature, pH)

● Holding times should be clearly stated and justified, if necessary (>24 h sterile products; > 30 days for non-sterile products). Media fills (aseptic process).

● NfG on Starting the shelf-life of the finished dosage form.

● CPPs (P.3.4) need justification. In line with information in P.2.3 & P.3.5.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

21

3.2.P.3 Manufacture

● Process validation and/or evaluation – standard vs. non-standard process – as defined in Annex II to Note for Guidance on Process Validation CHMP/QWP/848/99 and EMEA/CVMP/598/99 non- standard processes

● Standard process – the process validation protocol

● Non-standard process – full scale validation data for all batch sizes (range!) 1. Manufacture of specialized pharmaceutical forms ( ≤ 2.0% API, modified release); 2. Incorporation of some new technology into a conventional process (new wet granulation process); 3. (Highly) Specialized processes with new technologies or an established process known, or likely, to be complex and therefore to require particular care (lyophilization); 4. Non-standard methods of sterilization (different to Ph.Eur. 5.1.1).

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

22