CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.3 Manufacture

Case study:

Validation of Non-standard manufacturing processes: ● Sterile single use, single dose eye-drops (2.4% API) with aseptic manufacturing. ● Proposed batch size range: 100-1000 L. ● Validation data for 3 batches of 100 L and 1000 L batch size 3 batches of 100 L + 3 batches 1000 L + discussion variations in batch size does not affect product CQAs (point 6 Process Validation GL) unless it is justified that the manufacturing is standard (point 8 Process Validation GL): name and reg. numbers in EU/EEA member states, history of GMP compliance and amount of knowledge gained. → Not sufficient

Alternatively: batch size 100 AND 1000 L

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

23

3.2.P.4 Control of Excipients

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

24