CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.8 Stability

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

33

3.2.P.8 Stability

● Stability protocol – in line with ICH guideline Q1A

●

The first choice:

✓ Long-term conditions: 25 ± 2 °C / 60 ± 5 % RH (6 or 12 months) ✓ Accelerated conditions: 40 ± 2 °C / 75 ± 5 % RH (6 months) ● If accelerated fails, then intermediate conditions:

✓ Intermediate conditions: 30 ± 2 °C / 65 ± 5 % RH (6 months)

● Data for at least two/three primary batches, identical formulation, active substance sources, manufacturing process and packaging as proposed.

● 12 months long-term stability on three primary batches for critical dosage forms.

● In justified cases – storage in refrigerator or freezer

● Shelf life and storage claim based on available data.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

34