We now are trying to submit the registration dossior for applying a generic chemical drug product. A stability study for under 20℃, 65% for 24 months has been conducted, and obtained a satisfied result. but we now would like to apply a 24 month-shelflife under recommened condition 2℃-8℃ due to commercial reason.
So, that is sound nt so reasonable. how could we do that ?
Without stability data at 2°C-8°C or suitable justification, most regulatory agencies will not accept a shelf life at 2°C-8°C based only on stability at under 20°C.
To apply for a 24-month shelf life under 2°C-8°C for your generic drug product, you would typically need to:
- Conduct a real-time stability study at 2°C-8°C for an adequate duration (ideally at least 12 months and preferably 24 months).
- Alternatively, provide a strong scientific rationale or bridging data explaining why stability data at under 20°C can be extrapolated to 2°C-8°C storage. This could involve the following:
- Accelerated stability data and kinetic modeling under various temperature conditions.
- Demonstration that the drug degrades faster at higher temperatures (such as 20°C) so stability at 20°C implies stability at 2-8°C.
- Supporting evidence such as chemical, physical, and microbiological stability data at 2°C-8°C for a shorter period with justified extrapolation.