Posted for a colleague
Drug product in bottles, has to be stored at 2-8ºC. When opened it cannot be stored in the fridge but It can be maximum 3 month outside the fridge. How many batches would be needed in the stability study to comply with these requirements in order to submit to FDA ?
I think that the requirement would be for 3 registration batches, but I would want to conduct 1-3 TOR (Time Out of Refrigeration) studies (at 25C or 30C?) associated with the stability batches, minimally at the end timepoint, but perhaps at several or all pull-points for the purpose of trending. Would be interesting to know why it can’t go back to the fridge.
Here’s some further input from a very experienced industry colleague: “I agree with 3 and at least 2 batches having TOR studies at end time points to confirm, and one batch with a TOR study at some other point, but 3 batches with TOR studies at the end would be preferable. That said, they might incorporate pulls to move samples to Room Temp at multiple time points (12, 24 and expiry?) and not have a full separate study.”
As always, generate a justification for your plan based on requirements, guidances, and industry best practices, obtain internal QA and regulatory approval and at first opportunity confer with the regional regulatory authorities.
Any additional thoughts or related experiences from our readers?
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