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Hello RAPS Forum,
Internally we are having a discussion on the requirement and expectation when the SUPAC guidance requires "One batch on long-term stability data reported in annual report."
It makes sense to me that this must be the first batch manufactured after the change, but is this specified anywhere? Or is it expected and industry standard but not explicitly specified? Or maybe it is neither?
I assume the first batch is best practice so if there is an OOT on stability after a change, one would get the earliest read on this. But that would still be months after the fact. If there is a first batch expectation, do you know the scientific or regulatory rationale behind it?
I suppose if the requirement is only to report in an annual report, it could be any batch that would provide data in advance of the next annual report. Correct?
Looking forward to the Forum's input and thoughts.