Can validation batches be used for post approval stability testing?
Hi
I assume you mean, “validation batches” and not the process standardization batch(es).
In process standardization batches, the process parameters are still getting established. That’s not the case with validation batches. One only re-confirms process parameters that were set in the standardization batches.
So, there is no harm in using them for stability studies. These batches can even be commercialized, if there are no other considerations against it.
Good luck