Does Reprocessing need to be validated and, if so, is concurrent release appropriate? Then, the statement is made that this practice could result in validation packages remaining open for long periods of time. Why don’t you address that, and there are a couple of other twists I can throw in if you don’t have enough fun with that one.

If you recall the definition for reprocessing in the API arena, that’s taking a batch that either
conforms or non-conforms and putting it back into the process, and repeating steps that are part
of the established process. Now, if your established process was validated, then we don’t see a
need for re-validating the reprocessing. If, for example, the original crystallization process was
validated and your reprocessing step is a re-crystallization, than we frankly, do not see a need for
re-validating that re-crystallization step. It’s already been validated. If the step is not originally
validated and used for reprocessing it should normally not require validation either. Validation of a
step is driven by whether the step is critical or not.