For rework and reprocessing, Part 211 requires changing batch numbers to make it evident that the batch has been reprocessed/reworked. Is this still a requirement for APIs under Q7A? It’s very burdensome when reprocessing occurs based on in-process testing.
Q7A does not specifically require or state how you would number either your first batch or your
reworked/reprocessed batch. It does say that you must have unique batch identification, and that
the batch must be traceable through all of its history.
