It’s very important to make this distinction because, first of all, there are very stark differences
between these two activities in the API arena. In reprocessing, you can reprocess conforming and
non-conforming material. You can only rework non-conforming material. Reprocessing involves
taking the material, introducing it back into a batch and basically repeating a step or steps that
are part of the established process. Reworking involves taking material, putting it back into the
process and doing something to that batch that is different from the established process. The
reprocessing of APIs is typical; reworking is non-typical. So there are clearly very distinct
differences between the two. It’s important that you clearly understand what these distinctions are
because when you have these kind of problems, what you do and how you handle the situation
is, in general, going to depend on how it’s classified, whether it’s a reprocessing or a rework.
