An unusual reclaim process

Q: Filled product is recovered from dose checks or improperly stoppered vials, is dumped into a holding tank, in a class 100,000 area, and once in the tank, it is pumped back to the main product holding tank. It is mixed with the product in the holding tank, refiltered and filled again during the course of the filling operations. Wouldn't this "reclaim process" be considered a reworking of the product? Unless this process was submitted along with the ANDA originally, and validated, it seems that this would not be following good cGMP practice for sterile filling operations. I don't think FDA or any other regulatory agency would find this to be an acceptable practice. What are your thoughts?

A:

Jim Agalloco replies:

I fully agree—that’s a most unusual process. I've seen re-claims of this type before, but they typically aren't a part of every batch. They are used to recover an entire lot that may be off-spec. Unless it is filed that way (along with supportive data), I think the practice described is non-compliant.