I think you have the key issues in mind - can there be mixups and what would the impact of a mixup look like.
While I don't believe there is any specific problem with this from a technical perspective as you note these would not be ganged and each would have its own record, really, the key here is the internal process at your label supplier. Could this be done and done well with no issues? Possibly. But are you confident enough in your supplier's systems in place that you would be willing to bank on this happening without a hitch? If not, I would suggest that you bring the issue up with your supplier.
Since the records you would keep (the supplier's job number, the original product number, the original PO numbers) would (or should!) be consistent. That should mitigate any issues from an inspectional standpoint, but I would still normally prefer that they have some sort of "number" on the invoice. Even if they use the same "base" number and then addend to it a "-1" or "A", "-2" or "B". That way, at the supplier facility they can use just the base number but your paperwork will reflect the fact that the runs were different and specific to a particular item.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 22-Aug-2019 05:23
From: Anonymous Member
Subject: label printing for ingestible OTC
This message was posted by a user wishing to remain anonymous
Hello,
A label printer has suggested less expensive pricing if they print multiple items under the same job number that they would use. The products would not be ganged - they would have their own records. The pricing seems great but I am concerned that their manufacture job number would be the same for multiple items even though our product numbers and PO numbers would also be on the records. Visually the products look similar.
This doesn't seem like a good practice - easy for a mix-up?? - is it in violation of FDA regulations? Would FDA see this and question it?
Thank you.