Over-Labeling Sterile Packaging - Shelf Life

[shimonv]

Hi Fellows,
A colleague of mine has this situation: They have a disposable product in sterile packaging (pouch) with expiration date of one year.

Just recently the results of real-time shelf-life testing for three years came back successfully. To my knowledge the product and packaging did not change since the one year shelf life report was issued.

Now they would like to over-label products in the inventory so they will say three years instead of one year.

I am not aware of any RA issue besides to the need to document the rework wisely and reference the recent shelf-life test report.

What say you?


Thanks,
Shimon

 

[Ronen E]

Can they prove that the overlabeling itself doesn't affect the shelf life?

 

[shimonv]

Thanks Ronen.
The thought crossed my mind. The label is imprinted on the side of the pouch that is made of the 'breather' material that EtO can penetrate.

If they were to put the label on the other side of the pouch (transparent plastic) there would be conflicting information on the immediate packaging.

To put a label just on the carton box that contains 20 to 30 pieces is not enough.

Over-Labelling the expiration section on the 'breather' should not effect the packaging integrity. it seems far fetched that a 'dirty' sticker can compromise the sterility of the device. But I cannot prove it.

Perhaps a better idea would be to mark out the expiration date on the 'breather' side with a black marker and put a label on the other side of the pouch (transparent plastic) with the new expiration date. What do you think about that?

Shimon

By the way - you are not 'just a person'

 

[shimonv]

I found this statement in the Quality system regulation labeling requirements:

"Relabeling and Over-labeling

Over-labeling by placing a new label over an old label is discouraged by FDA but is acceptable as long as the new label and its use meet GMP requirements for attachment, legibility, reprocessing, and change control. (Over-labeling is also discouraged in some foreign countries.)"

Learn and be wise!

Shimon