shimonv
Trusted Information Resource
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
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