Regulatory Open Forum

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 the need to document the rework wisely and reference the recent shelf-life test report.

Any  thoughts on the subject  / previous experience that you can share?

Thanks,
Shimon

Over the years companies I've worked for have done this several times. It is not a big deal from a regulatory standpoint in the US (assuming the shelf life protocol was part of the original submission). As you say, the key is to reference the report for rationale and be able to prove nothing in the packaging etc has changed. The key is documentation for the change - for instance, it may be a good idea to give a new lot number to reworked products so you can tell them apart.

Now, there are geographies who want you to do a new submission before you change shelf life on the label (Brazil comes to mind) so you will want to make sure of the RA pathways if the re-labeled product will be going to any of those markets.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 04-Apr-2017 03:43
From: Shimon Vaknin
Subject: over-labeling sterile packaging

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 the need to document the rework wisely and reference the recent shelf-life test report.

Any  thoughts on the subject  / previous experience that you can share?

Thanks,
Shimon

Thanks Ginger. Good points.

Shimon
Original Message:
Sent: 04-Apr-2017 08:11
From: Ginger Glaser
Subject: over-labeling sterile packaging

Over the years companies I've worked for have done this several times. It is not a big deal from a regulatory standpoint in the US (assuming the shelf life protocol was part of the original submission). As you say, the key is to reference the report for rationale and be able to prove nothing in the packaging etc has changed. The key is documentation for the change - for instance, it may be a good idea to give a new lot number to reworked products so you can tell them apart.

Now, there are geographies who want you to do a new submission before you change shelf life on the label (Brazil comes to mind) so you will want to make sure of the RA pathways if the re-labeled product will be going to any of those markets.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 04-Apr-2017 03:43
From: Shimon Vaknin
Subject: over-labeling sterile packaging

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 the need to document the rework wisely and reference the recent shelf-life test report.

Any  thoughts on the subject  / previous experience that you can share?

Thanks,
Shimon

I had a similar situation in which we considered over-labeling a sterile product.  My concern was ensuring the sterility of the product once it was removed from its shipping containers, put into the packaging line for labeling, and then manually packed back into the shipping containers.  The package insert doesn't say, "the contents are sterile", it just says "sterile-R" (implying everything is sterile until opened).  

Is that concern unwarranted?  

------------------------------
William Coulston, M.S., PMP

San Antonio TX
United States
------------------------------

Original Message:
Sent: 04-Apr-2017 08:11
From: Ginger Glaser
Subject: over-labeling sterile packaging

Over the years companies I've worked for have done this several times. It is not a big deal from a regulatory standpoint in the US (assuming the shelf life protocol was part of the original submission). As you say, the key is to reference the report for rationale and be able to prove nothing in the packaging etc has changed. The key is documentation for the change - for instance, it may be a good idea to give a new lot number to reworked products so you can tell them apart.

Now, there are geographies who want you to do a new submission before you change shelf life on the label (Brazil comes to mind) so you will want to make sure of the RA pathways if the re-labeled product will be going to any of those markets.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 04-Apr-2017 03:43
From: Shimon Vaknin
Subject: over-labeling sterile packaging

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 the need to document the rework wisely and reference the recent shelf-life test report.

Any  thoughts on the subject  / previous experience that you can share?

Thanks,
Shimon