Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

I suppose the manufacturing site is also the Legal Manufacturer location(?)

I have only limited and anecdotal experience, but when we changed our legal manufacturer address we had a few months to phase out packaging with the old address. We immediately applied stickers on the box, one overlaying the old address with the new address and one notifying that the single-unit packaging and IFU inside the box contains the old address and what our new address is.

All customers (distributors) were informed beforehand, but additionally when shipping products with the 'old' packaging we attached a letter with each shipment, informing them of the address change and that the products they have received contains labelled packaging. 

We set a deadline for ourselves we could only apply this temporary labelling measure for 3-4 months, to give ourselves time to sell-out old products, acquire new packaging for new products (or rework of existing stock) etc. I was aware that 3-4 months would be the maximum.

We actually had to postpone that deadline a little and combine it with a difference QMS change, but that was also OK'ed by the NB; we performed a risk analysis beforehand and mitigated risks as far as possible, e.g. ensuring that customers and authorities who would potentially try to contact us were able to do so by keeping the same regional telephone number (even though we moved to a different region), ensuring that the address was updated on Google, ensuring that digital communication was not affected by the site change, etc., so the probability of people/authorities not being able to contact us was very limited.

In short, I would say that it depends on the NB who will assess the associated risks. For example, our product is a temporary, bioresorbed implant with a shelf life of two years. The implant itself can't contain the address, just the packaging, which will be tossed away after use. If you have equipment with a 10 year life containing a label with your company information, I estimate that it is more stringent that you re-label your product with the correct address before putting it on the market.

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Vincent van der Meer
Netherlands
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Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

If the address of A and B are considered the legal manufacturer, in most regulatory scenarios there is a requirement to have the manufacturer's name, address, and contact information located on the labelling.  Therefore, if you are changing location from A to B as the legal manufacturer, in most likelihood you will need to update the product labelling.  You should develop a Quality Plan for how this change would occur, activities and tasks to complete, who is responsible, and timeline for when the cross-over would occur.  Hopefully you have on demand printed labelling so from a manufacturing perspective this should be easy process to switch over in a short amount of time.  The simple answer to your question is you would need to change the labelling to reflect the new address.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 20-Nov-2019 03:14
From: Vincent van der Meer
Subject: Manufacturing site change - labeling change

I suppose the manufacturing site is also the Legal Manufacturer location(?)

I have only limited and anecdotal experience, but when we changed our legal manufacturer address we had a few months to phase out packaging with the old address. We immediately applied stickers on the box, one overlaying the old address with the new address and one notifying that the single-unit packaging and IFU inside the box contains the old address and what our new address is.

All customers (distributors) were informed beforehand, but additionally when shipping products with the 'old' packaging we attached a letter with each shipment, informing them of the address change and that the products they have received contains labelled packaging.

We set a deadline for ourselves we could only apply this temporary labelling measure for 3-4 months, to give ourselves time to sell-out old products, acquire new packaging for new products (or rework of existing stock) etc. I was aware that 3-4 months would be the maximum.

We actually had to postpone that deadline a little and combine it with a difference QMS change, but that was also OK'ed by the NB; we performed a risk analysis beforehand and mitigated risks as far as possible, e.g. ensuring that customers and authorities who would potentially try to contact us were able to do so by keeping the same regional telephone number (even though we moved to a different region), ensuring that the address was updated on Google, ensuring that digital communication was not affected by the site change, etc., so the probability of people/authorities not being able to contact us was very limited.

In short, I would say that it depends on the NB who will assess the associated risks. For example, our product is a temporary, bioresorbed implant with a shelf life of two years. The implant itself can't contain the address, just the packaging, which will be tossed away after use. If you have equipment with a 10 year life containing a label with your company information, I estimate that it is more stringent that you re-label your product with the correct address before putting it on the market.

------------------------------
Vincent van der Meer
Netherlands

Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

Hi Anonymous,

I'm not sure your question is being answered. The correct labeling of product is a requirement when you place the product on the market (you can do that as outlined in the prior responses). I am not aware of any regulatory requirement to take action with the fielded product, but....

As others have said, you should do the risk analysis and determine actions needed for the product in the field (probably no action needed). You should consider other action though, such as forwarding of any phone numbers or deliveries (how are ensuring that customers can report complaints, return product or send other feedback on that fielded product). Most business also send a notification to their customers of the change of location. Make sure you document each of these decisions for review by your NB (or regulators).

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

This message was posted by a user wishing to remain anonymous

What type of product are you manufacturing? This question would have different answers depending on if this is a drug, a PMA device, or something else. As you have said, this is a complex scenario, so a little more detail is required for response.
Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

This message was posted by a user wishing to remain anonymous

Thank you all for your input. Here's a little more information, the company is the legal manufacturer of class II implantable devices in the US. Most manufacturing processes are outsourced to subcontractors, but the address on the labels is the registered facility of the company's headquarters. We understand the need to change the address on documentation in-house, the main point of my question is to understand to what extent and in what time-frame we need to correct labeling on product in the field. Most inventory is held by distributors on a consignment basis until it is used in surgery, so this would be a huge effort to return all parts for re-labeling with the new address.
Original Message:
Sent: 22-Nov-2019 08:23
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

What type of product are you manufacturing? This question would have different answers depending on if this is a drug, a PMA device, or something else. As you have said, this is a complex scenario, so a little more detail is required for response.
Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

Hello Anon,
based on you response: If you are only the legal manufacturer (LM) of the product (not physical manufacturer) and in process of changing the company's HQ site address, then you need to contact all the countries (in your case distributors), need to notify the change and and seek regulatory assessments where the products have been registered.Once you understand the impact, documentation requirements and approval timelines in those registered countries, devise a RA plan and strategy. For example: Singapore change in legal site change requires labeling,letter from Organisation there is no change in manufacturing etc.and have 2-3 months of approval timeline before you make the change.
You also need to work with your subcontractors to make sure they understand the changes and documents that needs to be revised as a result of LM site change.
If you sell in EU, you need to notify and work with Authorized Rep and NB and create new DoC and Labeling and provide before the new labeling change product comes into distribution. For the old product that is already into the respective countries, you don't need to worry about that. I am working on similar change: change in LM and site address. Please let me know if you have more questions. Thanks


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Jinali Bhavsar RAC
Regulatory Affairs Specialist
San Jose CA
United States
------------------------------

Original Message:
Sent: 25-Nov-2019 10:42
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Thank you all for your input. Here's a little more information, the company is the legal manufacturer of class II implantable devices in the US. Most manufacturing processes are outsourced to subcontractors, but the address on the labels is the registered facility of the company's headquarters. We understand the need to change the address on documentation in-house, the main point of my question is to understand to what extent and in what time-frame we need to correct labeling on product in the field. Most inventory is held by distributors on a consignment basis until it is used in surgery, so this would be a huge effort to return all parts for re-labeling with the new address.
Original Message:
Sent: 22-Nov-2019 08:23
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

What type of product are you manufacturing? This question would have different answers depending on if this is a drug, a PMA device, or something else. As you have said, this is a complex scenario, so a little more detail is required for response.
Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?

Hello Jinali,

Thank you for your comments, I hope to find you well in this message!

I am curious about how was your transition? This because we are going to have the same process, change of the Legal Manufacturer's address, 
We have identified the documents we will need for starting the process:  Quality Transition Plan, ISO 13485, Labelling, Site organigram chart for QA and Manufacturing, CFG's or FSC's
Did you need some extra documents that you didn't expect?
Thank you in advance
Regards
Fabiola

------------------------------
Fabiola Patino
Pharmaceutical Chemist
Mexico
------------------------------

Original Message:
Sent: 26-Nov-2019 16:22
From: Jinali Bhavsar
Subject: Manufacturing site change - labeling change

Hello Anon,
based on you response: If you are only the legal manufacturer (LM) of the product (not physical manufacturer) and in process of changing the company's HQ site address, then you need to contact all the countries (in your case distributors), need to notify the change and and seek regulatory assessments where the products have been registered.Once you understand the impact, documentation requirements and approval timelines in those registered countries, devise a RA plan and strategy. For example: Singapore change in legal site change requires labeling,letter from Organisation there is no change in manufacturing etc.and have 2-3 months of approval timeline before you make the change.
You also need to work with your subcontractors to make sure they understand the changes and documents that needs to be revised as a result of LM site change.
If you sell in EU, you need to notify and work with Authorized Rep and NB and create new DoC and Labeling and provide before the new labeling change product comes into distribution. For the old product that is already into the respective countries, you don't need to worry about that. I am working on similar change: change in LM and site address. Please let me know if you have more questions. Thanks


------------------------------
Jinali Bhavsar RAC
Regulatory Affairs Specialist
San Jose CA
United States

Original Message:
Sent: 25-Nov-2019 10:42
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Thank you all for your input. Here's a little more information, the company is the legal manufacturer of class II implantable devices in the US. Most manufacturing processes are outsourced to subcontractors, but the address on the labels is the registered facility of the company's headquarters. We understand the need to change the address on documentation in-house, the main point of my question is to understand to what extent and in what time-frame we need to correct labeling on product in the field. Most inventory is held by distributors on a consignment basis until it is used in surgery, so this would be a huge effort to return all parts for re-labeling with the new address.
Original Message:
Sent: 22-Nov-2019 08:23
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

What type of product are you manufacturing? This question would have different answers depending on if this is a drug, a PMA device, or something else. As you have said, this is a complex scenario, so a little more detail is required for response.
Original Message:
Sent: 19-Nov-2019 16:03
From: Anonymous Member
Subject: Manufacturing site change - labeling change

This message was posted by a user wishing to remain anonymous

Hi all,
I'm wondering if anyone's got a simple answer to this potentially complex scenario. When moving a manufacturing site from location A to location B, with the intent of closing location A, all labeling must be revised to reflect the new address for B. To what extent does the manufacturer need to relabel product and/or labeling documents in the field to reflect that address change?