Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!

Hi,
The way I have seen it done was that the lot results were electronically sent to the legal manufacturers quality manager for review and signature. I don't believe the whole batch record, label retains, raw data, etc. were sent due to the logistics. The signed form was then emailed back to the contract manufacturer.
Hope this helps,
------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Carver MN
United States
------------------------------

Original Message:
Sent: 26-Aug-2019 18:12
From: Anonymous Member
Subject: Contract Manufacturing Question

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!

I work in the drug world and we are do sign off on batch release of every lot.  This has been my experience with several past companies where we used CMOs.

------------------------------
Tom
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 27-Aug-2019 10:19
From: Maddi Myers
Subject: Contract Manufacturing Question

Hi,
The way I have seen it done was that the lot results were electronically sent to the legal manufacturers quality manager for review and signature. I don't believe the whole batch record, label retains, raw data, etc. were sent due to the logistics. The signed form was then emailed back to the contract manufacturer.
Hope this helps,
------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Carver MN
United States

Original Message:
Sent: 26-Aug-2019 18:12
From: Anonymous Member
Subject: Contract Manufacturing Question

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!

We are a contract manufacturer as well as a manufacturer.  The devices we contract manufacture are Class 1 and Class 2.  Our customers do not receive any batch information or perform any release after design validation is completed.  We treat the products just like they are our own and maintain all of the DHR.  We send a CoC with each shipment indicating the lot numbers of the devices.

These companies have passed their FDA inspections and ISO audits under this process for many years.

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 26-Aug-2019 18:12
From: Anonymous Member
Subject: Contract Manufacturing Question

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!

There are many ways that contract manufacturers and the company with legal responsibility can execute product release. The most important thing from an audit/ inspection stand point is to ensure that the relationship is clearly explained in your quality agreement with your contract manufacturer. As with all QMS aspects, document what the process is, follow the established process, and keep records as evidence of execution (not necessarily at both locations).

As a side note, also ensure that they are qualified appropriately as a supplier based on their level of responsibility - (i.e.: you may have additional qualification requirements if they are doing all lot release activities). 

Hope this was helpful - please reach out at the email below if more specific information is desired.

Good Luck!

------------------------------
Andrea Pilon Artman, MS, CQE, RAC
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com
------------------------------

Original Message:
Sent: 28-Aug-2019 07:22
From: D Michelle Williams
Subject: Contract Manufacturing Question

We are a contract manufacturer as well as a manufacturer.  The devices we contract manufacture are Class 1 and Class 2.  Our customers do not receive any batch information or perform any release after design validation is completed.  We treat the products just like they are our own and maintain all of the DHR.  We send a CoC with each shipment indicating the lot numbers of the devices.

These companies have passed their FDA inspections and ISO audits under this process for many years.

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 26-Aug-2019 18:12
From: Anonymous Member
Subject: Contract Manufacturing Question

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!

I've seen contract manufacturing release done a few ways. We've had partners (manufacturer of record) who were involved in the full process, reviewing the entire batch record and all release data before authorizing release. Then we've had others that didn't want to review anything and just wanted the CoC when it was shipped to them. A majority would put in place a batch release protocol. It would outline that the partner would review a certain number of batch documentation and if no errors or mishandled NCPs occurred, then they would decrease oversight. Which ever option you choose to go with should be justified, just like with any control you put over a supplier.

------------------------------
Mica Elizalde
Project Manager II, Regulatory & Quality
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 28-Aug-2019 08:09
From: Andrea Artman, MS, CQE, RAC
Subject: Contract Manufacturing Question

There are many ways that contract manufacturers and the company with legal responsibility can execute product release. The most important thing from an audit/ inspection stand point is to ensure that the relationship is clearly explained in your quality agreement with your contract manufacturer. As with all QMS aspects, document what the process is, follow the established process, and keep records as evidence of execution (not necessarily at both locations).

As a side note, also ensure that they are qualified appropriately as a supplier based on their level of responsibility - (i.e.: you may have additional qualification requirements if they are doing all lot release activities).

Hope this was helpful - please reach out at the email below if more specific information is desired.

Good Luck!

------------------------------
Andrea Pilon Artman, MS, CQE, RAC
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 28-Aug-2019 07:22
From: D Michelle Williams
Subject: Contract Manufacturing Question

We are a contract manufacturer as well as a manufacturer.  The devices we contract manufacture are Class 1 and Class 2.  Our customers do not receive any batch information or perform any release after design validation is completed.  We treat the products just like they are our own and maintain all of the DHR.  We send a CoC with each shipment indicating the lot numbers of the devices.

These companies have passed their FDA inspections and ISO audits under this process for many years.

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 26-Aug-2019 18:12
From: Anonymous Member
Subject: Contract Manufacturing Question

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!

This message was posted by a user wishing to remain anonymous

Thank you everyone for your input.  This is all very helpful.  Our internal auditor (who is also is a contracted Notified Body auditor) had a observation/recommendation that we increase our controls for final batch release at our contract manufacturer and should do a final review and sign off for release.  It appears we are in line with all your inputs and our NB auditor did not bring this up last year so I'm not sure why this is a concern.  

Thanks again!
Original Message:
Sent: 28-Aug-2019 10:21
From: Mica Elizalde, RAC
Subject: Contract Manufacturing Question

I've seen contract manufacturing release done a few ways. We've had partners (manufacturer of record) who were involved in the full process, reviewing the entire batch record and all release data before authorizing release. Then we've had others that didn't want to review anything and just wanted the CoC when it was shipped to them. A majority would put in place a batch release protocol. It would outline that the partner would review a certain number of batch documentation and if no errors or mishandled NCPs occurred, then they would decrease oversight. Which ever option you choose to go with should be justified, just like with any control you put over a supplier.

------------------------------
Mica Elizalde
Project Manager II, Regulatory & Quality
Salt Lake City UT
United States

Original Message:
Sent: 28-Aug-2019 08:09
From: Andrea Artman, MS, CQE, RAC
Subject: Contract Manufacturing Question

There are many ways that contract manufacturers and the company with legal responsibility can execute product release. The most important thing from an audit/ inspection stand point is to ensure that the relationship is clearly explained in your quality agreement with your contract manufacturer. As with all QMS aspects, document what the process is, follow the established process, and keep records as evidence of execution (not necessarily at both locations).

As a side note, also ensure that they are qualified appropriately as a supplier based on their level of responsibility - (i.e.: you may have additional qualification requirements if they are doing all lot release activities).

Hope this was helpful - please reach out at the email below if more specific information is desired.

Good Luck!

------------------------------
Andrea Pilon Artman, MS, CQE, RAC
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 28-Aug-2019 07:22
From: D Michelle Williams
Subject: Contract Manufacturing Question

We are a contract manufacturer as well as a manufacturer.  The devices we contract manufacture are Class 1 and Class 2.  Our customers do not receive any batch information or perform any release after design validation is completed.  We treat the products just like they are our own and maintain all of the DHR.  We send a CoC with each shipment indicating the lot numbers of the devices.

These companies have passed their FDA inspections and ISO audits under this process for many years.

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 26-Aug-2019 18:12
From: Anonymous Member
Subject: Contract Manufacturing Question

This message was posted by a user wishing to remain anonymous

Hi,

For those of you who use a contract manufacturer for your final finished device, do you as the company with legal responsibility review and sign off on final product release at your contract manufacturing location before the lot is released and moved to inventory?  Or do you simply review the final batch record after the lot has been released to inventory thus relying on your contract manufacturer to do the final release?

Thanks!