In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR?

#1
Hello everyone. A manufacturer has contracted with an overseas CMO that will produce part of the device. Meanwhile, the manufacturer itself will also produce the other part of the device. However, the final packaging arrangement is interesting. For devices sold in the part of the world where the CMO is located, the final packaging and testing will be done by that CMO because of the geographic proximity so the original manufacturer will send their part of the device to the foreign CMO. On the other hand, if the final device is to be sold in the part of the world where the original manufacturer is located,the CMO would send over their part of the device for final packaging with the original manufacturer. In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? Who is keeping the manufacturing documentation? The final release would be performed by the legal manufacturer, not the CMO, I presume? If the final packaging is done overseas, how does the legal manufacturer have control over the final release documentation?

I would appreciate any insight into this.

Thanks.
 

somashekar

Staff member
Super Moderator
#2
Hello everyone. A manufacturer has contracted with an overseas CMO that will produce part of the device. Meanwhile, the manufacturer itself will also produce the other part of the device. However, the final packaging arrangement is interesting. For devices sold in the part of the world where the CMO is located, the final packaging and testing will be done by that CMO because of the geographic proximity so the original manufacturer will send their part of the device to the foreign CMO. On the other hand, if the final device is to be sold in the part of the world where the original manufacturer is located,the CMO would send over their part of the device for final packaging with the original manufacturer. In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? Who is keeping the manufacturing documentation? The final release would be performed by the legal manufacturer, not the CMO, I presume? If the final packaging is done overseas, how does the legal manufacturer have control over the final release documentation?

I would appreciate any insight into this.

Thanks.
When the CMO sends you parts to integrate, he sends you with the DHR to the extent of his supplies, which you will integrate with your DHR for due traceability and complete the documentation and release. Likewise in the reverse case.
As a part of your as well as the CMO's QMS agree that both will maintain the DHR to the full extent and share the same with you after release.
About control, the DHR in itself is not total control. Its a record of activities and release authorization. This support higher levels of controls that you would have put in place before operations as well as during the operations.
 

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