Outsourcing manufacturing - Who controls the suppliers of parts to the CMO?

S

snoopy2017

#1
#1
A company is going to outsource parts of manufacturing to a foreign entity. Shouldn't the legal manufacturer (whose name is on the device label) exercise control over the suppliers of parts to the CMO? In other words, should the legal manufacturer approve or be made aware of all the suppliers who will deal directly with the foreign CMO?
Thanks!
 
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William55401

William55401

Quite Involved in Discussions
#2
#2
Short answer: it depends. I have seen outsourcing models where the legal manufacturer defines and controls the suppliers of components to the outsourced manufacturer. I have also been involved with outsourcing models where the legal manufacturer defers to the outsourced manufacturer on supplier selection and control. In this case, the legal manufacturer only has one supplier to control-- the outsourcing partner. Yes, there are risks of giving up this control but if the legal manufacturer is a small entity without supply chain knowledge, the outsourced manufacturer can provide those services. Bottom line, the legal manufacturer has to decide what makes sense. I would suggest a risk benefit analysis and document the solution in a quality agreement with the outsourced foreign entity.
 
Y

yodon

Staff member
Super Moderator
#3
#3
The bottom line is that you're responsible for ensuring the requirements of the regulations are met. You can give the CM the responsibility of qualifying and approving their subs but they need to do so in a compliant manner. Same for purchasing (data / verification). You need to be able to ensure all those required records are available to inspectors / auditors.
 
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