Hello,
Editing a supplier agreement template that looks like it covers some aspects related to virtual manufacturing including holding registrations. but is termed a supplier agreement.
We have a number of suppliers who manufacture (inc. packing non-sterile) and will hold the original formulation or design. Leaving us with the job of label creation distribution etc. However they are not a virtual manufacturer as they don't hold certification and do not sell the product themselves. Therefore the relationship here is a critical supplier one.
So first question can anyone help me with the specifics of a critical supplier relationship, what are the obligations here?
Is it a case of ensuring that their procedures that cover the manufacture of our device and their QMS documentation is in line with the standard?
Are we obligated to make them virtual manufacturers?
For Virtual manufacturers, they will be selling the product themselves so have their own regulatory registrations and guidance from MHRA is clear about what should be in the agreement: Virtual manufacturing of medical devices
However, would the same provisions that you require for a critical supplier be applicable as well? For example VM agreement clauses + Critical Supplier arrangements?
Editing a supplier agreement template that looks like it covers some aspects related to virtual manufacturing including holding registrations. but is termed a supplier agreement.
We have a number of suppliers who manufacture (inc. packing non-sterile) and will hold the original formulation or design. Leaving us with the job of label creation distribution etc. However they are not a virtual manufacturer as they don't hold certification and do not sell the product themselves. Therefore the relationship here is a critical supplier one.
So first question can anyone help me with the specifics of a critical supplier relationship, what are the obligations here?
Is it a case of ensuring that their procedures that cover the manufacture of our device and their QMS documentation is in line with the standard?
Are we obligated to make them virtual manufacturers?
For Virtual manufacturers, they will be selling the product themselves so have their own regulatory registrations and guidance from MHRA is clear about what should be in the agreement: Virtual manufacturing of medical devices
However, would the same provisions that you require for a critical supplier be applicable as well? For example VM agreement clauses + Critical Supplier arrangements?