Supplier - Process Validation

A

Ashwini_U

#1
We are only designing the product and the product is sent to a contract manufacturer. If I have to prepare DHF file then is it necessary to validate the supplier's manufacturing process? or I can just validate it over the incoming inspection? (Note: inspection is not 100%, its sample based)
 
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somashekar

Staff member
Admin
#2
We are only designing the product and the product is sent to a contract manufacturer. If I have to prepare DHF file then is it necessary to validate the supplier's manufacturing process? or I can just validate it over the incoming inspection? (Note: inspection is not 100%, its sample based)
So the product is yours as I understand...
As a final responsibility, what your contract manufacturer makes is upon you, and that includes the validation of the design as well as the process. You would have selected such a contract manufacturer.
The incoming inspection can serve the purpose of routine controls, but cannot replace validation.
 

Ajit Basrur

Staff member
Admin
#3
#4
Somashekar is correct - it is whoever that has design authority that must ensure that a) the output of processes be 100% verified, or if not, b) the processes be validated.

Whether it is the contractor's responsibility to perform the validation or not will likely be part of the statement of work between you and the contractor.
 
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