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I have a customer who states the following:
"The FDA expects special processes to be validated. It is in the QSR's".
I fully accept that processes such as sterilization, injection molding, etc., require validation.
But can anyone show where in the QSR's it states that "special processes" must be validated? Who defines what is special?
"The FDA expects special processes to be validated. It is in the QSR's".
I fully accept that processes such as sterilization, injection molding, etc., require validation.
But can anyone show where in the QSR's it states that "special processes" must be validated? Who defines what is special?