Medical Device Validation and Pharmaceutical Validation differences?

[ifserav]

Hi to everibody!
I want to know if is there any difference between the medical device validation and the pharmaceutical process validation?

i know the process are quite different, but i want to know if the equipments need to be qualified, write a protocol and the same methodology.

Thanks a lot

Sergio Ávila

[yodon]

Speaking strictly from the medical device side...

A device does need to be verified (conforms with requirements) and validated (meets user needs and intended uses). If equipment is used in the V&V activities, it does need to be qualified. There's not really an equivalent for pharma products, I don't think.

Where there is some equivalence is in the production of medical devices. Often times the production processes need to be validated and / or the production equipment needs to be qualified. The management and control of these production processes are, I believe, generally consistent with the process validation requirements on the pharma side.