Design verification driven by new equipment. How is this different than process validation?

P

prkpr

Registered
#1
#1
Hi, I have been an avid user of Elsmar since 2015 yet this is my first question in the forum. I am seeking guidance from folks who have dealt with design verification and process validation. The situation is:

My product is a Class I medical device.

We have a process output that is 100% verified. We are introducing a new equipment in the process to improve the verification of the output. This equipment is a centrifuge with a range of speeds and it was determined that although the process output is 100% verified, we need to verify if design inputs for the product are still being met at the ends of the speed range.

What should be the mental model I need to create to understand how the "process validation (namely OQ)" is intersecting with the design verification aspect?
I am also looking for guidance on how to document this in the test protocol - is this design verification or process validation? The process output is 100% verified so we should not be performing process validation. Then is it just design verification driven by the introduction of a new equipment?

I would be grateful if you could also provide a resource where I could look up more information - I have looked up the GHTF guidance but haven't been able to find an answer on the intersection of design verification and process validation.
 
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Y

yodon

Staff member
Super Moderator
#2
#2
Design verification is generally in the context of the medical device. So in that respect, there really is no intersection.

Manufacturing equipment needs to be qualified (you mentioned OQ - that's typically one aspect of qualification but there's really no hard and fast rules about how qualification must be done). Once your equipment is qualified, you can then have confidence that your process validation (using the qualified equipment) gives reliable results.

You should start with your requirements for the equipment and then confirm those. Some things to possibly consider: will it hold speed consistently at the ranges and for the intended use time? Will it perform repeatedly throughout the intended use day (how many times a day must it perform)? Does the system give you an indication of proper operation (display, reports, etc.) and improper operation (e.g., if there was a power spike, will operations be affected and, if so, reported or if somehow couldn't reach desired speed)? (I'm just winging it here, not knowing your intended use or what aspects actually matter.)
 
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