Revalidation machine line and Stability Studies impact.

#1
Hi Team: I am new working in the Medical Device World. I have the fallowing question:

It will be moving a coating / Varnish machine from one building to an other and a re-validation process will be perform, However, it is required to create a stability study to monitoring the product up to shelf life? I think that should be... but I do not have all the Medical Device guidance in other to confirm.

Your expertise will be more than welcome;

RSanchez
 
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#3
You have to re-validate process. GHTF Validation guidance.
However you don't need to perform stability study, unless there is a performance loss because of displacement. You have to evaluate internally.
 
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