A new cone mill machine (for tablet granulation process) is purchased to substitute the oscillating granulator in our company.
I would like to know what validation activities shall be performed during the PQ on this new machine.
Our preliminary proposal is to perform PV (with consecutive 3 batches) of a product to prove that the outcome products (i.e. the intermediate products and the bulk tablets) maintain our predefined requirement.
Is it appropriate? Any recommendation & comment?