Hi everyone,
If i have a new equipment and I want to perform a PQ on this, so I run the machine as the fixed parameter as dictated in a known process (like 15rpm) or I must run the machine on a wide range (ie. 15rpm, 22rpm,… operation range of this machine)
Thank everyone !
Hi, You can validate the equipment only for the specific process but if you will need to change the parameter, you will need to perform re-validation so eventually it’s up to you to decide: Short and limited validation or longer and more versatile.
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For PQ, you need to qualify on Process parameters (15rpm). In OQ you need to verify wide/extreme/manufacturing range.
So when I need to manufacture another Product X (that need to 22rpm) then do I need to re-qualification the machine ?
Absolutely, need to perform PQ. Make sure the new parameters are in the operational range/ OQ.
So then I think that will double work with the process validation ? Or should I only perform the process validation and omit this PQ ?
No, PQ is different from Process validation. So Still need to perform PQ. In process validation, product will be verified in process step for the acceptance criteria.