[quote=yodon]I’ve typically seen what you describe as a “PPQ” (Process Performance Qualification).
I think your approach sounds generally defensible. When replacing equipment, though, I would do IQ/OQ/PQ on that piece of equipment to ensure it does not introduce any change to the overall process. If you can demonstrate that the equipment change does not affect the output then you should be in a good position.
It would be a good idea to document this approach in either a top-level Validation Master Plan or in the process-specific Validation Plan. When you do that, you demonstrate to inspectors / auditors that you defined the approach and followed it.[/quote]
Thanks again Yodon.
Yes, I did the IO,OQ and PQ when I replaced the equipment. That is based on the risk analysis and impact assessment that I did which concluded as revalidation (IOPQ) is required.
My question is when I complete the IOPQ for that change, do I need to run a PV or what the new term call PPQ? FYI, I have more than 30 different models that are running through that new equipment. Is PQ alone sufficient? what is correct sequence? IQ–>OQ—>PQ---->PV/PPQ or can I opt to have IQ—>OQ—> PQ or PV?