I’m evaluating our options for qualifiying old equipment, installed during R&D operations, 1 year ago.
In a previous company, we did the complete IQ, OQ, PQ, despite the fact that the instrument had already been installed. We could justify IQ and OQ, because we could say that we moved the equipment to a new location, hence the “retrospective” IQ/OQ are needed. In this new company, the instrument has been used before for R&D, but we want to use it for GMP now. Can we get away doing only PQ, or is IQ, and OQ also needed?
My opinion is that you need some form of IOQ to ensure that you have the right instrument configured correctly. Do you have any specifications? What about a Plan?
Practical Qualification Rule: assess the risk to scope re-validation.
Durga is right in that if you move, for example, measurement equipment where movement could result in misalignment / quality issues, you do need to re-validate. However, if there’s no risk as a result of the move, re-validation is not necessary (the assessment should be documented and added to the validation file).
Not knowing more about your equipment, it’s not possible to say what’s necessary. If you can justify that there’s no risk to product quality as a result of the move then re-validation should be quite minimal. You have to have documented, defensible rationale, though.
Thank you for all this valuable input! The instrument, a set of small Stability Chambers in this case, will not be moved. The question, is should I go ahead and do a retrospective IQOQ, or is this doing more harm than good?
I was thinking that it would be good to have all that information in one place, and that it would definetely be a benefit to the ultimate validation report. But perhaps someone thinks differently, and that I should just do PQ as part of the validation.
What I understand from your post is, you have a old stability chamber already installed in the setup & being used for the R & D Purposes. Now you want to use that system for GMP setup. You don’t have any formal docs (IQ/OQ/PQ) as they generally not needed for initial stages where GMP is not applicable from old perspective…is it?
If yes, you should go with the document IQ/ OQ & PQ…approach is your organizations decision…it may be a one document with three subsection for verification of Installation (Obviously not a new installation, so only available documents & physical verification, compilation of data will be sufficient), Operation (System is already in use…review the history) & PQ with feature verification or three different doc. heading IQ, OQ & PQ. Not a big deal…document properly & refer the APIC guidance “Qualification of existing equipment 2004” for more details.