Just keep this in mind. A process validation contains multiple separate qualifications that focus on different elements of the process. ;) A complete standard process validation consists of three separate qualifications. IQ, OQ, PQ. So, if you are talking about multiple qualifications, then it’s a validation. If you are talking about just one or two qualifications. That’s all it is, a qualification, not a process validation. 😊
Hi S. Al, Yes, that is acceptable as long as you meet all the expectations for both. In my experience its hard to keep them straight and meet all requirements when they are combined. Also, when deviations occur in OQ, it can lead to needed updates to the PQ protocol which is in your explain already approved as a combined protocol. Anyway, you can combine them if your local procedure allows it. :) Check out my later videos on IQ, OQ, and PQ. Sincerely, Aaron
Thank you Aaron. This is the clearest and most concise explanation I've seen for process validation.
Thank you for the comment and feedback! I means a lot. :)
Straight to the point informative video
Thank you Sir for the great feedback!
When to use term validation vs qualification while explaining project? Thank you in advance
Just keep this in mind. A process validation contains multiple separate qualifications that focus on different elements of the process. ;) A complete standard process validation consists of three separate qualifications. IQ, OQ, PQ. So, if you are talking about multiple qualifications, then it’s a validation. If you are talking about just one or two qualifications. That’s all it is, a qualification, not a process validation. 😊
a combination of OQPQ is acceptable
Hi S. Al,
Yes, that is acceptable as long as you meet all the expectations for both. In my experience its hard to keep them straight and meet all requirements when they are combined. Also, when deviations occur in OQ, it can lead to needed updates to the PQ protocol which is in your explain already approved as a combined protocol.
Anyway, you can combine them if your local procedure allows it. :)
Check out my later videos on IQ, OQ, and PQ.
Sincerely,
Aaron