Periodical Operational Qualification


Need some help with the following question.

[i]"In our company we are using few Inspection Machines for ampoules and vials (to detect filling volume, particles, black spots,…).

All machines are already validated (IQ,OQ,PQ).

What is neccessary to include in periodical operational qualification which will be executed once per year?

What are the functional specifications that are needed to be re-qualified?

Before any new batch we make a round test with good and bad samples. To be sure that the inspection machine recognize bad sample."[/i]

Thanks in advance for your help.


Presuming the answer is not provided in the company’s VMP.

Where is the once per year re-qualification defined? What’s the rationale?

If NOTHING has changed (and there’s a LOT that could change, especially under the covers), then I would think a very limited re-qualification would be all that’s needed. Clearly there’s considerable risk mitigation with the pre-run checks.

Of course, many things CAN change (databases grow, OS patches are made, equipment maintenance occurs, utility supplies get updated, etc.). Maybe look at those aspects to drive a (risk-based) re-qualification.

Maybe look at the OQ and see what might not be covered in the pre-run checks. Maybe look back at the production logs to see if the PQ runs are still representative (i.e., if every run for the year was for 10k units but the PQ ran 100k units, maybe you don’t have good assurance that runs over 10k units are capable).

Those are my immediate thoughts. Hope it helps.

Thanks for the answers. I understand that there is necessary for re-qualification in case of any hardware or software changes.
I was thinking if it is necessary to re-test (periodical) rejection system (running the machine with few god and few bad samples and check if the samples wich are recognized like bad, go to the reject tray)?

Have a nice day!

It’s never a bad idea to do that!

It’s not possible to give an exact answer. Every case is different. Validation and re-validation should be risk based. Monitor your situation: if rejections are getting through then running the same old tests may not be of any benefit. Examine your process capability. Do you see any trends? Maybe that implies something that should be addressed in (re)validation.