Qualification of Freezer with IQ and PQ but no OQ

[Mhike777]

Hi guys.

Just new member and seeking if someone could help me.

We are trying to conduct a qualification for our freezer unit, however, IQ and PQ were already conducted and the results were passed base on our requirements.

But we have not yet conducted the OQ as it is still have some items inside. Is it possible to perform the OQ in different date once the freezer empty without redoing the PQ if the result of OQ is passed?

If it is ok, hope someone can provide me a supporting reference.

Thanks a lot!

 

[BradM]

Hello there! Welcome to the forum!

So you have completed an IQ and documented accordingly. You have completed a PQ (test the freezer in the manner in which you are going to use it), but have not completed an OQ (verify freezer operates as mfg. intended? ).

Did your organization write the IQ/OQ/PQ, or were they packages purchased from the vendor?

What was in your protocol/ technical document/ etc. that was approved outlining how the freezer was to be qualified?

How different is the OQ from the PQ? Does the PQ address most of the parameters of the freezers, or are there still critical parameters not addressed?

I guess I'm trying to figure out what you stated you were going to do (is there a deviation here), or is this more of a box checking exercise ( imagine... "Well, we always do an IQ, then a OQ, then a PQ...).

You mentioned there are items inside. I'm inquisitive how product was OK to put in there without qualification activities complete.

Anyway... sorry for a zillion questions. Just want to find out a little more before making any kind of suggestion.

 

[Ajit Basrur]

Brad has raised very valid questions.

The OQ is required to verify proper functioning of an equipment and depending on the complexity and user needs could be either combined with IQ or PQ. I have seen many canned protocols from equipment manufacturers document and record in that manner.

Could you confirm if your equipment OQ would have been covered in that manner?