IQ/OQ

[danielbor]

Dear forum members,


I would highly appreciate if someone could give me an answer to the following question:

Is it essential to have a documented IQ/OQ from the HPLC manufacturer?

If some company is willing to take upon itself to carry out this operation internally, is it allowed to do so? Would the FDA accept this procedure?

In my opinion it would make sense to be able to do this internally. The situation is that companies who sell HPLCs, although you have purchased from them the software and all the possible licenses, try to make additional money by convincing you that you should necessarily have their protocol with their original signature in order to have the FDA accept the reliability of your system.

Can someone please clarify this point?

Thank you

[philippem]

Dear danielbor,

You are not obliged to use the IQ OQ documentation from the supplier.
If you have to qualify your equipment , you have to do this properly and this process asks for IQ OQ and PQ. You can prepare your own documentation , which should be checked by quality department.
For example the Gamp 4 gives a lot of information how to prepare these documents.

One can also consult an exteranal company to prepare these documents.
We can advise you on this subject.

regards

Philippe

[Mark Tracy]

Dionex makes and sells IQ/OQ/PQ software for our data systems. Speaking from my own experience, there is a lot of interdependence in the tests, it has taken a lot of fine tuning to get the tests the way they are, and the software is unforgiving of ignorance and screw-ups. That is why we prefer it if you have our service reps do it as part of the scheduled maintenance. Home brewing your OQ/PQ protocols is certainly possible, but you will discover that it is harder than it looks. Hence the offer from consultants. It comes down to who gets paid for the job? Your own QA staff? The vendor? A consultant?

[Bruce Hamilton]

As noted above, the instrument manufacturers usually have fine tuned their procedures for common models, and it's sensible to have them perform the IQ/OQ as part of the installation.

If you operate in a regulated environment and have facility to easily perform the tests, then you can do that. However, you must ensure that a suitable process is followed, and approved by QA in advance of performing the steps. Most vendors provide their documents, so you can perform the tests, PROVIDED you are demonstrated and documented as skilled/trained to perform those tests!.

In other words, for an IQ, the vendor ( or somebody ) should have provided documented training to show that you are competent to perform the IQ/OQ for that instrument. If you aren't, the documents can be used as toilet paper. In reality, I suspect only multi-instrument site can justify the expense of having trained people for IQ/OQ to regulatory standards.

You should already have gone through the Design Qualification/preparing a User Requirement Specification for the HPLC before selecting the vendor, and also used that opportunity to ensure the total package price ( including training and IQ/OQ ) is competitive.

There is a problem with bespoke or less common systems, the vendor usually has to adapt their documents, and the cost of adding deviations can be quite large. You may be better to document the IQ/OQ, and perform the tests, depending on the value you assign to your time, and the skills of the local vendor.

Remember, in-house qualifications have to be performed by people whose experience and training are suitable, obvious and documented. It's the first item on most audit lists - " show me the training records of the person who performed the work ".

Bruce Hamilton

[danielbor]

Thank for all of you for your detailed answers.


Dear Mark Tracy

Since we have already purchased Chromeleone to operate these systems, can we perform IQ/OQ/PQ with chromeleon?
Does it fulfill the FDA requirements? If yes, could you please send me a reference which I can relate to when dealing with our local reps (of dionex)?

Thanks

[Mark Tracy]

Yes, Chromeleon does instrument IQ/OQ/PQ. Ask your local Dionex rep to talk to the Chromeleon Product Manager (Fraser McLeod) to get the definitive word on IQ/OQ/PQ and its standing with regulatory agencies.

[Alfred88]

Dear danielbor:

I have done the IQ/OQ for our Dionex HPLC in-house (took 2 days). We adapted (not adopted) the instructions from Dionex, and wrote our internal SOPs. It will be easier if you have someone with experience with the software. And it will be a nightmare to learn how a new software works (steep learning curve indeed), while trying to pass IQ-OQ.

But getting the vendor of the instrument to do the IQ-OQ may not be the ideal solution. When we acquired the Shimadzu LC, the vendor (name withheld) used instructions from Shimadzu to perform the IQ, OQ for us. They supplied us the results 3 months later (not 2-3 weeks as promised). And when I looked into it, I found that they did not do many tests that we assumed that they did (e.g. reproducibility of pumps, linearity of detector, linearity of injector, reproducibility of gradient elution, ripple of pump, etc.). Noise and drift was checked for.... 2 minutes! (Hope that other users of Shimadzu LC had better experience).

And as Mark Tracy wrote, making an internal SOP may be harder than you have imagined (it took me ~2 weeks of spare time to fine-tune the PQ I wrote for the Shimadzu LC).

Alfred.