IQ OQ PQ

[AdrianF]

In the good old days we took delivery of HPLC equipment plugged it in and started to use it.

Of course we did calibrations and system suitability but we were not burdened by having to produce vast amounts of documentation.

Now it can take months before equipment is available for use.

Has the validation industry gone too far?

[juddc]

It shouldn't take months.

It's certainly work, but I did a full IQ/OQ/PQ on my current system when it was installed in less than a week. I'm certified by the mfr to perform qualifications and they provide (for a fee, of course) all of the materials and documentation needed to properly qualify the machines.

It's not really that tough and it simply verifies that your hardware is operating within specification and that your software and data system are aquiring and calculating your results correctly, so no, I don't think that it's a waste of time.

[Mark Tracy]

I have found that the IQ/OQ/PQ process takes about one full day if all the components are working correctly. The first time takes longer, but after a few runs through, it is not so bad. The process is not forgiving of errors, and if you try it without training, you will have a miserable few days.

[shaun78]

yes, the industry has gone too far.

System suitability is run and evaluated before every on on a HPLC. If the instrument is not performing peroperly, then sustem suitability will fail. Hence, it is my opinion that the OQ/PQ on a HPLC system is pointless.

Having said that, I have done IQ/OQ/PQ on ever piece of equipment I have purchased. I don't want to give the FDA a chance to give me a 483...

[JJG]

In my experience it has taken me about 1 to 2 days to complete IQ/OQ/PQ. It takes more time to assemble the documentation, if you're not purchasing it from the manufacturer. I disagree though, that the OQ and PQ are a waste of time. System suitability established for each run does not guarantee that the HPLC system is working 100% properly, just that results for that assay are similar to historical data. And, this all depends on what you use as your system suitability criteria.

Only through a PQ can you demonstrate that the pumps are pumping the correct flow rate, that your pumps are proportioning correctly, that there are no leaks in the pump heads, and usually you replace seals and clean check valves during a PQ, so you are also performing preventative maintenance. If you develop a method on a system which meets system suitability but does not have a PQ done regularly, the flow rate may be off, and when you transfer that method to other systems, you may have issues.

While it may seem extreme to follow FDA guidelines often, they can be tailored in such a way that it is beneficial to your efficiency and productivity.

[Dan]

I spoke with an FDA agent once about IQ/OQ/PQ. In the eyes of the FDA, the PQ is not a one-time process but rather an onging one that includes the initial PQ and the ongoing repairs, preventitive maintenance AND system suitability. Of course, you must also have proper documentation all along the way.

I think the IQ/OQ/PQ process is needed as it does serve a purpose. The procedures should take only 2-3 days at most.

Usually what slows down the process is QA Specialists that don't understand the instrumentation/procedures and, thus, the documentation process becomes bogged down in a kind of red tape mentality as QA tries to do the science rather than the quality assurance function.

Regards,
Dan

[AdrianF]

When I said the qualification procedure can take months - I didn't mean it takes months of work but assembling documention,arranging for people to do the work, getting all the sign offs etc can mean that from the time the shiny new piece of kit arrives to when its actually generating results is a long time.

I still cannot see it has much value if the proper daily system suitability is carried out together with regular servicing of the equipment. Some of the more absurd regulations are the need for revalidation if the equipment is moved to another room!

Just because all the qualification tests have been carried out doesn't mean you will have reliable results. It is only by constant monitoring and having good trouble shooting skills that reliable results can be obtained. HPLC is far from being a 'Speak your weight' technique.

Is there any evidence that this extra burden is producing better results.

[shaun78]

Is there any evidence that this extra burden is producing better results.

What, you want some gratification other than the warm fuzzy feeling you get inside when you know it has finally been completed? How dare you.

[Chris]

I agree with Dan that PQ basically never ends. Also don't underestimate the importance of design qualification.

IQ and OQ is performed so frequently by vendors that they have all the systems in place so with a bit of work you can get the vendor to perform this at a reasobale price and they will typically perform in a day or two. I would stress that it is worth checking what they are going to do and signing off on the IQ/OQ/PQ protocols rather than just accepting that the vendor 'knows what they are doing'.

[Bruce Hamilton]

Is there any evidence that this extra burden is producing better results.

There will be evidence, as many qualifications have to issue deviations for software/hardware/operator malfunctions.

The cost burden is passed onto clients, and there should be increased profits as turnover increases, but the increased administrative overhead often negates that potential.

My question would be; " Is this onerous operation providing effective utilisation of resources?".

The answers will vary, but I've been employed in a company that spent so much time building and maintaining large cGxP quality systems that they didn't deliver products to their clients in a cost-effective and timely manner, and were eventually closed down after the clients went elsewhere.

There are some wonderful quality people out there who know how to build simple, low-maintenance systems that encourge workers to initiate improvements, but the vast majority of quality people in the pharmaceutical industry seem to have the school prefect mentality.

The problem with almost all quality systems is that they can't address the fundamental issue of whether the process and product are the most cost-effective and appropriate solutions for the client. That applies to analytical protocols as much as it does to manufacturing.

Bruce Hamilton