IQ/OQ/PQ of HPLC systems after a change of components

[Rob Burgess]

Hi All,

If you change one of your HPLC module on your system, be it a pump, A/S, UV detector or even the addition of another detector, does this warrant a complete overhaul of IQ/OQ/PQ of the entire system? Thoughts anyone?

[yogesh#14]

Hi All,

If you change one of your HPLC module on your system, be it a pump, A/S, UV detector or even the addition of another detector, does this warrant a complete overhaul of IQ/OQ/PQ of the entire system? Thoughts anyone?

Hi Rob,

If you change any one of the modules you will need to calibrate the module and the system as a whole. It is not neccesary to perform the IQ OQ and PQ of the system again.

[JS]

Hi Rob,

I've just spent the last day and half reviewing the data from the requalification of two of our Alliances. The qualification overview that Waters supply specifically states;

"Requalify the affected chromaography module each time any major instrument component is changed. Document the repair in the maintenance log and then requalify the module or system as appropriate."

It also goes on to say - and I'm paraphrasing here - that any major change to the system warrants performing a complete system qualification.

Hope this helps,

Jon

[Rob Burgess]

Hi John,
Thanks for the reply.

Does all this "extra" qualification make sense to you? To me it doesn't quite add up. For instance how will the chagne over of a new A/S affect the wavelength calibration of the UV detector? Hence why the need to do the 3Q's all over again!

[tom jupille]

Back in 1994, that question came up in a public forum in New Jersey, addressed to Tom Layloff (who was at that time the director of the FDA CDER lab in St. Louis). The specific question concerned swapping out a defective pump in the middle of a run. His reply was that you should simply re-run the system suitability test(s). If you pass system suitability, then the system is, by definition, suitable for the intended purpose.

You have to take that statement with a couple of caveats:
- Layloff came from the lab side of FDA, not the regulatory side.
- It presumes that you have reasonable (and reasonably rigorous) system suitability criteria, so there is an element of judgement involved (there are a lot of validated methods, usually old ones, with bad system suitability requirements!).

Basically, what you need is an SOP that says "system suit = PQ".

[ntruong]

If you change one of your HPLC module on your system, be it a pump, A/S, UV detector

If you replace module or part like for like, PQ is good enough as Tom has said since it represents the system as a whole.

even the addition of another detector

IQ/OQ/PQ is warrant for the new addition, not the system as a whole.

[KarenJ]

The answer to your question really depends on your company's procedures and any procedures that you have written for your specific instrument. As long as your procedures agree, it doesn't seem that you need to requalify all of the components, just the new component. In the pharma company that I used to work for, we had to write the requirements for requalification into our instrument SOP or OQ protocol for each instrument. For example we might say that OQ should be performed after each annual PM but was not need after replacement of consumables (eg column). Also, the OQ had sections for each individual component so that the components could be qualified separately if only one component was repaired. In your situation, we would have filled out an IQ for just the new component recieved, performed an OQ on just the new component, and then run a system suitability to show that the entire system was ready for use. It is likely that your QA department can tell you what they expect to see in your company.

[JS]

Hi Rob,

Sorry for the delay in replying to you, I've had a few days off! It seems that your question has been quite thoroughly answered already. I would just add as a postscript that, going back to the Waters overview, it seems to recommend what is essentially a common-sense approach to the issue. In the example that you cite re: the A/S, as this would not affect flow rate accuracy, detector accuracy etc etc and as such would not constitute a major change to the system therefore you would only requalify the affected component.

Jon

[DR]

One must also consider the interaction between the new component and the rest of the system. In an environment where the new component has little or no control functions over the rest of the system, there may be nothing to do or just passing system suitability on the next run could suffice. In a mixed brand system or if a component has significant control functions, verification of correct operation these functions should be considered. You never know (well, most don't bother to check until there's a problem) when a new version of firmware can sneak in there and bite your backside. This applies to controllers, ready/start cables, programmable events - stuff like that.

[venkatanil]

I dont think the entire IQ, OQ, and PQ for the system should be repeated if we change any module. Only performance test can be done and the system can be calibrated once.

[Consumer Products Guy]

Agree with "venkatanil" above. No way would I do a complete !!! Also brings up a question of what is routine (such as routine changing a pump purge frit or a GC septum or liner) and what is not routine. Some people (like our QA can be unbelievably "anal".