Information on Qualification of HPLC

[Leni]

So i have the following issue...
Our QC lab works according to the Eu.Ph.(in the European Union) and every year the authorized company makes the yearly checkes and qualifications(OQ/PQ). But my question is, how often do we have to make the PV in-house. Our current procedure says twice a year, once after the OQ/PQ and once 6months after that.(I need to clarify, that all our working methods include system suitability check)
Due to cost and mostly time reducing measures(PV takes up a few days) i've been asked to modify the procedure to only one PV (6months after OQ/PQ), due to the fact that the authorized company verifies and leaves everything in perfect working conditions, so it seems meaningless to check for something that has been done a few days earlier by a more qualified specialist. Problem is, i couldn't find any reglementations to this in the Eu.Ph. or European Technical Guidelines. Can anyone tell what the time interval requierments are for these test(are there any) specified in USP or maybe Eu.Ph.(maybe i overlooked it) or elsewhere?!

Your help would be highly appreciated. Thanks

[zheyin]

I don't think.
Even there is, those are guidelines.
Half-year or one-year should be both good.

So i have the following issue...
Our QC lab works according to the Eu.Ph.(in the European Union) and every year the authorized company makes the yearly checkes and qualifications(OQ/PQ). But my question is, how often do we have to make the PV in-house. Our current procedure says twice a year, once after the OQ/PQ and once 6months after that.(I need to clarify, that all our working methods include system suitability check)
Due to cost and mostly time reducing measures(PV takes up a few days) i've been asked to modify the procedure to only one PV (6months after OQ/PQ), due to the fact that the authorized company verifies and leaves everything in perfect working conditions, so it seems meaningless to check for something that has been done a few days earlier by a more qualified specialist. Problem is, i couldn't find any reglementations to this in the Eu.Ph. or European Technical Guidelines. Can anyone tell what the time interval requierments are for these test(are there any) specified in USP or maybe Eu.Ph.(maybe i overlooked it) or elsewhere?!

Your help would be highly appreciated. Thanks

[mburk]

Qualification intervals are not defined in any of current standards. How often you perform the performance qualification/verification is up to you and should be based on instrument usage and performance history. Most HPLC systems need maintenance on a yearly basis so the industry standard, at least in the US, is yearly.

[Consumer Products Guy]

We do one-year, and our SOP states that. System Suitability is run for every regulated-product assay.

Passing System Suitability is an excellent indicator of a properly-operating system.

[Leni]

thank you all for your replies...base on our equipment history PV-s almoust always are OK for our HPLC at the "6 months after OQ/PQ by certified service"-verifications, and at the "directly after OQ/PQ"-verifications we never encounterd any problems. That's why we thought that those verifications are unneccesary. i just want to be sure that by reducing the number of PV i don't ignore any reglementations (that would be a "off with his head" kind of thing:P)
Thank you all, and any other oppinions are still welcome.

[juddc]

Performing a periodic PQ more frequently might help keep people happy. Codify it, do it, and keep track of the data. A PQ on a UV equipped LC typically only takes about an hour.

[Leni]

Performing a periodic PQ more frequently might help keep people happy. Codify it, do it, and keep track of the data. A PQ on a UV equipped LC typically only takes about an hour.

well unfortunatly it's not that simple...we don't really have an option: we either perform full performace verification(pump,injector, DAD --- linearities, accuracies etc.) or we don't. can't really justify why to do only some of them or a trimmed down version. it's a lot easier to justify that it is not neccesary at all(for reduced PV you have to make risk evaluation = explain what the difference could be, what problems might occur etc.)...but if we drop it all together the explanation is a lot simpler=it is not neccesary because the service professionals have just performed it 2 days ago.

i hope you understand what i'm trying to describe here. thanks for your reply.

[juddc]

I don't see a periodic PQ as being difficult to justify because it's not capricous. In order to pass a PQ, all of your system's components need to be operating properly, at least theoretically. Furthermore it helps document the peformance history of your system over time and it is much closer to "real world" use of the instrument than any isolated OQ test. Also, I've never met any regulatory / QA manager that wanted less documentation of system performance.

With that said, I respect your position and wish you luck.

[Leni]

I don't see a periodic PQ as being difficult to justify because it's not capricous. In order to pass a PQ, all of your system's components need to be operating properly, at least theoretically. Furthermore it helps document the peformance history of your system over time and it is much closer to "real world" use of the instrument than any isolated OQ test. Also, I've never met any regulatory / QA manager that wanted less documentation of system performance.

With that said, I respect your position and wish you luck.

Yes i agree with you on this. What i understood wrong is the part with "it takes an hour". It usually takes us 2-3 days(meaning 2-3 x 8hour shift) to perform the PV (from first test to final approval signiture). This means 2-3days wasted, since we are now requiered to perform a PV right after OQ...this is what i meant. we have weekly checkes for all equipment(we wash the whole system, we run pump, DAD etc. tests to be sure everything is working fine BUT don't document everything(no reviews and approval signitures etc....plus we use system suitability parameters for all tests. what we want to 'get rid of' is the PV right after OQ.

Thanks for your oppinion, it is highly appreciated...and i hope you understand my point of view now.

[Uros]

OQ/PV with PM for 1100/1200 HPLC systems, take less then 8 hour. After that there is only PQ where you inject your PQ standard, to verify system suitability.

[LC_labrat]

I know we've covered this topic before, you may want to do a quick search.

Does the PQ include the same tests as your PV? If so do you enough data to confirm the tests always pass, and therefore are not needed or at least reduce them.

As previously said system suitability is your performance check.

[Leni]

I know we've covered this topic before, you may want to do a quick search.

Does the PQ include the same tests as your PV? If so do you enough data to confirm the tests always pass, and therefore are not needed or at least reduce them.

As previously said system suitability is your performance check.

Yes, our PQ and PV include the same tests, altough some of them differ in method details(nothing major). This is exactly the reason we are trying to reduce them, because basically we do the exact same thing twice in a row, but for some reason our QA insists(they are just afraid because they don't understand the point of OQ,PQ,PV - sad, i know) that we keep the procedure as it is. The big problem is, it is this way because of a translation error (the frase "PV is done twice a year" from the original procedure was translated as "PV is done twice a year by the analysts"), and i just wanted to be sure that there is no reglementation wich specifically asks for PQ and PV to be done as separate operations.
Thank you very much for your answer. I will look it up to see what else has been discussed on the forum

[Leni]

OQ/PV with PM for 1100/1200 HPLC systems, take less then 8 hour. After that there is only PQ where you inject your PQ standard, to verify system suitability.

Thank you for your kind answer. Unfortunately according to our current procedure OQ,PQ,PV are all done identically, wich means about 2x 8hour shifts wasted + can't use the HPLC until the whole PV is reviewed and signed by all authorized personell.