HPLC Performance Qualification (PQ)

[GregK]

In an attempt to bring our lab more in line with industry standard and cGLP requirements, we are implementing PQ testing on our new LCs. In the past, we've considered our monthly verification (flow rate check, column compartment temperature check, and injection linearity) along with our daily system suitability requirements as our PQ. We do have the manufacturer (Agilent, in our case) perform their IQ and OQ, then we supplement that with our internal IQ/OQ procedure (which, basically, ensures the proper documents are in place, but doesn't perform additional physical testing of the system).

My question is: what is the industry standard for PQ? From what I can tell, most companies perform a PQ after annual PM as well as after any unscheduled maintenance. I can't seem to find any specifics on what that PQ testing entails.

We are thinking about using 2-3 validated methods to determine assay results on our "unqualified" system and comparing those results to those obtained on a "qualified" system. This approach seems to make sense to me, as obtaining an assay result will require system suitability to be performed and will challenge the new system to perform as expected. But is this approach the "industry standard"?

Also, I realize that we are held accountable to our internal SOP and that document defines PQ for our company. I want to make sure we set up that SOP to "industry standard". Currently, it states that assay results will be obtained and compared to those obtained from a qualified system, but gives no specifics (what methods, how many methods, how many sample replicates, etc.).

Any advice/guidance is appreciated.

[DR]

As usual, there is no "industry standard" approach to PQ SOPs for LCs.

A better approach than cherry picking a couple of methods would be to make sure that your PQ covers the range of conditions likely to be encountered for all methods likely to be run on a given system. That, and at least being aware of OEM specifications (which is a good, defensible place to go if you have no other demonstrably lesser standard to attain) are a good starting point.

System suitability is still important, but there are a lot of things not typically covered by most SS criteria.

[Alfred88]

Hi.
Regarding the "industry practice" for PM and PQ: They must be done "at least" once a year. You can set/define the frequency at 6 months (it's better).
In your case, doing internal monthly check is very good.
For Agilent HPLCs, I have seen a copy of the procedure for OQ/PV. It is short and at least one test was missing (light intensity test). Also, the temperature accuracy check of column heater is done at one set point only, so it is deficient.
Alfred

[kubowicz.tomasz]

Hello

... at least one test was missing (light intensity test).
Alfred

Lamp intensity test (UV/FLD detectors) is part of PM procedure not OQ/PV.

Regards

Tomasz Kubowicz

[bunnahabhain]

THer is a nice collection of tests and specifications available from Dionex: http://ifbg.org.ua/~files/ccu/UltiMate_ ... ct2008.pdf
Try to use this as a template for your equipment.

[Alfred88]

Dear kubowicz.tomasz.
The verification/calibration/PQ for HPLCs shall include the light intensity test according to a regular, periodic schedule per a written procedure. You may have this test in your PM as well.

Imagine you get a warning from US auditors for not doing this test, such as this one:

Failure to have an adequate performance qualification (calibration) program for the QC laboratory instruments.
Your HPLC calibration lacks a carry over test (sample injection residual test), sample energy (intensity of light source), and lamp use hours determination.

Yunnan Hande Bio-Tech. Co. Ltd. 10/15/10.
Read more: http://www.fda.gov/ICECI/EnforcementAct ... 230829.htm

Dear bunnahabhain. I agree with you that people can benefit a lot from the FREE resources from Thermo-Dionex. BTW, I do not work for Thermo-Dionex!

Happy Mother Day for those in the US.

Alfred.