By Anonymous on Monday, September 16, 2002 - 08:59 am:

I would like to ask everybody some questions:

How do you perform operational qualification, and/or performance qualification?

What parameters are you testing?

How often do you do this?

Are there some time saving tricks?

Are there related links on the www?


I hope to clear out this stuff!

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By Melissa on Monday, September 16, 2002 - 09:21 am:

If you have waters equipment, they sell qualification protocols and standards that you can use.
For a detector you would use a solution to test the wavelength accuracy and then the linearity.
For an autosampler, you test the carousel positioning and also the injector accuracy
For a pump, you test the flow rate and the gradient valve.
For the data system, you make sure the software was installed with no errors and that in a given set of calculations it comes back with the same values.
For the pq, you take a specified sample and do linearity and reproducibility similar to what you do for system suitability.

How often you do it depends on how often the instrument is in use and what you specify in your SOPs to satisfy regulatory requirements.

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By Anonymous on Friday, September 20, 2002 - 01:30 pm:

Thanx Melissa!

Too al the others who haven't posted yet on this topic:
Any related links on the www??

(Melissa, you may post if you want, but you have already done you job ;)

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By Suzanne on Monday, January 20, 2003 - 03:11 pm:

There is an article available from chromatographyonline.com, in the September 2002 issue of LGCC North America, that covers the basics of performing a PQ on an LC. Hope this helps!

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By Daren on Tuesday, January 21, 2003 - 06:48 am:

check out www.labcompliance.com

and go to equipment validation

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By Jonathan on Monday, March 22, 2004 - 10:07 pm:

I would like to know who should do the newly installed performance qualification. Me the user or the vendor?

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By Anonymous on Friday, March 26, 2004 - 09:25 am:

Jonathan,

You should do the PQ. You should use your sample and standard to prove the system is suitable for YOUR assay.

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By James Exarchakis on Tuesday, April 27, 2004 - 01:28 pm:

two questions:
1. For an autosampler, Do you have to test the carousel positioning? I see much more benefit to the accuracy and reproducibility tests of the autosampler.

2. Can SST fulfill the PQ requirements?