Hello

I am interested to know how other people are qualifying their HPLC equipment.

We have isocratic and gradient pumps, manual and automatic injectors, column ovens, UV plus fluorescence and refractive index detectors.
We also have data systems connected either directly to the instruments or via an A/D converter.

I look forward to hearing from you.

Luke

GMP compliance _suggests_ a general rule: if the instrument controls it, confirm it.

Pumps: flow rate, mixing
Detectors: wavelengths, potentials, absorbance accuracy, RI accuracy, output amplifier accuracy and range
Data systems: A/D accuracy
etc

There is an outfit on the East Coast (US) that will do the qualifaction for you -- Analytical Sales and Services. I think their web site is www.analytical-sales.com. Their e-mail is info@analytical-sales.com. I don't know how much they charge, though.

hope this helps!

Hello

Thanks for the useful information.

Does anyone have any comments on the qualification tests offered by instrument suppliers, HP, Waters, PE etc...?

Thanks

Luke

Luke,
We are using the OQ/PV tests that are advised by HP. Although HP prefer to have one of their engineers perform the OQ/PV, it can easily be done by yourself. You need to purchase the correct column and the caffeine standards. These, along with their part numbers are listed in the HP book which comes with a new system. The OQ/PV test covers almost all aspects of your system and can be performed in a day or less.
I believe most of the LC manufactures provide a similar OQ/PV package.

Hi,
Qualification can be an elusive subject - it always depends on the regulatory requirements/standards you need to satisfy and everyone, including myself, has their own idea of how far to go. I would recommend following HP or Water`s excellent qualification protocols however,as a quick DIY guide:

Data systems- software communication
Pumps - flow accuracy & precision;gradient accuracy and composition for all channels
Column compartment - temp accuracy
UV Detector - wavelength accuracy;D2 and Holmium
noise;wander;drift;response linearity
RI Detector - noise;wander;drift;temp stability &
temp accuracy;response
linearity
Injector - Precision area& height;carry over area & height;sa compartment T accuracy

I`ve found that one vendor can offer a much more comprehensive qualification package than another for the same price and some have more comprehensive documentation than others so don`t accept what they offer at face value - go with your own requirements first and take their advice second.
I vendor qualify instruments annually( only because we can`t spare the time ourselves) and partially re-qualify after major changes such as gradient valve replacement, lamp changes, sample loop change,software upgrades or relocation.
Hope this is some help to you

I just completed one IQ/OP from HP. Let it be known that you have 2 different systems to IQ/OQ, the software system and the hardware system. I spent alot of time with the engineer and verified everything, which turned out to be good. The protocols were not perfect and having the extra set of eyes saved from writing up deviations.

Our lab director is still toying with the idea of using system suit. as the qualifier of instruments once the IQ/OQ is completed. Similar to Sue, we would perform re-qualifications after component replacements. Additionally, these systems will be concidered "validated systems" so our Change Control procedures will apply.