HPLC Calibration requirements

[StephenO]

When carrying out annual calibration of HPLC systems (Waters 2695) is there any guidence from the FDA what should be covered, currently I carry out the below parameters

Detector
Wavelength Accuracy
Wavelength Linearity

Seperation Module
injector accuracy
Flow Rate
carosel positioning
Column heater Temperature
Valve Proportioning test

Does the 'noise and Drift' and the 'carry over' have to be checked on an annual basis as well. as in the initial installation of the HPLC

Thanks in advance

[danko]

You can get away with a PQ in this situation. But you’ll have to describe it in an instruction.
The way I’ve done it previously, is as follows:
You pick up a challenging method of analysis – preferably one that makes full use of the system’s capabilities (fx. gradient elution, good system suitability tests, wavelength change etc.).
Write down in the PQ instruction that this will be your PQ and even more importantly the requirements that have to be met in order to approve the analytical run. Then describe the potential control chart or whatever. And finally write down that such a sequence would not be used for product release but exclusively for the purpose of controlling the equipment’s performance.
Then you are ready to run the standards, controls, blanks etc. that are relevant. And if the results are as described/expected then the system is performing according to your needs.

Best Regards

[DR]

The FDA will expect you to carry out whatever system checks are called for in an SOP written to cover the subject. They offer no instrument specific guidance.

In our lab, we check injector precision and linearity. We also check pump mixing via step test and linear gradient formation. From the gradient formation run, we also calculate and note the system's dwell volume, though there is no spec. for this.

Wavelength linearity, I'm guessing is for DADs only?

[StephenO]

Linearity is just different known percentage concentrations of the same solution, the absorbence is then measured at the same wavelength and the results are then used to calculate the sensitivity

[DR]

Ah - I've done that, but referred to it as molar absorptivity (sp?).