Survey---HPLC calibration frequency

[WISPHARM]

How often do you calibrate your HPLC? annually? quarterly?

[tom jupille]

A bit of terminology here: "calibration" is done at least daily for a given analysis. It consists of establishing the proportionality between response and analyte amount.

In a regulated environment (e.g., pharmaceuticals), any valid method will also have "system suitability" tests which must be met before the method can be run on real samples.

System suitability overlaps a bit with "performance qualification" (which I think is what you are actually referring to). This involves running a defined series of tests on the chromatograph as a system, and often on the individual components. The frequency should be a matter of your SOPs (Standard Operating Procedures), and is typically at least once per year, and certainly after any maintenance or service operations have been performed on the system.

[Consumer Products Guy]

For us, PM/PV once a year by contract engineer, and daily system suitability injections and calculations for our cGMP and GLP work.

[Blazer]

Our HPLCs are requalified every six months by Agilent.

[DR]

Annual PM and performance verification (calibration check), system suitability (at least standard RSD, if not resolution and tailing as well) on every run.

[LC_labrat]

PM/PV once a year by vendor, and system suitability injections with every run.

[scottythree]

PM/PV every 6 months minimum performed by in-house staff, system suit every run. Vendor only called if major breakdowns occurs.