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Survey---HPLC calibration frequency
Posted: Wed Jul 07, 2010 8:52 pm
by WISPHARM
How often do you calibrate your HPLC? annually? quarterly?
Posted: Thu Jul 08, 2010 5:09 am
by 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.
Posted: Thu Jul 08, 2010 1:42 pm
by 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.
Posted: Thu Jul 08, 2010 2:22 pm
by Blazer
Our HPLCs are requalified every six months by Agilent.
Posted: Mon Jul 12, 2010 2:29 pm
by DR
Annual PM and performance verification (calibration check), system suitability (at least standard RSD, if not resolution and tailing as well) on every run.
Posted: Mon Jul 12, 2010 8:12 pm
by LC_labrat
PM/PV once a year by vendor, and system suitability injections with every run.
Posted: Tue Jul 13, 2010 7:36 am
by scottythree
PM/PV every 6 months minimum performed by in-house staff, system suit every run. Vendor only called if major breakdowns occurs.