hplc external calibration

[anajdenkoska]

How often is recomended to carry out external calibration of hplc system. Is there any International standard for that porpose????

[Consumer Products Guy]

We have ours qualified every year if they are used for cGMP or GLP. On our others we run %RSD as per system suitability.

[LC_labrat]

I agree once a year is pretty standard, at least for GMP. They also have the preventative maintenance done which definitely helps keep them running.

[zokitano]

In the lab where I work (ISO 17025 accredited national lab), OQ/PV of the HPLC instruments is done on annual basis. But we also do system suitability (%RSD) check and consistency of the peak area and retention time of test compounds every quarter of the year and plot these parameters on Shewhart chart. Of course before any HPLC analysis is performed we do the regular system suitability check...

Regards

[DR]

I think some labs (where the LCs pretty well never quit running) do cal. checks twice per year. For more routine use, annual is pretty normal - but you should take into account your use level.

As with cars - every 3 months may be an adequate oil change interval for most, but for taxis and police cars, it may be more like once per week.

[Consumer Products Guy]

In the lab where I work (ISO 17025 accredited national lab), OQ/PV of the HPLC instruments is done on annual basis. But we also do system suitability (%RSD) check and consistency of the peak area and retention time of test compounds every quarter of the year and plot these parameters on Shewhart chart. Of course before any HPLC analysis is performed we do the regular system suitability check...

Regards

We do system suitability (RSD of retention times and peak areas, tailing factor, and resolution if applicable) on our our regulated assays. ChemStation software does this automatically in sequence summary report.

[ksharp]

OQ/PV is less than a day's work, we do this annually and our instruments (2 1100's) are active about 1/3 of the time.

[zokitano]

We do system suitability (RSD of retention times and peak areas, tailing factor, and resolution if applicable) on our our regulated assays. ChemStation software does this automatically in sequence summary report.

CPG,

We also have Agilents' HPLCs and I love the Extended Statistics option in the Sequence summary report

[Rvaindra Patil]

Hi

About clibartion I think it depends on your use. In my lab we have 6 HPLC's( Agilent 1100 & 1200 VWD ) running 5 days a week. so it is very heavy use hence we do AMC twice a year & calibration twice a year.

My clibration includes

1 Calibrate Lamp intensity.
2 Calibrate the thermostatic function.
3 Calibrate temperature accuracy in column compartment.
4 Calibrate flow accuracy.
5 Calibrate wavelength accuracy by Holmium.
6 Calibrate wavelength accuracy.
7 Calibrate Noise and Temperature Stability.
8 Calibrate detector response linearity.
9 Calibrate gradient composition.
10 Calibrate Injection Precision and Carryover.

All these tests are part of Agilent OQ/PV

I would like to mentions here that we have at least one audit in every three months. we have been audited by EU,WHO, Local FDA, Vendours & our own GQA ( Global quality assurance ).

Hope this will hepl you