calibration of HPLC systhems

[danielbor]

Hello forum members.

I would highly appreciate your recommendations regarding frequencies of calibration required by FDA for HPLC Systems in the Pharmaceutical industry?

Can somebody recommend on a specific guideline regarding this issue?

Thanks in advance

[Dan]

danielbor,

The FDA doesn't provide a set calibration frequency, They only require you to set one in an SOP and then follow it.

In general, HPLCs are calibrated every 6 months in the industry. We calibrate every 6 months except for the column heater which we calibrate yearly.

Things to consider:
How old is the system? Older systems may need more frequent calibration.
Do you need to do all of the calibration tests? If you are not going to use the system for gradient work, then don't calibrate it for that but label the system appropriately.
Vendors can give recommendadtions for calibration frequencies as well as guidance for what to calibrate and what tolerances to apply.

Lastly, the USP is developing a new General Information Chapter. You may find it useful. It is USP<1058> Analytical Instrument Qualification. You can find the latest version in the most recent issue of the USP Pharmacopeial Forum (32(6)).

Regards,
Dan

[DR]

We calibrate annually (Pharma R&D labs).
As said above - put, in writing, whatever you think is required to assure yourself of good, reliable results and follow it.

[grreddy]

can any one send the USP Analytical Instrument Qualification Draft. which is there in 32(6) that is usp<1058>

[Sunjay]

Dear Reddy,
You can go thru following artile. This article is given in the PF.

Qualification of Analytical Instruments for Use in the Pharmaceutical Industry: A Scientific Approach
Surendra K. Bansal,1 Thomas Layloff,2 Ernest D. Bush,1 Marta Hamilton,3 Edward A. Hankinson,4 John S. Landy,5 Stephen Lowes,6 Moheb M. Nasr,7 Paul A. St. Jean,8 and Vinod P. Shah7

http://www.aapspharmscitech.org/view.asp?art=pt050122
http://www.aapspharmscitech.org/article ... 050122.pdf

Hope this will help...

Regards