Chromatography Forum

Usually HPLC system calibration frequency for GMP is done every 6 months. What are the risks is calibration is done every 12 months or 18 months?

We have yearly 3rd party qualification.

We do system suitability bracketing our samples each day of cGMP use.

We have yearly 3rd party qualification.

We do system suitability bracketing our samples each day of cGMP use.

We are in the same boat, although we are doing our first in-house qualification this week.

IMO, the risk of doing yearly vs 6 months is minimal as long as you do system suit for each run. The only change is the size of the investigation if you have a failed qualification, and the potential amount of runs that are impacted.

I would suggest 6 monthly is good but if you do the same analyses regularly and can plot control charts from system suit parameters then you have justification for extending your qualification period out to a year.

I would suggest 6 monthly is good but if you do the same analyses regularly and can plot control charts from system suit parameters then you have justification for extending your qualification period out to a year.

Maybe the same criteria could be used to extend qualification period out to 18 months.

Regulatory agencies expect you to follow your procedures, it could be 6, 12, or 18 month qualifications. 18 might be too long in my opinion, usually it's 12 months. If you are running samples 24/7 you may need 6 months as I would think the HPLCs would need more frequent preventative maintenace.

To be a bit pedantic, "calibration" is done every time you run a method. "Performance Qualification" is done to verify the performance of the system. As a minimum, it should be carried after any maintenance work is done on the system, certainly including the regularly scheduled preventive maintenance. Along with most people, I would recommend annual preventive maintenance as a minimum; more frequently might be indicated if there is a high incidence of failures/problems in between.

If you are regularly running the same methods in a GLP or cGMP environment, control charting of your system suitability results can also give some insight into the need for maintenance and requalification or justification for modifying your SOP to extend the schedule to 12 months instead of 6.