callibration frequency

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prabhakarthota
prabhakarthota's picture
callibration frequency

Hai,
I am using UV Spectrophotometer and am calibrating this instrument every month as per the pharmacopoieal requirement ,

and my question is can i change the frequency of the calibration from every month to quarterly ? (as the instruments usage is very les).

To do this what I have to do?( How can i justify my change).

regards
Prabhakar

Dr. Analytical
Dr. Analytical's picture
If you are operating in a GMP

If you are operating in a GMP environment, you can set your calibration frequency at any time that you wish.  If you do not follow the Pharmacopoiea schedule, then you should write a technical justification stating why you think a different schedule is acceptable.

I do not know your laboratory, but you could use the following arguments:

1. The instrument has always passed calibration every month (or has not failed often).  If there are no changes to the instrument, and you are following proper maintenance procedures, you should not expect more frequent failures.

2. The instrument is not used often, and when it is used, the procedures require analysis of standards.  If these standards meet the method criteria, there is no reason to suspect that the instrument is defective.  Or, you could argue that if the instrument went out of calibration, you would notice it during normal analytical testing.

Consult with your Regulatory Affairs group, or maybe even ask your regulating government authority for advice.