Calibration and qualification in analytical laboratories is needed because laboratory equipment should demonstrate suitability for the intended use. The way to do this is by calibrating and qualifying them. Calibration and qualification in analytical laboratories are also necessary because they are subject to FDA inspections.
Laboratory equipment is high risk systems
Calibration and qualification in analytical laboratories are necessary also because laboratory equipment is high risk systems in that they impact product quality greatly. Because of this categorization, equipment calibration and qualification is a frequently cited deviation in FDA inspectional observations. They are also targets of warning letters. To avoid all these scenarios, calibration and qualification in analytical laboratories is called for, although it is possible that many times, companies are not sure on exactly which of their equipment they need to calibrate, qualify, test and document.
Three important factors impact the reliability of analytical data generated from chemical and physical analyses critically:
- How much validity the analytical methods used have;
- The extent to which the instruments used for the experiments are reliable;
- How well and how appropriately the analysts undertaking the calibration and training are trained
What does the FDA say?
The FDA’s c-GMP requirements (CFR – Code of Federal Regulations, Subpart I: Laboratory Controls, S211.160 (b) (4)) has this to say about the scope of calibration and qualification in analytical laboratories:
“The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.”
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