Calibration in FDA Regulated Laboratories

Healthcare is heavily dependent upon various different kinds of technology, which often come from different eras – while a substantial number of them are now computerized and digital, they are still measuring physical and chemical phenomenon – and, as with all instruments, these instruments need to be regularly calibrated to ensure accuracy. Unfortunately, with the rapid and changing pace of technology, technicians and the staff of such laboratories are no longer as apprised as the requirements of their instrumentation as they used to be. FDA regulated laboratories often lack the resources or training to meet the standards of calibration.


The importance of getting accurate results from such laboratories cannot be overstated. Whether these are diagnostic laboratories or research laboratories, they are only as good or useful as the results and observations they make. Vital and expensive research or even lives could depend upon the accuracy of the devices and the results of these tests. As such, the calibration of instruments within these laboratories is important and is regulated by the FDA. The FDA’s Form 483 and Warning Letter observations have mentioned that the calibration of instruments in the lab is an important issue. FDA regulated labs are covered under paragraph 160(b)(4) of Subpart I, Laboratory Controls of GMPs, which lays out expectations for a laboratory instrument calibration program.


To keep and maintain your laboratory instruments at the standards required for FDA regulated laboratories and FDA compliance rules, the staff of these laboratories need guidance and training on determining the methods of calibration, and ensuring that they receive all the basic information they need to improve their existing instrument calibration program or implement a new one. Meeting FDA compliance rules is also important because not doing so could lead to fines and negative publicity that would be disastrous for a medical laboratory. To receive the required information and training, FDA regulated laboratories can check out online seminars on the subject, given by expert speakers, which will give them all they need to ensure a good laboratory instrument calibration program.


I suggest you attend this Live Audio Conference on Thursday, Jan 21, 2016 by Dr. Jerry Lanese, an expert consultant in the area of quality systems and cGMP compliance, to get guidance on building or improving your laboratory instrument calibration program in compliance with FDA rules.

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