The purpose of equipment and instrument calibrations is to ensure accurate measurements. The FDA defines calibration as the demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an appropriate range of measurements.
According to 21 CFR 820.72, calibration program and procedures must include specific directions and limits for accuracy and precision. Calibrations should be performed according to a specific schedule and using standards traceable to certified standards. Records of the calibrations should be maintained and the calibration status should be displayed on or near the equipment. Any equipment found not to be within calibration should be investigated and product manufactured with the equipment should be evaluated to determine if there was any adverse effect on the quality of the product.
A company recently received the following observation:
…. Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
Specifically, your firm’s test equipment/instrument calibration procedures, SOP …, “Equipment Calibration Program,” were inadequate in that:
a. The calibration tracking system was not properly maintained. Actual in-house calibrations of equipment were not performed per the equipment calibration calendar (within scheduled calibration date). For example, calibrations of the … were performed … months after the calibration due date.
b. The Equipment Calibration Procedures did not include the “specified range for calibration” or specified tolerance of the equipment. The SOP for instrument … stated: … and was incomplete. It did not reference the manufacturer’s user manual or specific log sheet to use. It was not revised until last month.
c. Records of the results of calibration and verification were not documented correctly or reviewed for accuracy.
To view more observations pertaining to calibration, refer to the following GMP Trends® Issues: 1101, 1088, 1082, and 1079.
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