Pay Close Attention To Equipment Calibration Certificates, FDA Says
This article was originally published in The Silver Sheet
Executive Summary
DEVICES MANUFACTURED WITH IMPROPERLY CALIBRATED EQUIPMENT can pose a hidden risk for companies, FDA says. The agency urges firms to investigate if they discover that a product made with out-of-specification equipment has gone to market. Further, many device firms are not adequately reviewing the work of third-parties that calibrate their manufacturing equipment. "What we typically see is that companies are blindly accepting calibration certificates from test houses," FDA/GMP expert Kim Trautman says. Companies must determine and document how often equipment should be tested and calibrated, as well as decide how they will store equipment instruction manuals - both of which will likely be reviewed by FDA during a facility inspection. Manufacturers also need to keep a sharp eye on test houses, just as they would any other supplier