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Viraj D replied to the topic Discussion Topic: Playing with IQ, OQ, PQ in the forum Process Validation and Process Risk 8 years, 1 month ago
For the antibiotic releasing hip stem manufacturing line which creates an artificial hip with an antibiotic coating on the surface, I believe the IQ involved in this manufacturing line would be written procedures on how to use the equipment to manufacture the artificial hip. As well as contain calibration/maintenance schedules to make sure the equipment is up to code and that there are no issues of malfunction. The OQ would be finding the control limit on the application of the antibiotic coating on the surface of the artificial hip. Lastly, the PQ would be producing a great number of hips with the same amount of antibiotic coating to show no variability.