Frequently Asked Questions

All equipment must undergo Installation Qualification (IQ) — verifying it's installed per specifications, Operational Qualification (OQ) — confirming it operates correctly in all anticipated ranges, and Performance Qualification (PQ) — proving it performs consistently with actual products. Qualification must be completed before routine use. Re-qualification is required at defined intervals and after any significant changes.

QC laboratory equipment must meet the same IQ/OQ/PQ qualification requirements as production equipment. Additionally, all measuring and analytical instruments must be calibrated at defined intervals using certified reference standards. Calibration records must be maintained. Equipment failing calibration must be clearly marked and removed from use until recalibrated.

Calibration must be performed at defined intervals using certified reference standards. While Schedule M doesn't specify exact frequencies for all equipment, the intervals must be based on the equipment manufacturer's recommendations, regulatory requirements, and the criticality of the measurement. Typical frequencies range from daily checks for critical instruments to annual recalibration for less critical ones.