The following list contains some on the top audit findings when auditors inspect equipment qualifications.

Equipment qualification is one of the most important aspects of the whole validation process when developing drugs and medical devices, not only is it critical to have fully qualified equipment working within spec’s and ranges it is also paramount that they are calibrated and are maintained in the qualified state for the lifecycle of the production cycle.

Common List of Audit Findings

1. Failure to document and investigate discrepancies.

2. Failure to follow a change control system for equipment.

3. Equipment systems were not adequately qualified (IQ, OQ, PQ).

4. No Computer System Validation Philosophy / Plan.

5. Worst-case conditions are not undertaken during the validation study.

6. Cleaning failures noted in the ongoing cleaning validation program are not investigated and corrected.

7. The maintenance person was using an obsolete SOP for maintenance and calibration of equipment.

8. The firms cleaning validation program has not addressed how long a product can remain in the processing equipment before the equipment must be cleaned.

9. There are no maintenance records for the machines to indicate when routine repairs and replacement of parts is performed.

10. Filters used to sterilize bulk drug solutions are not being subjected to a pre-filtration integrity test.

11. There are no written procedures for calibration and preventive maintenance of laboratory instruments.

12. Lack of adequate recording systems for calibration of sensors.