21 CFR 117.145 - Monitoring

What it says

The facility must establish and implement written procedures, including the frequency of performance, for monitoring the preventive controls, in order to provide assurance that they are consistently performed, and must keep records of that monitoring.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Monitoring is the routine, in-the-moment check that the control is working, such as reading a temperature at the frequency the plan sets.
• The frequency should be justified, because a control checked too rarely can fail unnoticed for a long time.
• Monitoring records are reviewed separately, as part of verification.

What FDA inspectors look for

• Whether monitoring procedures exist for each preventive control.
• Whether monitoring is done at the stated frequency.
• Whether records are accurate and made at the time of monitoring.

Related regulations