21 CFR 117.155 - Verification

What it says

Section 117.155 sets out the verification activities for preventive controls, as appropriate to the facility, the food and the nature of the control. They include validation, verification that monitoring is being conducted, verification that corrective action decisions are appropriate, verification of implementation and effectiveness, and reanalysis. All verification activities must be documented in records.

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

What it means in practice

• Verification asks whether the system works, not whether a single check was done. It brings together validation, verification of monitoring, verification of corrective action decisions, verification of implementation and effectiveness, and reanalysis.
• Verification of implementation and effectiveness covers activities such as calibration of instruments, product testing, environmental monitoring and review of records, with the extent set by the nature of the control.
• All verification activities must be documented in records, so an activity that was performed but not recorded will not hold up in an inspection.

What FDA inspectors look for

• Whether validation evidence exists for the preventive controls that need it, and whether it is current.
• Whether monitoring and corrective action records are reviewed, by whom and within what time.
• Whether instruments used for monitoring and verification are calibrated, and whether product testing and environmental monitoring programs match the plan.

Related regulations