21 CFR 117.160 - Validation of Preventive Controls

What it says

The facility must validate that the preventive controls it applies, other than food allergen controls, sanitation controls, supply-chain controls and the recall plan, are capable of effectively controlling the identified hazard, using scientific and technical evidence, generally within the first 90 calendar days of production of the food or another timeframe justified in writing.

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

What it means in practice

• Validation asks whether the control can work in principle, as opposed to monitoring, which asks whether it worked today.
• A kill step, for example, would typically need evidence that the chosen time and temperature achieves the required reduction of the pathogen.
• Validation draws on sources such as scientific literature, regulatory guidance and the facility's own studies, and must be revisited when the process changes.

What FDA inspectors look for

• Whether validation records exist for process controls and cover the parameters used.
• Whether the evidence cited actually supports the parameters in the plan.
• Whether validation was repeated after relevant changes to the process or equipment.

Related regulations