If you are controlling a hazard at your own facility, you need to implement a preventive control that will significantly minimize and prevent the identified hazard. Preventive controls need to have corresponding procedures for monitoring, verification and corrective actions to ensure that they are appropriately implemented.
In particular, as part of the umbrella of “verification” FDA will expect:
- that you validate the efficacy of your preventive control (e.g., have validation to demonstrate that your kill step is effective to control for Salmonella) 9 and
- engage in environmental monitoring if post-processing contamination is identified as a hazard requiring a preventive control
