Preventive controls work in conjunction with which of the following programs?

Preventive controls work in conjunction with which of the following programs?

• A. They replace GMPs
• B. They work in conjunction with GMPs
• C. They are unrelated to GMPs
• D. They only cover distribution

Answer: (B)

Preventive controls are designed to work hand in hand with GMPs. GMPs provide the baseline requirements for safe, sanitary operations across a facility—things like facility design, equipment hygiene, and personnel practices. Preventive controls, on the other hand, add a proactive, hazard-based layer: conducting a hazard analysis, establishing specific control measures at each step of production, and implementing monitoring, verification, and corrective actions. They complement GMPs by targeting known or reasonably foreseeable hazards and ensuring those controls are consistently applied, without replacing the general GMP foundation. They also cover more than distribution, addressing processing, packaging, and holding as part of the control plan.

Preventive controls are designed to work hand in hand with GMPs. GMPs provide the baseline requirements for safe, sanitary operations across a facility—things like facility design, equipment hygiene, and personnel practices. Preventive controls, on the other hand, add a proactive, hazard-based layer: conducting a hazard analysis, establishing specific control measures at each step of production, and implementing monitoring, verification, and corrective actions. They complement GMPs by targeting known or reasonably foreseeable hazards and ensuring those controls are consistently applied, without replacing the general GMP foundation. They also cover more than distribution, addressing processing, packaging, and holding as part of the control plan.