Which areas are usually controlled in pre-requisite programs such as GMPs?

• A. Process
• B. Sanitation
• C. Hazard Analysis
• D. Verification

Answer: (B)

Pre-requisite programs like GMPs are about keeping the production environment clean and safe so everything else can function properly. The area they primarily control is sanitation—establishing cleaning and sanitation procedures, schedules, facility and equipment cleanliness, and operator hygiene. This creates the baseline conditions that minimize contamination and support HACCP-based controls later. Hazard analysis and verification are elements of HACCP and its validation/verification activities, not the foundational sanitation controls covered by GMPs. Process controls are addressed within the HACCP plan rather than the GMP sanitation framework.