Subpart B of 21 CFR Part 117 is where food safety starts on the plant floor. It sets the baseline sanitary and operational conditions every covered facility must maintain, and it is where FDA investigators spend much of their time during a routine inspection.

The requirements begin with people. Facilities must exclude personnel with an illness or condition that could contaminate food from operations where that risk exists, and must enforce hygienic practices, from handwashing to appropriate garments, throughout production areas. From there, the requirements move to the physical plant itself: grounds free of pest-harboring conditions, adequate space and ventilation, and a safe, adequate water supply with proper backflow prevention.

Sanitation requirements cover both the general condition of the facility and the specific design of food-contact equipment, which must be easily cleanable and resistant to corrosion. Process controls then govern how raw materials, in-process product, and rework are handled to prevent contamination from entering the food stream. Finally, warehousing and distribution requirements extend these same protections through storage and transportation, so that a product built safely on the line does not become compromised before it reaches a customer.

This course walks through each of these areas in turn, grounded in the specific CGMP citations that inspectors reference during a facility audit.