21 CFR 117 Subpart B - Current Good Manufacturing Practice for Human Food

What it says

Subpart B sets the baseline CGMP requirements for human food facilities, covering personnel (disease control, cleanliness, training), plant and grounds, sanitary operations and facilities, equipment and utensils, and production and process controls, including measures to prevent cross-contact with allergens and contamination during processing and storage.

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

What it means in practice

• These are the everyday controls, such as handwashing, pest control, cleaning and protection of food from contamination, that support everything in the food safety plan.
• Preventing allergen cross-contact appears in the process controls, so allergen handling, changeovers and cleaning between products are part of CGMP and not only part of the preventive controls.
• Training and supervision matter here, because personnel with appropriate education, training or experience are a stated expectation.

What FDA inspectors look for

• Whether sanitation, pest control and cleaning are performed as written and documented where required.
• Whether employee hygiene practices on the floor match the written policies.
• Whether equipment, utensils and food-contact surfaces are designed and maintained so they can be adequately cleaned.

Related regulations