21 CFR 117.80 establishes the cGMP requirements for manufacturing and processing operations at food facilities under the FSMA Preventive Controls rule. These are the operational standards that apply to actual food production — covering raw material controls, process controls, allergen management, and contamination prevention during manufacturing.

Raw Material and Ingredient Controls

Under 21 CFR 117.80(a), raw materials and other ingredients must:

• Be inspected and segregated so that defective or contaminated materials are not used in food manufacturing

• Be stored under appropriate conditions of temperature and humidity to prevent deterioration and contamination

• Be used only from approved suppliers or after adequate sampling/testing has been conducted

• Be handled in a way that prevents cross-contamination between raw materials and finished products

For dietary supplement manufacturers, this requirement interacts with the cGMP component testing requirements under 21 CFR Part 111 — all components must be identified and tested (or verified through supplier documentation) before use.

Manufacturing Operations Controls

Under 21 CFR 117.80(b), during manufacturing and processing:

• Food-contact surfaces must be sanitized as appropriate before use and after any time contamination could have occurred

• Temperature-sensitive foods must be held at appropriate temperatures during manufacturing to prevent pathogen growth

• Containers and packaging materials must be appropriate for the food and maintained in a way that prevents contamination

• Time and temperature controls must be monitored and recorded where they are critical to food safety

Protection of Food from Contamination

During manufacturing, food must be protected from contamination by:

• Physical contaminants: The facility must take measures to prevent glass, metal, and other physical hazards from entering food during production

• Biological contaminants: Food must be protected from contamination by pests, personnel (illness, hygiene failures), and environmental pathogens

• Chemical contaminants: Cleaning chemicals, lubricants, pest control materials, and other non-food chemicals must be stored separately and used in a manner that prevents contamination of food

Allergen Controls During Manufacturing

For facilities that process products with different allergen profiles on shared equipment, manufacturing controls must include:

• Scheduling practices: Running allergen-free or low-allergen products before allergen-containing products where possible

• Equipment cleaning and changeover: Documented cleaning procedures between allergen-containing and allergen-free production runs, with verification that cleaning is effective

• Rework handling: Rework (food incorporated back into production) must be handled to prevent inadvertent allergen introduction — rework from an allergen-containing batch cannot be incorporated into an allergen-free product

Temperature Controls

Where temperature is a food safety parameter (for pathogen control, preventing toxin formation, or maintaining product safety during processing):

• Temperatures must be monitored by calibrated instruments

• Time-temperature records must be maintained

• Deviations from temperature parameters must trigger corrective actions

For shelf-stable products that rely on water activity, pH, or other hurdle technologies rather than refrigeration, the relevant parameters must be controlled and documented.

Air Quality and Water Quality

Water used in food manufacturing must be from a safe, adequate supply. Water used in direct food contact (as an ingredient or for washing food contact surfaces) must meet potable water standards.

Air in manufacturing areas must not be a source of contamination. This includes:

• Compressed air used in food contact or processing applications must be clean (oil-free, filtered)

• HVAC systems must not introduce contamination into food production areas

Calibration of Instruments

All instruments used to measure food safety parameters (thermometers, pH meters, water activity meters, scales) must be:

• Calibrated against known standards at specified frequencies

• Maintained in accurate working condition

• Taken out of service and recalibrated if they are found to be out of calibration

Calibration records are reviewed during FDA inspections and must demonstrate adequate frequency.

Dietary Supplement Manufacturing Specifics

For dietary supplement manufacturers, 21 CFR 117.80 overlaps with the manufacturing operations requirements in 21 CFR Part 111. Key supplement-specific considerations:

• Blending and encapsulation: Manufacturing steps must be controlled to ensure uniform blend and accurate fill weight

• Granulation and drying: Temperature and moisture control during drying to prevent microbial growth

• Tablet coating and film coating: Temperature, humidity, and air flow control during coating operations

• Liquid supplement manufacturing: Mixing, temperature control, and pathogen risk management for liquid dose forms

How Truli Helps with Manufacturing Operations Compliance

• Operations cGMP documentation review: Truli evaluates whether manufacturing operations documentation covers the required elements under 21 CFR 117.80

• Allergen changeover procedure review: Truli assesses written allergen changeover procedures and cleaning verification protocols for shared-equipment operations

• Temperature control record review: Truli evaluates temperature monitoring records for completeness and flags deviations that required corrective actions

Related Regulations

• 21 CFR Part 117 — FSMA Preventive Controls — Full FSMA rule overview

• 21 CFR 117 Preventive Controls — The preventive controls that supplement cGMP manufacturing operations

• 21 CFR Part 111 — Supplement cGMP — Dietary supplement-specific manufacturing quality requirements

• FALCPA / FASTER Act Allergen Labeling — Allergen labeling requirements that manufacturing controls must support

Frequently Asked Questions

Do we need to test every batch of raw materials before using them?
Under 21 CFR 117.80(a) and related supplier controls, you must have a system for ensuring raw materials are safe for use. Testing every lot is one approach; reviewing supplier COAs, conducting periodic testing, and maintaining approved supplier programs are alternative or complementary approaches. The appropriate approach depends on the hazard profile of the raw material and the controls in your food safety plan.

We use the same kettle for both a soy-containing product and a soy-free product. What's required?
You need a documented cleaning procedure for the kettle between production runs, written validation that the cleaning effectively removes soy allergen residue, monitoring records showing each cleaning was performed as specified, and periodic verification testing (allergen swabs) to confirm the cleaning remains effective. A single cleaning with no verification is not adequate for a shared-equipment allergen control.

What temperatures are required for food manufacturing?
There is no single temperature requirement — it depends on the food and the hazard. Raw material holding temperatures, process temperatures (kill steps), and finished product holding temperatures are all specified based on the specific food safety parameters relevant to each product. Your food safety plan's hazard analysis and preventive controls should establish the required parameters for your specific products and processes.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. Reflects 21 CFR 117.80 as of April 2026. Book a demo to see how Truli monitors food safety compliance.