cGMP for Food Manufacturing: Complete Guide to 21 CFR Part 117 Subpart B

What Are Food cGMPs?

Food cGMPs are the baseline sanitary and processing standards that all food manufacturers must follow. They establish the foundation upon which more specific food safety requirements (like FSMA Preventive Controls) are built. While Preventive Controls require a risk-based food safety plan, cGMPs apply to every aspect of food manufacturing operations regardless of specific hazards.

The cGMP regulations were originally codified as 21 CFR Part 110 and were moved to 21 CFR Part 117, Subpart B as part of the FSMA Preventive Controls rule finalization. The substantive requirements remain largely the same.

Who Must Comply?

All facilities that manufacture, process, pack, or hold food for human consumption and are required to register with FDA under 21 CFR Part 1 must comply with food cGMPs. This includes:

• Food manufacturers and processors
• Packaging operations
• Food warehouses and distribution centers
• Both domestic and foreign facilities producing food for the US market

There are no size-based exemptions from food cGMP requirements. Even facilities that qualify for modified requirements under the Preventive Controls rule must comply with Subpart B cGMPs.

Personnel Requirements

Personnel are a primary source of food contamination. cGMPs require:

• Disease control: Persons with illness, open lesions, or infections that could contaminate food must be excluded from food handling areas
• Cleanliness: Adequate personal cleanliness including clean outer garments, hairnets, and proper handwashing
• Handwashing: Hands must be washed thoroughly after using restrooms, before starting work, after handling contaminated materials, and at any time hands may have become contaminated
• Personal habits: Eating, drinking, smoking, and chewing gum or tobacco are prohibited in food processing areas
• Personal items: Jewelry, watches, and other personal items that could fall into food must be removed or covered

Plant and Grounds

Grounds

• Properly maintained to prevent contamination sources (standing water, refuse, uncut vegetation)
• Adequate drainage to prevent food contamination
• Waste treatment and disposal systems that do not create contamination risks

Plant Construction and Design

• Adequate space for equipment placement, storage, and operations to prevent contamination
• Floors, walls, and ceilings that are cleanable and in good repair
• Adequate lighting in processing, storage, and handwashing areas
• Adequate ventilation to minimize odors, vapors, and condensation
• Adequate screening of windows and doors to exclude pests

Sanitary Operations

Sanitary operations cover the maintenance and cleaning of the physical plant:

• Facility maintenance: Buildings, fixtures, and equipment must be maintained in sanitary condition
• Cleaning compounds: Only approved, food-safe cleaning and sanitizing agents may be used
• Pest control: Effective measures to exclude and eliminate pests (insects, rodents, birds)
• Sanitary facilities: Adequate toilet facilities, handwashing stations with soap and sanitizer, and waste receptacles
• Water supply: Adequate supply of safe, sanitary water for processing, cleaning, and handwashing
• Sewage disposal: Adequate sewage and waste disposal systems

Equipment and Utensils

Production and Process Controls

All food manufacturing operations must be conducted under conditions and controls necessary to minimize the potential for contamination:

• Raw materials: Inspect and sort raw materials to ensure they are clean and suitable for processing
• Manufacturing operations: Conduct all operations (washing, peeling, trimming, cutting, sorting, inspecting, cooking, cooling, packaging) to minimize contamination
• Temperature controls: Maintain appropriate temperatures during processing, holding, and storage to prevent pathogen growth
• Allergen controls: Prevent cross-contact of major food allergens through equipment cleaning, product scheduling, and labeling
• Chemical and physical controls: Prevent contamination from chemicals (lubricants, cleaners, pesticides) and physical hazards (metal, glass, plastic)

Warehousing and Distribution

Storage and transportation of finished food products must maintain food safety:

• Store food under conditions that protect against contamination and deterioration
• Maintain proper temperature control during storage and distribution
• Protect food from physical damage, contamination, and deterioration during transport
• Maintain clean and sanitary vehicles and transportation equipment
• Prevent cross-contamination between food and non-food products during transport

Defect Action Levels

FDA has established Defect Action Levels (DALs) for natural or unavoidable defects in food that present no health hazard. These levels represent the maximum levels of natural defects (insect fragments, rodent hairs, mold, etc.) that FDA considers acceptable. Products exceeding DALs may be considered adulterated even if no specific health hazard exists. Maintaining cGMP-compliant operations is the best defense against exceeding defect action levels.

How Assurentry Can Help

Assurentry provides comprehensive food cGMP compliance support:

• FDA facility registration: Registration and biennial renewal for all food facility types
• cGMP gap assessment: On-site evaluation of your facility against 21 CFR Part 117 Subpart B requirements
• Preventive Controls integration: Building your cGMP foundation to support your FSMA Food Safety Plan
• Inspection readiness: Preparing your facility and documentation for FDA inspections