Under the requirements of Title 21, Part 117, Subpart B, Code of Federal Regulations (CFR), manufactured food establishments must establish current good manufacturing practices to serve as the backbone for ensuring the production of safe foods. These practices must cover the following topics:
Personnel Roles and Responsibilities
- Personnel reporting illness or reportable disease
- Personnel hygienic practices
- Clean outer garments
- Proper hand washing and sanitizing
- Removing jewelry
- Wearing hairnets, beard guards, etc.
- No eating, drinking, chewing gum or smoking in area where food production and cleaning is taking place
- Taking precautions to protect against allergen cross-contact and cross-contamination
Plant and Grounds
- Properly storing equipment, removing litter and waste, cutting weeds and grass so as to avoid an attractant, breeding place or harborage area for pests
- Maintaining roads, yards and parking areas
- Ensuring adequate drainage
- Plant must be constructed and designed properly.
- Take precautions to protect against allergen cross-contact and cross-contamination.
- Plant must have properly constructed floors, ceilings, ventilation and lighting
Sanitary Operations
- Building must be clean, sanitary and in good repair.
- Cleaning and sanitizing of equipment and utensils
- Proper storage and use of all chemicals
- Pest control
- Food-contact surfaces cleaned and sanitized as frequently as necessary to prevent allergen cross-contact and cross-contamination
- Non-food-contact surfaces cleaned and sanitized as frequently as necessary to prevent allergen cross-contact and cross-contamination
- Proper storage of clean equipment and utensils
Sanitary Facilities
Proper Water Supply
- Approved source
- Suitable temperature
Plumbing
- Properly convey sewage and liquid waste
- Adequate floor drainage
- Proper backflow protection
Toilet Facilities
- Readily accessible
- Clean and properly supplied
Handwashing Facilities
- Conveniently located
- Adequate and properly designed
- Properly supplied with soap, sanitizer and hand towels
- Water provided at a suitable temperature
Equipment and Utensils
Proper Design and Construction
- Food-contact surfaces must be corrosion resistant.
- Smooth seams
- Clean and sanitary
- Freezers and cold storage units must have indication thermometer.
- Instruments and controls used for measuring, regulating or recording control, or preventing growth of microorganisms must be accurate, precise and maintained.
Process and Controls
General
- Food and packaging must be suitable for human consumption and use (quality control).
- Overall sanitation must be assigned to individual(s).
- Ensure precautions for control of allergen cross contact.
- Reject any food that has become contaminated.
- Testing procedures must be used when necessary.
Raw Materials and Other Ingredients
- Must be inspected to ensure they are clean and suitable for use in food production
- Must be stored properly (in a manner that protects against allergen cross-contact and against contamination)
- Must be washed and cleaned as necessary
- Must not contain levels of microorganisms that may render food injurious to humans
- If susceptible to aflatoxin or other natural toxins, must comply with U.S. Food and Drug Administration (FDA) regulations for poisonous or deleterious substances
- If susceptible to contamination with pests, undesirable microorganisms or extraneous materials, must comply with FDA regulation for natural or unavoidable defects
- Must be held at proper temperature (and humidity if required)
Manufacturing
- Equipment, utensils and containers must be clean, sanitary and maintained.
- Food that can support the rapid growth of undesirable microorganisms must be held at proper temperatures.
- Measures such as pasteurizing, cooking, freezing, refrigeration, controlling pH, etc., must be taken to destroy or prevent the growth of undesirable microorganisms. Monitoring can be accomplished through use of continuous monitoring of temperature controls, properly calibrated thermometer or pH meter, time/temperature controls for cooked products, etc.
- Work in progress and finished product must have proper protection from allergen cross-contact and contamination.
- There must be protection from physical hazards such as metal and glass.
- There must be protection from other adulterants (condensation, employee practices, etc.).
Prevention of Allergen Cross-Contact
Prevention of allergen cross-contact must be incorporated into applicable sections:
- Personnel practices
- Proper storage
- Food-contact surfaces
- Non-food-contact surfaces
- Rework
Warehouse and Distribution
- Proper storage (temperature control)
- Protection from allergen cross-contact
- Protection from cross-contamination
Human Food By-Products for Use as Animal Food
- Proper construction of containers and equipment
- Protection against contamination (including trash)
- Properly labeled and identified
Defect Action Levels