Good Manufacturing Practices

Good Manufacturing Practices (GMPs) are FDA regulations that guide processors. GMPs describe the minimal standards for producing safe and wholesome foods. Manufactured food businesses are required to adhere to GMPs. These standards are verified during regulatory inspections.

The GMPs are integral when designing the physical facility, creating standard operating procedures (SOPs), developing Hazard Analysis Critical Control Points (HACCP), and creating training protocols.

Personnel

• Reportable Illnesses and Diseases
  • Employee sick policy
• Employee Hygiene Practices
  • Proper handwashing
  • Maintain clean outer garments
  • Remove jewelry
  • Use single-use gloves
  • Effective use of hairnets, beard coverings, hats, or other hair restraints
  • Storage of personal items
  • No eating, drinking, chewing gum, or smoking in production and cleaning areas
  • Prevent allergen cross-contact
• Education and Training
  • Better Processing School (Resources page)
  • Preventive Controls Qualified Individual
  • Maintaining Employee Training Records

• Exterior Facility Maintenance
  • Grass and weeds cut, not overgrown
  • Roads, yards, and parking lots are not a source of food contamination
  • Prevent harborage, attractants, and pest breeding by:
    • Removing litter and waste frequently
    • Removing and storing unused or broken equipment
  • Proper drainage around the property thus preventing pest breeding, seepage, or foot-borne filth
  • Approved and functional systems for treating and disposing wastewater
  • Special care taken to inspect, exterminate, and exclude pests, dirt, and filth when grounds or bordering properties are not under the operator’s control
• Plant Construction and Design
  • Adequately sized facility for the equipment and storage necessary for safe food production and sanitary operations
  • Facility is designed to prevent allergen cross-contact, contamination of foods, or contamination of packaging with microorganisms, chemicals, filth, and other extraneous material by:
    • Separation by space or time
    • Air flow systems or dust control
    • Enclosed systems or other effective means
  • Design outdoor bulk containers to protect against environmental contamination and pests
  • Floors, walls, and ceilings must be easy to clean, maintained clean, and in good repair
    • Food, food-contact surfaces, or food-packaging are protected from condensate or moisture that occurs during processing
    • Work areas, production lines, and equipment are spaced for easy cleaning and to prevent contamination of food, food-contact surfaces, and food-packaging
  • Lighting must be adequate in the following areas:
    • Handwashing
    • Employee locker rooms
    • Restrooms
  • Lighting must be adequate and shatterproof in the following areas:
    • Where food is exposed, processed, packaged, and stored
    • Where equipment is cleaned
  • Ventilation designed to minimize dust, odors, and vapors
    • Prevent allergen cross-contact
    • Fans and blowers used to minimize contamination of food, food-packaging materials, food-contact surfaces, and to prevent allergen cross-contact
  • Protect outer openings, use roll-up doors and operable windows with screens or air curtains to prevent pests

• General Maintenance
  • Physical facility, building, and fixtures must be designed then maintained clean, sanitary, and in good repair
  • Cleaning and sanitizing equipment and utensils must be done to prevent allergen cross-contact, food contamination, food-contact surface contamination, or food-packaging material contamination
• Cleaning and Sanitizing Agents
  • Use chemicals for their intended purpose
    • Sanitizers for sanitizing; degreasers for degreasing
  • Use and store only the toxic agents necessary for
    • Cleaning
    • Sanitizing
    • Laboratory testing
    • Equipment maintenance
    • Plant maintenance
  • Agents must be labeled, held, and stored to prevent contamination of food, food-contact surfaces, or food-packaging materials
• Pest Control
  • Effective measures used to exclude all pests from the manufacturing, processing, packing, and holding areas
  • Protect foods against contamination by pests
  • Use pesticides under precaution; restrict the application in food, food-contact surfaces, and food-packaging materials areas
• Sanitization of Food-Contact Surfaces
  • Food-contact surfaces and utensils must be cleaned then sanitized as often as necessary to protect against allergen cross-contact and food contamination
  • Cleaning and sanitizing of wet processing food-contact surfaces should be completed before use and after production interruptions. Continuous production facilities should also clean and sanitize utensils and food-contact surfaces as necessary.
• Sanitization of Non-Food Contact Surfaces
  • Cleaned as often as necessary to prevent contamination
  • Cleaned in any manner to prevent contamination
• Storage and Handling of Portable Equipment and Utensils
  • Cleaned, sanitized, and stored to protect against allergen cross-contact and contamination of food, food-contact surfaces, and food-packaging materials

• Water Supply
  • Adequate and approved source
  • Under pressure
  • Suitable temperature
• Plumbing
  • Designed and sized adequately
  • Supplies water throughout facility
  • Disposes sewage and wastewater
  • Designed and installed to prevent contamination
  • Adequate floor drains in areas that are flood-cleaned or where wastewater is produced during production
  • Backflow and cross-connection prevented when designed and installed
• Sewage Disposal
  • Sewer system or approved on-site system used for disposal
• Toilet Facilities
  • Adequate
  • Accessible
  • Clean
  • Maintained in good repair
• Handwashing Facilities
  • Adequate
  • Convenient and easily accessible
  • Supplied with running water of suitable temperature
• Rubbish Disposal
  • Conveyed, stored, and disposed to prevent harborage or an attractant for pests
  • Removed to prevent contamination of food, food-contact surfaces, and food-packaging materials, water supplies, and ground water

• Designed and maintained for adequate cleaning and prevention of allergen cross-contact and contamination by any source
• Designed, constructed, and used to avoid adulteration of food by lubricants, fuel, metal fragments, contaminated water, or other contaminants
• Installed for easy cleaning and maintenance
• Corrosion-resistant food-contact surfaces
• Nontoxic materials for food-contact surfaces
• Seams and welds of food-contact surfaces smooth, minimize accumulation of food particles, dirt, organic matter, and biofilms
• Non-food contact surfaces designed, constructed, and maintained to be kept clean and in sanitary conditions
• Holding, conveying, and manufacturing systems designed and constructed to be maintained clean and in sanitary conditions
• Refrigeration and freezer units with thermometers that maintain food at required temperatures
• Measuring devices such as thermometers, pH meters, and water activity meters maintained accurately and precise
• Gases or compressed air used during processing must be filtered to prevent food contamination or allergen cross-contact

• General
  • Adequate sanitation principles implemented
  • Quality control used to ensure food and packaging is safe
  • A qualified supervisor must be clearly assigned the responsibility of ensuring the safe production of food
  • Precautions to prevent contamination
  • Testing used to identify sanitation failures, allergen cross-contact, and food contamination
  • Adulterated foods must be rejected or further processed to eliminate contamination
• Raw Materials and Ingredients
  • Clean and suitable for processing
  • Washed to remove soil or contamination
  • Cannot contain levels of microorganisms harmful to humans
  • Approved source or Certificate of Analysis
  • Proper temperatures and humidity for holding
• Manufacturing Operations
  • Equipment, utensils, and food containers in adequate condition and can be disassembled for thorough cleaning
  • Minimize potential growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food during processing
  • Pasteurization, refrigeration, freezing, cooking, and controlling pH are examples of measures taken to control microorganisms. These processes should be monitored by checking temperatures, adhering to time/temperature controls, and pH verification with properly calibrated thermometers or pH meters.
  • In progress and finished products protected from allergen cross-contact and contamination
  • Maintain food temperatures to prevent growth of microorganisms
  • Must be protected from physical contamination (e.g., metal and glass)
  • Must be protected from other adulteration (e.g., employees intentionally or unintentionally contaminating, condensation)
  • Batters, breading, sauces, and dip solutions handled to minimize growth of microorganisms
  • Acid and acidified foods must be maintained at 4.6 pH or below

• Foods must be protected in every step to prevent allergen cross-contact
  • Washing
  • Peeling, trimming, and cutting
  • Sorting and inspecting
  • Mashing
  • Dewatering
  • Cooling
  • Shredding
  • Extruding
  • Drying
  • Whipping
  • Defatting
  • Forming
• Allergens must be addressed with Standard Operating Procedures (SOPs)
  • Employee Practices
  • Storage
  • Cleaning and Sanitation
  • Portable Equipment Sanitation
• Filling, assembling, and packaging monitoring to prevent allergen cross-contact and food contamination
• Labeled to Identify Allergens

• Temperature control during storage
• Allergen cross-contact
• Cross-contamination prevention

• Quality assurance used to reduce or avoid defects to the lowest level feasible

Next: Qualified Facility