FDA Good Manufacturing Practices

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Lecture 5

• FDA Good Manufacturing Practices

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GMPs

• Good Manufacturing Practices
• 21CFR - Code of Federal Regulations
• Part 110 , Subparts
• General Provisions
• Buildings and facilities
• Equipment
• Production and process control
• Defect Action Levels

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General Provisions-Definitions

• Critical Control Points - lack of control creates
  hazard, filth or decomposition
• Food contact surface - direct or drainage
• Lot - identified by specific code
• defined by batch or time
• Microorganisms - yeasts, molds, bacteria, viruses
  
• that cause or indicate adulteration

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Definitions continued

• Pest - any objectionable animals or insects
• Plant - facility for manufacturing, packaging,
  storage, labeling,
• Quality control facility - systematic procedure
  to prevent adulteration
• Rework - clean unadulterated

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Definitions continued

• Water activity
• Safe moisture level
• Sanitize - treat to destroy vegetative cells w/o
  adverse effects
• Shall - mandatory
• Should - recommended

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Current GMP 110.5

• Food must be produced under sanitary conditions
  where it will not be contaminated by filth or
  rendered injurious to health
• A food is judged as adulterated if it is produced
  under conditions that is unfit for food

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Personnel 110.10

• Disease control
• personnel with communicable disease or illness
  will not be allowed to work
• personnel with open sores will not be allowed to
  work if chance for food contact

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Personnel Cleanliness 110.10

• Wearing apparel - storing of apparel
• hair nets, beard nets, headbands
• Personal cleanliness
• hand washing facilities and enforcement
• jewelry
• gloves
• eating confined to designated areas
• precautions to prevent contamination - sweat,
  cosmetics, tobacco, medicines etc..
• training of operators
• supervisors responsibilities defined

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Plant and Grounds 110.20

• Remove waste, grass, weeds etc..
• remove all harborage or breeding places
• Maintenance of roads, yard, parking lots
• Adequate drainage
• Waste treatment and disposal
• Design, size and construction for sanitation
• prevent potential for contamination of food or
  food surfaces
• Ventilation
• Lighting

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Sanitary Operations 110.35

• Physical facilities kept in good repair and in a
  good sanitary condition
• Proper cleaning and sanitation of food contact
  surfaces - frequency
• food contact surface free of microorganisms
• use and storage of toxic chemicals
• pest control - rodenticides, insecticides
• dry processes must stay dry
• wet processes - clean after every interruption
• sanitizing agents adequate and safe
• storage of cleaned portable equipment

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Sanitary Facilities 110.37

• Water supply - food and cleaning
• Plumbing - sufficient water, avoid contamination
• Adequate floor drains
• No possible backflow - cross contamination
• Toilets - adequate and accessible
• sanitary and good repair
• self closing doors - not directly into process
  areas
• hand washing, sanitizing, towel service, valve
  design, signs, refuse disposal

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Equipment 110.40

• Designed for ease of sanitation
• noncorrosive food surfaces
• Properly maintained
• Installation facilitates cleaning
• Must not contribute to adulteration
• lubricants, fuel, metal fragments, other
  contaminates
• No toxic materials in food contact areas

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Equipment continued

• Seams - smoothly bonded
• Non-food contact surface cleanable
• Holding, conveying systems
• Freezers/refrigerators
• temperature measuring and recording
• automatic controls to regulate temperature
• Instruments for pH, aw, temperature must be
  properly maintained
• Compressed air for food use

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Production Process Controls 110.40

• All operations will support sanitation
• receiving
• inspection
• transporting, segregating, preparing
• manufacturing
• packaging
• storing or warehousing

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Production Process

• Supervision of sanitation - competent personnel
• Testing procedures established and used
• identify sanitation failures
• identify possible food contamination
• Adulterated or contaminated food will be rejected
• treatment to eliminate contamination
• sifting, heat treatment, inspection

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Raw Materials

• Inspection, segregation
• ingredient, packaging, truck
• Stored - sanitary conditions - containers
• Washed and cleaned as appropriate
• water used in cleaning shall be safe
• if reused must not increase contamination
• Raw materials may not contain pathogenic bacteria
  - pasteurized
• suppliers certification or guarantee

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Raw Materials cont.

• Toxins - aflotoxin- FDA regulations
• action levels
• purchase under supplier certification
• cannot blend to reduce levels
• Raw materials susceptible to pests or
  microorganism shall comply w/FDA
• examination of ingredient
• certification by supplier

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Raw Materials continued

• Rework - held in sanitary environment that
  prevents adulteration
• Frozen ingredients - control temperature
• control thawing procedures
• Bulk storage shall protect against contamination

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Manufacturing Operations

• Equipment, utensils, containers shall be properly
  cleaned and sanitized
• All manufacturing processes will minimize growth
  of microorganism
• careful monitoring of processes
• heat, freezing, dehydration, acidification etc..
• time, temperature, humidity, aw

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Manufacturing continued

• Foods susceptible to micro. must be stored
  distributed properly
• refrigerated foods below 45oF
• frozen in frozen state
• hot foods above 140oF
• heat treatment of acidified foods
• preservation techniques must be adequate under
  standard processing to insure safety

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Manufacturing continued

• Work-in-process handled is safe manner
• Finished product must be protected from
  contamination by ingredients, refuse etc.
• Metal - magnets, metal detectors, sifters
• Process areas surfaces protected from
  contaminants that may drip, drain or be drawn on
  to food

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Manufacturing

• Dehydrated and intermediate moisture
• control by aw - carefully monitor
• control the soluble solids
• protect food from moisture pick - up
• if acidified, careful control of pH
• control of addition of acidified to low acid food
• Ice from clean water

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FDA Defect Action Levels

• Natural or unavoidable defects that at low levels
  are not hazardous to health
• Does not excuse poor sanitation
• Customer may require better than FDA DAL controls

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Greatest Threat?

• FDA
• State City Health inspectors
• Customers
• Media publicity