chp8 - GOOD MANUFACTURING GOOD PRACTICES FScN 4131 Food...

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Unformatted text preview: GOOD MANUFACTURING GOOD PRACTICES FScN 4131 Food Quality October 2, 2000 HACCP GMPs SANITATION Importance of GMPs ✢ Importance of GMPs ✢ Good Manufacturing Practices (GMPs) are (GMPs) regulations that describe the methods, equipment, facilities, and controls required for producing • • • • Human and veterinary products (21 CFR 21--211) Medical devices (21 CFR 820) Processed food (21 CFR 110) Dietary supplements (21 CFR 111) GMPs are the minimum sanitary and processing requirements to ensure production of wholesome food. The U.S. regulations are called "current" Good Manufacturing Practices regulations, to emphasize that the expectations are dynamic. ✢ History of GMPs ✢ GMP - 21 CFR 110 ✢ Five subparts: 1938 Food, Drug and Cosmetic Act - 1938 1969 Good Manufacturing Practices regulation 1986 GMP umbrella regulation ✢ ✢ A - General Provisions B - Buildings and Facilities C - Equipment D - [Reserved] E - Production and Process Controls F - [Reserved] G - Defect Action Levels (DAL) GMP - 21 CFR 110 GMP Subpart A-General Provisions 110.3 Definitions Acid foods Adequate Batter Blanching Critical control point Food Food-contact surfaces GMP - 21 CFR 110 Subpart A-General Provisions 110.3 Definitions (cont’d) (cont’d) Lot Microorganisms Pest Plant Quality control operation Rework Safe-moisture level GMP - 21 CFR 110 Subpart A-General Provisions 110.3 Definitions (cont’d) (cont’d) Sanitize Shall Should Water activity GMP - 21 CFR 110 Subpart A-General Provisions 110.10 Personnel a) Disease control Exclusion of persons who have or appear to have an illness or infectious disease. Mandatory report of any illness GMP - 21 CFR 110 Subpart A-General Provisions 110.10 Personnel b) Cleanliness b) 1. Wearing outer garments 2. Personal cleanliness 3. Washing hands thoroughly 4. No jewelry 5. Sanitary gloves GMP - 21 CFR 110 Subpart A-General Provisions 110.10 Personnel b) Cleanliness (cont’d) b) (cont’d) 6. Wearing hair restraints 7. Storing clothing and personal belongings 8. No food, gum, beverages, tobacco 9. Any other adequate precaution GMP - 21 CFR 110 GMP Subpart A-General Provisions 110.10 Personnel c) Education and training d) Supervision GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.20 Plant and grounds Grounds 1. Prevent conditions that favor harboring pests in surrounding areas 2. Maintaining roads, yards, and parking lots 3. Draining areas 4. Operating systems for waste management GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.20 Plant and grounds Plant construction and design 1. Space for equipment and storage of materials 2. Designed to reduce contamination of food 3. Protect outdoor food fermentation vessels 4. Design to facilitates cleaning and repair of floors, walls, ceilings GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.20 Plant and grounds Plant construction and design (cont’d) (cont’d) 5. Provide adequate lighting and designed with safe-type light bulbs, fixtures, skylights. 6. Adequate ventilation to eliminate odors and vapors 7. Adequate screening and protection against pests GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.35 Sanitary operations General maintenance 1. Sanitary conditions of buildings, fixtures and other physical facilities 2. Cleaning and sanitizing of utensils and equipment GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.35 Sanitary operations Substances used in cleaning and sanitizing: storage of toxic materials 1. Cleaning and sanitizing agents should be free from microorganism 2. Groups of toxic chemicals allowed in a food plant 3. Identification and storage of cleaning and sanitizing agents GMP - 21 CFR 110 GMP Subpart B - Buildings and Facilities 110.35 Sanitary operations Pest control 1. No pests allowed in any area of a food plant 2. Effective measures to exclude pests from the premises 3. Insecticides or rodenticides are permitted only under precautions GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.35 Sanitary operations Pest control An integrated pest management (IPM) program is a system designed to prevent pests from infesting the establishment and to get rid of any pests that are present. GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.35 Sanitary operations Sanitation of food-contact surfaces GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.35 Sanitary operations Storage and handling of cleaned portable equipment and utensils Should protect against contamination Shall be cleaned and sanitized as frequent as necessary 1. Dry or low moisture foods 2. Wet processing 3. Use of single-serve articles 4. Acceptable facility, procedure or machine to clean and sanitize GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.37 Sanitary facilities and controls a) Water supply Sufficient for operations from adequate source Safe and sanitary quality Suitable temperature Under pressure as needed GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.37 Sanitary facilities and controls b) Plumbing • Carry sufficient water to required locations Carry throughout the plant • Convey sewage and liquid disposable waste Convey • Not a source of contamination Not • Floor drainage Floor • Prevent back-flow or cross-connection Prevent between water for food manufacturing and waste water GMP - 21 CFR 110 GMP Subpart B - Buildings and Facilities 110.37 Sanitary facilities and controls c) Sewage disposal - Adequate sewerage facilities GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.37 Sanitary facilities and controls d) Toilet facilities - Should be readily accessible - Sanitary condition - In good repair - Self-closing doors - Doors should not open directly to food is exposed GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.37 Sanitary facilities and controls e) Hand washing facilities Facilitate hand washing and sanitation Effective hand cleaning Sanitary towel or drying devices Devices to protect against recontamination of clean hands Readily understandable directional signs Refuse receptacles GMP - 21 CFR 110 Subpart B - Buildings and Facilities 110.37 Sanitary facilities and controls e) Rubbish and offal disposal Minimize odor, pest harboring and potential contamination source GMP - 21 CFR 110 Subpart C - Equipment 110.40 Equipment and utensils a) Cleanable, made of non-toxic materials, Cleanable, designed to withstand use b) Smooth seams on food-contact surfaces c) Non-food equipment easy to clean d) Easy to maintain under sanitary conditions GMP - 21 CFR 110 Subpart C - Equipment 110.40 Equipment and utensils (cont’d) (cont’d) e) Freezer and refrigerated storage should have: a thermometer and an automatic control of temperature f) Instruments that measure pH, Temp., aw, acidity should be accurate g) Compressed air or gas in contact to food should be clean GMP - 21 CFR 110 GMP Subpart E - Production and Process Controls 110.80 Process and controls •All plant operations from receiving through packaging and storing conducted under sanitary conditions •Use of appropriate quality control operations •One or more supervisors for overall sanitation •Precautions against contamination during production GMP - 21 CFR 110 Subpart E - Production and Process Controls 110.80 Process and controls a) Raw materials and other ingredients Shall be inspected and segregated Shall not contain microorganisms that produce foodpoisoning Shall not contain toxins Shall comply with other FDA regulations Shall be kept free from contamination GMP - 21 CFR 110 Subpart E - Production and Process Controls 110.80 Process and controls b) Manufacturing operations 1. Equipment in an acceptable condition 2. Control devices for parameters that affect microbial growth GMP - 21 CFR 110 Subpart E - Production and Process Controls 110.80 Process and controls b) Manufacturing operations 3. Refrigeration and freezing temperatures Refrigeration < 45°F Frozen foods should be kept frozen Hot foods kept at > 140°F GMP - 21 CFR 110 Subpart E - Production and Process Controls 110.80 Process and controls b) Manufacturing operations 4. Adequate sterilization, irradiation, pasteurization 5. Work-in-process protected 6. Protection of finished product 7. Transportation equipment 8. Prevention of metal contamination 9. Disposal of adulterated raw or processed food GMP - 21 CFR 110 Subpart E - Production and Process Controls 110.80 Process and controls b) Manufacturing operations 10. Washing, peeling, trimming, sorting, cutting, shredding, drying, whipping, etc. 11. Heat blanching 12. Protection of batters 13. Filling, assembling or packaging steps GMP - 21 CFR 110 GMP Subpart E - Production and Process Controls 110.80 Process and controls b) Manufacturing operations 14. Dry foods --- Water activity 15. Acidified foods 16. Ice quality 17. Only food manufacturing GMP - 21 CFR 110 Subpart E - Production and Process Controls 110.93 Warehousing and distribution Store and transport finished food under conditions that protect against physical, chemical and microbial contamination and deterioration GMP - 21 CFR 110 Subpart G - Defect Action Levels (DAL) 110.110 Natural or unavoidable defects in food for human use that present no health hazard FFD&CA 406(a)(4) Tolerance limits for adulterants GMP - 21 CFR 110 GMP provide basics in food safety, but have several weaknesses: •Too broad •Too vague (“adequate”, “proper”) •All GMP have same importance •Do not address non-compliance •Do not require monitoring and recording ...
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This note was uploaded on 01/06/2011 for the course FDE 510 taught by Professor Prof.hamialpas during the Spring '09 term at Middle East Technical University.

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