FSN 436 Lecture Notes - Lecture 11: Good Manufacturing Practice, Aseptic Processing, Hazard Analysis And Critical Control Points
• GMPs vs SSOPs
• Personnel
– Disease control
– Cleanliness
– Education and training, supervision
• Plants and grounds
– Grounds
– Plant design and construction
• Sanitary operations
– General maintenance
– Substances used for cleaning
– Pest control
– Sanitation of food-contact surfaces
– Storage and handling.
• Sanitary facilities and controls
– Water supply
– Plumbing
– Sewage disposal
– Toilet facilities
– Hand-washing facilities
– Rubbish and offal disposal
• Equipment and utensils
• Processes and controls
– Raw materials
– Manufacturing operations
• Warehousing & distribution
• Exclusions
• Defect Action Levels
• A procedure for cleaning and sanitizing:
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– Equipment
– Walls
– Floors
– Tables
– Utensils
– Personnel
– Packaging
• If the facility manager is gone, the facility can still function by reading the SSOPs and SOPs
• Good Manufacturing Practices
• What are GMPs?
• Where can they be found?
• What areas of food processing are covered by GMPs?
• Prerequisite Program to HACCP
• Why should they be a prerequisite program to HACCP?
• Good Manufacturing Practices
• Definition -Current good manufacturing practice
– applied in determining whether a food is adulterated
• was it manufactured under such conditions that it is unfit for food
• was food prepared, packed, or held under insanitary conditions whereby it
may become contaminated with filth, or rendered injurious to health
• Good Manufacturing Practices
• Definition -Current good manufacturing practice - continued
– Food covered by specific current good manufacturing regulations is also subject to the
requirements of those regulations
• Good Manufacturing Practices
• Where can they be found?
– Code of Federal Regulations Title 21 Part 110
– Good Manufacturing Practice in Manufacturing, Packing and Holding of Human Food
– Last revised August 9, 2004
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– Still on going
• Good Manufacturing Practices
• Foods covered by Broad GMPS but also by Specific GMPs
– Nutrient content of infant formulas -21 CFR 106
– Low-acid canned foods –21 CFR 113 Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers
– Acidified Foods –21 CFR 114
– Bottled Drinking Water –21 CFR 129
• Good Manufacturing Practices
• Low –acid canned foods –What are they & why are they subject to special regulations?
• Definitions
– Aseptic processing & packaging
– Lot
– Retort
– Scheduled Process
• Good Manufacturing Practices
• Low-acid canned foods specific GMPs
– Personnel
• Operations that must be supervised by employee who attended & completed
an FDA approved course on preservation technology
– Processing systems –retorts
– Aseptic processing & packaging systems
– Product formulating systems
– Container closure inspection
• Good Manufacturing Practices
• Low-acid canned foods specific GMPs
– Equipment
• GMPs require all retorts to have
– MIG Thermometer
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Document Summary
Education and training, supervision: plants and grounds. Exclusions: defect action levels, a procedure for cleaning and sanitizing: Code of federal regulations title 21 part 110. Good manufacturing practice in manufacturing, packing and holding of human food. Still on going: good manufacturing practices. Foods covered by broad gmps but also by specific gmps. Nutrient content of infant formulas -21 cfr 106. Low-acid canned foods 21 cfr 113 thermally processed low-acid foods packaged in. Bottled drinking water 21 cfr 129: good manufacturing practices. Low acid canned foods what are they & why are they subject to special regulations: definitions. Personnel: operations that must be supervised by employee who attended & completed an fda approved course on preservation technology. Container closure inspection: good manufacturing practices. Equipment: gmps require all retorts to have. Each retort is listed along with requirements: good manufacturing practices. Specific closure requirements: closures must be checked periodically. Teardown: cooling water must be chlorinated. Product in can: good manufacturing practices.