Good Manufacturing Practices (GMPs)

1. Good Manufacturing Practices (GMPs)

2. GMP’s • 21 CFR - Code of Federal Regulations • Part 110 , Subparts: • General provisions • Buildings and facilities • Equipment • Production and process control • Defect action levels

3. General Provisions-DefinitionsOnly important ones are given below • Acid foods or acidified foods • 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

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

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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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