FDA Regulations and Process Validation Considerations

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FDA Regulations and Process Validation ConsiderationsNate Anderson, food and Drug AgenciesRegulatory Agencies Red Meat > 3% raw > 2% cooked Poultry Egg productsRegulatory Agencies Seafood Quality Grading (Grade A) HACCP Quality Management Program Fee BasedRegulatory Agencies Water (drinking and waste) Pesticides Antimicrobial InsectsRegulatory Agencies Additives Pesticides All foods not inspected by USDA Animal drugs Nutritional labeling Ingredients labelingAvenues of Compliance Governmental Acts Promulgated Regulations Policies Guidance documentsFD&CDirect/IndirectAdditivesDai ry/PMOLACFSeafoodJuiceLabels, Standards of IdentityFDA Requirements Federal food Drug and Cosmetic Act (FFDCA) 21 CFR 110 Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human FoodGMP Processes and Controls(a)Raw material

Preventive Controls Rule •Preventive Controls Proposed Rule for Human Food –Final Rule due Aug. 30th, 2015 •FSMA exempted LACF with respect to microbiological hazards –LACF processors will still have to address physical and chemical hazards –Acidified and acid foods not exempt— manufacturers of these products will have to

  Rules, Control, Food, Final, Preventive, Final rule, Preventive controls, Preventive controls rule