Transcription of FDA Regulations and Process Validation Considerations
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FDA Regulations and Process Validation Considerations
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/PMOLACFS eafoodJuiceLabels, 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 Pro
FSMA Preventive Controls • Facilities are required to conduct a hazard analysis and implement preventive controls for identified hazards. • Preventive controls: risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would
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