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 Processes and Controls(a)Raw materials and other ingredients.(2) Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoningor other disease in humans, or theyshall be pasteurized or otherwise treatedduring manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act.

control/reduction –is the treatment sufficient to prevent illness? •Validation must be based on the most resistant microorganisms of public health significance relevant to the food and the process. Criteria for Evaluation •Able to effectively control the hazard (meet

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