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 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.
where treatment dose is expected to be lowest—”cold spot”. • Sample sufficient amounts of product to have confidence in the results • Replicate validation experiments to establish ... – chemical (e.g., sterilant concentration) – mechanical (e.g., conveyor speed) – thermal (e.g., temperature, specific heat) – radiation (e.g ...
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