FDA Regulations and Process Validation Considerations
FDA Regulations and Process Validation Considerations
Nate Anderson, Ph.D. U.S. Food and Drug Administration
nathan.anderson@fda.
Regulatory Agencies
Regulatory Agencies
? Red Meat
? > 3% raw ? > 2% cooked
? Poultry ? Egg products
Regulatory Agencies
? Seafood Quality Grading (Grade A)
? HACCP Quality Management Program
? Fee Based
Regulatory Agencies
? Water (drinking and waste)
? Pesticides
? Antimicrobial ? Insects
Regulatory Agencies
? Additives ? Pesticides ? All foods not inspected
by USDA ? Animal drugs ? Nutritional labeling ? Ingredients labeling
Avenues of Compliance
? Governmental Acts ? Promulgated Regulations ? Policies ? Guidance documents
FD&C
Direct/Indirect Additives Labels, Standards of Identity
Dairy/PMO LACF
Juice Seafood
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