Good Manufacturing Practices (GMP)
FDA regulations establishing minimum sanitary and processing requirements for food manufacturing facilities.
What It Means
Good Manufacturing Practices (GMPs), formally known as Current Good Manufacturing Practice (cGMP) regulations, are the baseline sanitary and processing requirements established by the FDA for the manufacturing, packing, and holding of food products. Codified in Title 21 of the Code of Federal Regulations (Part 110 and Part 117), GMPs cover a wide range of practices that food facilities must follow to ensure food safety. Key areas addressed by GMPs include personnel hygiene (handwashing, protective clothing, illness reporting), building and facility design and maintenance (adequate lighting, ventilation, pest control, proper drainage), equipment design and maintenance (food-contact surfaces that are cleanable, corrosion-resistant, and non-toxic), production and process controls (preventing contamination, maintaining proper temperatures, protecting against adulteration), warehousing and distribution (proper storage conditions, protection from contamination), and defect action levels (allowable levels of natural or unavoidable defects). Compliance with GMPs is a legal requirement for all food facilities registered with the FDA. Failure to comply with GMP regulations can result in FDA warning letters, product seizures, injunctions, and recalls. During FDA inspections, investigators assess GMP compliance and may issue observations (Form 483) for any violations found. Under FSMA, GMP requirements have been updated and incorporated into the Preventive Controls for Human Food rule.
Related Terms
HACCP (Hazard Analysis and Critical Control Points)
A systematic approach to food safety that identifies, evaluates, and controls hazards throughout the production process.
FSMA (Food Safety Modernization Act)
The landmark 2011 law that shifted FDA food regulation from reacting to contamination to preventing it.
Food Safety Plan
A written document required by FSMA that details a facility's hazard analysis, preventive controls, and monitoring procedures.
FDA Warning Letter
An official communication from the FDA notifying a company of significant regulatory violations found during inspection.
Frequently Asked Questions
What does Good Manufacturing Practices (GMP) mean?
FDA regulations establishing minimum sanitary and processing requirements for food manufacturing facilities.
Why is Good Manufacturing Practices (GMP) important for food safety?
Good Manufacturing Practices (GMPs), formally known as Current Good Manufacturing Practice (cGMP) regulations, are the baseline sanitary and processing requirements established by the FDA for the manufacturing, packing, and holding of food products. Codified in Title 21 of the Code of Federal Regula...