Current Good Manufacturing Practices (cGMP)

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. The cGMPs in 21 CFR 507(B) provide a baseline safety and sanitation standards for the manufacturing, processing, packing, and holding of animal food. These cGMPs address general animal food safety and sanitation concerns and serve as a foundation for preventive controls. The preventive controls requirements in 21 CFR 507(C) relate to a facility's identification and evaluation of hazards in their animal food and measure to control hazards requiring preventive controls.

Establishments that are required to register as a food facility under 21 USC 350(d) because they manufacture, process, pack or hold animal food (includes animal food ingredients) for consumption in the U.S. are required to follow these cGMPs, unless they qualify for an exemption (21 CFR 507.5(a) and (h)).

Individuals who supervise or perform manufacturing, processing, packing, or holding activities for animal food must be qualified and receive training in the principles of animal food hygiene and animal food safety.

What can you expect during an inspection? Take a look at the following links:

• 21 CFR Part 507, Subpart B - Current Good Manufacturing Practice

• Preventive Controls for Animal Food Factsheet

• Sanitary Transportation of Human and Animal Food Factsheet

• Mitigation Strategies to Protect Food Against Intentional Adulteration Factsheet

• cGMP Checklist

General resources

• cGMP Requirements for Food for Animals

• Small Entity Compliance Guide

• DRAFT Human Food By-Products for Use as Animal Food

• Sanitation & Transportation Guidance Documents & Regulatory Information

• Preventive Controls of Animal Food