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GUIDANCE DOCUMENT

CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals October 2017

Final
Docket Number:
FDA-2016-D-1229
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance is intended for domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug and Cosmetic Act (the FD&C Act) because they manufacture, process, pack, or hold animal food for consumption in the U.S. This guidance contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food established in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015 (80 FR 56170) (the final rule). This guidance also provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping. The CGMP requirements are codified in 21 CFR part 507, subpart B (subpart B), and some related requirements are codified in 21 CFR part 507, subparts A and F (subparts A and F).
 


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1229.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
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Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002