CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals July 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2018-D-0388
• Issued by: Center for Veterinary Medicine

The purpose of this guidance is to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements.

Specifically, this document provides guidance on:

• the biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food
• the components of a food safety plan and the importance of each component
• how to conduct a hazard analysis and develop a food safety plan for the animal food that you produce
• identifying preventive controls for biological, chemical, and physical hazards associated with animal food and how to apply those preventive controls
• preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation))
• the recordkeeping requirements associated with the food safety plan and implementation of the food safety plan.

 

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Submit Comments

Submit Comments Online

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-2018-D-0388.

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