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GUIDANCE DOCUMENT

Guidance for Industry: Determination of Status as a Qualified Facility September 2018

Final
Docket Number:
FDA-2016-D-1164
Issued by:
Guidance Issuing Office
Office of Compliance
Office of Surveillance and Compliance

Determination of Status as a Qualified Facility under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

The FDA Food Safety Modernization Act (FSMA) establishes requirements for hazard analysis and risk-based preventive controls for facilities that produce food for humans and animals. We have issued two regulations to implement these requirements.

The first regulation is established in 21 CFR part 117 and is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (published in the Federal Register on September 17, 2015, 80 FR 55907). In the remainder of this guidance we refer to this regulation as “part 117.” Subparts A, B, and F of part 117 include current good manufacturing practice (CGMP) requirements for domestic and foreign facilities that manufacture, process, pack, or hold human food. Subparts A, C, D, E, F, and G of part 117 include requirements for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to conduct a hazard analysis and implement risk-based preventive controls for human food (the human food preventive controls requirements).

The second regulation is established in 21 CFR part 507 and is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (published in the Federal Register on September 17, 2015, 80 FR 56170). In the remainder of this guidance we refer to this regulation as “part 507.” For domestic and foreign facilities that are required to register under the FD&C Act, subparts A, B, and F of part 507 include CGMP requirements and subparts A, C, D, E, and F of part 507 include requirements to conduct a hazard analysis and implement risk-based preventive controls for animal food (the animal food preventive controls requirements).

A facility that meets the definition of a “qualified facility” in part 117 or part 507 is subject to CGMP requirements as well as the modified requirements described in 21 CFR 117.201 or in 21 CFR 507.7, respectively. These modified requirements include the requirement that the facility submit a form to FDA, attesting to its status as a qualified facility. Section II of this guidance explains how to determine whether your facility meets the definition of “qualified facility” under part 117 and how to submit Form FDA 3942a attesting to your status as a qualified facility that is subject to the modified requirements in 21 CFR 117.201. Section III of this guidance explains how to determine whether your facility meets the definition of “qualified facility” under part 507 and how to submit Form FDA 3942b attesting to your status as a qualified facility that is subject to the modified requirements in 21 CFR 507.7. The modified requirements also include a requirement that the facility attest to certain food safety practices. See 21 CFR 117.201(a)(2); 507.7(a)(2).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.  

Related Resources

Questions?

For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1700. For questions regarding this document as it relates to animal food, contact the Center for Veterinary Medicine (CVM) at 240-402-6246.


Submit Comments

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-1164.