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  4. Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements
  1. Guidance & Regulation (Food and Dietary Supplements)

Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements

Following Current Good Manufacturing Practices (CGMPs) help to ensure the safety of food.  CGMP regulations generally address matters including appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary operations, facility sanitation, and production and process controls during the production of food. 

In 1969, FDA established CGMPs in the Code of Federal Regulations (CFR) (21 CFR Part 110).  In September 2015, the agency modernized the CGMPs and established them in new Part 117 (21 CFR Part 117), along with new requirements for hazard analysis and risk-based preventive controls which where were issued as part of the implementation of the FDA Food Safety Modernization Act (FSMA).

In addition to the CGMPs in Part 117, FDA has issued CGMPs specific to certain types of food. 

CGMPs in CFR 21 Part 117

In 21 CFR Part 117, FDA established a CGMP regulation as part of the “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” rule.

Part 117 establishes requirements for CGMPs and for hazard analysis and risk-based preventive controls for human food (PCHF) and related requirements.

Generally, domestic and foreign food facilities that are required to register with FDA by Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must comply with the requirements for risk-based preventive controls in Part 117 (unless an exemption applies). The modernized CGMPs generally apply to establishments that manufacture, process, pack, or hold food and apply to some activities that are exempt from the preventive controls requirements, such as juice and seafood processing.

Additional CGMPs for Certain Types of Food

Dietary Supplements - 21 CFR Part 111
For additional information, see Current Good Manufacturing Practices (CGMPs) for Dietary Supplements.

Infant Formula - 21 CFR Part 106
For additional information, see Infant Formula Guidance Documents & Regulatory Information.

Low-acid Canned Foods - 21 CFR Part 113
Acidified Foods - 21 CFR Part 114
For additional information, see Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information.

Bottled Water - 21 CFR Part 129
For additional information, see Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Information.


Historical Background

In 2004, FDA initiated an effort to modernize its CGMP regulations (21 CFR Part 110). The agency hosted three public meetings to solicit comments, data, and scientific information about the current state of quality management techniques, quality systems approaches, and voluntary industry standards concerning CGMPs as well as other controls used by food manufacturers and processors to prevent, reduce, control, or eliminate foodborne hazards that may occur during food production, processing, or storage.