Good Manufacturing Practice in the United States

In this guide, we identify Good Manufacturing Practice (GMP) requirements contained in several regulations and explain their provisions. The regulations covered in this guide affect products such as food contact materials, cosmetic products, and medical devices.

Note that this guide is not intended to cover all regulations that contain Good Manufacturing Practice (GMP) requirements. For example, it does not cover GMP requirements relating to pharmaceuticals, biological products, and food.

What is Good Manufacturing Practice (GMP)?

Good manufacturing practice aim at ensuring that products are consistently produced to meet a certain quality standard. Regulations may contain GMP provisions. These requirements may differ between regulations. For instance, 21 CFR Part 174 set requirements that are specific for indirect food additives used in food contact products:

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(1) The quantity of any food additive substance that may be added to food as a result of use in articles that contact food shall not exceed, where no limits are specified, that which results from use of the substance in an amount not more than reasonably required to accomplish the intended physical or technical effect in the food-contact article; shall not exceed any prescribed limitations; and shall not be intended to accomplish any physical or technical effect in the food itself, except as such may be permitted by regulations in parts 170 through 189 of this chapter.

(2) Any substance used as a component of articles that contact food shall be of a purity suitable for its intended use.

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Which US regulations cover GMP requirements?

Here we provide a table that contains regulations that mention GMP requirements. More information about the regulations and their requirements can be found in the sections below.

Regulation	Parts that mention GMP
21 CFR Part 174 – Indirect Food Additives: General	Part – 174.5 General provisions applicable to indirect food additives
21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings	Part 175.105 – Adhesives Part 175.300 – Resinous and polymeric coatings
21 CFR Part 177 – Indirect Food Additives: Polymers	Subpart B – Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces Subpart C – Substances for Use Only as Components of Articles Intended for Repeated Use
21 CFR Part 178 – Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers	Part 178.3297 – Colorants for polymers Part 178.3650 – Odorless light petroleum hydrocarbons
21 CFR Part 179 – Irradiation in the Production, Processing and Handling of Food	Part 179.25 – General provisions for food irradiation.
21 CFR Part 181- Prior-Sanctioned Food Ingredients	Part 181.22 – Certain substances employed in the manufacture of food-packaging materials
21 CFR Part 182 – Substances Generally Recognized as Safe	Part 182.1 – Substances that are generally recognized as safe Subpart B – Multiple Purpose GRAS Food Substances Subpart C – Anticaking Agents Subpart D – Chemical Preservatives Subpart G – Sequestrants Subpart H – Stabilizers Subpart I – Nutrients
21 CFR Part 186 – Indirect Food Substances Affirmed as Generally Recognized as Safe	Part 186.1 – Substances added indirectly to human food affirmed as generally recognized as safe (GRAS). Subpart B – Listing of Specific Substances Affirmed as GRAS
21 CFR Part 700 – General	Part 700.13 – Use of mercury compounds in cosmetics including use as skin bleaching agents in cosmetic preparations also regarded as drugs.
21 CFR Part 820 – Quality System Regulation	Part 820.1 – Scope.

21 CFR Part 174 – Indirect Food Additives: General

This regulation covers indirect food additives found in food contact articles. The part contains GMP requirements that also applies to 21 CFR Parts 175, 176, and 177.

The GMP requires that the amount of food additives:

a. When no limits are specified, do not exceed reasonable amounts necessary to achieve the desired physical or technical effect in the food contact product

b. Do not exceed prescribed substance limitations

c. Do not physically or technically affect the food, unless permitted by 21 CFR Parts 170 to 189

Additionally, the GMP requires that any substance used as a component of articles that contact food must be of a purity suitable for its intended use.

A lab testing company could be engaged to help comply with GPM requirements (for instance, to test the product and ensure that no food additives exceed prescribed substance limitations).

Other Good Manufacturing Practice requirements for food contact materials

In Title 21 of the Codes of Federal Regulation, several regulations contain GMP requirements for food contact products. Here we provide a table that contains the title of each regulation, its scope, and its GMP requirements.

Title	Scope	GMP requirements
21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings	Adhesives and components of coatings	The quantity of adhesive that contacts packaged dry food must not exceed the limits of GMP Finished coatings intended for repeated food-contact use must be cleansed before their first use in contact with food Finally, there are GMP requirements for adhesives that are intended to be in contact with packaged fatty and aqueous foods
21 CFR Part 177 – Indirect Food Additives: Polymers	Polymers used in food contact materials	Specified substances in articles intended for repeated use in contact with food must be thoroughly cleansed before contacting food for the first time Remove volatile substances used in the manufacture of high-temperature laminates Specifies substances that must be maintained in a sanitary manner Rubber articles intended for use with dry food must be formulated under conditions of GMP to be suitable for repeated use
21 CFR Part 178 – Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers	Adjuvants, production aids, and sanitizers	The use levels of colorants and odorless light petroleum hydrocarbons must not exceed those reasonably required to accomplish their intended effect
21 CFR Part 179 – Irradiation in the Production, Processing and Handling of Food	Packaging materials for irradiated foods and sources of radiation	GMP is defined to include restrictions contained in Part 179.25
21 CFR Part 181- Prior-Sanctioned Food Ingredients	Food packaging	The quantity of substances listed in Subpart B that become a component of food as a result of use in food-packaging materials must: a. Not be intended to accomplish any physical or technical effect in the food itself b. Be reduced to the least amount reasonably possible c. Not exceed any limit specified in Subpart B
21 CFR Part 182 – Substances Generally Recognized as Safe	Substances for use in food and found in food packaging	GMP is defined to include the restrictions contained in Part 182.1(b) Note: there are many substances listed in Subpart B that are generally recognized as safe when used according to GMP
21 CFR Part 186 – Indirect Food Substances Affirmed as Generally Recognized as Safe	Indirect ingredients in food and food contact materials	Ingredient must be of a purity suitable for its intended use Ingredients’ use level must be no higher than reasonably required to achieve its intended technical effect in the food-contact article There are specific GMP requirements for the substances mentioned in Subpart B

Further details concerning the GMP requirements above are found in the respective regulations.

21 CFR Part 700 – General (Cosmetic products)

21 CFR Part 700 covers cosmetic products. The purpose of this Regulation is to enforce the Federal Food, Drug and Cosmetic Act. It mentions GMP in the context of cosmetic products containing mercury. Under the part, mercury is regarded as adulterated unless:

a. It contains a trace amount of mercury which is unavoidable under conditions of GMP

b. The amount of mercury is less than 1 part per million

However, we were unable to find any regulation or part containing GMP requirements for cosmetic products. We only found that the FDA has published a guidance page entitled: “Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics” to assist the industry.

The guidance page contains guidelines for the following:

• Building and facilities
• Equipment
• Personnel
• Raw material
• Production
• Laboratory controls
• Records
• Labeling
• Complaints
• Other

21 CFR Part 820 – Quality System Regulation (Medical devices)

21 CFR Part 820 covers medical devices. GMP requirements are contained in the quality system described in the part which applies to finished medical devices intended for commercial distribution.

Under the part, each manufacturer must establish and maintain a quality system appropriate for the specific medical device designed or manufactured. The quality system should contain the following essential elements required in this part, including some of the following controls:

• Design controls
• Document controls
• Purchasing controls
• Production and process controls
• Labeling and packaging controls

However, the FDA recently published a final rule that amends the GMP requirements of the quality system in this part. From the effective date of the rule, February 2, 2026, this part will incorporate by reference the following standard: ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

Thus, the above-mentioned standards will have to be used to comply with the GMP requirements.