cGMP means current good manufacturing practice: the Current Good Manufacturing Practice regulations enforced by the FDA. Human food cGMP is 21 CFR Part 117, subpart B. A dietary supplement manufacturer must comply with that subpart and with 21 CFR Part 111, and Part 111 applies where they conflict. 21 CFR Parts 210 and 211 are drug cGMP, for context only.

What the "c" means

FDA's facts page on CGMP states: "CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA." On that page, which discusses drug CGMP, FDA states: Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.

The food, supplement, and drug rules use that word in their titles. Part 111 is "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements." Part 117 is "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." Part 210 is "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General." Part 211 is "Current Good Manufacturing Practice for Finished Pharmaceuticals."

Which rule applies

Dietary supplements. 21 CFR 111.1 states that, except as provided in paragraph (b), you are subject to Part 111 if you manufacture, package, label, or hold a dietary supplement. That includes a dietary supplement you manufacture but that is packaged or labeled by another person, and a dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. Paragraph (b) says the holding requirements do not apply when you hold dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer, or a warehouse or other storage facility that sells directly to individual consumers.

Human food. Subpart B of Part 117 is titled "Current Good Manufacturing Practice." Its sections are Personnel (§ 117.10), Plant and grounds (§ 117.20), Sanitary operations (§ 117.35), Sanitary facilities and controls (§ 117.37), Equipment and utensils (§ 117.40), Processes and controls (§ 117.80), Warehousing and distribution (§ 117.93), Holding and distribution of human food by-products for use as animal food (§ 117.95), and Defect action levels (§ 117.110).

Section 117.1(a) states that the criteria and definitions in Part 117 apply in determining whether a food is adulterated within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the food has been manufactured under such conditions that it is unfit for food) or section 402(a)(4) (prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health), and in violation of section 361 of the Public Health Service Act.

Dietary supplements: Part 111 and Part 117, subpart B. In its FSMA frequently asked questions, FDA answers DS.4 this way: "A dietary supplement manufacturer would be required to comply with the CGMP regulations in 21 CFR part 117, subpart B in addition to the regulations in 21 CFR part 111, unless the regulations conflict. To the extent regulations conflict, the manufacturer would comply with the regulation in part 111." FDA points that answer to Response 197 of the preventive controls final rule, 80 Fed. Reg. 55908 at 55978.

Section 117.5(e) states that subparts C and G do not apply to any facility with regard to the manufacturing, processing, packaging, or holding of a dietary supplement that is in compliance with Part 111 and section 761 of the Federal Food, Drug, and Cosmetic Act (serious adverse event reporting for dietary supplements). In FSMA FAQ DS.3, FDA states that this exemption does not apply to the manufacturing, processing, packing, or holding of dietary ingredients. Dietary ingredients are subject to Part 117, including subpart B, subpart C, subpart G, and subpart F (records).

Section 117.1(c) states: "Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations."

Drugs, for context only. 21 CFR 210.1(a) states that the regulations in Part 210 and in parts 211, 213, 225, and 226 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. 21 CFR 211.1(a) states that Part 211 contains the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs and medical gases as defined in § 213.3(b)(12)) for administration to humans or animals. Those are drug rules. They are not the cGMP rules for a human food or a dietary supplement.

This note is not a product-specific determination. Ask which rule covers the SKU before you treat a plant's program as the right one.

What cGMP covers

Part 111 states the topics in its subpart titles. Subpart B is Personnel. Subpart C is Physical Plant and Grounds. Subpart D is Equipment and Utensils. Subpart E is Requirement to Establish a Production and Process Control System. Subpart P is Records and Recordkeeping. The part also has subparts for quality control, components, packaging, and labels, the master manufacturing record, the batch production record, laboratory operations, manufacturing operations, packaging and labeling operations, holding and distributing, returned dietary supplements, and product complaints.

Section 111.55 states: "You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record." Section 111.3 defines quality as meaning "that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act."

Section 111.12 states that you must have qualified employees who manufacture, package, label, or hold dietary supplements, and that you must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations. Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions.

Section 111.605 states that you must keep written records required by Part 111 for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records. Section 111.610 states that you must have all records required under Part 111, or copies, readily available during the retention period for inspection and copying by FDA when requested.

For human food, subpart B is the current good manufacturing practice subpart, and the section titles above are what it covers. Section 117.10 states that the management of the establishment must take reasonable measures and precautions to ensure disease control and cleanliness. Section 117.40(a)(1) states that all plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination. Section 117.80(a)(1) states that all operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspecting, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.

Recordkeeping for Part 117 is not a section of subpart B. Section 117.4(d) requires records that document the training in § 117.4(b)(2). Section 117.9 states that those records are subject to subpart F. Subpart F is titled "Requirements Applying to Records That Must Be Established and Maintained."

What to ask a co-manufacturer

NXTCPG's Source & produce work includes co-manufacturer selection, with ingredient sourcing and quality and scale readiness. The commercial questions — whether the plant manufactures, packs only, or supplies the formula, and what a pilot must show — are in how to choose a co-packer. cGMP is the regulatory layer under that choice.

Which operations, and which rule. Ask the plant to name the activities it will perform. Under § 111.1, Part 111 applies to a person who manufactures, packages, labels, or holds a dietary supplement, with the retail-holding exception in § 111.1(b). Under Part 117, ask whether the facility manufactures, processes, packs, or holds the food. Ask whether the plant is relying on an exemption in § 117.5, including § 117.5(e) for a dietary supplement in compliance with Part 111 and section 761. For a dietary ingredient, use FDA's DS.3 answer: the Part 111 exemption from subparts C and G does not apply.

A dietary supplement you release under your label. FDA's Small Entity Compliance Guide on the dietary supplement CGMP rule gives this example: "A distributor who contracts with a manufacturer to manufacture a dietary supplement, which the distributor then distributes under its own label, has an obligation to know what and how manufacturing activities are performed so that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution." The guide states that contractors who provide a particular service to a firm subject to the rule must comply with those regulations directly applicable to the operations they perform (72 FR 34752 at 34790). It also states that it is not practical to list all possible contractual relationships. The example is not a ruling on your contract.

Specifications and quality control, for a dietary supplement. Section 111.70(a) requires a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Section 111.70(b) requires component specifications for each component you use in the manufacture of a dietary supplement, and § 111.70(b)(1) requires an identity specification. Section 111.73 states: "You must determine whether the specifications you establish under § 111.70 are met." Ask who establishes those specifications, who determines whether they are met, and who is identified under § 111.12 as responsible for quality control operations.

Procedures and records. Section 111.8 states that you must establish and follow written procedures for fulfilling the requirements of the personnel subpart. Other Part 111 subparts have their own written-procedure sections. Ask which procedures cover this SKU. Section 111.610 requires the records to be readily available to FDA. It does not say the brand receives a copy. Whether you may review them is a term of the agreement.

Registration is not approval. 21 CFR 1.242 states: "Assignment of a registration number to a facility means that the facility is registered with FDA. Assignment of a registration number does not in any way convey FDA's approval or endorsement of a facility or its products." FDA's consumer update on approval states that the agency does not approve manufacturing facilities independently. It inspects regulated facilities to verify they comply with applicable current good manufacturing practices and other requirements. Ask to see how the plant meets the rule that covers your product.

Human food. Section 117.3 defines "you," for purposes of Part 117, as the owner, operator, or agent in charge of a facility. Section 117.10 assigns the personnel measures to the management of the establishment. Ask who that is at the plant that will manufacture, process, pack, or hold the food.

Where this sits with NXTCPG

Choosing the plant sits in Source & produce. If the open question is which co-manufacturer can run a food, dietary supplement, or active-nutrition product, and which cGMP rule applies to that product, start a project. For the rest of the plant decision — equipment, minimums, who buys the ingredients, and who owns the formula — use how to choose a co-packer.

FAQ

What does cGMP mean?

cGMP means current good manufacturing practice. FDA states that CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. On FDA's Facts About the Current Good Manufacturing Practice (CGMP) page, which discusses drug CGMP, FDA states that the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.

What is the difference between GMP and cGMP?

The regulations are titled current good manufacturing practice. 21 CFR Part 111, 21 CFR Part 117, 21 CFR Part 210, and 21 CFR Part 211 each use that phrase in the part title. FDA states that the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. That wording is on FDA's drug CGMP facts page.

Which cGMP rules apply to dietary supplements and to human food?

FDA states that a dietary supplement manufacturer would be required to comply with the CGMP regulations in 21 CFR Part 117, subpart B, in addition to 21 CFR Part 111, unless the regulations conflict, and that if they conflict the manufacturer would comply with Part 111. Human food current good manufacturing practice is 21 CFR Part 117, subpart B. Drug cGMP is addressed in 21 CFR Part 210 and Part 211, among the parts named in 21 CFR 210.1, and those are drug rules. This answer is not a product-specific determination.

Does FDA approve a facility as cGMP?

No. FDA states that it does not approve manufacturing facilities independently. It inspects regulated facilities to verify they comply with applicable current good manufacturing practices and other requirements. For a food facility, 21 CFR 1.242 states that assignment of a registration number means the facility is registered with FDA and does not in any way convey FDA's approval or endorsement of a facility or its products.

If a brand uses a co-manufacturer, who is responsible for dietary supplement cGMP?

FDA's Small Entity Compliance Guide states that a distributor who contracts with a manufacturer to manufacture a dietary supplement, which the distributor then distributes under its own label, has an obligation to know what and how manufacturing activities are performed so that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution. The guide also states that a contractor must comply with the regulations directly applicable to the operations the contractor performs. The guide says it is not practical to list every contractual relationship. This answer is not a determination for a particular agreement.