cGMP Certification for Dietary Supplements: 21 CFR Part 111 Audits

cGMP certification for dietary supplements is an independent, third-party audit showing that a facility manufactures, packages, labels or holds supplements in compliance with 21 CFR Part 111, FDA's current Good Manufacturing Practice rule for dietary supplements. The audit covers Subparts B through P: personnel, plant and equipment, production and quality control, specifications and identity testing, master manufacturing and batch production records, laboratory operations, packaging and labeling, holding, returns, complaints and records.

No. Compliance with 21 CFR Part 111 is required for anyone who manufactures, packages, labels or holds dietary supplements for the U.S. market, and FDA inspects against it, but no law requires a third-party certificate. Certification is voluntary and is usually requested by retailers and brand-owner customers as independent evidence of compliance. Some sales channels, such as Amazon, set their own certification requirements.

Every business that manufactures, packages, labels or holds a dietary supplement, including supplements imported or offered for import into the United States. That covers manufacturers, contract manufacturers, packagers and labelers, and warehouses. Retail stores are exempt from the holding requirements when they hold supplements only for direct sale to consumers. Brand owners that sell product made by a contract manufacturer under their own name are covered too: FDA inspects them against Part 111 and says they must know what manufacturing is done and how.

Part 117 sets cGMP and preventive controls requirements for human food. Part 111 is specific to dietary supplements and adds requirements food cGMPs don't have: quality control personnel who approve or reject every batch, an identity test for every dietary ingredient, written specifications for identity, purity, strength and composition, a master manufacturing record for each formulation and batch size, a batch production record for every batch, and reserve samples. A facility's supplement operations that comply with Part 111 and the serious adverse event reporting law are exempt from Part 117's hazard analysis, preventive controls and supply-chain program requirements (Subparts C and G), but FDA says Part 117's Subpart B cGMPs still apply where they don't conflict with Part 111.

Usually not. A company that makes a dietary ingredient for other manufacturers to process further is covered by 21 CFR Part 117, not Part 111. Part 111 does apply if you sell the ingredient to consumers as a supplement, or sell it in bulk to a company that only packages or labels it. Ingredient makers typically choose a food cGMP audit such as cGMP Food Processing or a GFSI certification, and their supplement customers must still test the identity of every dietary ingredient they receive.

The auditor reviews your written procedures and records, inspects the plant, laboratory, equipment and storage areas, interviews staff and traces a batch from component receipt through quality control release and distribution. The audit follows Part 111 Subparts B through P, so specifications, identity testing, master manufacturing records, batch production records, laboratory methods, label control, complaint handling and record retention are all reviewed.

A master manufacturing record (MMR) is the written recipe and instructions for a supplement. Part 111 requires one for each unique formulation and each batch size you manufacture. It lists every component and its amount, each dietary ingredient declared on the label, any intentional overage, theoretical and expected yields, a description of the packaging with a representative label, step-by-step instructions with specifications and control points, and corrective action plans for when a specification isn't met.

A batch production record (BPR) documents how one batch was actually made. You prepare one every time you make a batch, following the master manufacturing record. It records the batch number, equipment used, component lot identifiers and amounts, yields, monitoring and test results, and each step as it's performed, and it shows quality control's review and its approval or rejection of the batch for distribution.

Yes. Before using a dietary ingredient, you must run at least one appropriate test or examination to verify its identity, unless FDA has granted an exemption in response to a petition. For other components, you can test them or rely on a supplier's certificate of analysis, but only after you've qualified the supplier by confirming its test results, and you must re-confirm those results periodically.

Keep Part 111 records for 1 year past the shelf-life date, if you use shelf-life dating, or for 2 years beyond the date you distributed the last batch associated with those records. Records must be available for FDA to inspect and copy, as originals or true copies, and electronic records must meet 21 CFR Part 11.

Reserve samples are retained portions of each lot of packaged and labeled supplement you distribute. Hold them in the same container-closure system as the product, identified with the batch or lot number, in at least twice the quantity needed for all required tests. Keep them for 1 year past the shelf-life date, if you use shelf-life dating, or 2 years from distribution of the last batch associated with the sample.

No. Part 111 doesn't require expiration dates or stability testing. If you put an expiration or "best if used by" date on a label, FDA says it should be supported by data. Shelf-life dates matter in Part 111 only for retention: when you use them, records and reserve samples are kept for 1 year past that date.

Missing specifications. In FDA's fiscal year 2025 inspection data, 21 CFR 111.70 (specifications) drew 446 of the 1,938 Part 111 citations on system-generated Form 483s, the most of any section for the third year in a row. Next came §111.75 (identity testing, supplier certificates of analysis and finished batch verification) with 265, then gaps in master manufacturing and batch production records, with 351 citations between them. Most written-procedure citations were for procedures that hadn't been established at all. See the full list.

It depends on your facility size, number of employees, products and processes, and which operations are in scope: manufacturing, packaging, labeling or holding. Kiwa ASI confirms the audit length when it quotes, and plans the on-site days around your production schedule.

Supplements not made, packed or held under Part 111 are adulterated under the Federal Food, Drug, and Cosmetic Act. After an inspection, FDA lists its observations on a Form 483 and expects a written response within 15 business days. If the response isn't adequate, FDA can issue warning letters and use detention, registration suspension, mandatory recall, seizure or injunction, and imported supplements can be refused entry.

Yes. The major food allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act apply to dietary supplements. Declare any of the nine major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame (added January 1, 2023). FDA guidance lets supplements declare them in the Supplement Facts panel, the ingredient list or a "Contains" statement.

No. Kiwa ASI's dietary supplement cGMP audit is a third-party audit against FDA's regulation. It isn't GFSI-benchmarked or accredited. If a customer requires accredited or GFSI-recognized certification, ASI Food Safety, LLC is ANAB-accredited to ISO/IEC 17065 for the SQF Food Safety Code: Dietary Supplement Manufacturing (Edition 9). See SQF certification for dietary supplements.

It depends on the certificate. As of September 2026, Amazon's U.S. dietary supplement policy requires products from facilities that comply with 21 CFR Part 111 or 117, shown by a current cGMP audit or certification from an accredited third party, and one of Amazon's authorized testing, inspection and certification (TIC) providers must validate your documents. Kiwa ASI isn't an Amazon-authorized TIC provider, and its Part 111 audit isn't accredited. Amazon does name SQF food safety codes edition 9 among the programs it accepts, and ASI Food Safety, LLC is ANAB-accredited for the SQF Dietary Supplement Manufacturing code (Edition 9). Before you choose an audit, confirm with your TIC provider which certificates it will accept, and check the current policy in Seller Central.

Carefully. FDA allows truthful, non-misleading label statements, but in the 2007 Part 111 final rule it said an unqualified claim such as "produced in compliance with dietary supplement current good manufacturing practice requirements" could suggest a product is safer or better than others made under the same rules, and would likely be considered misleading. Explaining that all dietary supplements must be made under CGMP, and that compliance doesn't mean a product is safe or effective, may cure it. Review label claims with your regulatory advisor.

Yes. Facilities that manufacture, process, pack or hold dietary supplements or dietary ingredients for consumption in the United States must register with FDA as food facilities before they start operating, and renew their registration between October 1 and December 31 of every even-numbered year.

Cost depends mainly on audit time, which Kiwa ASI quotes from your facility size, employees, products, processes and scope. Budget as well for any training and facility improvements. Call 1 (800) 477-0778 or request a quote for your site.