21 CFR 111
21 CFR Part 111 is the FDA regulation setting current good manufacturing practice (cGMP) for dietary supplements.
It applies to anyone who manufactures, packages, labels, or holds a dietary supplement for sale in the United States, and it is built around one idea: every product must be made consistently according to a written master manufacturing record, with a batch record proving it was.
In writing, Part 111 demands a lot: written procedures for personnel hygiene, sanitation, equipment calibration and maintenance, quality control operations, receiving and testing components, manufacturing, packaging and labeling, holding and distribution, returned products, and complaints.
It requires a master manufacturing record for each formulation and batch size, a batch production record for every batch, specifications for components and finished products, and records showing the quality control unit reviewed and approved each step. The FDA inspects against these documents.
Who has to comply
Any domestic or foreign firm that manufactures, packages, labels, or holds dietary supplements for the US market, including contract manufacturers and own-label distributors who hold product. Retailers holding product only for direct sale to consumers are excluded. Small-firm phase-ins ended years ago; all sizes are covered.
What the assessor asks to see
Facility registration and organization chart; written procedures across all Part 111 subparts; master manufacturing records for each product and batch size; batch production records with quality control review and sign-off; component, in-process, and finished product specifications and test results; supplier qualification and certificate of analysis verification; equipment calibration, cleaning, and maintenance logs; personnel training and hygiene records; laboratory controls and out-of-specification investigations; product complaint files and adverse event records; returned and reprocessed product records; label and packaging control records; distribution records supporting recall.
Where the requirement sits: 111.14 personnel qualifications/training; 111.103, 111.123 etc. 'written procedures'; 111.605 records
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AllyMatter is a full system for every internal policy your company keeps, including the ones 21 CFR 111 turns on. Build the whole library in one place, across every department, and prove who has read what.
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ISO 9001 Quality Policy and Documented Information: who needs it, what goes in it, how often it is reviewed and who signs it off. Run exactly that in AllyMatter, alongside every other policy your company keeps.
How it works
Every document is approved by someone other than its author, versioned, distributed to the people it covers and acknowledged by name. Sign it where a signature is what the standard wants, send a set out together as a package, and export a dated record of who read which version when an assessor asks.
The written policies this standard turns on live here, with every version and every acknowledgment on the record.
Who helps with 21 CFR 111
A well-developed cGMP consultant ecosystem exists, often staffed by former FDA investigators and quality managers. Consultants run mock inspections, write the procedure set and master manufacturing records, set up specification programs and supplier qualification, train staff, and help respond to FDA Form 483 observations and warning letters.
Third-party cGMP certification programs (for example NSF/ANSI 455-2 or the UL or USP programs) are voluntary add-ons that retailers sometimes require.
Firms that name this framework in their own material. A listing is not a recommendation. Each firm can confirm its own.
Consultants
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Who assesses 21 CFR 111
FDA investigators (government inspection). Voluntary third-party cGMP audits and certifications exist but do not replace FDA inspection. (regulatory inspection).
Third-party certification bodies may be accredited to ISO/IEC 17065 by ANAB or similar for voluntary programs.
Assessors
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Tools for 21 CFR 111
Tools that name this framework in their own material.
Grouped by type. Inside each group the order is random, reshuffled each time the page loads. AllyMatter, the publisher of this site, is always first.
AllyMatterPolicy management tool, the policy and acknowledgment layerPublisher of this siteRelated reading
- Dietary supplement cGMPs: regulatory framework and historical contextThe trade body's account of how Part 111 came about and how its written-record obligations are read in practice.Natural Products Association
- Dietary supplements and FDA compliance: an update on GMPs and 483sTrade-press look at which Part 111 clauses actually generate Form 483 observations, so you can prioritize the written procedures.Nutritional Outlook
Independent third-party explainers, chosen by hand. Not affiliated with this site and not paid placements. All links are nofollow.
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From the publisher
Run the Policy Side of 21 CFR 111 in AllyMatter
Approve the policies 21 CFR 111 asks for, keep every version, and record a named acknowledgment from each person who has to read them.