Dietary Supplement cGMP Quality System (21 CFR 111)
A complete, ready-to-implement quality management system for companies that manufacture, package, label, hold or distribute dietary supplements in the U.S. It is built to 21 CFR Part 111, the 21 CFR Part 101 labeling rules, FD&C Act section 761 serious adverse event reporting and ISO 9001:2026. It includes 112 editable Word documents.
21 CFR Part 111 asks a lot of a supplement company: written specifications for every component and finished product, an identity test on every lot of every dietary ingredient, a master manufacturing record for each formula, a complete batch record for each batch, a quality control unit that approves every release, and records that FDA can inspect. Specifications and identity testing are among the most frequently cited problems in FDA inspections of supplement firms.
This system gives you the procedures, forms and records to meet those requirements and run an operation that an FDA investigator, a retailer or an NSF/ANSI 455-2 auditor will recognize:
Quality Management System Manual (QMSM-DS): your quality policy, scope, organization and processes, with a cross-reference showing where each subpart of 21 CFR Part 111 and each related FD&C Act duty is addressed.
60 standard operating procedures: specifications, component identity testing and supplier qualification, master manufacturing record, batch production record, packaging and labeling operations, Supplement Facts and claims review, new dietary ingredients and product safety, food facility registration, contract manufacturer quality agreements, holding and distribution, serious adverse event reporting, reserve samples, quality control unit responsibilities, personnel hygiene, plant and pest control, cleaning and sanitation, calibration, the laboratory, out-of-specification results, complaints, recall, CAPA, internal audit, management review and more.
46 forms and records: specification sheet, identity test and CoA review, master manufacturing record, batch production record, label reconciliation, material review and disposition, adverse event intake and log, SAER submission checklist, label and claims review checklist, NDI determination record, quality agreement, Part 111 gap assessment checklist and others.
Four lists: a master document list mapped to 21 CFR 111, the FD&C Act and ISO 9001; external regulations and standards with full titles and editions; a brand owner responsibilities matrix; and an approved supplier list.
Who it is for
Dietary supplement manufacturers, packagers and labelers
Brand owners who also hold or distribute product
Contract manufacturers who need a documented Part 111 system for customers or for NSF/ANSI 455-2 certification
Companies preparing for an FDA inspection or responding to a 483
What you receive
An instant download of one organized zip file with a READ ME, the Quality Manual and organization chart, the lists, procedures sorted by section, and the forms. All documents are editable Microsoft Word files, plus one Excel workbook.
Good to know
The FDA regulations and guidance cited are free from FDA. ISO 9001, USP chapters and NSF/ANSI 455-2 are copyrighted; the procedures refer to them but do not reproduce their text.
Sell under your own label and use a contract manufacturer? See the Supplement Brand Owner Compliance Pack ($395).
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