Supplement manufacturer audit checklist
A printable supplier qualification checklist based on 21 CFR Part 111. Use it to prepare a GMP audit and record questions for your supplement manufacturing partner. It is a starting point for product-specific review, not a complete regulatory audit or certification.
Source reviewed October 16, 2026. Manufacturer: ____________________ Reviewer / date: ____________________
Evidence to request from the manufacturer
Public records cannot answer these questions. Mark each item after reviewing the evidence. Blank means not assessed, not a failed audit. Notes entered here are not saved or included in a shared URL.
Request role-specific training records and the named quality contact.
21 CFR 111.12Request a site walkthrough, sanitation controls and equipment maintenance records (also §111.25).
21 CFR 111.20Request written identity, purity, strength, composition and contaminant specifications for your product.
21 CFR 111.70Ask how each dietary ingredient is identified and how suppliers and certificates of analysis are qualified.
21 CFR 111.75Request quality control procedures, release authority and handling of deviations and rejected batches.
21 CFR 111.105Request the approved product-specific master manufacturing record and change-control process.
21 CFR 111.205Review a completed batch record with traceability to components, processing and release.
21 CFR 111.255Request scientifically valid test methods, sampling plans and laboratory controls for your specifications.
21 CFR 111.315Request procedures that prevent label mix-ups and control packaging and label reconciliation.
21 CFR 111.403Ask how storage conditions protect identity, purity, strength and composition during holding and distribution.
21 CFR 111.453Request complaint review and investigation procedures; discuss returned-product controls under §111.503.
21 CFR 111.553Confirm retention and access to records supporting your batches.
21 CFR 111.605Open any manufacturer profile and choose “Due-diligence report” for a printable summary of its available public records. Compare its facility address and certified scope with the actual site in your quote.