Supplement contract manufacturing: who decides what

Section 111.1 covers anyone who manufactures, packages, labels or holds a dietary supplement, with a limited exception for holding at retail for direct sale to consumers. Map which operations each party performs; that shows which Part 111 duties each holds.

Under 21 CFR 111.105, quality control personnel approve or reject specifications, processes, procedures and deviations, and review supplier qualification. Under 111.127, quality control approves packaging and labeling records and approves or rejects packaged and labelled supplements for distribution.

FDA's 2016 guidance describes defining who does what, how changes are approved, how results and deviations are shared, and how disagreements are resolved. For supplements, add specifications, testing responsibility, label and artwork approval, complaints, records access and recall roles.

A practical sequence is: the manufacturer completes the batch record and tests; its quality control reviews; the party responsible for release records the decision; records are shared as agreed. Keep the evidence in a form both parties can inspect.

Write down who approves changes to formula, supplier, process or label, who receives complaints, and who leads a recall. Each party still keeps its own legal duties.