21 CFR 111.75(a)(1)(i) requires at least one appropriate test or examination to verify the identity of any dietary ingredient used as a component, before use. Supplier CoA alone is not sufficient unless the supplier is qualified under 111.75(a)(2) and the qualification is periodically re-verified. The recurring 483 is releasing botanical or vitamin lots on CoA without an in-house identity check — and is the single most cited supplement-cGMP observation.

Regulatory anchors

21 CFR 111.75

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.