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 records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

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 scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Component identity confirmation (21 CFR 111.75)

Next step

Component identity confirmation (21 CFR 111.75)

Next step