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Compliance

Supplier qualification audit (supplements)

In short

Supplier qualification under 21 CFR 111.75(a)(2) and NSF/ANSI 455-2 requires an initial on-site or documented audit, a quality agreement, a risk classification (Tier 1 active/botanical, Tier 2 functional excipient, Tier 3 commodity), and a re-qualification cycle (typically Tie...

Supplier qualification under 21 CFR 111.75(a)(2) and NSF/ANSI 455-2 requires an initial on-site or documented audit, a quality agreement, a risk classification (Tier 1 active/botanical, Tier 2 functional excipient, Tier 3 commodity), and a re-qualification cycle (typically Tier 1 every 2 years, Tier 2 every 3 years, Tier 3 paper requalification annually). Skipping the on-site for a Tier 1 active is the audit gap behind most supplier-driven recalls.

Regulatory anchors
  • 21 CFR 111.75(a)(2)
  • NSF/ANSI 455-2
Where this term comes up
Contract manufacturing
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.
Supplier portal — chase nothing. Score everything.
Suppliers log in, see what you need, submit it against your spec, and watch their scorecard. SCARs are raised, replied to and closed in the portal — not in your inbox.
Related terms
Supplier CoA verification programmeComponent identity confirmation (21 CFR 111.75)
Software that covers Supplier qualification audit (supplements)
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