Vitamin overage is the deliberate excess of a labile nutrient (Vit A, B1, B12, folate, D3) added at compounding so that after process loss and end-of-shelf-life decay the analytical value still meets the Supplement Facts label claim under 21 CFR 101.9(g) (within +20% reasonable excess). The overage is set per nutrient from stability degradation data, not guessed, and the master manufacturing record (MMR) carries both the label claim and the as-compounded target with the supporting decay curve.

Regulatory anchors

21 CFR 101.9(g)
21 CFR 111.70

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.

Vitamin overage (label-claim overage)

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Vitamin overage (label-claim overage)

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