USP <2091> weight variation, the supplement-specific complement to drug-product Uniformity of Dosage Units <905>, requires that the average weight of 10 dosage units fall within ±10% (single-component supplements) or ±15% (multi-component) of the labelled weight, with no individual unit outside double those limits. It is the routine in-process and release test for capsules, tablets and softgels in 21 CFR 111 plants.

Regulatory anchors

USP <2091>
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.

Weight variation USP <2091>

Next step

Weight variation USP <2091>

Next step