Yield Reconciliation
yield rec · mass balance
The signed batch-close calculation comparing theoretical yield vs actual yield. Variance outside limits triggers an investigation under 21 CFR 211.103 / 111.310.
Yield reconciliation is the mathematical close-out of a batch: theoretical yield (from BOM × release size), actual yield (measured at packout), and accounted-for losses (samples, in-process testing, retained, waste). Variance outside pre-set limits is a deviation that must be investigated before the batch is released — explicitly required by 21 CFR 211.103 (pharma) and 211.192 / 111.310 (supplements).
V5 calculates yield reconciliation live as packout progresses, blocks batch close if variance is out-of-limit, and records the investigation directly in the batch record.
- 21 CFR 211.103
- 21 CFR 211.192
- 21 CFR 111.310
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