Reconciliation is the comparison of the theoretical and actual quantities of a material or component used in a batch, with any difference accounted for. It applies to yields of manufactured product and, most critically, to printed packaging components — labels, cartons and leaflets — where a missing or extra label could end up on the wrong product.
For printed components the calculation is simple: the quantity issued, minus the quantity used, minus the quantity returned to stock, minus the quantity destroyed, should equal zero. Any unaccounted quantity outside the defined limits must be investigated before the batch is released.
Why it matters in GMP
Labelling mix-ups are a leading cause of product recalls. 21 CFR 211.125 requires labelling materials issued for a batch to be examined and reconciled, with discrepancies investigated, and EU GMP Chapter 5 requires significant or unusual discrepancies in packaging reconciliation to be investigated and satisfactorily explained before release.
- Record issued, used, returned and destroyed quantities for each component.
- Block packaging completion until the reconciliation balances or is approved by QA.
- Make the reconciliation part of the batch release checklist.
How Swat iQua Suite handles it
Swat iQua Suite reconciles printed components for each packaging order as issued − used − returned − destroyed = unaccounted, classified as balanced or discrepancy. A discrepancy blocks completion until it balances or QA approves it with an e-signature, and “packaging reconciled” is an item on the batch release checklist. Dispensed weights are also reconciled against their minimum and maximum windows, and batch yield is classified against the formula’s yield range.