Glossary
Reconciliation
Comparing, with due allowance for normal variation, the quantity that theoretically should have been produced or used against the quantity actually there; discrepancies, especially in labelling and bulk product, must be investigated.
Details
The EU GMP glossary defines reconciliation as a comparison, making allowance for normal variation, between the amount of product or materials theoretically produced or used and the amount actually produced or used. Chapter 5 §5.8 requires yield checks and quantity reconciliations to be carried out as necessary so that there are no discrepancies outside acceptable limits, and §5.61 requires the amounts of bulk product and printed packaging materials and the number of units produced to be reconciled during packaging, with any significant or unusual discrepancy investigated and satisfactorily accounted for before release; 21 CFR 211.125(c) requires the quantities of labelling issued, used, and returned to be reconciled and any discrepancy outside narrow limits based on historical operating data to be investigated under 211.192 (exempt where 100% labelling examination under 211.122(g)(2) is performed). If yield is the output ratio of a process, reconciliation is the counting exercise that asks where a missing label went, and a failed labelling reconciliation connects directly to the possibility that mislabelled product reached the market. Inspections cite labelling reconciliation not performed at all, discrepancies written off as waste without investigation, and reconciliation limits set wide with no justification.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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During the inspection, a reconciliation of samples that should have been taken during manufacturing…
FDA · FDA Warning Letter · 2024-04-09 -
In your 10/18/2024 response, you did not provide documentation for vial lot reconciliation, such as…
FDA · FDA Warning Letter · 2025-07-01 -
For example, you failed to ensure: Establishment of suitable quality oversight procedures (e.g., investigations, returns/complaints, CAPA, and label reconciliation)…
FDA · FDA Warning Letter · 2025-08-12
