A product recall is the action taken to remove or correct distributed products that are defective or could be harmful — for example a contamination, a labelling error or a stability failure. A recall depends on traceability: being able to trace any lot forward to every customer who received it, and backward through packaging, manufacturing and dispensing to the raw-material lots that went into it.
A recall process typically covers the decision and its classification, identification of affected lots and customers, notification, collection and reconciliation of returned stock, an effectiveness check that enough of the affected product has been recovered, and closure with a report.
Why it matters in GMP
EU GMP Chapter 8 requires a recall procedure that can be put into operation promptly at any time, with its effectiveness regularly evaluated. In the United States, 21 CFR Part 7 describes recalls, which the FDA classifies as Class I, II or III depending on the health hazard. Slow or incomplete traceability is one of the biggest risks in a real recall.
- Record genealogy links at each step, not reconstruct them afterwards.
- Resolve affected lots and customers automatically.
- Measure recovery and close with documented evidence.
How Swat iQua Suite handles it
Swat iQua Suite traces any lot forward and backward in one view over links recorded as the work happens — material lots, dispensing, batch, intermediates or bulk, packaging, finished-goods lot, shipment and customer. Shipments refuse any lot that is not QA-released. A recall automatically resolves the affected lots and customers, then records the notification to each customer, returns, reconciliation with recovery percentage and an effectiveness check, and closes with an e-signature and a SHA-256 checksum evidence manifest.