In GMP, quarantine is the status of starting or packaging materials, intermediates, bulk or finished products that are isolated — physically, or by other effective means such as a validated computerised system — while they wait for a decision on their release or rejection. A received raw material lot is in quarantine until it has been sampled, tested and released; a finished batch is in quarantine until it has been released.
Physical quarantine uses separate, labelled areas. System quarantine relies on status controls in a warehouse or ERP system that prevent quarantined stock from being reserved, issued or shipped. Either way, the status must be unambiguous and changed only by authorised people.
Why it matters in GMP
21 CFR 211.82(b) requires components, containers and closures to be stored under quarantine until they have been tested or examined and released, and EU GMP Chapter 5 sets equivalent expectations. Using quarantined material by mistake is a serious error, because untested material may enter a batch that is then distributed.
- Receive every lot into quarantine automatically.
- Prevent the system from issuing or shipping anything that is not released.
- Allow status changes only through defined, authorised transitions.
How Swat iQua Suite handles it
In Swat iQua Suite, material enters only through a posted goods receipt against an approved purchase order line and lands as a quarantine lot. A 12-state lot status refuses illegal jumps, and only unrestricted stock — released by QA after a conforming CoA, an identity result and approved QC tests — can be reserved or dispensed. Finished-goods lots are created in quarantine and move to released only through the e-signed batch release decision; shipments refuse any lot that is not released.