Returned Goods Must Be Quarantined with Proper Labels
Remember: Always isolate and clearly label returned goods—this prevents mix-ups and ensures GMP-compliant disposition decisions.
Why This Matters in GMP
Returned pharmaceutical goods—whether from customers, distributors, or hospitals—pose potential risks due to unknown storage conditions, damage, or expired status. Placing them back into regular inventory without proper quarantine can lead to mix-ups or unintentional reissue. GMP guidelines require returned goods to be immediately segregated and quarantined with clear identification labels stating “Returned,” “Do Not Use,” or “Under Investigation.” These labels ensure all personnel are aware of their status and prevent accidental usage. Proper quarantine maintains inventory integrity and allows QA to evaluate whether goods should be reprocessed, destroyed, or returned to stock.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.204 requires procedures for evaluating returned drug products. EU GMP Chapter 5 mandates documented handling and quarantine of returned goods. WHO GMP and Schedule M specify that returned goods be stored separately with restricted access and labeling. Regulatory bodies inspect returned goods records, warehouse segregation, and decision logs. Improper handling can result in severe penalties, including observations for risk of product diversion or unauthorized release. Quarantine is a critical part of product lifecycle control under GMP.
Implementation Best Practices
- Use designated quarantine zones physically separated from released stock.
- Apply prominent red or yellow labels indicating product status—“Returned,” “Quarantined,” or “Hold.”
- Record details such as product name, batch number, return reason, and date of receipt on the label.
- Restrict access to returned goods to QA-authorized personnel only.
- Establish SOPs for investigation, evaluation, and disposition of returned goods with QA review and approval.
Regulatory References
- FDA 21 CFR Part 211.204 – Returned Drug Products
- EU GMP Chapter 5 – Production and Control
- WHO GMP – Handling of Returned Products
- Schedule M – Material Quarantine and Labeling Requirements