ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 14.5: Quarantine returned intermediates and APIs, reprocess, rework or destroy them where storage or container condition casts doubt, and record each return

What does 14.5 require?

Any returned API or intermediate should be identified as a return and quarantined. Where the storage or shipping conditions before or during return, or the container condition, cast doubt on quality, the material should be reprocessed, reworked or destroyed, whichever fits. Records of returns should be kept, giving the consignee's name and address, the product, batch number and quantity returned, the reason and the use or disposal of the material.