How should returned or recalled medicines be segregated and managed on the premises?

Managing returned or recalled medicines is a key closed-loop control in the pharmaceutical quality control system and must be strictly implemented. First, a physically segregated area must be established in the warehouse specifically for returned/recalled medicines, with clear and prominent signage such as “Returned/Recalled Products Area - Not for Use”. All medicines returned by customers or recalled under instructions from the manufacturer or Department of Health must be moved to this area immediately upon receipt and must not be mixed with released stock. Second, detailed records must be kept for each batch of returned/recalled medicines, including the medicine name, batch number, quantity, reason for return/recall, source and date received. These medicines should be treated as “non-conforming goods” and must remain segregated until the quality control department makes a final disposition decision (for example, destruction or return to the supplier).