What are the specific record-keeping and management requirements for returned, rejected or recalled medicines?

Managing returned, rejected and recalled medicines is a key control point for preventing non-conforming goods from re-entering the market. You must establish strict procedures and a record system. First, all such medicines must be immediately segregated in a dedicated, secure, clearly identified physical area and must not be mixed with released goods. Second, every return, rejection or recall must be documented in detail, including the medicine name, batch number, quantity, source (customer), reason and date received. Third, the quality department must assess the medicines and decide on their final disposition. There are only three possible outcomes: a) if it can be confirmed that the medicine’s quality has not been affected (for example, it was simply sent in error and transport conditions were controlled throughout), it may be returned to stock with approval from the head of the quality department; b) if it needs to be destroyed, follow the destruction procedure; or c) if it has been recalled, handle it in accordance with the recall plan. All assessments, decisions and final disposition actions must be documented.