What final disposition procedure should be followed for non-conforming medicines that need to be destroyed (Final Disposition)?

Destroying non-conforming medicines is the final step in quality management and requires equally strict controls and records to ensure that the medicines do not accidentally re-enter the market. The disposal procedure should include: 1. **Formal decision**: The decision to destroy must be made by an authorised person in the Quality Department (such as the RP), who must sign a written destruction instruction. 2. **Segregation and records**: Medicines awaiting destruction should be kept in a secure, dedicated area clearly labelled ‘Awaiting Destruction’. Before destruction, check and record the name, batch number and quantity of the medicines one final time. 3. **Select a qualified destruction service provider**: Medicines must not be disposed of like ordinary rubbish. A specialist company qualified and authorised by the government to handle pharmaceutical waste must be engaged. You should verify its qualifications. 4. **Secure transport**: Transport the medicines awaiting destruction securely to the service provider’s premises and keep a record of the transport. 5. **Witnessing and certification**: If possible, send a staff member to witness the destruction on site. Whether or not it is witnessed, you must obtain a formal Certificate of Destruction from the service provider. This document is key legal evidence that the medicines have been disposed of lawfully. 6. **Update inventory**: Once destruction is confirmed, reduce the quantity of the medicines to zero in your inventory management system and archive all relevant records.