Q369 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
The destruction of expired or non-conforming medicines must be strictly controlled and documented to prevent them from re-entering the market. The correct procedure is as follows: 1. Segregation and records: First, remove the medicines awaiting destruction from normal inventory and place them in a secure area clearly labelled ‘Non-conforming Goods’ or ‘Awaiting Destruction’. At the same time, prepare a detailed destruction list stating the name, batch number, quantity and reason for destruction of each medicine. 2. Select a destruction method: The method must ensure that the medicines cannot be reused. Common methods include incineration, chemical decomposition or solidification in cement. Medicines must never be disposed of directly in ordinary rubbish bins or drains. 3. Engage a qualified company: Destruction should be carried out by a specialist waste-treatment company holding the relevant licence. 4. On-site supervision: During destruction, the licence holder should send a staff member to supervise on site and ensure that all medicines are completely destroyed in accordance with the agreement. 5. Keep records: After destruction, obtain a Certificate of Destruction from the waste-treatment company and archive it together with all other documents, including internal destruction records and supervision records, for at least two years.