Rejected, recovered and returned materials
Article 31
1. Rejected materials shall be clearly marked as such and stored separately in restricted areas. They shall either be returned to the suppliers or, where appropriate, reprocessed or destroyed. Whatever action is taken, it shall be approved and recorded by authorised personnel. 2. The reprocessing of rejected materials can only be accepted exceptionally and provided that the quality of the final product is not affected and that the specifications set out in the marketing authorisation are met. The recovery of materials conforming to the required specifications from a distinct batch is only possible after an evaluation of the risks, including any possible effect on the shelf-life. Records shall be kept. 3. The need for additional testing of any finished product which has been reprocessed, or into which a reprocessed material has been incorporated, shall be evaluated by the quality control department. 4. Returned products, which have left the control of the manufacturer, shall be destroyed, unless their quality is confirmed by the quality control department. The nature of the product, its condition and history, any special storage conditions, and the time elapsed since it was issued shall be taken into account in that assessment. Where any doubt arises over the quality of the product, it shall not be considered suitable for re-issue or re-use. Any action taken shall be recorded.