Rejection and returns
Article 15
1. Batches of active substances and active substance intermediates failing to conform to the specifications established in accordance with Article 12(1) shall be rejected, labelled as such and quarantined. 2. The manufacturer who reprocesses or reworks rejected batches of an active substance that do not conform to specifications, or recovers raw materials and solvents for re-use in the manufacturing process, shall follow the procedures established in accordance with Article 7(1) and shall perform appropriate controls to ensure that: (a) the reprocessed or reworked active substance meets the quality specifications established in accordance with Article 12(1); (b) the recovered raw materials and solvents are suitable for their intended use in the manufacturing process. 3. Returned active substances shall be identified as such and quarantined.