(2003; 148 pages)
7. Production and distribution records
7.1 The processing records of regular production batches must provide a complete account of the manufacturing history of each batch of a radiopharmaceutical, showing that it has been manufactured, tested, dispensed into containers and distributed in accordance with the written procedures.
7.2 Separate records for the receipt, storage, use and disposal of radioactive materials should be maintained in accordance with radiation protection regulations.
7.3 Distribution records should be kept. Since the return of radioactive products is not practical, the purpose of recall procedures for such products is to prevent their use rather than an actual return. If necessary, the return of radioactive products should be carried out in accordance with international and national transport regulations.