Establishing of quality assurance system in Karaj cyclotron

Introductions: In this article the efforts on establishment of QC and QA on produced radiopharmaceuticals at Agriculture, Medicine and Industry Research School is explained. Methods: From 1994, when the first radiopharmaceutical was produced, production of medical radioisotopes was gradually expanded, until now which is six radioisotopes contain; Tl-201, Ga-67, In-111, Kr-81m, F-18 and I-123 produce. In 1997 production of 18FDG was begun which enables to perform PET examination. Quality control tests on produced radiopharmaceuticals according to European Pharmacopeias have been performed by QC group. Due to increasing regulation and standards imposed by EP and USP, continuous upgrading of QC procedures and methods has been started. Mean time the department was received the ISO 9001-2000 RW-TüV certificate. Surveillance of the dispatched radiopharmaceuticals is organized by QA. Results and Conclusion: These efforts were programmed to establishment of some GMP criteria on radiopharmaceutical production, although all activities for receiving the GMP still continue. Clear definition of the responsibilities for different aspects of production, quality control and quality assurance has established. In this direction several activities by support of IAEA in the form of TC projects, experts' missions and training of staff have been performed. This efforts summarized on appropriate and adequate laboratories equipments, validation, consistency, accuracy and precision in QC tests, safety, strength, identity of productions, and building facilities, documentation and record of history .