Establishment of Quality Manager System on Quality Control of Radiopharmaceuticals

摘要

Objectives: This paper will refer to establishment of quality manager system and quality assurance in quality control of radiopharmaceuticals regarding to Good Manufacturing Practice (GMP) requirements on quality control of Radiopharmaceuticals. Methods: Last year we received our ISO (ISO9001 version 2000 RWTüV) certificate. Quality Assurance and Quality Control is one of the main aspects of Quality Manager System. This system is contained standard methods and roles and references on quality control. Therefore quality control labs in Nuclear Medicine and Cyclotron department which is for determination of specification of produced radiopharmaceuticals fall into two categories, Physico-chemical tests and Biological tests. Results: Implementation of ISO requirement that is included the below activities in quality control labs, are the main results of our work; - Training of staff - Documentation - Regular calibration of equipments on proper time - Facilities for locations Conclusion: Establishment of Quality System and Quality Assurance on Control of Radiopharmaceuticals in Cyclotron and Nuclear Medicine department.