ABSTRACT

Radiopharmaceuticals are medical products that are used for diagnosis and/or treatment in humans and containing one or more radionuclides (radioisotopes). The shelf life and expiry period of the radiopharmaceutical preparation depends primarily on the physical half-life of the radioisotopes. Many radiopharmaceutical preparation contain with very short half-lives may be released for use before completion of the all quality control tests. In this case, it is become more important to establish an effective Quality Assurance (QA) System. One of the most important stakeholders of the QA is the personnel. The competencies and education of the staff should be well defined and ensure that provided. This document gives guidance on the personnel and their education/training regarding to Good Radiopharmacy Practices (GRP), which involves to regulations on Good Manufacturing Practices (GMP) as well as radiation protection.