GMP – rules and recommendations

Good manufacturing practice (GMP) is a crucial part in the production of medicinal products. The quality and safety of medicinal products play an essential role in good manufacturing practice. Radiopharmaceuticals that are used in nuclear medicine for the diagnosis and therapy of diseases are also defined as medicinal products but at the same time underlie radiation safety regulations which is often contradictive to good manufacturing practice regulations. In principle, radiopharmaceuticals can legally wise be divided into three groups, namely radiopharmaceuticals that are holding a marketing authorization, radiopharmaceuticals that are used in clinical trials and radiopharmaceuticals that are prepared extemporaneously. In Europe a large variety of regulations with regards to good manufacturing practice for radiopharmaceuticals is observed and leads sometimes to confusion for large-scale manufacturer of radioactive pharmaceuticals, investigators of clinical trials or a small radiopharmacy in a nuclear medicine hospital department. This chapter gives an overall overview on the existing binding and non-binding regulatory documents issued by important organizations and stakeholders and shows guidelines taking the specific character and requirements of radiopharmaceuticals into account.