title: The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.
abstract: Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.
authors.affiliation: Department of Nuclear Medicine, Ghent University Hospital, Belgium bPET-Centre Groningen GUMC, University of Groningen, the Netherlands. filipx.devos@Ugent.be
authors.forename: Filip J
authors.initials: FJ
authors.lastname: De Vos
authors.forename: Mario
authors.initials: M
authors.lastname: De Decker
authors.forename: Rudi A
authors.initials: RA
authors.lastname: Dierckx
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D019983:Guideline Adherence; D038622:Internationality; D007553:Isotope Labeling / Q000592:standards; D013677:Medical Laboratory Science / Q000592:standards; D009683:Nuclear Medicine / Q000379:methods / Q000592:standards*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000379:methods / Q000592:standards*; D019275:Radiopharmaceuticals / Q000138:chemical synthesis* / Q000592:standards*
chemical_list: D019275:Radiopharmaceuticals