Sterile kits for the preparation of radiopharmaceuticals: some basic quality control considerations

Quality control concepts involved in the formulation of radiopharmaceutical kits, as well as all other radiopharmaceuticals, are meant to protect both the patients who receive these products and the practitioners of nuclear medicine who use these products in their practice. These concepts include the adequacy of site and facilities in which these products are formulated, the level of training and experience of personnel responsible for the formulation of the products, quality assurance procedures employed to monitor the acceptability of products, and, finally, a professional dedication to excellence in all these matters. The absence of any of these in a nuclear medicine or radiopharmaceutical program will result in almost certain disaster