Problèmes techniques et problèmes legaux poses en Belgique par le contrôle pharmaceutique des radioelements à usage médical

After stating essential differences existing between the pharmaceutical industry and the production of radioeIements for medical use, a study is made of the technical difficulties and legal problems to be faced by the pharmaceuticaI control in a radioisotooe production or distributing centre. Some technical difficulties are being related, namely the risks of contamination and of irradiation. In the case of most regular productions, the sample taken for the control usually allows complete examination of the various properties of the whole lot. In the case of exceptional productions or importation of radioeIements for single delivery, the nature of the isotope and the level of radioactivity must be defined individually. A complete control is made on probe, usually at the rate of one sample out of five. Stipulations of the royal decree of February 28, 1963 concerning the pharmaceutical control of radioeIements for medical use are then being reminded and they confirm the utility of this control and the important part it has in the field.