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In this paper the prevalence of metastatic bone pain is estimated in our country in no less than 3 750 patients. Moreover, the role of 32P-phosphate, which effectiveness is comparable to other radiopharmaceuticals, and the possible return to its previous general use, as it is cheaper, is examined. The fact that 32P is considered more radiotoxic doesn’t invalidate it as a treatment option, which is also evidenced by the Cuban experience. The Center of Isotopes (Centis) has established a production line of up to 37 GBq (1 Ci) per week of high quality 90Y. The fact of its being obtained through a radionuclide generator by electrochemical separation from 90Sr makes the import of radioactive raw material practically not required for indefinite time. This implies that the radionuclide could be available in a sustainable way. By having the 90Y greater β- emission energy, it might be more radiotoxic than 32P. Nevertheless, some evidences show that 32P in the form of orthophosphate is more radiotoxic than 90Y citrate. In Europe, a radiopharmaceutical consisting of a lyophilized kit of EDTMP and 90Y Chloride solution was able to relief pain in 191 patients. Centis has registered the 900Y chloride solution for labeling. Then the task is to introduce in the market a radiopharmaceutical with this radioactive precursor and the imported lyophilized kit in order to increase the treatment to an important number of patients that, as a result, could be benefitted. [ABSTRACT FROM AUTHOR]

The obtainment of the Sanitary License for Pharmaceutical Operations requires the risks analysis of quality in the manufacturing process of each product. The main aim of the present work was to apply this evaluation to the production process of freeze-dried kit for labeling with Technetium-99m of monoclonal antibodies, which are developed in the Isotope Center. The failure modes and effects analysis technique and the Cuban code SECURE-MR-FMEA version 3.0 were used. The lifting of the sub-processes, stages and failure modes was carried out through brainstorming. A task group of experts reconciled their results and determined the most influential causes. The model consists of ten sub-processes, 28 stages, and 40 failure modes. Of the 98 possible combinations, 39 Sub-Process-Stage-Failure Mode-Cause ones were identified, with a risk priority number (RPN) ≥100 and a severity index (ISev) ≥7. The most contributing sub-processes were: manufacturing, conditioning and sanitizing of the clean area, preparation of glassware and materials, and the obtaining of the water for injection. The most important causes were: qualification and training of the staff; non-compliance with practices, protocols, procedures or standards; and the use of qualified equipment. The results of the sensitivity analysis showed that the solution of these causes makes possible a significant reduction of the risks of the manufacture process and, thus, contributes the compliance with good manufacturing practices, with the priority of actions and resources in these directions. [ABSTRACT FROM AUTHOR]