Resumo

CRUZ ARENCIBIA, Jorge. Good practice in the production of radiopharmaceuticals. Nucleus [online]. 2012, n.52, pp. 9-12. ISSN 0864-084X.

In the paper the evolution of concepts regarding the quality of the pharmaceutical products is analyzed in the framework of the production of radiopharmaceuticals at CENTIS. The world trends range from the quality control of the final product to the comprehensive concept of quality management. It is concluded from the analysis that CENTIS has an appropriate system of Good Manufacturing Practice as a result of 15 years of systematic, growing and qualified attention to the issue, in correspondence with the world tendencies and the continuous support of CECMED, the Cuban regulatory authority. That is certified by the fact that all the production processes of CENTIS have been licensed and all the CENTIS products in the market have been registered. The existing conditions at CENTIS are favorable to establish and certificate a Quality Management System.

Palavras-chave : radiopharmaceuticals; quality assurance; certification; culture.

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