Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial

Abstract

Technology transfer step is part of the life cycle of a drug. This stage aims to transfer the information, generated during the development phase, to the industrial manufacturing stage. It must also, generate the necessary knowledge to achieve the efficient implementation of an industrial process transferred between different industrial plants. In this study the implementation of an industrial process of tablet manufacturing is carried out identifying, through risk analysis techniques, the process more risky steps (medium or high risk) on which knowledge must be increased, through experiments, until achieve a level of acceptable risk. Techniques such as OFAT or DOE are used for this purpose. Statistical analysis is applied to the results in order to obtain scientifically based conclusions. Also, it is define the manufacturing process parameters safety zone for this specialty.