Abstract

PENABAD, Alejandro A et al. Biopharmaceutical Industry, Quality. Quality Management, Management Systems. Vaccimonitor [online]. 2010, vol.19, n.3, pp.30-38. ISSN 1025-028X.

Once the majority of the organizations of the Biopharmaceutical Industry have understood the need of implementing both Quality Management Systems as a way to reach an increased efficiency and reliability in the application and fulfilment of Good Manufacturing Practices (GMP) and other regulations aiming at ensuring quality, safety and effectiveness of such products, the challenge now is to continue improving those systems in order to achieve a higher and sustainable performance. This paper aims at showing the main tendencies in this regard that are currently followed worldwide by providing a summarized characterization of their content and identifying the more relevant elements to be considered to improve Quality Management Systems, focusing in the need of their progressive implementation by institutions of the Biopharmaceutical Industry, especially those which have obtained great advances in the field.

Keywords : Biopharmaceutical Industry; Quality; Management; Management systems.

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