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Pharmaceutical Risk Control Systems

This paper outlines an initial investigation of the bio-pharmaceutical industry (BPI) and the steps it is taking to meet the new FDA risk mandate. It reviews the industry’s’ current strategy of improving its quality management systems that are central to achieving best practices within its operations. In addition the paper also reviews the strategy for upgrading to the next generation manufacturing execution systems which will control the enterprise facilities through full data integration and actionable intelligence. U.S. PHARMACEUTICAL INDUSTRY The U.S. life science industry is a business sector with high visibility which faces the significant task of developing, testing and manufacturing of pharmaceuticals. Within the complex environments in which bio-pharmaceuticals are developed, there is a strong need for IS systems that monitor, control and manage the production processes. These industrial strength systems (Booch, 1994) can drive each of the steps within the product life cycle and are critical for guaranteeing that quality standards are met. The internal standards are set through quality assurance techniques developed from ‘best practices,’ while the external standards are set by the U.S. Food and Drug Administration (FDA).