Martínez-Rivera R, Crespo-Reinoso Y, Rodríguez-Cotilla Z

Language: Spanish
References: 0
Page: 26-36
PDF size: 61.53 Kb.

ABSTRACT

Biopharmaceutical production has been historically done under Good Manufacturing Practice requirements and more recently, the principles of International Organization for Standardization are being included to structure its quality management systems. In the Cuban context, High Technology Enterprises of biopharmaceutical sector do not achieve in all cases sustained success or synergy with standards for quality management systems or distinctive characteristics by this type of companies. While ISO 9004: 2009 is an important starting point, which provides support for sustained success and tools for assessing the maturity level of management systems on the way to operational excellence; it has not yet been consciously assumed by the High Technology Companies, due to that it is a bit far from the particularities of the sector. This paper aims at showing a new instrument with a specifi c design to evaluate the maturity level of the quality management system in High Technology Companies, which is complemented with another particular instrument for pharmaceutical quality system evaluation. Both instruments include elements related to the principles of risk management and resilience and consider the relevance of having a tool more closely approximates to the particularities of biopharmaceuticals organizations.