Qualidade por concepção: uma nova abordagem para acelerar o desenvolvimento tecnológico e inovação na área da saúde

Abstract

This article seeks to present a systematic and proactive quality management model based on scientific rigor, as well as on analysis and risk management, known as Quality by Design (QbD). Since 2012, regulatory agencies from the United States and the European Union have pressed the manufactures to speed the adoption of QbD principles for processes and products development. In Brazil, the new approach has received increasing attention from the pharmaceutical∕biotechnological community, as well as from Anvisa, and it is now seen as a global regulatory initiative to assure the rational development of products, reducing the lead and launch time to market, incrementing the elaboration of clinical protocols, controlling costs and increasing success chances of the pharmaceutical sector. In this context, the adoption of the QbD concepts aims to add value to existing quality policies in organizations, providing not only more agility and assertiveness, but also more confidence in the new developed products.