Evolution of quality on pharmaceutical design: regulatory requirement?

Quality by design (QbD) concept was first outlined by quality pioneer Joseph M. Juran, who believed quality could be designed into a product, preventing, therefore, most quality problems, normally related to the way quality was planned. This concept, as others related to quality conception and management, has already been applied by other industries, as automotive, and later introduced to pharmaceutical industry through US Food and Drug Administration and The International Council on Harmonization of Technical Requirements for Medicinal Products for Human Use guidelines. Brazil mostly applies statistical quality control and still does not have specific regulations regarding QbD, neither other countries in Latin America. Thus, the current stage of pharmaceutical quality regulation in Latin America must be understood to implement better strategies that can positively affect the development of drug products to reach advanced levels of quality. This article reviews aspects related to quality of pharmaceutics and assesses data to analyze whether Brazilian pharmaceutical industry can adapt to this scenario as a pilot for other South American countries.