ABSTRACT
In 2004, Quality by Design (QbD) framework was implemented in chemistry, manufacturing and controls review process in Pharmaceutical Current Good Manufacturing Practices for the 21st Century initiative to achieve a desired state in quality pharmaceutical manufacturing. In 1997, three pivotal scientific organizations, American Association of Pharmaceutical Sciences, United States Food and Drug Administration and United States Pharmacopeia jointly organized a workshop to revisit the regulatory principles governing transdermal drug product development. Through sound science and quality risk management, QbD mediated development lay emphasis on thorough product, process understanding and enhanced process control. The International Conference on Harmonization guidelines have helped to transform conventional, univariate, trial and error-based product development approach into multivariate, science-based and risk-based practices governed by the principles of QbD. Plethora of case studies has been documented in literature for inception of QbD in development of several drug products.
