QUALITY BY DESIGN (QBD): A QUALITY IMPROVEMENT PERSPECTIVE FOR PHARMACEUTICAL DEVELOPMENT
Khade Megha M, Jawalkoti Sunil P, Salunkhe Ashwini M, Shinde Poonam D · 2013
Quality by design (QbD) is a new modern perspective towards the qualitative pharmaceutical development. This is a systemic approach to design and development of the pharmaceutical formulations and manufacturing processes that ensures the predefined product quality. This QbD consists elements which on execution gives the consistent quality over time. Implementation of QbD enables the assurance of pharmaceutical quality by understanding and controlling formulation and manufacturing variables. Quality risk management (QRM) s erves the base for control strategy, which is only can attain by process understanding. This new paradigm of drug development provides relief from regulatory framework that imparts flexibility, increase in efficiency by offering important benefits by busin ess point of view throughout the product’s life cycle. Continual improvement can be achieve by QbD implementation as it is systematic way of product and process development.