Abstract

A REVIEW: QUALITY BY DESIGN (QBD) IS NOVEL APPROACH FOR DEVELOPMENT OF PHARMACEUTICAL

Rajveer Bhaskar, Prashant Deore*, Monica Ola, Prakash Patil and Mayur Deore

Abstract

Quality by design (QbD) is a new modern perspective towards the qualitative pharmaceutical development. This is often a systemic approach to design and development of the pharmaceutical formulations and manufacturing processes that ensures the predefined product quality. This QbD consists parts that on execution provide 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) serves the base for control strategy, that is only will 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 business 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.

Keywords: Quality by Design (QbD), Target Product Profile(TPP), Critical quality attributes(CQA), Design Space, Control Strategy, Product lifecycle.