Abstract

QUALITY BY DESIGN: A NEW CONCEPT IN PHARMACEUTICAL PRODUCT DEVELOPMENT

*Rajveer Bhaskar, Monika Ola, Ram Choure and Prakash Patil

Abstract

Quality by Design (QbD) refers to a new approach in productdevelopment that could increase efficiencies, provide regulatory reliefand flexibility throughout the product life cycle. It supports bothindustry and FDA to move towards a more scientific, risk based,holistic and proactive approach to pharmaceutical development.During designing and development of a product in QbD, a companyneeds to define desire product performance profile [Target ProductProfile (TPP), Target Product Quality Profile (TPQP)] and identifycritical quality attributed (CQA). The company then designs theproduct formulation and processes to meet the product attributes. Thisleads to understanding the impact of raw materials [Critical MaterialAttributes (CMA)], on the CQAs and identifies and control sources of variability. Thissystematic approach to product development and manufacturing has received a great dealfrom the traditional approach, which was extremely empirical. QbD is necessary in regulatoryrequirement and to implement new concepts such as design space.

Keywords: Quality by design, Quality target product profile, Critical quality attributes, Design of experiment, Pharmaceutical manufacturing, Quality risk management, Design space.