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Pharmaceutical Quality by Design: A New Approach in Product Development

Abstract

Quality by Design (QbD) refers to a new approach to product development that could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product life cycle. It supports both industry 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 company needs to define desire product performance profile [Target Product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). The company then designs the product formulation and processes to meet the product attributes. This leads to understanding the impact of raw materials [Critical Material Attributes (CMA)], on the CQAs and identifies and control sources of variability. This systematic approach to product development and manufacturing has received a great deal from the traditional approach, which was extremely empirical. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, International Conference on Harmonization‟s guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT).

Ashwini Gawade, Satyam Chemate and Ashwin Kuchekar

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