Abstract

OVERVIEW OF QUALITY BY DESIGN (QBD) IN PHARMACEUTICAL DEVELOPMENT

M. Padma Sai Sree, S. K. Rahila Towhid, S. K. Shahina, P. Jyothsna Krishna, B. Sai Jithendra, M. M. Eswarudu, P. Srinivasa Babu and P. Siva Krishna*

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Abstract

Quality by Design (QbD) represents a proactive approach in pharmaceutical development aimed at building quality into products from the outset. This systematic method focuses on a thorough understanding of product and process design, with a strong emphasis on defining a Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQAs) essential for product performance. By employing risk assessment tools, design of experiments (DoE), and process analytical technology (PAT), QbD enables optimization of manufacturing processes, improves consistency, and minimizes variability in product quality. This paper provides an overview of QbD principles, regulatory expectations, and its advantages in enhancing product efficacy, safety, and manufacturing efficiency. The shift towards QbD is endorsed by global regulatory agencies, including the FDA and EMA, as it aligns with regulatory trends favoring sciencedriven, risk-based approaches in drug development.

Keywords: Quality by Design, QbD, pharmaceutical development, Quality Target Product Profile, Critical Quality Attributes, design of experiments, process analytical technology, regulatory compliance.