QUALITY BY DESIGN- AN OVERVIEW ON OBJECTIVES AND APPLICATIONS Authors: Ashwini P , SHIVANI K AND PRASANTHI R*
ABSTRACT
Background: Quality by design (QbD) is an essential part of the modern approach to
pharmaceutical quality. This paper gives an idea about Quality by Design is emerging to
increase the promise of providing safe and effective medicines to customers and to improve
the efficiency of product quality. Parameters: It is based on the ICH Guidelines Q8 for
pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical
quality systems. QbD defines the quality Target Product Profile (QTPP), Critical Quality
Attributes (CQA), Risk assessment, Control Strategy, and life cycle management to design and
develop the formulation and process. Conclusion: The purpose of this paper is to explain how
QbD may be applied to guarantee the efficient production and high quality of pharmaceutical
goods.
Keywords: Quality by Design, ICH Guidelines, QTPP, CQA, Control Strategy Publication date: 01/01/2025 https://ijbpas.com/pdf/2025/February/MS_IJBPAS_2025_8689.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2025/14.2.8689
