QUALITY BY DESIGN: CHANGING OUTLOOK OF PHARMACEUTICAL DEVELOPMENT
AbstractThe concept of quality by design (QbD) justifies the saying that, quality is not an act, it is a habit. This innovative and systematic approach to pharmaceutical development based on scientific principles has been a breakthrough in developing quality products with a high level of reproducibility. The process of QbD is based on risk management which leads to a better understanding of the product and its manufacturing process, resulting in products with required quality, safety, and efficacy. As the quality and reliability requirements of today’s world are constantly increasing, QbD serves as an important tool in outperforming the global competition. This paper comprehensively discusses the concept of pharmaceutical quality by design, elements of QbD; quality target product profile (QTPP), critical quality attributes (CQAs), design space, control strategy, and lifecycle management. Application of QbD across various fields of pharmaceutical development including formulation development, analytical method development, phytopharmaceutical & biopharmaceutical product development are encompassed in the review.
Article Information
9
4100-4108
699
1367
English
IJPSR
S. Kalyan * and A. Parle
Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India.
sahil111kalyan@gmail.com
23 October 2018
30 January 2019
11 February 2019
10.13040/IJPSR.0975-8232.10(9).4100-08
01 September 2019
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