National Journal of Pharmaceutical Sciences
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P-ISSN: 2788-9262, E-ISSN: 2788-9270

2024, Vol. 4, Issue 1, Part B


A review on quality by design approach for pharmaceuticals


Author(s): Apeksha Patel, Mayank Gupta, Dr. Siddhi Upadhyay and Dr. Umesh Upadhyay

Abstract: Quality by design (QbD) is an important part in today's pharmaceutical quality developments. Quality design (QBD) is a modern and systematic approach to product development and pharmaceutical quality. Quality by design is a concept proposed by well-known quality expert Joseph M. Juran. This paper presents Pharmaceutical Quality by Design (QbD) and how it can be used to ensure pharmaceutical quality. QbD provides a comprehensive framework that integrates quality principles, risk assessment, and knowledge management throughout the product lifecycle. This explores the key concepts and principles of QbD, including the use of Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs). The implementation of QbD involves the application of various tools and methodologies, such as design of experiments (DoE), risk assessment techniques, and process analytical technology (PAT). The objective of this review is to discuss the concept of quality by design and describe its application in pharmaceutical product development.

Pages: 83-92 | Views: 198 | Downloads: 61

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National Journal of Pharmaceutical Sciences
How to cite this article:
Apeksha Patel, Mayank Gupta, Dr. Siddhi Upadhyay, Dr. Umesh Upadhyay. A review on quality by design approach for pharmaceuticals. Nat J Pharm Sci 2024;4(1):83-92.


National Journal of Pharmaceutical Sciences

National Journal of Pharmaceutical Sciences

National Journal of Pharmaceutical Sciences
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