Quality by Design: An Over View in Pharma Industry

Author:

M. Wanegaonkar Anjali1,Chaudhari Manisha2,R Jadhav Kisan1,J. Kadam Vilasrao1

Affiliation:

1. Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Sector-8 CBD Belapur, Navi Mumbai - 400614, Maharashtra, India.

2. DYPatil Deemed to be University, School of Pharmacy, Nerul, Navi Mumbai.

Abstract

In recent years, the pharmaceutical industry has paid a lot of attention to the idea of "Quality by Design" (QbD) as a means of preserving quality. It acts as a link between the pharmaceutical sector and drug regulatory agencies, enabling us to advance in a process of pharmaceutical product development that is systematic, risk-based, thorough, and efficient. To ensure the quality of predetermined products, it mostly entails creating and implementing production forms and processes. A few QbD components are establishing the quality profile of the intended product, developing the product and production processes, determining the critical quality attributes, process parameters, and resource diversity, and controlling the production processes to produce consistent quality through time. The goal of this article's is to discuss the concept behind quality-based drug design. By describing and demonstrating how it is possible to check the creation and quality of pharmaceuticals.

Publisher

A and V Publications

Reference26 articles.

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3. Jain S, John S. Quality by design (QBD): A comprehensive understanding of implementation and challenges in pharmaceuticals development [Internet]. Available from: https://www.researchgate.net/publication/280019162

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5. Rajora A, Chhabra G. Quality by Design Approach: Regulatory Need, Current, and Future Perspective. 2021; 14: 2021. Available from: http://dx.doi.org/10.22159/ajpcr.2021v14i6.33733.

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