Author:
Sreelekha Salevendula,Kumar K Vinod,Mahammed Nawaz,Reshma T,Sree G Usha,Basha S Shakir,Bhuvaneswari M
Abstract
Quality by Design (QbD) is an essential approach to pharmaceutical development and manufacturing that has garnered significant attention in recent years. Quality in services, products, and procedures equates to customer satisfaction. Consequently, it facilitates a transition in the pharmaceutical sector and the Food and Drug Administration (FDA) toward a more scientific, risk-based, comprehensive, and proactive drug development strategy. The pharmaceutical industry is actively seeking new solutions to ensure product quality and efficiency. This paper provides a comprehensive overview of QbD principles and their application in the pharmaceutical industry. The benefits of implementing QbD principles are discussed, encompassing increased efficiency, reduced costs, and improved product quality, safety, and efficacy. As the pharmaceutical industry continues to evolve, QbD will remain a crucial aspect of drug development and manufacturing. This article aims to provide pharmaceutical professionals with a comprehensive understanding of the QbD approach.
Reference42 articles.
1. Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Journal of Pharmacology and Pharmacotherapeutics. 2015; 6(3): 185-7.
2. Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of chemistry. 2017; 10: S3412-S25.
3. Bhutani H, Kurmi M, Singh S, Beg S, Singh B. Quality by design (QbD) in analytical sciences: an overview. Quality Assurance. 2004; 3: 39-45.
4. Joseph J, Godfrey AB. Juran’s quality handbook. New York: McGraw-Hill; 1998.
5. Cook J, Cruañes MT, Gupta M, Riley S, Crison J. Quality-by-design: are we there yet? AAPS PharmSciTech. 2014; 15(1): 140-8.