Review Article on Quality by Design in Pharmaceutics: Enhancing Drug Development and Manufacturing
Year: 2025
Type: article
Abstract: Quality by Design (QbD) is a proactive, systematic approach in the pharmaceutical industry that ensures the consistent quality and safety of drug products. It emphasizes understanding and controlling critical quality attributes (CQAs) and their relationship with process parameters during the drug development and manufacturing phases. This article explores the evolution of QbD, its historical context, and the perspective of regulatory bodies like the FDA. It also highlights the current applications of QbD in the pharmaceutical industry, with a focus on how it addresses product quality and regulatory compliance. Furthermore, the article discusses the challenges pharmaceutical companies face in adopting QbD, such as resource constraints and the complexity of implementation. The article also examines the benefits of QbD, such as improved product consistency and reduced regulatory hurdles, alongside its limitations, including the need for substantial upfront investment and expert knowledge. Finally, it provides insights into how QbD is shaping the future of pharmaceutical manufacturing and regulatory approaches, positioning it as an essential framework for achieving high-quality drug products.
Author: Steven Joseph Nkuku*, Dr. Damit Kumar, Laikhuram Rishikanta
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6893294538
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