A Review on Quality by Design (Qbd) in Pharmacutical Development

Author(s)	Mayuri R Ankar, Rupali D Kuthe, Snehal S Ganorkar, Vishal C Ramteke
Country	India
Abstract	This review explains the idea of pharmaceutical Quality by Design (QbD) more clearly and talks about its main goals. QbD focuses on making sure that medicines are designed and made with high quality from the beginning. It includes several important parts. First, it starts with a Quality Target Product Profile (QTPP), which describes the key features the final drug should have. Then, it involves understanding the product and identifying important materials, called Critical Material Attributes (CMAs). It also includes designing the manufacturing process and identifying the key steps, known as Critical Process Parameters (CPPs) that can affect the drug’s quality. These materials and steps are linked to the Critical Quality Attributes (CQAs) of the drug. [1,2] A control strategy is also part of QbD. This means setting standards for the drug ingredients, added substances (excipients), the final product, and each step of the manufacturing process to make sure everything stays on track. QbD also focuses on how capable the process is and encourages continuous improvement over time
Field	Medical / Pharmacy
Published In	Volume 7, Issue 6, November-December 2025
Published On	2025-11-19
DOI	https://doi.org/10.36948/ijfmr.2025.v07i06.60910

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