Quality by Design (QbD) in Pharmaceutical Development

ISBN-13: 9783659775727 / Angielski / Miękka / 2024 / 68 str.

Siva Krishna Pusuluri; Munnangi Mukkanti Eswarudu; Rafath Sulthana Shaik

Opis

Quality by Design (QbD) is a systematic approach to pharmaceutical development that emphasizes building quality into a product from the outset, rather than relying solely on end-product testing. This approach involves understanding the science behind formulation and manufacturing processes, identifying critical quality attributes (CQAs), and designing processes that consistently deliver products meeting predefined quality standards. QbD integrates risk management, process optimization, and continuous improvement throughout the product lifecycle. It encourages the use of scientific knowledge, data analysis, and process control tools to enhance product quality, reduce variability, and ensure regulatory compliance. By focusing on design and process development, QbD aims to improve manufacturing efficiency as well as the safety and efficacy of pharmaceutical products.