An Overview on Quality by Design in Pharmaceutical Product Development
Main Article Content
Abstract
Current international regulatory thinking regarding pharmaceutical products is reflected in the Quality by Design concept. The performance of the pharmaceutical sector needs to be enhanced. More recent technology must be put into practice that can successfully lower costs while also raising the calibre of the final product. The best way to improve the quality of all pharmaceutical goods is through quality by design, or QbD. The primary goal of QbD is to guarantee the quality of the final product by combining existing knowledge with fresh estimations made during development. The International Conference on Harmony (ICH) and the Food and Drug Administration (FDA) are actively promoting QbD. The foundation of quality by design (QbD) in the pharmacy industry is knowledge of how process variables and materials impact the quality profile of finished goods. To comprehend the performance of dosage forms within the design space, this article discusses the essential components of QbD, which include the target product quality profile, critical quality attributes, risk assessment, design space, and control strategy. QbD also discusses its tools, which include process analytical technology, DoE, and quality risk management. The significance of QbD in fostering a science-based approach in the creation of pharmaceutical products is highlighted by these reviews.