Quality-by-Design in Pharmaceutical Development
Sri Venkatesh Uriti · 2024
Quality-by-Design (QbD) represents a paradigm shift in pharmaceutical development, emphasizing systematic and science-based approaches to product and process understanding. The exploration of ICH Q8 guidelines provides fundamental principles for implementing QbD in pharmaceutical manufacturing. QbD emerges as a crucial framework for ensuring product quality through systematic development approaches rather than relying solely on end-product testing through examination of regulatory and industry perspectives, along with practical applications. The integration of regulatory requirements with scientific methodologies demonstrates how QbD principles can be effectively implemented to enhance product quality, reduce variability, and streamline the approval process. Real-world applications illustrate the practical implementation of QbD principles across various pharmaceutical development scenarios, showcasing its value in modern pharmaceutical manufacturing.