About the Book:
Quality by Design (QbD) has
transformed the way pharmaceutical products are developed and manufactured.
Rather than relying solely on end-product testing, QbD focuses on building
quality into every stage of formulation and process development through
scientific understanding and risk-based decision making. This book presents a
comprehensive and practical introduction to Quality by Design (QbD) and Design
of Experiments (DoE)—two essential frameworks that support modern
pharmaceutical development. Drawing from real industry experience, including
early implementation of QbD initiatives at Dr. Reddy's Laboratories, the book
explains how scientific design, process understanding, and statistical tools
can be integrated to develop robust and regulatory-compliant pharmaceutical
products. Through conceptual explanations, practical examples, and case
discussions, readers will gain a clear understanding of how QbD and DoE can
improve efficiency, reproducibility, and innovation in pharmaceutical research
and manufacturing.
Key
Features
•
Comprehensive introduction to QbD principles in pharmaceutical development
•
Practical application of Design of Experiments (DoE) in formulation and
analytical method development
•
Explanation of regulatory expectations and global quality guidelines
•
Industry-oriented examples for real-world implementation
• Guidance for developing robust and reproducible
pharmaceutical processes |
