Industrial Pharmacy II: From Pilot Plant to Regulatory Affairs: From Pilot Plant to Regulatory Affai

A comprehensive guide to the essential industrial aspects of pharmaceutical manufacturing, this book takes readers through the entire journey of drug development, from pilot plant scale-up to regulatory approvals.

✔️ In-depth insights into scale-up techniques, technology transfer, and formulation challenges.

✔️ Expert analysis of Good Manufacturing Practices (GMP), Quality by Design (QbD), and regulatory compliance.

✔️ Detailed overview of Indian and international regulatory requirements, including CDSCO, FDA, and EMA guidelines.

✔️ Practical case studies and real-world applications to bridge the gap between theory and industry practices.

A must-have resource for students, researchers, faculty, and industry professionals, this book ensures a strong foundation in Industrial Pharmacy to navigate the highly regulated pharmaceutical sector with confidence.