Industrial Pharmacy II: From Pilot Plant to Regulatory Affairs
| AUTHOR | Dr Sushma; Dr Kameswara Rao; Dr Kishore Babu |
| PUBLISHER | Notion Press (02/11/2025) |
| PRODUCT TYPE | Hardcover (Hardcover) |
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.
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.