Industrial Pharmacy II: From Pilot Plant to Regulatory Affairs

By Dr. Sushma, Dr. Kishore Babu, Dr.Kameswara Rao

Book Overview

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.

• Format: Paperback
• Language: English
• ISBN: B0DWNMCKDX
• ISBN13: 9798897244249
• Release Date: February 2025
• Publisher: Notion Press
• Length: 244 Pages
• Weight: 0.98 lbs.
• Dimensions: 0.7" x 6.0" x 9.0"