A comprehensive book that covers various aspects related to regulations and industry trends concerning product quality in the pharmaceutical industry surrounding scale-up, as well as technology transfer in contract manufacturing!
**Features of this Book** - Comprehensive information on regulations and industry trends related to product quality in the pharmaceutical industry surrounding scale-up, as well as technology transfer in contract manufacturing, all in one volume! - Detailed explanations regarding GMP, ICH, PIC/S, equivalence evaluation, raw data, and more! - In-depth discussion on quality issues, impurity management, genotoxic impurities, continuous production, etc.! **Table of Contents** Chapter 1: Basics of Scale-Up Chapter 2: Issues in Scale-Up Chapter 3: Revised Pharmaceutical Affairs Law and GMP Chapter 4: Efficiency and GMP Measures Appendix at the End of the Chapter: The Cutting Edge of UHPLC Chapter 5: Crystal Polymorphism Chapter 6: Troubleshooting in Scale-Up Chapter 7: GMP for Investigational Drugs and Status of New Drug Development Chapter 8: Considerations When Changing Raw Materials and Points for Equivalence Evaluation Chapter 9: Handling of Raw Data and Laboratory Notebooks Chapter 10: What is Data Integrity? Chapter 11: Change Management and Deviation Management Chapter 12: Education and Training Chapter 13: Trends in Pharmaceutical Companies and Generic Drugs/Biosimilars Chapter 14: Flow of Active Pharmaceutical Ingredient Import Business Chapter 15: Trends in Pharmaceutical Companies and Contract Manufacturing Companies Chapter 16: Trends in GDP and Response Measures Afterword *For a detailed table of contents, please refer to the related link URL.*
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■ Release Date: February 20, 2025 ■ Author: Mitsuki Hashimoto ■ Price: Paperback (Black and White) 120,000 yen (tax included 132,000 yen) Book + CD (PDF version Color) 140,000 yen (tax included 154,000 yen) ★ Newsletter members: 10% off the regular price! ■ Format: A4 size, paperback, 639 pages ■ Published by: CMC Research Co., Ltd. ISBN 978-4-910581-62-0
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Booklet version (black and white) 120,000 yen (tax included 132,000 yen) Booklet + CD (PDF version color) 140,000 yen (tax included 154,000 yen)
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We provide the latest industrial insights to our clients. By conducting market trend analysis, publishing technology‑related books and research reports, and organizing and managing seminars, we support research and development across a wide range of industries, with a primary focus on manufacturing. Our coverage spans diverse fields such as energy, batteries, chemicals, and biotechnology.
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