Books: Implementation Procedures for Technology Transfer (Testing Methods and Manufacturing Processes) and Ensuring Equivalence

Challenges in Pharmaceutical Quality Systems and Management Strategies Based on QbD Approach/Q12 and EC

A collection of corporate experiences and wisdom viewed through the lens of "technology transfer"! This book is beneficial not only for practitioners involved in technology transfer but also for management overseeing operations and government officials! <Key Points of This Book> ✔ What are the challenges and organizational strategies for addressing technology transfer from the perspective of the QbD approach and ICH Q12 (pharmaceutical lifecycle)? ✔ What should be done, when, and to what extent? What development strategies change at different stages of development for successful technology transfer? This book explains technology transfer in active pharmaceutical ingredient and formulation development based on actual case studies from the perspective of ensuring equivalence! ✔ Diversifying manufacturing outsourcing to domestic and international CMOs... What are the selection and management processes for outsourcing partners, actual trouble cases that arise, and the various responses required by overseas authorities for each manufacturing CMO? ✔ As manufacturing outsourcing becomes common in biopharmaceuticals and antibody drugs, what are the key points for establishing an outsourcing system to ensure production as intended?

Technical and Reference Books