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?
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■Supervision Yukio Hiyama, National Institute of Health Sciences ■Authors Akio Imai, Eisai Co., Ltd. Osamu Hiruta, Meiji Seika Pharma Co., Ltd. Tomonori Nakagawa, Otsuka Pharmaceutical Co., Ltd. Mitsuhisa Yamano, Spira Pharma Co., Ltd. Makoto Yokoyama, Eisai Co., Ltd. Yuji Okada, Eisai Co., Ltd. Akiyoshi Kamiya, former Pfizer Inc. Ryoaki Orii, Astellas Pharma Inc. Kazunari Kio, Astellas Pharma Inc. Motoyoshi Okamura, PharmaTria Co., Ltd. ■Table of Contents Introduction: Ensuring Quality Consistency in Technology Transfer Part 1: Challenges in Business Systems (Pharmaceutical Quality Systems) in Technology Transfer and the QbD Approach Part 2: Case Studies/Responses by Type of Technology Transfer - Ensuring Equivalence in Manufacturing/Testing Method Technology Transfer and Corresponding Cases Part 3: Technology Transfer in Biopharmaceuticals and CMO Outsourcing
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