eBook version: 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
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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, Pharmatree 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 and Response Cases in Manufacturing/Testing Method Technology Transfer Part 3: Technology Transfer in Biopharmaceuticals and CMO Outsourcing
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