Book: The Essence of Risk Management in Pharmaceutical Manufacturing and Case Studies of Its Application
Challenges in Implementing Risk Management at Manufacturing Sites and Examples of Risk Assessment - Specifically, how should we confront risks?
This book explains and presents case studies based on the authors' experiences regarding approaches to risk. Please use the cases introduced here as a reference to prevent omissions in risk when implementing them in your own company. # Points raised in inspections related to risk management # Are you unsure about how to specifically confront risks? # Have you been conducting risk assessments until now? # Understanding of risk, sharing within the company, and the quality of risk assessments.
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■Editors Katsuharu Miyajima, NanoCarrier Co., Ltd. ■Authors Yukio Hiyama, National Institute of Health Sciences Yoshimura Maeda, NanoCarrier Co., Ltd. Nobuyuki Isshiki, Kissei Pharmaceutical Co., Ltd. Akihito Yasuda, Nippon Shinyaku Co., Ltd. Yukie Matsumura, Quality Management Advisor [Formerly Eisai Co., Ltd.] Tadayuki Takashima, Filler Systems Co., Ltd. [Formerly Astellas Pharma Inc.] ■Table of Contents Chapter 1: The Importance of Risk Management in Drug Development and Manufacturing Chapter 2: Basics of Risk Management Chapter 3: Key Points for Creating Risk Management SOPs Chapter 4: Risk Management and Process Validation Chapter 5: Fundamental Concepts of Risk Communication and Risk Review Chapter 6: Specific Examples of Risk Assessment in Pharmaceutical Factories Section 1: Case Studies of Risk Evaluation in Pharmaceutical Manufacturing Sites Section 2: Case Studies of Risk Evaluation in the Research and Development Stage for Production Transfer Chapter 7: Corrective and Preventive Action Systems and Quality Risk Management - Using Deviation Handling as an Example - Chapter 8: Inspections and Risk Management
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