In this book you will find crucial information on:
- An introduction to the various risk methodologies and their terminology
- Selecting the best method for a particular stage in the drug lifecycle
- Building risk management into the Quality Management System
- Many practical examples from real industry applications, including PAT
- The application of risk management for optimising the benefit/risk ratios
This book has been written by several authors who are experts in their field. It covers all stages of the drug lifecycle from R&D, to the clinical phases, the launch and pharmacovigilance stages, and the discontinuation step. It is written for the practitioner in the operational part of the organisation, who wishes to select from practical examples, and it will be equally of interest to those working in quality assurance / compliance, who wish to learn more about implementing risk management as a quality concept.
Table of Contents:
Chapter 1: Introduction
Chapter 2: Compliance and the Lifecycle Concept
Chapter 3: Impact on Quality Management Systems
Chapter 4: Risk-Based Approach to Compliance
Chapter 5: Implementing Process Analytical Technology: The Challenges and Pitfalls of Applying a Science and Rick-Based Approach in Research and Manufacturing
Chapter 6: The Applicability of ICH Q9
Chapter 7: Benefit Risk Assessment During R&D
Chapter 8: The Cost of Quality
Chapter 9: How to Implement?
Chapter 10: Documented Evidence
Chapter 11: Quo Vadis?