ICH Quality Guidelines: An Implementation Guide - Hardcover

Hardcover

ISBN 10: 1118971116 ISBN 13: 9781118971116

Publisher: Wiley, 2017

Synopsis

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.

•    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
•    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
•    Uses case studies to help readers understand and apply ICH guidelines
•    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
•    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

About this title

About the Author

Andrew Teasdale, PhD, is a principal scientist in pharmaceutical development with AstraZeneca. He has over 20 years' experience within the industry and has held a number of leadership roles both internally and externally at a cross industry level encompassing key ICH topic areas.

David Elder, PhD, is an independent CMC consultant. He has 40 years' experience within the pharmaceutical industry. He was formerly a director within GlaxoSmithKline's platform technology and science function. He is an expert member for the British Pharmacopoeia and has extensive CMC experience encompassing many of the key ICH topics.

Raymond W. Nims, PhD, is a Senior Consultant at RMC Pharmaceutical Solutions, with experience in a variety of GMP quality assurance and quality control topics from a biologics point of reference. He has served on ad hoc panels supporting a number of USP chapters and ANSI Standards.

From the Back Cover

In 1989, global regulatory authorities in the United States, Europe, and Japan – together with pharmaceutical trade associations from the same regions – established an International Conference on Harmonization (ICH) to standardize the quality and safety requirements for drug product registration. Through the ICH process, more than fifty guidelines have been produced covering quality, non-clinical safety, clinical efficacy and safety, and multi-disciplinary topics. While the guidelines provide a clear framework in terms of requirements, there remains the necessity to interpret how compliance can be achieved practically. Interpreting and implementing the ICH quality guidelines from a practical point of view is thus a challenge facing the entire pharmaceutical industry.

Motivated by the pressing need for a consistent and integrated view of how the guidelines inform drug development strategic planning and decision-making, ICH Quality Guidelines: An Implementation Guide focuses on the quality guidelines and requirements along with their implications and practical implementation. Featuring chapters by authors who were involved in the development of the guidelines and subject matter experts, the book offers a succinct and definitive text with practical case study examples.

Topics include stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP). The book provides a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of the guidelines, giving not only a definitive narrative, but also actual solutions to effectively manage the associated identified issues.

Encompassing both R&D and marketing environments, ICH Quality Guidelines details the appropriate application during the phases of drug development – a truly global issue and thus valuable to anyone involved in the pharma industry throughout the world.

From the Inside Flap

In 1989, global regulatory authorities in the United States, Europe, and Japan – together with pharmaceutical trade associations from the same regions – established an International Conference on Harmonization (ICH) to standardize the quality and safety requirements for drug product registration. Through the ICH process, more than fifty guidelines have been produced covering quality, non-clinical safety, clinical efficacy and safety, and multi-disciplinary topics. While the guidelines provide a clear framework in terms of requirements, there remains the necessity to interpret how compliance can be achieved practically. Interpreting and implementing the ICH quality guidelines from a practical point of view is thus a challenge facing the entire pharmaceutical industry.

Motivated by the pressing need for a consistent and integrated view of how the guidelines inform drug development strategic planning and decision-making, ICH Quality Guidelines: An Implementation Guide focuses on the quality guidelines and requirements along with their implications and practical implementation. Featuring chapters by authors who were involved in the development of the guidelines and subject matter experts, the book offers a succinct and definitive text with practical case study examples.

Topics include stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP). The book provides a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of the guidelines, giving not only a definitive narrative, but also actual solutions to effectively manage the associated identified issues.

Encompassing both R&D and marketing environments, ICH Quality Guidelines details the appropriate application during the phases of drug development – a truly global issue and thus valuable to anyone involved in the pharma industry throughout the world.

Edition details

• Publisher: Wiley
• Publication date: 2017
• Language: English
• ISBN 10: 1118971116
• ISBN 13: 9781118971116
• Binding: Hardcover
• Edition number: 1
• Number of pages: 736
• Editor: Teasdale Andrew, Elder David, Nims Raymond W.