ICH Quality Guidelines: An Implementation Guide

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. Interpreting and implementing the ICH quality guidelines is a challenge facing the entire pharmaceutical industry; but the advice relating to the guidelines has (to date) been fragmented, ad hoc, and piecemeal in nature.

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, 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.

Andrew Teasdale, PhD, is a principal scientist in pharmaceutical development with AstraZeneca. He has held a number of leadership roles there, including analytical chemistry and quality assurance, with over 20 years experience within the industry.

David Elder, PhD, is a director within GlaxoSmithKline s (GSK) platform technology and science (PTS) function. He has 20 years experience at GSK and another 16 within the pharmaceutical industry, at Sterling Winthrop and Syntex.
 
Raymond W. Nims, PhD, is a consultant at RMC Pharmaceutical Solutions with experience in GMP quality assurance and control.