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, together with impact on marketed products.

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.