IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17


Inside this issue


ICH Quality Guidelines: An Implementation Guide

Andy Teasdale, a principal scientist at AstraZeneca and team leader of IPEC Europe’s task force on ICH Q3D elemental impurities, has co-authored a new book entitled ICH Quality Guidelines: An Implementation Guide, which has been published by Wiley.

Examining the implications and practical implementation of multi-disciplinary ICH topics, the book – which covers topics such as stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP) – gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.

“ICH guidelines have undoubtedly made a positive contribution to the management of many key quality and safety aspects associated with production of safe and efficacious pharmaceuticals.  They have helped establish a harmonised framework in terms of requirements, one applied across ICH regions and beyond,” commented Teasdale.

“However, guidelines can only go so far leaving the challenge in many cases around how to practically apply the guideline concerned. This book is focused specifically on that practical implementation challenge.” 

It aims to provide that additional guidance, where possible through example, to assist in the pragmatic implementation of these guidelines, according to Teasdale, who notes that while each guideline is considered as individually through a dedicated chapter, throughout the book the interrelationship between guidelines is evaluated.

The intention is to provide – for the first time – an overall holistic framework of practical guidance in this important area, he said.

The book is co-authored by David Elder, a director within GlaxoSmithKline’s platform technology and science (PTS) function, and Raymond Nims, a senior consultant at RMC Pharmaceutical Solutions.




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