Edited by
Andrew Teasdale
AstraZeneca, London, UK
David Elder
Consultant (Former GSK), Hertford, Hertfordshire, UK
Raymond W. Nims
RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA
This edition first published 2018
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Library of Congress Cataloging‐in‐Publication Data
Names: Teasdale, Andrew, editor. | Elder, David (David P.), editor. | Nims, Raymond W.
Title: ICH quality guidelines : an implementation guide / edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA.
Other titles: International Conference on Harmonization quality guidelines
Description: First edition. | Hoboken, NJ : Wiley, 2018. | Includes bibliographical references and index. |
Identifiers: LCCN 2017013162 (print) | LCCN 2017014318 (ebook) | ISBN 9781118971123 (pdf) | ISBN 9781118971130 (epub) | ISBN 9781118971116 (hardback)
Subjects: LCSH: Drug development. | Drugs–Testing. | Drugs–Quality control. | BISAC: MEDICAL / Pharmacology. | TECHNOLOGY & ENGINEERING / Quality Control. | SCIENCE / Chemistry / Industrial & Technical.
Classification: LCC RM301.25 (ebook) | LCC RM301.25 .I24 2018 (print) | DDC 615.1/9–dc23
LC record available at https://lccn.loc.gov/2017013162
Cover image: © Yagi Studio/Gettyimages
Cover design by Wiley
Morten Allesø
Chemical and Pharmaceutical Research
H. Lundbeck A/S
Valby
Denmark
Joel P. Bercu
Gilead Sciences, Inc.
Foster City, CA
USA
Phillip Borman
GSK
Ware
UK
Mette C. Bryder
Chemical and Pharmaceutical Research
H. Lundbeck A/S
Valby
Denmark
Jeanine L. Bussiere
Amgen Inc.
Thousand Oaks, CA
USA
Patricia W. Cash
MedImmune
Gaithersburg, MD
USA
David Clapham
David Clapham, Independent Pharmaceutical Consultant
Hertfordshire
UK
John Connelly
ApoPharma Incorporated
Toronto, Ontario
Canada
John G. Davies
MedImmune
Gaithersburg, MD
USA
David Elder
David P Elder Consultancy
Hertford
UK
Daniel Galbraith
BioOursource Ltd.
Glasgow
UK
Di Gao
AstraZeneca
Frederick, MD
USA
Richard Harris
AstraZeneca
Frederick, MD
USA
James Harvey
GSK
Ware
UK
Per Holm
Chemical and Pharmaceutical Research
H. Lundbeck A/S
Valby
Denmark
René Holm
Chemical and Pharmaceutical Research
H. Lundbeck A/S
Valby
Denmark
Yoen Joo Kim
MedImmune
Gaithersburg, MD
USA
Kim Li
Amgen Inc.
Thousand Oaks, CA
USA
Zhong Liu
Merck & Co. Inc.
Kenilworth, NJ
USA
and
Currently at: Adello Biologics
Piscataway, NJ
USA
Robert McCombie
Genentech Inc.
San Francisco, CA
USA
Raymond Peter Munden
Munden Consultancy
Royston
UK
Gordon Munro
Munro‐Elbrook Associates
Welwyn
UK
Raymond W. Nims
RMC Pharmaceutical Solutions, Inc.
Longmont, CO
USA
Ronald Ogilvie
Pfizer
Sandwich
UK
Danny Ooi
Genentech, a Member of the Roche Group
South San Francisco, CA
USA
Mark Plavsic
Lysogene
Cambridge, MA
USA
David Pollard
Merck & Co. Inc.
Kenilworth, NJ
USA
and
Currently at: Amicus Therapeutics
Cranbury, NJ
USA
Qiang Qin
AstraZeneca
Frederick, MD
USA
and
Current Affiliation: GlaxoSmithKline
Rockville, MD
USA
Jinshu Qiu
Amgen Inc.
Thousand Oaks, CA
USA
Anil Raghani
Coherus BioSciences, Inc.
Camarillo, CA
USA
Ramani R. Raghavan
Merck & Co., Inc.
Rahway, NJ
USA
Andy Rignall
AstraZeneca
London
UK
Scott R. Rudge
RMC Pharmaceutical Solutions, Inc.
Longmont, CO
USA
Timothy L. Schofield
Current Affiliation: GlaxoSmithKline
Rockville, MD
USA
and
MedImmune
Gaithersburg, MD
USA
Garry Scrivens
Pfizer
Sandwich
UK
Steven Spanhaak
Janssen Pharmaceutica NV
Beerse
Belgium
Andrew Teasdale
AstraZeneca
Macclesfield
UK
Sarah Thompson
AstraZeneca
Macclesfield
UK
Larry Wigman
Genentech, a Member of the Roche Group
South San Francisco, CA
USA
Jianxin Ye
Currently at: Amicus Therapeutics
Cranbury, NJ
USA
and
Merck & Co. Inc.
Kenilworth, NJ
USA
Roujian Zhang
AstraZeneca
Frederick, MD
USA
The International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use was initiated in April 1990. ICH had the initial objective of coordinating the regulatory activities of the European, Japanese, and the United States bodies (along with the pharmaceutical trade associations from these three regions), to discuss and agree the scientific and technical aspects arising from product registration. This was recently supplemented by the addition of Health Canada and Swissmedic, to the core ICH Steering Committee (SC) [1].
At the initial ICH SC meeting the terms of reference were agreed and it was decided that harmonisation initiatives would be divided into Safety (S), Quality (Q), and Efficacy (E), reflecting the main criteria which underpin the approval and authorization of new medicinal products. It was subsequently realised that several topics were multi‐disciplinary (M) in nature.
Thus, ICH’s mission was to realize greater harmonization in both the interpretation and application of requirements for new product registration, with the objective of minimizing repetition/duplication of both testing and reporting, which is routinely performed as part of the development of new medicinal products. Harmonizing these differences via the ICH guidelines would help industry reduce development times, save resources and benefit the patient.
It is difficult not to underestimate the benefits of the ICH initiative in general and the ICH Quality guidelines in particular (and those related Multi‐Disciplinary guidelines), to the CMC community. Although it is fair to state that not all of the guidelines have been equally successful; it is very clear that the majority have been very successful and there is an ongoing recognition of the need to update and maintain the guidance in line with new developments and technological advances. Furthermore, the desire to extend the benefits of harmonisation beyond the ICH regions through collaborative efforts is to be welcomed and brings us a step closer to global harmonisation of these important principles of medicinal product evaluation. As part of the objective to extend its global outreach, ICH recently welcomed new regulatory members from Brazil and South Korea. In addition regulatory authorities from Cuba, Kazakhstan, and South Africa were also agreed as ICH Observers [2].
The success of the ICH guidelines, in many ways has been due to the adoption of overarching principles and a guidance framework describing the main requirements for compliance without being overly prescriptive. Yet while varying levels of detailed information has been included in the different guidelines to facilitate understanding, it has left many seeking further clarification on the practical application of the guidance. The purpose and benefit of this book is that it allows the reader a deeper insight provided through dedicated chapters into the practical aspects of a specific guideline’s application.
Each of the chapters seeks to examine the key requirements of the specific guidelines and then considers the challenges both in interpretation and practical implementation. It is this perspective, looking behind the basic framework; and then examining both the intent and practical guidance that I believe will make this text an essential aid to those involved in CMC matters, both from an industry and regulators’ perspective.
To achieve the intended goal the Editors have pulled together an unrivalled collation of subject matter experts aligned to each chapter, many involved directly in the derivation of the ICH guidelines themselves.