To purchase this product, please visit https://www.wiley.

com/en-us/9783527335633

Method Validation in Pharmaceutical Analysis: A

Guide to Best Practice, 2nd Edition
Joachim Ermer (Editor), Phil W. Nethercote (Editor)

E-Book 978-3-527-67218-9 August 2014 $156.00

Hardcover 978-3-527-33563-3 November 2014 Print-on- $195.00

demand

O-Book 978-3-527-67220-2 August 2014 Available on Wiley

Online Library

DESCRIPTION

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new

Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing.

As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes
how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic

approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are

established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines

for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance

Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate

the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH)

regulatory authorities are considered throughout.

The undisputed gold standard in the field.

 ABOUT THE AUTHOR

Joachim Ermer is Head of Quality Control Services Chemistry at Sanofi in Frankfurt, Germany, and Global Reference Standards

Coordinator of Sanofi. He studied biochemistry at University of Halle, Germany, and obtained a PhD in enzyme kinetics in 1988.
He has more than 20 years of experience in pharmaceutical analytics including development projects, global responsibilities

as Director of Analytical Processes and Technology, and Head of Quality Control. He is member of the USP Expert Panel

on Validation and Verification, of the EFPIA Quality by Design Working Group, and of the Focus Group Analytics and Quality

Assurance of the International Association of Pharmaceutical Technology (APV). From 2000 till 2008, he was Deputy Head of the
Working Group Quality Control / Pharmaceutical Analytics of the German Pharmaceutical Society (DPhG). His special interest has

been focused early on analytical validation and related topics, such as performance evaluation, statistics, and transfer of analytical

procedures..

Phil Nethercote is the Analytical Head and API Analytical Lead for the Global Manufacturing and Supply division of GSK. He has

a degree in chemistry from Herriot Watt University in Edinburgh and obtained a PhD in HPLC retention mechanisms from the

University of Stirling in 1987. He is a Chartered Chemist and a member of the Royal Society of Chemistry. He has over 25 years of

experience in the pharmaceutical industry the majority of which has been with Glaxo, Glaxo Wellcome and GSK where he has led

analytical development and new product introduction teams in the UK and in Singapore. In his current role he provides leadership

for analytical systems, processes and standards across GSKs global network of manufacturing sites. He is member of the USP

Expert Panel on Validation and Verification, of the EFPIA Analytical Quality by Design Working Group and led the revision of the

analytical section of the second edition of the ISPE technology transfer guide He has a passion for ensuring efforts invested in
Analytical Method Validation and Transfer add real value in ensuring the methods produce fit for purpose data and has been a

strong advocate in applying QbD principles to help achieve that aim.

To purchase this product, please visit https://www.wiley.com/en-us/9783527335633