Method Validation in Pharmaceutical Analysis

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.