Method Validation in Pharmaceutical Analysis (2nd completely rev. & updated Ed. (2^nd Ed.) A Guide to Best Practice

This second edition of a global best–seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies 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.

INTRODUCTION Analytical Validation within the Pharmaceutical Lifecycle ANALYTICAL EQUIPMENT QUALIFICATION Analytical Instrument and System Qualification Efficient and economic HPLC Performance Qualification ESTABLISHMENT OF MEASUREMENT REQUIREMENTS Analytical Target Profile and Decision Rules Performance Based Specifications METHOD PERFORMANCE CHARACTERISTICS Precision Accuracy and Range Specificity Linearity Detection and Quantitation Limit Glossary METHOD DESIGN AND UNDERSTANDING Method Selection, Development and Optimisation Analytical Quality by Design and Robustness Investigations Case Study Robustness Investigations System Suitability Tests METHOD PERFORMANCE QUALIFICATION Case Study: Qualification of an HPLC Method for Identity, Assay, and Degradation Products Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurised Metered Dose Inhaler Implementation of Compendial/Pharmacopeia Test Procedures Transfer of Analytical Procedures CONTINUED METHOD PERFORMANCE VERIFICATION Routine Monitoring Investigating and Addressing Aberrant Data Continual Improvement

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 p