Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

By Joachim Ermer

New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2 and Q14

Following an all-encompassing lifecycle approach to analytical procedures in pharmaceutical analysis, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis.

This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP Validation & Verification Expert Panel on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses trending topics in the field such as data integrity and continuous monitoring of analytical performance.

Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on sample topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle Continued HPLC performance qualification, analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and the lifecycle approach to transfer of analytical procedures

Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QA officers, and public authorities tasked with relevant regulatory responsibilities.

• Format: Hardcover
• Language: English
• ISBN: 3527348905
• ISBN13: 9783527348909
• Release Date: June 2025
• Publisher: Wiley-Vch
• Length: 544 Pages