Method Validation in Pharmaceutical Analysis (Hardcover)

Joachim Ermer

ISBN 10: 3527348905 / ISBN 13: 9783527348909

Edité par Wiley-VCH Verlag GmbH, Berlin, 2025

Hardcover. New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, 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 on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot 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 relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualificationAnalytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical proceduresMethod selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategyImplementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a 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, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. N° de réf. du vendeur 9783527348909

Synopsis :

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.

À propos de l?auteur:

Joachim Ermer worked for 30 years in the pharmaceutical industry, including analytical development, global responsibilities, Head of Quality Control, and head of QC Lifecycle Management, before he started in December 2020 his consultancy business.

Phil W. Nethercote was the analytical leader for the Global Manufacturing and Supply Division of GSK until he retired in 2016. He has over 30 years of experience in the pharmaceutical industry, the majority of which has been with Glaxo, Glaxo Wellcome and GSK.

Détails bibliographiques

Titre : Method Validation in Pharmaceutical Analysis...
Éditeur : Wiley-VCH Verlag GmbH, Berlin
Date d'édition : 2025
Reliure : Hardcover
Etat : new
Edition : 3ème Édition