J Ermer

Gebundenes Buch

Method Validation in Pharmaceutical Analysis

A Guide to Best Practice

Herausgegeben: Ermer, Joachim; Nethercote, Phil W.

Beschreibung

The third edition of this global standard guide for validated pharmaceutical analysis now incorporates the 2023 ICH guidelines Q2 and Q14, and new sections on data integrity and continuous monitoring.

Autor

Joachim Ermer is Head of QC Lifecycle Management Chemistry at Sanofi in Frankfurt, Germany. He is also Global Reference Standards Coordinator and responsible for the Reference Standards Logistic group in Frankfurt. He studied biochemistry and obtained a PhD in enzyme kinetics from University of Halle in 1988. He has almost 30 years of experience in pharmaceutical analytics including development products, global responsibilities as Director of Analytical Processes and Technology, and Head of Quality Control Chemistry. He is member of the USP Expert Panel on Analytical Procedure Lifecycle, of the EFPIA support team for the update/establishment of ICH Q2/Q14, and of the European Pharmacopoeia Working Group Chromatographic Separation Techniques. Dr. Ermer is a frequent speaker at national and international conferences with more than 200 presentations, courses and workshops and the author of more than 50 publications on analytical topics.   Phil Nethercote was the analytical leader for the Global Manufacturing and Supply Division of GSK until he retired in 2016. 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 has over 30 years of experience in the pharmaceutical industry the majority of which has been with Glaxo, Glaxo Wellcome and GSK where he led analytical development and new product introduction teams in the UK and in Singapore. In his role as analytical leader in GSK he provided leadership for analytical systems, processes and standards across GSK's global network of manufacturing sites. He was a member of the USP expert panel on Validation and Verification and the EFPIA Analytical Quality by Design working group and is currently a member of the British Pharmacopeia AQbD working group.

Produktdetails

• Verlag: Wiley-VCH
• Artikelnr. des Verlages: 1134890 000
• 3. Aufl.
• Seitenzahl: 544
• Erscheinungstermin: 5. Februar 2025
• Englisch
• Abmessung: 244mm x 174mm x 32mm
• Gewicht: 666g
• ISBN-13: 9783527348909
• ISBN-10: 3527348905
• Artikelnr.: 71215217