Method Validation in Pharmaceutical Analysis

A Guide to Best Practice
3. Auflage 2025
ISBN: 978-3-527-34890-9
Verlag: Wiley-VCH GmbH

Buch, Englisch, 544 Seiten, Format (B × H): 174 mm x 244 mm, Gewicht: 1180 g

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.

Autoren/Hrsg.

Ermer, Joachim

Nethercote, Phil W.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Verfahrenstechnik, Chemieingenieurwesen
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Naturwissenschaften Chemie Chemie Allgemein Chemische Labormethoden, Stöchiometrie

Inhaltsverzeichnis

1. Analytical Validation within the Pharmaceutical Lifecycle
2. Data Governance, Data Integrity and Data Quality
3. Analytical Instrument Qualification & System Validation Lifecycle
4. Continued HPLC performance qualification
5. Analytical Target Profile
6. Decision Rules and Fitness for Intended Use
7. Performance Characteristics of Analytical Procedures
8. ICHQ14 Analytical Procedure Development
9. Method Selection, Development, and Optimization
10. Multivariate Analytical Procedures
11. Case Study: Robustness Investigations
12. Risk Assessment and Analytical Control Strategy
13. ICH Q2(Revision 2): Validation of Analytical Procedures
14. Case Study: Validation of an HPLC Method for Identity, Assay, and Degradation Products
15. Case Study: Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurised Metered Dose Inhaler with a Focus on Sample Preparation.
16. Case Study: Validation of a Bioassay Method
17. Implementation of Compendial/Pharmacopeia Test Procedures
18. Transfer of Analytical Procedures
19. Lifecycle Approach to Transfer of Analytical Procedures
20. Continuous Improvements, Adjustments and Changes
21. Monitoring of Analytical Performance

Über Autor(innen)

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.