Method Validation in Pharmaceutical Analysis (eBook, PDF)

A Guide to Best Practice
Redaktion: Ermer, Joachim; Nethercote, Phil W.

• Format: PDF

Produktbeschreibung

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 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 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.

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Produktdetails

• Verlag: Wiley-VCH
• Seitenzahl: 542
• Erscheinungstermin: 25. Februar 2025
• Englisch
• ISBN-13: 9783527831692
• Artikelnr.: 73498586

Autorenporträt

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.

Inhaltsangabe

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