Method Validation in Pharmaceutical Analysis

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.

Auteur

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. 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.

Contenu

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