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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.
List of contents
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
About the author
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.
