Description
Analytical test method validation is a fundamental QC requirement both for product registration and GMP inspection of laboratories. GMP auditing trends worldwide are now focusing on Good Laboratory Practices, and in particular, analytical method validation.
This module is designed to provide participants with techniques and procedures for the validation, analysis and control of analytical test methods. The presentation covers such topics as definitions of performance parameters and their acceptance criteria and how to set up for cost efficient accuracy, precision and linearity studies, etc. The industry requirements for documenting method validations (ICH, TGA, and FDA) will be presented, as well as tips and techniques for method transfer.
Course Objectives
Students completing this course should be able to:
- List the key method performance parameters used in validation
- Describe and calculate precision and accuracy
- Describe and calculate selectivity and sensitivity
- Describe and calculate linearity and range
- Describe and calculate robustness and system suitability
- State the differences between validation and verification of methods
Course Outline
INTRODUCTION
1. Introduction
2. Analytical method users
3. Regulatory standards
4. ICH standards
5. Summary
6. Review
VALIDATION PHILOSOPHY
7. Introduction
8. Basic validation philosophy
9. Pre-requisites
10. Analytic methods
11. Performance parameters
12. Protocol structure
METHOD PERFORMANCE PARAMETERS
13. Introduction
14. Performance parameters
15. Precision I
16. Precision II
17. Accuracy I
18. Accuracy II
19. Method capability
20. Method specificity
21. Linearity and Range
22. Sensitivity, LOD and LOQ I
23. Sensitivity, LOD and LOQ II
24. Sensitivity, LOD and LOQ III
25. Ruggedness/robustness
26. Review
METHOD TRANSFER
27. Method transfer verification
28. Requirements
29. Review
STABILITY INDICATING ASSAYS
30. Requirements
31. Review
COMPENDIAL METHOD VALIDATION
32. Pharmacopoeial methods
CONCLUSION
33. Summary