Description
This module introduces the student to the requirements for stability programs, their purpose, and how they are reviewed. Basic requirements for scheduling tests will be presented.
Course Objectives
Students completing this course should be able to:
- Describe the purpose and value of stability programs
- List the different standards and cGMP requirements for stability programs
- Set up a schedule for a stability program
- List which stability indicating tests are expected for which dose forms
- Assign a shelf life based on typical stability regression lines
- State why methods need to be stability indicating in nature
Course Outline
OVERVIEW
1. Introduction
2. International stability testing guidance
3. Importance
4. Purpose of stability studies
5. Stability and container closure systems
6. Stability and degradation products
7. Forced degradation profile
8. Kinetic models
9. Review
STABILITY PROTOCOLS AND SCHEDULES
10. Introduction
11. Stability studies
12. Real-time studies
13. Accelerated studies
14. Significant changes
15. Importance of stability protocols
16. Stability protocols
17. Bracketing
18. Matrix design
19. Testing frequency
20. Review
STORAGE CONDITIONS AND TESTS
21. Introduction
22. Storage conditions
23. Stability trial storage conditions
24. Active raw materials
25. Finished dose forms
26. Expected tests
27. Presentation of results
28. Review
STABILITY RESULTS AND SHELF LIFE
29. Introduction
30. Stability trial design
31. Evaluation of results
32. Typical problems
33. Nominating shelf life
34. Calculating shelf life
35. Review
STABILITY INDICATING METHODS
36. Introduction
37. Stability indicating methods
38. Test methods I
39. Test methods II
40. Review
SUMMARY
41. Summary