Description
Builds on the Contamination Control module. Controls for starting materials, dispensing and processing, what actions to take when confronted with non-conforming materials, products and processes, and calculating yields and reconciliations.
Course Objectives
Students completing this course should be able to:
- Identify the controls required for receiving, storing, and dispensing raw materials
- Identify the process controls in room and line clearance, formulation, in-process checks, and batch records
- State the GMP requirements for handling manufacturing deviations
- Recognize how yield and reconciliation are calculated
Course Outline
INTRODUCTION
1. Welcome
2. Objectives
3. Reviews and assessments
4. What do you think?
5. GMP solution
6. GMP and production
STARTING MATERIAL CONTROL
7. What do you think?
8. GMP solution
9. Overview
10. Receiving and issuing raw materials
11. Receiving materials
12. Storing received materials
13. Sampling and testing
14. GMP storage requirements
15. Protecting raw materials
16. Issue of materials
17. Review
DISPENSING CONTROL
18. What do you think?
19. GMP solution
20. Overview
21. The dispensing process
22. Dispensary room clearance
23. Setup
24. Weighing
25. A dispensing step
26. Identifying dispensed material
27. Clean-up
28. Review
PROCESSING CONTROL
29. What do you think?
30. GMP solution
31. Overview
32. Room and line clearance
33. Introducing materials
34. Formulation controls
35. In-process checks
36. Monitoring processes
37. Testing line samples
38. Batch records
39. GMP and batch records
40. Post-processing clean-up
41. GMP regulatory citations
42. Review
PROCESS MONITORING
43. What do you think?
44. GMP solution
45. Overview
46. Handling process deviations
47. Controlling a process
48. GMP and handling deviations
YIELD AND RECONCILIATION
49. Overview
50. Theoretical yield & expected yield
51. Actual yield
52. Calculating reconciliation
53. GMP and yield/reconciliation
54. Review
CONCLUSION
55. Summary
56. Summary II