Description
The GMP requirements for the control of packaging materials and operations. Participants explore why labeling problems are still one of the most common causes of product recall.
Course Objectives
Students completing this course should be able to:
- Define what is meant by mislabeling
- State the critical GMP requirements for packaging controls
- Describe the GMP controls for pre-printed matter
- Identify the GMP requirements of setting up a packaging line
- State the importance of online controls
- Perform basic reconciliation calculations
Course Outline
INTRODUCTION
1. Welcome
2. Outcomes
3. Reviews and assessments
4. What do you think?
5. GMP solution
6. Top reasons for drug recalls
POTENTIAL MISLABELLING
7. What do you think?
8. GMP solution
9. Overview
10. Labelling recalls
11. Packaging controls
PRINTED MATERIALS CONTROL
12. What do you think?
13. GMP solution
14. Overview
15. GMP controls at the printers
16. Receiving printed matter
17. Printed matter issue, coding and returns
18. Review
LINE CLEARANCE & SETUP
19. What do you think?
20. GMP solution
21. Overview
22. Line clearances
23. Performing a line setup
24. Clearing the line post-use
25. Review
ONLINE CONTROLS
26. What do you think?
27. GMP solution
28. Overview
29. Checking fill volume and seal integrity
30. Run charts
31. Control charts
32. Monitoring packaging and deviations
33. Review
RECONCILIATION
34. What do you think?
35. GMP solution
36. Overview
37. Calculating reconciliation
38. Reconciliation walkthrough
39. Reconciliation example
40. Review
SUMMARY
41. Summary