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GMP4: Cleaning and Sanitation

  

Description


Participants are given a thorough understanding of the importance of cleaning and sanitizing procedures and their responsibilities, and why these are important parts of their (and not cleaners') jobs.

Course Objectives


Students completing this course should be able to:

  • Define the meaning of the words "cleaning" and "sanitation"
  • Recognize why you need to clean before you sanitize
  • Identify the GMP requirements for documenting cleaning and sanitizing activities
  • Explain the reasons why you must use only approved cleaning and sanitizing materials
  • Explain why cleaning and sanitation prevents product contamination

Course Outline


INTRODUCTION
1. Welcome
2. Objectives
3. Reviews and assessments

CLEANING AND SANITATION DEFINED
4. What do you think?
5. GMP solution
6. Overview
7. What is cleaning?
8. What is sanitation?
9. Types of sanitizing agents
10. GMP rules and cleaning
11. What must be cleaned?
12. Protecting yourself
13. Review

FACILITY CLEANING
14. What do you think?
15. GMP solution
16. Overview
17. GMP issues when cleaning
18. Cleaning the facility
19. Buildings and grounds
20. Inward goods and product storage areas
21. Correct cleaning techniques
22. Pest control
23. Review

EQUIPMENT CLEANING
24. What do you think?
25. GMP solution
26. Overview
27. Common and dedicated equipment
28. Equipment hold times
29. Cleaning status tags
30. The use of water
31. Cleaning agents
32. Cleaning equipment
33. Review

CLEANING RECORDS
34. What do you think?
35. GMP solution
36. Overview
37. Status tags & cleaning logs
38. How clean is clean?

CLEAN-IN-PLACE (CIP) SYSTEMS
39. Overview
40. CIP system considerations

SUMMARY
41. Summary