Description
An introduction to control and management of manufacturing and quality control testing of pharmaceutical products.
Course Objectives
Students completing this course should be able to:
- Describe what types of micro-organisms may be found in pharmaceutical products, water, and the environment
- Identify the major sources of microbial contamination and what is considered to be "objectionable"
- Identify microbial contamination problems in the workplace
- Identify procedures to reduce the chance of microbial contamination
Course Outline
INTRODUCTION
1. Welcome
2. What do you think?
3. GMP solution
4. Objectives
5. Reviews and assessments
BACTERIA AND FUNGI
6. What do you think?
7. GMP solution
8. Overview
9. Roles of bacteria and fungi
10. Basic classification of bacteria
GROWTH OF MICROBES
11. What do you think?
12. GMP solution
13. Overview
14. Physical environment
15. How bacteria grow
16. How fast can bacteria multiply?
17. How bacteria die
18. Review
MICRO-ORGANISM CONTROL
19. What do you think?
20. GMP solution
21. Objectionable organisms
22. Minimising microbes
23. Microbial control issues
24. Starting materials control
25. Control of equipment
26. Control of water
27. What do you think?
28. GMP solution
29. Control of environment
30. Personal hygiene
31. Some GMP citations
32. Review
CONCLUSION
33. Summary