Description
This module provides an introduction to the basic concepts and requirements of QC for microbiological testing laboratories under GMP requirements. The module reviews introduction to the basic concepts and requirements, and discusses issues focused on by laboratory auditors, specific pharmaceutical regulatory requirements, including requirements and guidelines for microbial limits for non-sterile products. The module also reviews the current laboratory guidelines published by the TGA and FDA.
Course Objectives
Students completing this course should be able to:
- Identify different classes of micro-organisms
- Describe and list typical objectionable organisms for different products
- Describe the basic cGMP requirements for a microbiology laboratory
- Follow correct procedures for safe disposal of cultures
- Describe the flow of samples and materials through the laboratory
Course Outline
BASIC MICROBIOLOGY
1. Introduction
2. Defining micro-organisms
3. Eukaryotes/Prokaryotes
4. Classifying bacteria
5. Counting difficulties
6. Review
OBJECTIONABLE ORGANISMS
7. Introduction
8. Concerns
9. Sources and examples
10. Review
GLP REQUIREMENTS
11. Introduction
12. Role of the laboratory
13. Sampling requirements
14. Overcoming issues
15. Lab system elements
16. Key media requirements
17. Culture collections
18. Biological indicators
19. Reporting results
20. Positive/Negative controls
21. Issues affecting validity
22. Review
HOUSEKEEPING AND WASTE DISPOSAL
23. Introduction
24. Risks of contamination
25. Entering/exiting the lab
26. Contaminated samples
27. Review
MATERIALS FLOW
28. Introduction
29. Importance
30. Key attributes
31. Stages
32. Review
CONCLUSION
33. Summary