Description
The role of documentation in providing a history of manufacturing from supplier to customer. The requirements of Standard Operating Procedures (SOPs), Batch Processing Records, Quality Control Records and Logs are discussed and developed.
Course Objectives
Students completing this course should be able to:
- Recognize the importance of procedures
- Recognize the importance of record keeping
- Identify the possible consequences of not completing and certifying GMP documents
- Identify how to complete batch records and associated supporting documents
Course Outline
INTRODUCTION
1. Welcome
2. Outcomes
3. Reviews and assessments
NEED FOR DOCUMENTATION
4. What do you think?
5. GMP solution
6. Need for documentation
7. GMP compliant documents
8. Documentation & records
9. Document control
10. GMP rules for control
11. Introducing a standard procedure
12. Review
GMP DOCUMENTATION
13. What do you think?
14. GMP solution
15. Specification
16. Inward goods
17. Production
18. Packaging
19. Quality Control
RECORD KEEPING
20. What do you think?
21. GMP solution
22. Importance of record keeping
23. Completing records
24. Changes to records
25. Review
THE FIXITKWIK CASE STUDY
26. What do you think?
27. GMP solution
28. Introduction
29. Investigation
30. What is your conclusion?
31. Review
SUMMARY
32. Summary