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Navigable Slide Index

1. Introduction
2. Contents
3. Principles of GLP
4. Documents for compliance monitoring authorities
5. Consensus documents (1)
6. Consensus documents (2)
7. Advisory documents
8. OECD guidelines for the testing of chemicals
9. Documents in GLP quality system
10. Documents produced in each step of the study
11. Definition of SOPs
12. SOPs - what are they?
13. What should be covered by SOPs?
14. Why do we need SOPs? (1)
15. Why do we need SOPs? (2)
16. The SOP of SOPs
17. Who writes SOPs?
18. Roles of different personnel
19. Role of QA with SOPs
20. Role of management
21. Who is management? (1)
22. Who is management? (2)
23. Role of study personnel
24. Deviations from SOPs
25. Storage of SOPs
26. List of SOPs: test and reference items
27. List of SOPs: apparatus and materials
28. List of SOPs: computerised systems
29. Record keeping, reporting, storage and retrieval
30. List of SOPs: test system (1)
31. List of SOPs: test system (2)
32. List of SOPs: QA inspections covering
33. SOPs from sponsors
34. e-SOPs (1)
35. e-SOPs (2)
36. SOPs for field studies
37. Multi-site situation?
38. Multi-site: procedures described in SOPs
39. Multi-site: test site SOPs
40. Multi-site: if test facility SOPs used
41. Multi-site: deviations
42. Inspecting SOPs: at the starting conference
43. Inspecting SOPs: the SOP of SOPs
44. Inspecting SOPs: study deviations
45. Inspecting SOPs: the laboratory area and QA
46. Inspecting SOPs: inspect different roles of people
47. Deviations sometimes observed
48. References

Topics Covered

• Reasons for having SOPs
• Requirements needed for SOP systems to comply with OECD principles
• SOP requirements for sponsors
• e-SOPs
• Field Studies
• Multi-site studies
• How to inspect SOPs

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

• Mrs. Katariina Rautalahti has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.