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Navigable Slide Index

1. Introduction
2. OECD council decision - C(89)87(Final)
3. GLP compliance monitoring definition
4. Annex II to OECD recommendation C(89)87(Final)
5. The number of test facilities globally
6. Types of research under GLP
7. The inspector
8. The inspector: revised guidance no. 3
9. GLP inspections - frequency
10. Implementation inspection
11. Compliance monitoring inspection
12. For cause inspections
13. GLP inspections - announcement
14. GLP inspections - number of inspectors
15. Pre-inspection
16. Regular GLP inspection
17. Introductory meeting - who should attend
18. Introductory meeting (1)
19. Introductory meeting (2)
20. Short tour (optional)
21. Organisation and personnel
22. Quality assurance
23. Inspection tour
24. Facilities
25. Biological test systems (1)
26. Biological test systems (2)
27. Test systems
28. Test and reference items
29. Apparatus, materials, reagents, specimens
30. Computerised systems (1)
31. Computerised systems (2)
32. SOPs
33. Archiving
34. Study audits: study plan vs. performance
35. Study audits: final report
36. Closing conference
37. Definition of deficiencies
38. Follow-up to inspections and study audits
39. GLP status
40. Certificates
41. Where serious deviations are found
42. Confidentiality
43. Appeals procedures

Topics Covered

• Inspection procedures
• The organization of official authorities
• The performance of official authorities
• How to assess compliance with the OECD principles of Good Laboratory Practice

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

• Mr. Theo Helder has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.