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Navigable Slide Index

1. Introduction
2. Procedural assessments of SOPs
3. The assessment cycle
4. The assessment tool
5. Working instruction template
6. Key areas
7. The SOP title
8. Filling the working instruction template
9. Key areas- the scope of content
10. The scope of content
11. When scope covers multiple tasks
12. When scope is a part of a larger process
13. Filling the scope in our template
14. Key areas - content
15. Filling the procedure in our template
16. Authors of content
17. Authors of content recap
18. General content requirements
19. Further elements for the content (1)
20. Further elements for the content (2)
21. Importance of up-to-date information
22. Proper writing of the content
23. Proper revising of the content
24. Filling the checklist in our template
25. Preparing a checklist
26. Draft checklist (1)
27. Key areas - regulatory requirements
28. Sources of information
29. Other sources
30. Documentation
31. Key areas- format and language
32. Format (1)
33. Format (2)
34. Format (3)
35. Language
36. Draft checklist (2)
37. Draft checklist (3)
38. Points to remember
39. Key areas - added value
40. Added value
41. Key areas - feasibility
42. Feasibility
43. Complete working instruction template
44. Thanks and acknowledgements

Topics Covered

• Procedural assessment cycle and tools of SOPs
• Working instruction template
• The SOP title
• The scope of content
• When scope covers multiple tasks or is a part of a larger process
• Filling the scope, procedure & checklist in our template
• Authors, general requirements and further elements of content
• Importance of up-to-date information
• Proper writing & revising of the content
• Preparing a checklist
• Regulatory requirements
• Sources of information
• Documentation
• Format and language
• Points to remember
• Added value – Feasibility

Links

Series:

• SOPs for Regulatory Applications for the Pharmaceutical Industry

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Ollier, S. and Wilson, P. (2013, June 13). Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved June 3, 2023, from https://hstalks.com/bs/2565/.
Export Citation (RIS)

Publication History

• Published on June 13, 2013

Financial Disclosures

• Mrs. Susan Ollier has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
• Mrs. Pam Wilson has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.