Cleaning Validation - Destin A. LeBlanc

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Résumé :

Terminology

1. Use of the Term Product
2. Use of the Terms Grouping and Matrixing
3. Deviations and Nonconformances
4. Clarifying Terms: Blanks vs. Controls
5. Meaning of Dedicated?
6. Words (Again??)
   

Health-based Limits

7. What's at Stake with HBELs
8. A Look at the Revised Risk-MaPP
9. EMA's Q&A Clarification: Part 1
10. EMA's Q&A Clarification: Part 2
11. The EMA Q&A Clarification on Limits
12. The EMA Q&A on Routine Analytical Testing
13. Other Issues in EMA's Q&A
14. Highly Hazardous Products in Shared Facilities
    

Limits - General

15. EMA vs. ISPE on Cleaning Limits?
16. Does a High Margin of Safety Protect Patients?
17. What If the Next Product is the Same Product?
18. Limits for Product A to Product A
19. Surfaces Areas in Carryover Calculations
20. Carryover Calculation Errors to Avoid
21. Protocol Limits for Yeasts/Molds?
22. Cleaning Validation for Homeopathic Drug Products
23. A Possible Approach for Biotech Limits
24. Establishing Clearance for Degraded Protein Actives
    

Visually Clean

25. Avoiding Visually Dirty Observations
26. What's a Visual Limit?
27. Visual Residue Limits - Part 1
28. Visual Residue Limits - Part 2

Analytical and Sampling Methods

29. Two More Nails in the Coffin?
30. More Swab Sampling Issues
31. Timing for Swab Sampling in a Protocol?
32. Pass/Fail Analytical Test Methods
    

Product Grouping

33. Issues in Product Grouping
34. Toxicity as a Worst-Case Grouping Factor
35. Another Worst Case Product Grouping Idea
    

Protocols and Procedures

36. Issues in Rinsing - Part 1
37. Issues in Rinsing - Part 2
38. Routine Monitoring for Highly Hazardous Products
39. Concurrent Release for Cleaning Validation
40. Dirty and Clean Hold Time Protocols
    

API Manufacture

41. A Critique of the APIC Guideline
42. Another Issue for API Synthesis
43. Contaminants in API Manufacture
    

Miscellaneous

44. Significant Figures: Back to Basics
45. The Value of a Protocol Worksheet for Manual Cleaning
46. Dealing with Used and New Equipment
47. Solving Cleaning Validation Problems by Analogy
48. Causing Cleaning Validation Problems by Analogy

Appendix A: Acronyms Used in this Volume

Appendix B: Shorthand Notations for Expressing Limits

Index