Cleaning Validation - Destin A. LeBlanc

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Auteur(s) : Destin A. LeBlanc

Editeur : Taylor & Francis Ltd

Langue : Anglais

Parution : 01/12/2022

Format : Moyen, de 350g à 1kg

Nombre de pages : 204

ISBN : 1032430834

Résumé :
Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this Volume will help in designing a more effective and efficient cleaning validation program.

Biographie:

Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing series published by PDA and DHI. He is a member of PDA and ISPE and has trained FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.

Sommaire:

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