Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3 (single user digital version)

Published
May 2017
ISBN
1933722681
Pages
251
PDA Item Number
18035
Format
PDF Single user
Member Price
$212.00
Nonmember Price
$263.00
Government Price
$144.00

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In Destin LeBlanc's Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation.

Volume 3, a complement to Destin's two earlier books on the same subject, presents modifications and updates of his monthly Cleaning Memos originally published from January 2009 through December 2012. Each Cleaning Memo is presented as a chapter, with the chapters then organized by common topics. For example, topics related to setting limits are in one section, those related to sampling in another section, and so forth. An appendix with a list of acronyms is included as well.

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Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

General Topics

    1. The Changing Paradigm for Cleaning Validations
    2. Differences between Cleaning and Process Validation
    3. "Design Space" for Cleaning Processes
    4. Understanding the Cleaning Process in 2010 (and Beyond)
    5. "Continued" vs. "Continuous" Process Verification
    6. Revisiting "Cleaning Verification"
    7. How to Completely Avoid Doing Cleaning Validation
Special Situations
    8. Significance of Water Activity for Cleaning Validation
    9. Issues in Cleaning Validation for Parts Washers
    10. Manual Cleaning Issues — Part 1
    11. Manual Cleaning Issues — Part 2
    12. More on Campaign Length
    13. Use of Alkali/Acid Cleaning Agents in Biotech
Residue Limits
    14. Revisiting Limits Based on Process Capability
    15. Differing Ways to Express Limits
    16. My Revised Shorthand for Expressing Limits
    17. Limits Below the LOD in Rinse Solutions — Part 1
    18. Limits Below the LOD in Rinse Solutions — Part 2
    19. Limits Below the LOD in Rinse Solutions — Part 3
    20. Limits for Rinse "Grab" Samples
    21. Another Alternative for Rinse Sampling Limits?
    22. Basics of "Stratified Sampling"
    23. More on "Stratified Sampling"
    24. Final Notes on "Stratified Sampling"
    25. A Conundrum Regarding Limits
    26. The Science Behind Limits
Risk-MaPP
    27. A Critique of Cleaning Validation Issues in ISPE's RiskMaPP
    28. More on ISPE's RiskMaPP
    29. Where Risk-MaPP Got it Wrong
    30. The Good, the Bad and the Inexplicable of Risk-MaPP
    31. How are ADEs Determined for Non-Highly Hazardous Actives?
    32. Another Critique of Risk-MaPP
Visually Clean
    33. Visually Clean and Visual Limits
    34. More Uses for Visual Limit Determination
    35. Statistics for Visual Limits
Sampling
    36. What's an "Equivalent" Swab?
    37. Use of Multiple Swabs for Sampling
    38. The Rationale for Rinse Sampling for Cleaning Agents
Sampling Recovery
    39. Revisiting Linearity of Swab Recovery Results
    40. Swab Sampling Recovery as a Function of Residue Level
    41. Acceptable Variability for Sampling Recovery Studies
    42. An Alternative Swab Recovery Procedure
    43. More on an Alternative Swab Recovery Procedure
    44. Grouping for Surfaces for Swab Recovery Studies?
Protocol Issues
    45. What's Happening to Worst-case Process Conditions?
    46. What does the FDA Process Validation Guidance say about the Number of Qualification Runs
    47. Selecting the Number of Validation Runs for Equipment Grouping
    48. Hold Time Issues
Regulatory Issues
    49. Regulatory Guidances I'd Like to See Changed — Part 1
    50. Regulatory Guidances I'd Like to See Changed — Part 2
Appendix A:
Acronyms Used in this Volume

About the Authors

About the Author

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 trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.

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