About the Book:

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. 

Features 

• Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. 

• The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. 

• Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. 

• Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. 

• A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.

Contents:

Section I - 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??)

Section II - 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

Section III - 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

Section IV - 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

Section V - 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

Section VI - Product Grouping

33. Issues in Product Grouping

34. Toxicity as a Worst-Case Grouping Factor

35. Another "Worst Case" Product Grouping Idea

Section VII - 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

Section VIII - API Manufacture

41. A Critique of the APIC Guideline

42. Another Issue for API Synthesis

43. Contaminants in API Manufacture

Section IX - 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