Cleaning Validation

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.

Autorentext

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.

Inhalt

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