Destin A. Leblanc

Cleaning Validation (eBook, PDF)

Practical Compliance Approaches for Pharmaceutical Manufacturing

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 216
• Erscheinungstermin: 23. Dezember 2022
• Englisch
• ISBN-13: 9781000835595
• Artikelnr.: 66716201

Autorenporträt

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.

Inhaltsangabe

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