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.
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.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
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
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
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