1st Edition
Cleaning Validation Practical Compliance Approaches for Pharmaceutical Manufacturing
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.
Terminology
- Use of the Term "Product"
- Use of the Terms Grouping and Matrixing
- Deviations and Nonconformances
- Clarifying Terms: Blanks vs. Controls
- Meaning of "Dedicated"?
- Words (Again??)
- What's at Stake with HBELs
- A Look at the Revised Risk-MaPP
- EMA's Q&A Clarification: Part 1
- EMA's Q&A Clarification: Part 2
- The EMA Q&A "Clarification" on Limits
- The EMA Q&A on Routine Analytical Testing
- Other Issues in EMA's Q&A
- Highly Hazardous Products in Shared Facilities
- EMA vs. ISPE on Cleaning Limits?
- Does a High "Margin of Safety" Protect Patients?
- What If the Next Product is the Same Product?
- Limits for "Product A to Product A"
- Surfaces Areas in Carryover Calculations
- Carryover Calculation Errors to Avoid
- Protocol Limits for Yeasts/Molds?
- Cleaning Validation for Homeopathic Drug Products
- A Possible Approach for Biotech Limits
- Establishing Clearance for Degraded Protein Actives
- Avoiding "Visually Dirty" Observations
- What's a Visual Limit?
- Visual Residue Limits – Part 1
- Visual Residue Limits – Part 2
- Two More Nails in the Coffin?
- More Swab Sampling Issues
- Timing for Swab Sampling in a Protocol?
- Pass/Fail Analytical Test Methods
- Issues in Product Grouping
- Toxicity as a Worst-Case Grouping Factor
- Another "Worst Case" Product Grouping Idea
- Issues in Rinsing - Part 1
- Issues in Rinsing - Part 2
- Routine Monitoring for Highly Hazardous Products
- "Concurrent Release" for Cleaning Validation
- Dirty and Clean Hold Time Protocols
- A Critique of the APIC Guideline
- Another Issue for API Synthesis
- Contaminants in API Manufacture
- Significant Figures: Back to Basics
- The Value of a Protocol Worksheet for Manual Cleaning
- Dealing with Used and New Equipment
- Solving Cleaning Validation Problems by Analogy
- Causing Cleaning Validation Problems by Analogy
Health-based Limits
Limits - General
Visually Clean
Analytical and Sampling Methods
Product Grouping
Protocols and Procedures
API Manufacture
Miscellaneous
Appendix A: Acronyms Used in this Volume
Appendix B: Shorthand Notations for Expressing Limits
Index
Biography
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.
