Full Description
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
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??)
Health-based Limits
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
Limits - General
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
Visually Clean
Avoiding "Visually Dirty" Observations
What's a Visual Limit?
Visual Residue Limits - Part 1
Visual Residue Limits - Part 2
Analytical and Sampling Methods
Two More Nails in the Coffin?
More Swab Sampling Issues
Timing for Swab Sampling in a Protocol?
Pass/Fail Analytical Test Methods
Product Grouping
Issues in Product Grouping
Toxicity as a Worst-Case Grouping Factor
Another "Worst Case" Product Grouping Idea
Protocols and Procedures
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
API Manufacture
A Critique of the APIC Guideline
Another Issue for API Synthesis
Contaminants in API Manufacture
Miscellaneous
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
Appendix A: Acronyms Used in this Volume
Appendix B: Shorthand Notations for Expressing Limits
Index
