Cleaning Validation

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