Description
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
