Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing

Cover
Half Title
Title Page
Copyright Page
Table of Contents
Preface
About the Author
Section I: Terminology
	Chapter 1: Use of the Term “Product”
		References
	Chapter 2: Use of the Terms Grouping and Matrixing
		References
	Chapter 3: Deviations and Nonconformances
		References
	Chapter 4: Clarifying Terms: Blanks vs. Controls
		References
	Chapter 5: Meaning of “Dedicated”?
		References
	Chapter 6: Words (Again?)
		References
Section II: Health-Based Limits
	Chapter 7: What’s at Stake with HBELs
		References
	Chapter 8: A Look at the Revised Risk-MaPP
		Some Partially “Good” News
		What’s New Or Different
		References
	Chapter 9: EMA’s Q&A Clarification: Part 1
		Question #1
		Question #2
		Question #3
		Question #4
		Question #5
		References
	Chapter 10: EMA’s Q&A Clarification: Part 2
		Question #6
		Question #7
		Question #8
		Question #9
		Question #10
		Question #11
		Question #12
		Question #13
		Question #14
		References
	Chapter 11: The EMA Q&A “Clarification” on Limits
		References
	Chapter 12: The EMA Q&A on Routine Analytical Testing
		References
	Chapter 13: Other Issues in EMA’s Q&A
		References
	Chapter 14: Highly Hazardous Products in Shared Facilities
		References
Section III: Limits: General
	Chapter 15: EMA vs. ISPE on Cleaning Limits?
		References
	Chapter 16: Does a High “Margin of Safety” Protect Patients?
		References
	Chapter 17: What If the Next Product Is the Same Product?
	Chapter 18: Limits for “Product A to Product A”
	Chapter 19: Surfaces Areas in Carryover Calculations
	Chapter 20: Carryover Calculation Errors to Avoid
		References
	Chapter 21: Protocol Limits for Yeasts/Molds?
		References
	Chapter 22: Cleaning Validation for Homeopathic Drug Products
		References
	Chapter 23: A Possible Approach for Biotech Limits
		References
	Chapter 24: Establishing Clearance for Degraded Protein Actives
		References
Section IV: Visually Clean
	Chapter 25: Avoiding “Visually Dirty” Observations
	Chapter 26: What’s a Visual Limit?
	Chapter 27: Visual Residue Limits: Part 1
		References
	Chapter 28: Visual Residue Limits: Part 2
		References
Section V: Analytical and Sampling Methods
	Chapter 29: Two More Nails in the Coffin?
		References
	Chapter 30: Timing for Swab Sampling in a Protocol?
	Chapter 31: More Swab Sampling Issues
		Controlling the Swabbed Area in Protocols
		Controlling the Swabbed Area in Recovery Studies
		Use of an Extension Pole for Swabbing Inaccessible Locations
		Use of Multiple Swabs for the Same Surface
	Chapter 32: Pass/Fail Analytical Test Methods
		References
Section VI: Product Grouping
	Chapter 33: Issues in Product Grouping
		One Approach for All Examples
		References
	Chapter 34: Toxicity as a Worst-Case Grouping Factor
	Chapter 35: Another “Worst Case” Product Grouping Idea
		Reference
Section VII: Protocols and Procedures
	Chapter 36: Issues in Rinsing: Part 1
		Reference
	Chapter 37: Issues in Rinsing: Part 2
	Chapter 38: Routine Monitoring for Highly Hazardous Products
		References
	Chapter 39: “Concurrent Release” for Cleaning Validation
		References
	Chapter 40: Dirty and Clean Hold Time Protocols
Section VIII: API Manufacture
	Chapter 41: A Critique of the APIC Guideline
		Daily Dose Definition
		Safety Factors for LD50 Calculations
		General Limit
		Rinse Limit
		Confusing Terminology
		Swab Sampling Equation
		References
	Chapter 42: Another Issue for API Synthesis
		References
	Chapter 43: Contaminants in API Manufacture
		References
Section IX: Miscellaneous Topics
	Chapter 44: Significant Figures: Back to Basics
		References
	Chapter 45: The Value of a Protocol Worksheet for Manual Cleaning
	Chapter 46: Dealing with Used and New Equipment
	Chapter 47: Solving Cleaning Validation Problems by Analogy
		References
	Chapter 48: Causing Cleaning Validation Problems by Analogy
		References
Appendix A: Acronyms Used in This Volume
Appendix B: Shorthand Notations for Expressing Limits
Index