Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing

✍ Scribed by Destin A. LeBlanc

• Publisher: CRC Press
• Year: 2022
• Tongue: English
• Leaves: 216
• Series: Practical Compliance Solutions for Pharmaceutical Manufacturing, 5
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

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