Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing

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. 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