Overview

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.

Full Product Details

Author:   Destin A. LeBlanc
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.400kg
ISBN:  

9781032431734

ISBN 10:   1032431733
Pages:   204
Publication Date:   09 October 2024
Audience:   College/higher education ,  Professional and scholarly ,  Tertiary & Higher Education ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

"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"

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Author Information

Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the ""Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing"" series published by PDA and DHI. He is a member of PDA and ISPE and has trained FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.

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