Optimizing Cleaning Validation in the Pharmaceutical Industry

Pharmaceutical manufacturers and upper management are facing new challenges in implementing science-based and risk-based approaches to cleaning validation. To overcome these challenges, it is essential to design and implement an effective and efficient cleaning validation program. This comprehensive guide provides timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area that is rapidly evolving in terms of health-based limits.

Expert Insights and Industry Experience

Written by Destin A. LeBlanc, a renowned expert in the field of cleaning validation and hazardous materials, this book draws on his vast experience to provide practical guidance and insights on the latest developments in cleaning validation. From EMA vs. ISPE on cleaning limits to revised Risk-MaPP for highly hazardous products in shared facilities, this book covers a diverse range of topics, including protocol limits for yeasts and molds, and cleaning validation for homeopathic drug products.

Key Features and Benefits

• Timely coverage of cleaning validation for the pharmaceutical industry
• Practical guidance on designing a more effective and efficient cleaning validation program
• Expert insights from an experienced author in the field of cleaning validation and hazardous materials
• Covers a range of topics, including EMA vs. ISPE on cleaning limits and revised Risk-MaPP for highly hazardous products in shared facilities
• Provides valuable information on protocol limits for yeasts and molds, and cleaning validation for homeopathic drug products

Publisher: CRC Press, December 2022, Language: English, ISBN: 9781000835595, ISBN: 9781000835618

Stay ahead of the curve in cleaning validation and ensure compliance with the latest regulations and guidelines. This book is an essential resource for pharmaceutical manufacturers, upper management, and quality assurance professionals seeking to improve their cleaning validation programs.