Optimizing Cleaning Validation in Pharmaceutical Manufacturing: A Science-Based Approach

Pharmaceutical manufacturers and upper management must rise to the challenges of implementing science-based and risk-based approaches to cleaning validation. By adopting some of the principles and practices outlined in this comprehensive volume, industry professionals can design and implement more effective and efficient cleaning validation programs.

Timely Coverage of a Critical Topic

This essential resource provides timely coverage of cleaning validation in the pharmaceutical industry, an area that is rapidly evolving in terms of health-based limits. The author, an expert in the field of cleaning validation and hazardous materials, encourages pharmaceutical manufacturers and upper management to take a proactive approach to addressing the challenges of cleaning validation.

Key Features and Benefits

• Draws on the author’s vast experience in cleaning validation and hazardous materials
• Examines the differences between EMA and ISPE on cleaning limits
• Discusses the revised Risk-MaPP for highly hazardous products in shared facilities
• Covers a diverse range of topics, including protocol limits for yeasts and molds and cleaning validation for homeopathic drug products

This comprehensive resource is an essential guide for pharmaceutical manufacturers, quality assurance professionals, and regulators seeking to optimize their cleaning validation programs and ensure compliance with the latest industry regulations and guidelines.

Published by CRC Press in December 2022, this volume is a valuable addition to any pharmaceutical industry professional’s library. With its focus on science-based and risk-based approaches to cleaning validation, it provides a roadmap for industry professionals seeking to improve the efficiency and effectiveness of their cleaning validation programs.

Language: English
ISBN: 9781000835595, 9781000835618