Cleaning Validation : Practical Compliance Solutions for Pharmaceutical Manufacturing

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. Timely coverage of cleaning validation for the pharmaceutical industry is a dynamic area in terms of health-based limits. Author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based 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. Diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products--

Author: Destin A. LeBlanc

Publisher: CRC Press LLC

Publication Date: Oct 09, 2024

Number of Pages: NA pages

Language: English

Binding: Paperback

ISBN-10: 1032431733

ISBN-13: 9781032431734