Wholesale Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing - Paperback

by Destin a. LeBlanc (Author) 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. Number of Pages: 204 Dimensions: 0.46 x 9 x 6 IN Publication Date: October 09, 2024