Cleaning Validation
Practical Compliance Approaches for Pharmaceutical Manufacturing
Samenvatting
Timely coverage of cleaning validation for the phamaceutical industry, 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