Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 5

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 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