Publisher's Synopsis
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.
