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.