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.