Cleaning Validation; Practical Compliance Approaches for Pharmaceutical Manufacturing
by Destin A. LeBlanc
English | 2022 | ISBN: 1032430834 | 216 pages | True PDF | 7.52 MB
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.