Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing

By Destin A. LeBlanc

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.

• Format: Hardcover
• Language: English
• ISBN: 1032430834
• ISBN13: 9781032430836
• Release Date: December 2022
• Publisher: CRC Press
• Length: 204 Pages