Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing

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.

Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the ＂Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing＂ series published by PDA and DHI. He is a member of PDA and ISPE and has trained FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.