Pharmaceutical Published Articles

Perspectives on Method Validation II: Validation is a multistep process with USP regulatory guidelines at each step
Pharmaceutical Formulation Quality, February/March 2010

Authors:
Heather Bridwell - Group Leader/Chemist
Jennifer Roark - Group Leader/Chemist
Thomas Lehman, PhD - Manager of Method Development

Perspectives on Method Validation: Importance of adequate method validation
Pharmaceutical Formulation Quality, December/January 2010

Authors:
Heather Bridwell - Group Leader/Chemist
Vikas Dhingra, PhD - Group Leader/Biochemist
Daniel Peckman, PhD - Group Leader/Biochemist
Jennifer Roark - Group Leader/Chemist
Thomas Lehman, PhD - Manager of Method Development

Contract Consulting & Pharmaceutical Services
BioPharm International, September 2009

Editorial comments:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development/Validation

It’s Clean, but Can You Prove It? Validation and revalidation are key when establishing cleaning methods
Pharmaceutical Formulation Quality, July/August 2009

Authors:
Eric A. Lingenfelter - Group Leader/Chemist
Henry L. Evans - Chemist
Wesley B. Atkins - Senior Chemist
Harolyn M. Clow - Manager, Microbiology Department – Facility Validation & Environmental Monnitoring

How to Improve Cleaning Processes. Some key methods for a more efficient cleaning validation process
Pharmaceutical Formulation Quality, June 2009

Authors:
Eric A. Lingenfelter - Group Leader/Chemist
Henry L. Evans - Chemist
Wesley B. Atkins- Senior Chemist
Harolyn M. Clow - Manager , Microbiology Department – Facility Validation & Environmental Monnitoring

CRO Roundtable - The Future Of The CRO-Pharma Relationship
Life Science Leader, March 2009

Editorial comments:
Timothy Oostdyk, Ph.D.
Executive Vice President and COO, Lancaster Laboratories

A Look at the Newly Harmonized Microbial Limits Methods and Future Impact on the Industry
Contract Pharma, March 2009

Author:
Mike Yunginger - Manager, Microbiology Department - Non-Sterile Products

Clearing the Air on Residual Solvents
Pharmaceutical Technology, February 2008

Editorial comments:

Travis Emig - Director of Pharmaceutical Sciences
Delwyn Schumacher - Principal Chemist, Analytical Method Development / Validation

Outsourcing Analytical Testing
Contract Pharma, September 2007

Editorial comments:
Tim S. Oostdyk, Ph.D., COO
Lancaster Laboratories

Identification and Risk-Assessment of Extractables and Leachables
Pharmaceutical Technology Primer, January 2006

Author:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

Validating On-line TOC Analyzers for Real-Time Release
Pharmaceutical Manufacturing, November/December, 2006

Author:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation