Joan Tell, Robert Drinane, Bruce Naumann, Jessica Vestel, and Gregory Gagliano, Merck & Co., Inc.||June 2, 2016
An approach for setting limits on pharmaceuticals discharged in manufacturing effluent
B.D. Naumann, P.J. Nigro, U. Bruen, L. Parola, D. Cragin and A. Schatz, Merck & Co., Inc. and Ashland, Inc.||May 5, 2016
Health-based exposure limits are needed to support risk assessments
September 11, 2015
A workshop was convened to advance harmonization and best practices in ADE/PDE derivation and application
Dr. Cynthia Wooge and Dr. Jyothi Swamy , SAFC ||November 13, 2014
A look into today’s ADC landscape and how collaboration aims to address ADC customer challenges.
Stephanie Wilkins , PharmaConsult US, Inc.||November 13, 2014
Industry needs to prepare in order to comply with the updates.
Kristin Brooks, Contract Pharma||October 14, 2014
A look back at the pharma/biopharma industry and outsourcing.
Dave Rottjakob, Deborah Ensign, Shawn Sherry, and Kate Bloomrose||September 8, 2014
Unfortunately, most manufacturers wait until after a 483 or performance problem to revisit qualification practices. Proactive testing and continued monitoring ensure patient safety and compliance
Kristin Brooks , Contract Pharma||April 3, 2014
Vaccines and biosimilars, clinical production and cell therapy are driving demand for better control and consistency.
Stephanie Wilkins, PharmaConsult Us ||March 7, 2014
Let’s move forward, allowing good science to guide the way.
Karen Ginsbury; Destin A. LeBlanc, PCI Pharmaceutical Consuting; Cleaning Validation Technologies ||January 22, 2014
Clarifying the uncertainty remaining in the quest to define “certain” products
Stephanie Wilkins, PharmaConsult US, Inc.||November 13, 2013
Uncertainty remains in the quest to define certain products
Deborah Ensign, Microtest Laboratories||January 22, 2013
Test methods, validation and more
Herbert N. Prince and Jason W. Prince, Gibraltar Laboratories||September 6, 2012
Celebrating — in parody — the King James Bible and the Sherley Amendment
Martin Lush, NSF-DBA||May 4, 2012
Causes and prevention: What can we learn from the mistakes of others?
Ross Acucena and Randy Wilkins||April 4, 2012
Best practices for sterile filtration validation of re-use and extended-use processes
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