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Parenteral Drug Association Connecting People, Science and Regulation ®

September/October Issue Includes QRM Survey Results

Aug 29, 2017

Where does the industry stand when it comes to quality risk management (QRM)? PDA members Kelly Waldron, Emma Ramnarine and Jeffrey Hartman provide results from the 2015/2016 Quality Risk Management Benchmarking Survey in the PDA Journal of Pharmaceutical Science and Technology.

Review

Kelly Waldron, Emma Ramnarine, Jeff Hartman, “2015/2016 Quality Risk Management Benchmarking Survey“

Research

Dennis Jenke, “Extractables Screening of Polypropylene Resins used in Pharmaceutical Packaging for Safety Hazards“

Ruojia Li, Weiguo Cai, Marcel Zocher, “A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays“

Technology/Application

Christopher L. Timmons, Chi Yuen Liu, Stefan Merkle, “Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial“

Neil McLeod, M. Clifford, J.M. Sutton, “Evaluation of novel process indicators for rapid monitoring of hydrogen peroxide decontamination processes“

Jay Bolden, Kelly Smith, “Application of recombinant Factor C reagent for the detection of bacterial endotoxins in pharmaceutical products“

Commentary

Derek Willison-Parry, et al., “Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective“

Conversations

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