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Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations
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PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 626-639; DOI: https://doi.org/10.5731/pdajpst.2018.008615
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Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development
Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan Mcvey, Nan-Xin Qian, Qingxiang Wei, Michael W. Laird, Yuan Zhu, Robyn Emmins, John A. Follit, Alison Porter, Andrew J. Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Hervé Broly, Frank Lee, Matthew Reeser, Jared Spidel, Karin Anderson, Christine Demaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R. Kumar and Tony Gill

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 438-450; DOI: https://doi.org/10.5731/pdajpst.2018.008789
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Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective
Marie Murphy, Brian L. Bell, James Moshi, Rob Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Mousumi Paul, Andreas Keller, Bill Carpenter, Una Hearty and Derek Willison-Parry

PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 213-221; DOI: https://doi.org/10.5731/pdajpst.2017.008045
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Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry

PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
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Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry

PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
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Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective
Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis and David Bain

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 413-420; DOI: https://doi.org/10.5731/pdajpst.2016.007351
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Quantitative Microbial Risk Assessment of Pharmaceutical Products
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PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: https://doi.org/10.5731/pdajpst.2016.007047
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Biocompute Objects—A Step towards Evaluation and Validation of Biomedical Scientific Computations
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PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 136-146; DOI: https://doi.org/10.5731/pdajpst.2016.006734
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Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner

PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999
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Disinfectant Effectiveness Testing Challenges
Carol Bartnett, James N. Polarine and David J. Shields

PDA Journal of Pharmaceutical Science and Technology January 2017, 71 (1) 59-65; DOI: https://doi.org/10.5731/pdajpst.2016.006700

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Parenteral Drug Association, Inc.