Risk assessment

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Interventions Risk Evaluation and Management in Aseptic Manufacturing
Hal Baseman, Subrata Chakraborty and Michael A. Long

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 485-496; DOI: https://doi.org/10.5731/pdajpst.2020.012245
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MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility
Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W Barone, Flora J Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy Springs

PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2021.012691; DOI: https://doi.org/10.5731/pdajpst.2021.012691
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A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages
Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Shu Chen and Marzena Ingram

PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 423-434; DOI: https://doi.org/10.5731/pdajpst.2019.010173
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Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
T. Cundell, D. Guilfoyle, T. R. Kreil and A. Sawant

PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021
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Achieving “Zero” Defects for Visible Particles in Injectables
Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton and Rick Watson

PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 640-650; DOI: https://doi.org/10.5731/pdajpst.2018.009027
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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171
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Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 677-712; DOI: https://doi.org/10.5731/pdajpst.2015.01077
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A Risk-Based Auditing Process for Pharmaceutical Manufacturers
Susan Vargo, Bob Dana, Vijaya Rangavajhula and Stephan Rönninger

PDA Journal of Pharmaceutical Science and Technology March 2014, 68 (2) 104-112; DOI: https://doi.org/10.5731/pdajpst.2014.00954
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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch and Christoph Herwig

PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 569-580; DOI: https://doi.org/10.5731/pdajpst.2013.00943
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The Reliability-Quality Relationship for Quality Systems and Quality Risk Management
H. Gregg Claycamp, Faiad Rahaman and Jason M. Urban

PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 512-517; DOI: https://doi.org/10.5731/pdajpst.2012.00888

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Parenteral Drug Association, Inc.