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PDA Journal of Pharmaceutical Science and Technology

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Risk assessment

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    A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
    Kelly Waldron, Amanda McFarland, Hal Baseman and Maik Jornitz
    PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 88-97; DOI: https://doi.org/10.5731/pdajpst.2024-003038.1
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    Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
    Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz and Lee Nagao
    PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 399-444; DOI: https://doi.org/10.5731/pdajpst.2022.012811
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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 L. Springs
    PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691
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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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    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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© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

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