Risk assessment

You have access
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
You have access
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
You have access
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
You have access
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
You have access
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
You have access
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
You have access
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
You have access
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
You have access
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
You have access
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

Main menu

User menu

Search

Risk assessment

Pages

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.