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A Quality by Design Approach to Microbial Retention Validation
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PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 18-26; DOI: https://doi.org/10.5731/pdajpst.2022.012739
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Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology
Hans Joachim Anders, Daniel Mannle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Gotzen, Corinne Oechslin, Cedric Joosen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah and David L Jones

PDA Journal of Pharmaceutical Science and Technology November 2022, pdajpst.2022.012742; DOI: https://doi.org/10.5731/pdajpst.2022.012742
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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study
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PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 285-291; DOI: https://doi.org/10.5731/pdajpst.2018.009340
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A Case Study to Address a Gap in the Device-to-Vial Interface Stopper Push-in by Chemo Spikes
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PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 92-109; DOI: https://doi.org/10.5731/pdajpst.2018.008664
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Development of a Premium Quality Plasma-derived IVIg (IQYMUNE^®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
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PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 176-187; DOI: https://doi.org/10.5731/pdajpst.2016.007393
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A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes

PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
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Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096
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Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
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PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 577-590; DOI: https://doi.org/10.5731/pdajpst.2016.006437
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Investigation of Air–Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents
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PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 272-281; DOI: https://doi.org/10.5731/pdajpst.2015.005736
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Particulate Study on NeoProfen, a Neonatal Injectable Product
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PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 76-92; DOI: https://doi.org/10.5731/pdajpst.2015.005587

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Parenteral Drug Association, Inc.