Risk-based approach

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Overview of “The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products”
Osamu Shirokizawa, Keisuke Inoue and Tsutomu Kamikukita

PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 490-505; DOI: https://doi.org/10.5731/pdajpst.2018.009308
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Risk Assessment Approach to Microbiological Controls of Cell Therapies
Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
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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 Approach to Setting Sterile Filtration Bioburden Limits
Harry Yang, Na Li and Stephen Chang

PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 601-609; DOI: https://doi.org/10.5731/pdajpst.2013.00942

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