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PDA Journal of Pharmaceutical Science and Technology

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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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