PT - JOURNAL ARTICLE AU - Leahy, Annie AU - Juneau, Jennifer AU - Souza, Kathleen AU - Miller, Corinne AU - Nguyen, Nhung AU - Lutz, Herb AU - Kolhe, Parag TI - A Quality by Design Approach to Microbial Retention Validation AID - 10.5731/pdajpst.2022.012739 DP - 2022 Jan 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - pdajpst.2022.012739 4099 - http://journal.pda.org/content/early/2022/07/15/pdajpst.2022.012739.short 4100 - http://journal.pda.org/content/early/2022/07/15/pdajpst.2022.012739.full AB - Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to sterilizing filtration supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to perform such testing easily and efficiently. Process and product parameters were varied to determine their effect on microbial retention to define a design space. To minimize the burden of filter validation retention studies for early stage (Phase 1) manufacturing, it is recommended that manufacturers perform a risk assessment to confirm their product and process conditions are within the established design space. For later stage product development prior to marketing authorization, product specific filter validation testing is expected.