RT Journal Article SR Electronic T1 A Quality by Design Approach to Microbial Retention Validation JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP pdajpst.2022.012739 DO 10.5731/pdajpst.2022.012739 A1 Leahy, Annie A1 Juneau, Jennifer A1 Souza, Kathleen A1 Miller, Corinne A1 Nguyen, Nhung A1 Lutz, Herb A1 Kolhe, Parag YR 2022 UL http://journal.pda.org/content/early/2022/07/15/pdajpst.2022.012739.abstract 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.