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 18 OP 26 DO 10.5731/pdajpst.2022.012739 VO 77 IS 1 A1 Annie Leahy A1 Jennifer Juneau A1 Kathleen Souza A1 Corinne Miller A1 Nhung Nguyen A1 Herb Lutz A1 Parag Kolhe YR 2023 UL http://journal.pda.org/content/77/1/18.abstract AB Regulatory and manufacturing requirements exist for performance of 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.