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.