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.