PDA PTC PUPSIT 1 PDF

Pre-use/Post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate has been due to the fact that scientific data were not available to provide additional clarity that could inform appropriate risk-based judgments and commensurate actions. To gain clarity on this and other topics related to sterile filtration, the Parenteral Drug Association (PDA) and BioPhorum formed the Sterile Filtration Quality Risk Management (SFQRM) consortium in late 2017. The consortium goals are to fill existing gaps in scientific data with studies and industry guidance that would provide professionals and license holders with the ability to make informed decisions about quality risk management strategies.