Sterile Filtration Quality Risk Management
This team is an established group of members, working to determine the best approaches to filtration quality assurance through risk assessments and best practices.
Determining best approaches
The team has published several documents on PUPSIT implementation and risk assessment. Annex 1 guidance requires PUPSIT of sterilizing filters, this may introduce more risk than benefit in terms of sterility assurance.
The team is trying to understand how the PUPSIT requirement is being implemented across industry following the introduction of the latest version of Annex 1.
To track the implementation of PUPSIT, it has developed a set of questions for an online survey, which can be found at BioPhorum Sterile Filtration Quality Risk Management Team: 2024 PUPSIT Survey.
After gathering some basic information, the survey asks how you perform or are planning to perform PUPSIT, how inspectors review and assess the PUPSIT process, and how you are managing your PUPSIT implementation.
Provide clear guidance for the best way to implement PUPSIT and the latest regulatory expectations
The team monitors the implementation of pre-use integrity testing and the acceptance of a risk-based approach by the regulatory authorities with the goal of:
- Improved confidence in maintaining sterility and supply assurance whilst complying with regulatory requirements
- Reduction in variability within filtration operations
It is hoped through sharing best practices and approach Members will achieve:
- Fewer deviations and failed batches and failed filters
- Reduced operational complexity
Sterile Filtration Quality Risk Management deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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