PDA's Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration summarizes the processes and outcomes of the risk Assessment and control mapping exercises performed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It describes the identification of the sterilizing filtration value stream throughout the process.

The authors also address the use of the FTA and FMEA tools to identify, analyze, and evaluate risks, and identification of risk controls intended to prevent sterilizing-grade filter failure. The overall risk to patient safety is discussed, focusing on the level of control over each identified risk.

This Points to Consider document is the first in a series of four produced by the multicompany consortium comprising more than 50 subject matter experts from 25 biopharmaceutical manufacturing companies and filter suppliers that was formed by PDA and Biophorum to consider the different aspects of sterile filtration risk management.

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Table of Contents:

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1. Introduction
2. Defining the Sterilizing Filtration Value Stream
3. QRM Tool Selection
4. Risk Assessment
5. Mapping of Common Risk Controls
6. Results and Discussion
7. An Alternate Risk Assessment Approach
8. Conclusion
9. References
10. Appendices

Figures and Tables Index