PDA Letter: The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration

The underlying principle of the work described in this article is the use of objective scientific data to address these shortcomings, characterize risk, prevent sterile filter failure, and ensure product sterility and patient safety.

This articles draws conclusions from the scientific studies, workstreams, and publications delivered by the Sterile Filtration Quality Risk Management (SFQRM) consortium of BioPhorum and the Parenteral Drug Association (PDA). It uses those conclusions to provide guidance to industry (sterile drug manufacturers, filter suppliers, and regulators) on the use of quality risk management principles and scientific data to prevent undetected non-integral sterilizing filters.

This deliverable has been published via the PDA website.

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