This Technical Report was prepared by members
of the PDA Quality Risk Management Task Force.
The methods used to assess risk should be appropriate for the organization
and the process being assessed. The purpose of this technical report is to
provide an overview of a quality risk management program and to present a model
to facilitate the risk assessment of aseptic processing of sterile products.
It provides a tool to assess and evaluate activities, conditions and controls
that impact establishing and maintaining aseptic conditions and endotoxin control.
Aseptic processing is unique because the severity of the harm is always going
to be high and detection of low levels of contamination is always going to
The scope of this report is the application of a quality risk management program
to aseptic processing. The quality risk management concepts provided in this
report may be used in other areas of pharmaceutical manufacturing too.
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2008. Volume 62, Issue
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