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 be low.

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.

2008. Volume 62, Issue No. S-1.

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Table of Contents:

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Introduction
Glossary of terms
Aseptic Processing and Quality Risk Management
Aseptic Processing Quality Risk Management Model
Conclusion
Appendix
References
Suggested Reading