Risk Assessment and Risk Control of Virus Contaminations

ABOUT

The goal of this project is to compile a Virus Contamination Risk Assessment and Risk Control handbook. This guide is intended to aid companies in their risk assessment and management process. Additionally, it will help scientists, engineers, and quality risk control personnel to effectively assess the risk from viral contaminations. The completed white paper should also facilitate general communication around methods that can be used to handle such events.

Follow on efforts are using the CAACB Risk Assessment and Risk Control handbook to conduct a model risk assessment case study of a viral contamination of biomanufacturing in an open ballroom. There is growing industry interest in moving towards open ballrooms with functionally closed manufacturing systems, as seen in a parallel CAACB project defining “functionally closed”. However, there are not public examples on how to assess the risk of these new manufacturing modalities. Given this, the CAACB is conducting a risk assessment of a model process that uses functionally closed systems in a ballroom setting.

OUTPUT

• Members Only White Paper on ‘Quality Risk Management in the Context of Viral Contamination’

PUBLICATIONS

• BOOK CHAPTER: PW Barone, FJ Keumurian, J Leung, SL Springs, R Domike, GK Raju, S Monpoeho, K Murray, S Reich, M Ruffing, and M Wiebe. “Quality Risk Management in the Context of Viral Contamination”. In, Microbial Control and Identification, edited by Donna Reber (PDA, Washington, 2018)