Decision tree to support alignment of risk assessment for changes to single-use biomanufacturing systems

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The BioPhorum single use change notification team has been working on developing and standardizing best practice for single use change notification since 2015.  The challenges around single-use system (SUS) change notification have been well documented (White and Ott 2015).

Throughout the collaborative process the team realized there is a need for better understanding throughout the supply chain of how an organization’s customers and suppliers operate in order to improve change notification workflows and effectiveness.

Because SUS changes can be of a diverse nature: understanding, and application rather than prescriptive categorization of changes is a key principle of the best practice.

Looking at how that understanding can be developed, and changes made to the way in which an industry communicates it became clear that replicating the discussion process the team had followed through the industry was not practical. There needed to be an easily accessible tool that orients practitioners to that understanding and supports embedding and growing it within organizations.

 

In September 2018 the team published “A guide to the classification of changes to single-use biomanufacturing systems”.  This document represents the team’s consensus opinion on how changes can best be categorized in a more standard way.

Evolution of the Tool

This is version 1 of the decision tree and represents the team’s best effort to provide a tool to align individuals and companies to a common way of thinking and working in an acceptable time frame.

This is your industry and your change notification process. We need your help to make this as effective as possible and so we are seeking feedback based on real world examples of how the tool can be improved. Feedback takes the form of a short survey which can be accessed online (here).

Periodically there will be a review to determine if the tool can be improved, for example by publishing version 2. It is currently intended that the first review will occur in Q4 2019.

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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