Single-use, change notification: A guide to the classification of changes to SU manufacturing systems

This Guide to the classification of changes to single-use biomanufacturing systems (decision tree tool) is the first of a number of practical tools to support development of a better understanding throughout the supply chain of how an organization’s customers and suppliers operate, better communication and increased workflow effectiveness.

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 change notification have been well documented in the teams first publication (White and Ott 2015). The team then went on to propose a best practice to resolve many of these challenges (Carter et al 2017).

When attempting to change the way in which an industry communicates, there needs to be an easily accessible tool that orients practitioners to that understanding and supports embedding and growing it within organizations. This decision tree allows for the diverse nature of SUS changes and represents the teams attempt to provide a tool to orient individuals and companies to a common way of thinking and working. This guide provides guidance on the classification of changes, helping those implement best practice establish consistency in their teams and thereby help them adopt good change notification practices more effectively. Adoption of these practices enables your company to connect more effectively with the global supply chain and avoid the impact and delay from misunderstood change notifications