Change notification​


The aim of BioPhorum and BPSA Single Use Change Notification team is to make the change notification process for single use systems as simple and effective as possible.

Implementation Status

For these practices to realize value the team recognized it is important that a critical mass of biomanufacturer and supply partner companies commit to and implement these practices. The team’s target is for 15 biomanufacturer companies and seven supply partner companies to implement these practices by the end of 2019.

Figures 1 and 2 show progress towards these targets. The invitation is now open for any biomanufacturer or supply partner company to implement these practices. Guidance on what is required to consider the practices implemented is available here along with tools to support you with implementation.

Annual Scorecard Survey – Volume of Changes handled

Annual Scorecard Survey – Quality of Change Notifications

Annual Scorecard Survey

The annual scorecard survey is a tool used to monitor the overall effectiveness of change notification for single use systems within the bioprocessing industry.

Figures  3 & 4 are taken from the annual scorecard survey and represent the combined input from all companies. This hides detail from the survey including differences within and between groups of companies at different tiers of the supply chain. Reports are written for each iteration of the survey and are available here:

Scorecard survey report Mar 18