Changes to critical, complex systems in our regulated environments must be 100% right. This was recognized by the single-use industry and key customers some five years ago and resulted in a number of papers and much better alignment to a standard language and ways of working around single-use system change controls.
However, there is always room for improvement and greater alignment in the industry, and the collective learnings have now been consolidated into BioPhorum’s new Guide to change notification data packages for single-use biomanufacturing systems.
The group is now keen to see more companies aligning their change notification methods to make the growing ecosystem more complete.
To this end, the revised guide is a one-stop-shop on change notification best practices for single-use biomanufacturing systems, incorporating previous papers as well as the learning and practical experience of the team over the past five years. It has been developed following a logical, risk-based approach through consultation between biomanufacturers and supply partners.
“Collaboration between BioPhorum, biopharma companies and suppliers were essential to developing an aligned and robust change notification and data package guidance,” said Audra Mathews, Supplier Quality Principal Technical Manager at Roche Genentech. “The effort and outcome from the Disposables – Change Notification Workstream drives greater understanding, communication, efficiencies and robust change management practices ultimately for the benefit of the people we serve and the businesses we are a part of.”
The paper provides new guidance on what information should be included in data packages and a revised decision tree to support change categorization. It contains industry-level guidance on what biomanufacturers should (and should not) standardly expect of suppliers. In turn, it says what suppliers should consider when making any change and what should be provided upfront as a data package.
Using the guide will ensure that all the information required arrives in one place at the time when it is needed so that end-users can make an informed decision about accepting the change. For companies with well-established change control practices, the guide will provide a useful sanity check and an opportunity to align language. For others, it sets out an industry-agreed starting point.
The guide drives a common language and agreed expectations, meaning that it should serve as a common framework when dealing with multiple customers of suppliers rather than having bespoke requirements for big customers or suppliers. Inherently, this drives efficiency and understanding.
It also supports a clear dialog that continually develops an end-user’s understanding of why a supplier is making a change, while suppliers will have a greater appreciation about the impact of changes on an end-user.
“Single-use equipment will undergo change; this is inevitable,” said Jeffrey Carter, Consumables Product Strategy Leader at Cytiva. “Since change can affect end-users, I felt it was important to align expectations between suppliers and end-users. That’s why I chose to involve myself with this work. The benefit I have tried to bring back to my organization is a better understanding of a consensus view of what concerns end-users, what they expect of suppliers, and then how we should try to change to meet those needs.”
Change might be unavoidable, but the BioPhorum guide will help make it go smoothly.