Change Notification: A guide to change notification packages for single-use manufacturing systems

Change is an inevitable feature of single-use systems (SUS). In a regulated environment, the risks associated with common changes must be considered, planned and successfully communicated. An efficient and effective change notification is a critical enabler for SUS in bioprocessing. The key is balance. Biomanufacturers and suppliers need to work together to deliver consistent therapeutic manufacturing processes meeting regulatory expectations, while maintaining a consistent supply of SUS. Data packages, and alignment on their contents, are a critical tool in managing the inevitable changes effectively. What is needed is clear guidance for suppliers on how to provide robust, timely, high-quality data during the change notification process to minimize the verification required by end-users.

This 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. It 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 as well as 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.

Change might be unavoidable, but the BioPhorum guide will help make it go smoothly.