Industry’s move towards single-use systems has many well-documented benefits, including lower capital costs, and better flexibility. These trends make single-use systems and their supply chain a key enabler, and effective change notifications become critical. Historically, change notification practices have been inconsistent and cumbersome, creating risk for us all.
As part of the disposables five-year plan, the Supplier Change Notification Workstream has worked hard to identify the right level of change notification and develop robust working practices for the industry to adopt in relation to single-use systems. These practices have been adopted by a number of companies and have now been drawn together in a knowledge base available to the industry via the BioPhorum website. We invite you to use the three surveys described later in this article to benchmark your company’s performance and contribute to ongoing development of these practices.
Manufacturers often find that change notification data packages lack critical information and are received without sufficient notice. They may also find they are not notified of critical changes or receive details of every small change and have to assess the impact of each one.
Suppliers, meanwhile, often find it difficult to understand the impact of a change on a customer, do not know how a manufacturer uses the product and find that there is no uniform set of needs and expectations.
A lack of standard terminology and no single point of contact for change notifications within a company also create challenges in communication and acceptance of a change.
Best practice improvements
The workstream aims to align all parties to a common best practice approach for change notification for single-use systems, with a clear definition of terms and clarified roles and responsibilities. These will all help improve communications and standardize processes across the industry.
We have created a knowledge base gathering all of the outputs from the BioPhorum change notification workstream into a portal on the BioPhorum website allowing you to access all of the tools and guidance on implementing them. The knowledge base includes sections on:
- Tools – including A guide to the classification of changes to single-use biomanufacturing systems and the single-use change notification guide
- Value – including the Single-Use Change Notification Industry Dashboard and the results from past scorecard surveys
- Implementation – including implementation requirements and tools, stakeholder mapping tools and communications letter templates
- Feedback – allowing access to the industry surveys described below
- FAQs – including how to categorize changes and what do we mean by non-notifiable change?
Industry surveys and continuous improvement
To understand how successful these new working practices are, the workstream has created three industry surveys, each with a deadline of 16 September:
- The first survey asks whether the changes to working practices have the desired effect, focusing on four key areas as described by the industry scorecard
- The second survey asks about the decision tree, any challenges during its use and how it can be improved
- The third survey aims to understand change notification contact points and support companies when identifying who to contact for changes.
As the industry moves increasingly to single-use systems, smaller batches and, ultimately, personalized medicine, collaboration between suppliers and manufacturers will become more critical. Strong change notification controls will be an increasingly important element to the success of single-use systems and will be a key pillar of BioPhorum’s program in this area.