What does the best practice involve?
The industry proposal for change notification practices for single use biomanufacturing systems was co-authored by representatives from biomanufacturer and supply partner companies in response to the challenges with change notification for this class of products. These challenges are well described in the 2015 article by Tony White and Kevin Ott.
The best practice is available on the BioPhorum and BPSA websites and is available here Industry Proposal
To support adoption of the best practice two tools have been developed which are intended to tackle the two main areas for improvement identified.
Change categorization and decision tree tool
How changes are categorized was found to vary quite widely from company to company, often based on experience with either customers or suppliers. There was no standardized way to categorize changes and no real way for supply partners lower down the value chain to appreciate how a seemingly small change may have a major impact on a biomanufacturer.
The goal of the team is ultimately for suppliers to continue to build a greater understanding of how their products are used and how changes they make may impact their customers since no two changes are identical. Biomanufacturers should make every effort to support reasonable requests from supply partners to build this understanding.
To provide a framework to orient supply partners and biomanufacturers with the complexity associated with a particular type of change and therefore the level of notification required, the team has developed a decision tree tool. In addition this tool can support ongoing learning and improve understanding through the value chain.
Data package requirements
One aspect that has been repeatedly highlighted is the need to provide sufficient information to allow biomanufacturers to assess the impact that these changes will have across their product portfolios. And for this information to be made available by the supply partner up front and without the need for request from the biomanufacturer.
Provision of correct data first time smooths workflows allowing end users to more rapidly provide feedback on the impact of the change to their supplier. Provision of this information in a timely manner will support development of business continuity plans allowing a smooth transition from current to new product. It should enable activities such as last time buys and give the supplier clear line of sight to when the change can be fully effected.
In order to provide the correct information first time it is essential that there is common expectation of what information should be included in a data package for a given type of change. The team have worked collaboratively to summarize these requirements and these will be available later this year