The SUS supplier(integrator is the direct interface with the end-user (i.e. the biopharmaceutical manufacturer) and, as such, is the primary supplier responsible for all aspects of quality for all components relating to the SUS it is selling. This includes assembling the required information regarding the extractables test data in the standardized format identified in the BioPhorum protocol and the Standard User Requirements package sent to each SUS supplier.
When required, the SUS suppliers need to have clear quality agreements in place with their own suppliers, stipulating the requirement for these data. The data can come from the component manufacturer to the SUS manufacturer – the key point is that the data are provided.
Sharing customer names is not a standard business practice, as often biotech component manufacturers can be N-1 suppliers as well as competitors. BioPhorum recommends the ‘data pass-through’ approach whereby the component manufacturer works out an agreement for the primary supplier/integrator to be able to share relevant reports with the end-user purchaser (See BioPhorum website). This is also consistent with approaches for other existing compendial requirements. In the event the component manufacturer is unwilling/unable to implement the pass-through approach for specific components, then the component manufacturer is expected to inform the integrator/primary supplier what datasets are available and how the primary customer/end-user can easily access.