In 2020, BioPhorum and Rx-360™ collaborated to develop a pilot program to assess that a Joint Audit Program® model was appropriate for use when auditing suppliers of single-use systems (SUS).
The pilot was deemed a success and the model was found to be transferrable across companies with potential benefits around cost, audit burden and resources for all stakeholders. The results were published in the Joint Audit Program – Pilot Program summary report.
To provide extra support when using this model, the companies have now published a Single-Use System Audit Guide for audits of SUS manufacturers.
Suitable for qualified auditors with experience in the SUS space, this guide is designed to support them when preparing for an audit, alongside the referenced standards that they will use to help determine compliance.
It will help auditors and auditees understand the areas of focus in SUS audits and help an auditor when reporting their assessment of SUS manufacturers to end-users.
The paper includes sections on general quality management systems, such as leadership, planning, risk, procurement, customer complaint handling, manufacturing, testing, release and certificate creation.
It also covers the products and production processes an auditor should consider and additional item-specific areas to provide insight into potential manufacturing elements, such as design/drawing management, molding and tubing.
As well as helping an auditor to perform a robust audit of SUS areas, the guide will help purchasers and suppliers of SUS and those involved in manufacturing SUS components to understand industry expectations for the items.
By companies implementing the use of the joint audit approach, they remove the duplication of effort. This creates better access for themselves and other companies who can leverage the audit report and saves time which is to the benefit of all. The original pilot program was a resounding success; this audit guide will only help reduce industry’s audit burden.