BioPhorum and Rx-360 pilot a joint audit model for single-use systems
BioPhorum and Rx-360 have agreed a pilot to validate the use of the Joint Audit Model in the single-use systems supply chain. The aim is to deliver consistent, rigorous and cost-effective quality audits, that will alleviate the supplier audit burden, while ensuring biopharmaceutical manufacturers are in control of their supply chain. The pilot is due to complete in October 2019.
Rx-360 is an international consortium that addresses pharmaceutical and medical device supply chain security that relates to public health concerns and patient safety.
BioPhorum and Rx-360 will use the British Standards Institute to conduct the pilot audits. A Steering Committee consisting of members from all three organizations will drive the pilot through the analysis of data and the implementation of best practices or improvements. The pilot will identify ‘reviewers’ who will take on the traditional roles of co-sponsors of the audits, as described in the current Rx-360 Joint Audit Model. The pilot will consist of 12 audits split into four sections of three audits.
Key measures that will be tracked during the pilot are:
- The delivery of final audit reports within 30 business days
- The number of times a completed audit is licensed
- Corrective and preventive action (CAPA) plans within 20 business days
- The reduction in supplier audit burden as measured by planning time, hosting time, responding to and reviewing multiple audits, and all associated costs
- Survey feedback from participants
- Observations identified during the pilot, categorized as ‘potentially critical’ or ‘other’.
Once completed, a team from BioPhorum and Rx-360 will publish a consensus paper in Q4 2019 detailing the results from the pilot.