Over the course of 14 months, eight site audits were carried out on BioPhorum’s Supply Partner supplier member company sites and these were made available for industry to license via the Rx-360 website. The audits were conducted through the Rx-360 Joint Audit Program and its audit partner BSI. To date these audits have been licensed approximately 40 times (a level comparable with rates achieved by established audits for other supplier sections of the industry), demonstrating the capability of this approach to reduce audit burden.
A sprint approach was used for the pilot program during which there was ongoing awareness and discussion of the pilot program across the BioPhorum in both Supply Partner and the Drug Substance Phorum. As part of the collaboration with Rx-360, BioPhorum sought to produce a Single-Use Audit Guide (SUAG). The audits conducted within the pilot were carried out using a baseline Raw Materials Rx-360 Audit Checklist. After each of the four sprints, improvements were carried forward into the development of the proposed SUAG and there was also input from the BioPhorum Single-Use Systems Leadership Team who would approve the guide as a deliverable for their own Disposables 5-Year Plan. This indicates increasing awareness and acceptance of the joint audit program approach within the manufacturing and technical operations community of the biopharma industry.
It is accepted that this approach to auditing may not be appropriate for all situations, for example ‘for-cause’ or ‘technical’ audits but it has demonstrated its usefulness in supporting surveillance and in some cases qualification audits.
This report details the methodology of the approach, the feedback and the findings of all the stakeholder groups involved and the reviewer panel involved in the pilot program.