An inefficiency in our industry is where multiple manufacturers individually audit the same supplier in the same year or use a third-party who repeats the same supplier audit for different clients. This creates a heavy burden for the industry.
In response, BioPhorum Supply Partner collaboration has worked to understand the value of a joint audit program approach where a third party performs one audit that is available to everybody.
The Phorum developed a pilot program with Rx-360 to validate that a joint audit program model was appropriate for use when auditing suppliers of single-use systems (SUS) and to increase awareness and utility around joint audit programs across the pharmaceutical industry. The pilot has been completed and the results have been published in the Joint Audit Program – Pilot program summary. The conclusion is that the pilot has been a success.
The program delivered eight licensable audit reports that, to date, have been licensed 31 times, demonstrating the capability of this approach to reduce the audit burden.
Using a joint audit program approach will remove many low-value-add audits, meaning there should be time to focus on more significant audits that are needed for new products, targeted problems, etc. It can open up the marketplace as biomanufacturers of all sizes will be able to use new suppliers and the process can be cascaded down to different supplier tiers.
The report details the approach’s methodology and the feedback and findings of all the stakeholder groups involved, i.e. SUS supplier auditees, BSI auditors, Rx-360 Joint Audit Program management and the reviewer panel.
Key findings include:
- The model is transferable and successful. With best practice initiatives validated and/or put in place, the model can be an audit foundation within single-use systems
- The joint audit program has potential benefits, including those around cost, audit burden and resources for all stakeholders
- Establishing a robust joint audit program can be used to alleviate the audit burden while increasing the robustness of audits by allowing the audit to be performed over two to three days
- A joint audit program focusing on SUS has enormous potential benefits to the industry.
The audit process
In collaboration with the Rx-360 audit program, the pilot program was conducted on several Phorum supplier member sites that volunteered to take part. It ran over several ‘sprints’ with the output of each pair of sprints informing the next one. Eight sites participated in the four sprints over the 14-month pilot program. After completing the final audit of the last sprint, those involved in the pilot were surveyed to understand their different experiences. The survey also gathered their thoughts on the principal questions around the utility of the joint audit program model approach for SUS companies. The survey results were used to inform the program report.
A single-use audit guide was developed with the support of BSI as the third-party auditors involved and the rest of the BioPhorum Supply Partner team, including Rx-360 members. This was used during the pilot program to help guide the auditors and improve the quality of the process. There was also input from the BioPhorum Drug Substance’s Single-Use Systems Leadership Team, which approved the guide as a deliverable in its Disposables Five-Year Plan. This indicates increasing awareness and acceptance of the joint audit program approach within the biopharmaceutical industry’s manufacturing and technical operations community.
Covid-19 is likely to drive the increased use of this joint audit program approach as it is a more efficient and safer way of working. It allows for the qualification of suppliers that might have been otherwise delayed and for new facilities to be brought on-line as soon as possible to help support the industry with availability at a critical time of high supply demand because of Covid-19’s impact on availability.
The BioPhorum/Rx-360 collaborative pilot program and report are excellent examples of how industry can work smarter, not just harder.