Site audits are an essential but increasing burden for manufacturers and customers and brought into sharp focus during Covid-19 when local and international lockdowns meant that traveling to sites was near impossible. What was needed was a new way of performing audits that was more efficient, did not require a visit by every customer, and allowed audit reports to be shared by a range of customers.
This is why BioPhorum and Rx-360 collaborated to assess whether a Joint Audit Program model was appropriate for manufacturers, with a specific spotlight on auditing single-use systems. The approach was deemed a success and further details can be found in BioPhorum’s Pilot Report and the Single-Use Audit Guide.
An Rx-360 Joint Audit Program® approach can offer audits of greater depth while reducing the audit burden as customers can buy a license to use the joint audit report. To find out how it is working in practice, we spoke to two subject matter experts at Pall Corporation about the benefits of a Joint Audit Program and how they have used it in their business.
What was the issue you needed to address?
“Although we have ISO certifications in place, our pharmaceutical customers still wanted to visit our sites to perform audits,” said Mark van Kollenburg, Global Quality Compliance Manager at Pall Corporation. “But we have seen an exponential growth in individual audits over the last few years and now have more than 300 annual audits when all our biotech sites are included. This obviously places a great demand on our resources and we wanted to find a better solution, especially when Covid-19 prevented customers from traveling.”
He explained that the main reason Pall wanted to use the Rx-360 Joint Audit Program® was to try to reduce the number of individual customer audits and for them to share a joint audit report. “We could see that around 80% of audits were comparable and asked similar questions. This independent joint auditing process gives our customers confidence that professional auditors perform the visits leading to an independent report that they can use. As a result, we have seen a significant uptake from customers and are over 100 licenses being bought, mostly in 2022.”
The exponential growth in using single-use systems by Pall’s pharmaceutical customers was also a driver. Van Kollenburg added, “We had extra qualification audits and significant growth in our sites and their onsite activities, leading to more customer notifications of our extended activities. This all led to more customers wanting to visit our sites to qualify our increased activities.”
The increased need for our products and customers’ travel restrictions meant everyone was more open to accepting alternative solutions.Mark van Kollenburg, Global Quality Compliance Manager at Pall Corporation
How have you implemented the solution?
“We have implemented the Joint Audit Program solution across all of our biotech sites for external facing audits, mostly focusing on consumable manufacturing sites,” said van Kollenburg.
Van Kollenburg explained that Pall’s equipment manufacturing sites are less frequently visited by customers because Pall supplies equipment with site acceptance tests directly to them, so there is a more one-on-one situation. “Whereas consumable products are supplied off-the-shelf or from our sites to multiple customers. The needs of the supplier or customer base are much greater for consumable parts, so the need for an audit is also much more significant. At the same time, we still do our own internal audits as originally planned.”
What are the benefits of the Rx-360 Joint Audit Program®?
“The growth in the number of requested audits means that we still have the same number per site, but by using the Rx-360 Joint Audit Program®, we can handle an extra 25% of audits without additional people,” said Hélène Pora – Vice President, Technical Communication and Regulatory Strategy at Pall Corporation. She added that this means Pall can allocate resources to other activities.
“The growth in our business and the number of change notifications to customers allows us to get their quick approval based on the joint audit report,” added van Kollenburg. “They may still come to perform their own audit later, but the benefit to us is that we can accelerate the expansion and approval of our activities.”
An additional benefit is that the reports are typically more detailed and provide more depth than the usual customer audit.
Did you have any issues and how did you overcome them?
“Conversations with senior management and legal departments about the benefits of the process took a while to work through,” said Pora, “and confidentiality of the information in the report was an important topic that we discussed. But it helped that we had plans to expand capacity and we wanted to drive the acceptance of additional lines and sites. Once we had a site ready to go, we didn’t want to wait one or two years until people started doing their audits. We found the Rx-360 Joint Audit Program® was a way to get quicker acceptance of our sites.”
She added, “Obviously, there is only a certain number of audits we can handle, so without the Joint Audit Program, the queue of customer audits would just get longer. For example, we have been booking visits for 2023 for some time.”
Do you have any pointers for the future?
“One thing to note is that once you’ve done an audit, you need to have a full maintenance program in place,” said Pora. “That is something we must plan for as we get additional lines at our manufacturing sites. Also, the audits will ‘age’, so we must repeat them to ensure they are still appropriate.”
Van Kollenburg said Pall usually has to pay for the audit approach, while the customer wanting the report must buy a license to use it. “The Rx-360 Joint Audit Program® however, allows us to request an audit of our facility, or we can go to Rx-360 and say that we want a site to be audited and they will then look for co-sponsors. Most of the time, they find sufficient co-sponsors, who are also our customers, and their members.”
In summary, the Rx-360 Joint Audit Program®has given more pharmaceutical companies faster access to audit reports, and enabled them to expand their capacity for receiving audits at their manufacturing sites, without increasing resources.
Note: Rx-360 and Joint Audit Program are trademarks of Rx-360 International Pharmaceutical Supply Chain Consortium a non-profit corporation.