Pall Hoegaarden: Joint Auditing and the BioPhorum/Rx-360 Pilot Trial

How do you strengthen a well proven process that begins to become unsustainable?

Look for a practical solution.

Spiralling audit burden has become a problem for both supplier and end user, that is in need of a practical solution for all the biopharma industry. For Pall, back in 2018, when confronted with more than 300 individual audits of manufacturing facilities on a yearly basis, it quickly became clear that this was unsustainable if the enormous growth in single-use systems (SUS) continued. Which it did, and it accelerated faster with the global race to bring multiple COVID-19 vaccines to market.

In 2018, like other suppliers and manufacturers, we began to search for an alternative to individual audits. As a member of the Supply Partner Phorum we found this in a joint auditing initiative by Biophorum who were also looking to relieve audit burden, with particular focus on single-use systems. They were partnering with Rx-360 who were already experienced in joint auditing through their Joint Audit Program◆. Not only were the Rx-360 procedures for joint audits well-established, reporting mechanisms were in place as were mechanisms for follow-ups. They also made use of knowledgeable notified bodies such as BSI, Blue Inspection and SQA. BioPhorum added specific single-use products to the program and by 2019 a pilot trial was developed and rolled out. Our Belgian single-use manufacturing facility in Hoegaarden was one of the eight facilities chosen to take part. It was an easy decision to say yes. As a company we wanted to help BioPhorum develop the trial and reduce audit burden for suppliers and end-users. The idea of an aligned audit approach was also an attractive way forward – standardization for continuous, industry-wide improvement.

Essentially this joint audit would end with a single-site report that could be accessed by multiple customers. This naturally sent alarm bells ringing for our legal department! How would we share sensitive information with multiple customers? What controls would we need? How are we going to protect intellectual property? Mark van Kollenburg, as Quality Compliance Manager for Global Systems at Pall, had the challenge of ensuring all non-disclosure agreements were in place to allow Pall Hoegaarden to be part of, and contribute to the success of, the BioPhorum/Rx-360 joint auditing pilot trial.

Mark van Kollenburg shares his thoughts on Pall Hoegaarden’s part in the joint auditing pilot trial

What are your views on the Joint Audit Program after experiencing it first hand?

Despite having many years’ experience in conducting audits and being audited, the Joint Audit Program was new to me. I found that it ran very well. In fact, the whole workstream pilot trial1 was a great success, opening the door for report standardization and a robust process that I believe will be taken up by many biopharmaceutical manufacturers and suppliers. The benefits for everyone are very clear!

How was the Pall Hoegaarden audit different to most traditional audits?

The Rx-360 audit was on site for three days with an experienced auditor from BSI. In comparison, individual customer audits are usually one day, with half of the day allocated to the site tour and general presentation, followed by a few hours delving into the detail – mostly documentation and supporting evidence of compliance. With the Rx-360 audit there is effectively an extra two days to look at the detail and this will be by an auditor who is a SUS subject matter expert. The reality is that most individual audits can be a very high-level look at Quality Management Systems and the requirements described in ISO9001. This is a necessity and invaluable, but the risk is that SUS manufacturing facilities are audited from a perspective limited to pharmaceutical manufacturing without specific knowledge relevant to manufacturing single-use products. Increased focus needs to be on the end-user’s expectation of a SUS manufacturer and the GMP requirements applicable and relevant for SUS products.

The three-day audit at Pall Hoegaarden was a tough, intense process. Despite our vast experience it expanded our thinking and brought us closer to the biomanufacturers and their current, and future expectations.

Audit ‘standardization’ was one aim of this BioPhorum initiative. Was this achieved?

Even when you use very experienced auditors there will be some degree of natural human variability. However, I believe the auditing guidance document, refined from review of the Biophorum and Rx-360 pilot trial, has resulted in a standardized process. It has also resulted in a standardized report, inclusive of a management summary, which is far more detailed, outlining equipment used, evidence, and any findings for each area covered. It is this report that has become licensable and become a real asset for suppliers and biopharmaceutical manufacturers alike. Another asset is the pilot trial’s Single-use Audit Guide that is available to all of industry.

If there was a capacity expansion or change of facility usage, is an audit automatically arranged so it can be licensed?

It is not automatic, but it is our intention to do a refresher audit on a 3-yearly basis to make sure the audit report does not become old. For instance, this Pall Hoegaarden audit was undertaken in 2019 so we have arranged for a refresher this year (2022). In this way, we reflect current state. If there are significant changes to scope, other processes introduced, or additional building activities, we can audit on a more frequent basis. This is expected, especially with all the expansion activities currently under way, such as those at our new Pall Duncan site. Of course, in the event of change, notification letters are sent to customers. They will quickly want to see evidence that we are compliant. So, it makes perfect sense for us to carry out an Rx-360 joint audit to prevent the burden of individual audits.

By say, five years’ time, can you see everyone buying into a joint auditing program as a standard process?

Yes! But it obviously can’t replace every audit such as the much less frequent ‘For Cause’ audits. These are of course, individual to each company and specific to any incidents observed. So, I see a combination in the future. The reality is around 80% of every audit is the same and with the Joint Audit Program you achieve a better assessment than you would do individually. I see customers utilizing the Joint Audit Program and licensing of the final report, but also arranging technical visits for more specific topics. This brings added value to every party. As a biomanufacturer you can focus on areas you want to improve and target resources, and expertise when needed. This is a good win of this program. I don’t expect it to be a full replacement, but uptake will rapidly increase when the benefits to both cost and time are witnessed first-hand. This data and the quality of the report will speak for itself.

Our Accelerator℠ Documentation Center provides a direct link to the Rx-360 licensable audit report requests for Pall Hoegaarden as well as those for Pall Fajardo, Pall Medemblik, Pall Ilfracombe and Pall Duncan.

◆ Joint Audit Program is a trademark of Rx-360