Case study

Updating the audit process to include the Rx-360 protocol

The context

For several years, Saint-Gobain Life Sciences has been a member of Rx-360 – an international pharmaceutical supply chain consortium designed to protect patient safety through best practice in healthcare supply chains. As part of this, Saint-Gobain Life Sciences has used the Rx-360 Joint Audit Program® for auditing its suppliers.

Having experienced the value of Rx-360 and its audit program, Saint-Gobain Life Sciences decided to take part as a supplier in a collaborative cross-industry project, between BioPhorum and Rx-360, aimed at further supporting the scope and focus of audits for Single Use Systems component suppliers. This includes creating a Single Use Audit Guide, and driving adoption by the biomanufacturer community, at a time of unique market pressure.

The company volunteered to take part in a BioPhorum/Rx-360 pilot program to demonstrate the utility of a joint audit approach.

Together, members trialled the joint audit approach across eight supplier member sites over 14 months and updated the Single Use Audit Guide content. The Phorum also shared ‘lessons learned’ and delivered a Pilot Program summary report on the utility of a Joint Audit Approach, as well as a suite of communications materials.

biophorum external collaborations stgobain resized merck 01 52
Saint-Gobain Life Sciences is a critical supplier in the manufacturing pathway for the global biopharmaceutical industry. The business unit comprises several brands which deliver key components for ensuring regulatory compliance, as well as peak performance, quality, security, and consistency of materials. Products include single use systems for containment, fluid transfer, filtration, connections and flow control, closure systems and single use assemblies.

The story

Saint-Gobain Life Sciences had used Rx-360 among its own suppliers, but not within its own customer base.

The company enabled this by updating its audit process to include the Rx-360 protocol, as updated by the BioPhorum/Rx-360, as part of development of the Pilot Program.

This joint audit approach was so successful, it is now being rolled out more widely across the business, to support rapid expansion. Key benefits included the ability to licence audit reports – which reduced the burden of audits, resulting in impressive efficiencies. The company also gained increased confidence in the quality of audits – which are tailored to SUS use in the biopharmaceutical sector – and delivered in an efficient manner.

Saint-Gobain Life Sciences’ interest peaked when the company needed to relocate one of its sites in Florida, to accommodate additional lines required for significant growth. This change in address notified to customers, triggered a requirement from them for fresh site audits, and within three months, around 50 companies needed an audit of their new facility.

Leaders knew that they did not have capacity to process 50 additional audits at pace, while managing their own rapid business expansion.

They knew the Rx-360 audit would:

 

    • Enable customers to licence a high-quality audit of their new facility – better than many could perform for themselves
    • Respect legal and commercial sensitivities – Some customers are both suppliers and competitors to Saint-Gobain. The system enables completion of valid audit reports, while maintaining organizations’ confidentiality and respecting commercial sensitivities
    • Reduce the need for on-site visits – Freeing up the time of Saint-Gobain senior leadership and subject matter experts for redeployment onto other projects
    • Better meet the specific needs of the biopharmaceutical industry – with a specific SUS Audit Guide approach
    • Accelerate product availability – By allowing more customers to include Saint-Gobain as an approved supplier off the back of the licenced audit report. This helps Saint-Gobain to alleviate supply chain stress for products and enables their release from the new facility.
We found that Rx-360 has a much more comprehensive audit then we would be able to provide to our customers… and also better than most audits that our customers would come in and do.

Polly Hanff, Global Regulatory Affairs and Quality Director

The benefits

Saint-Gobain Healthcare and Life Sciences realized a host of benefits from implementing the updated audit approach, including:

 

    • Reduced burden of administration and site visits – So far, the company has agreed to licence the audit report for its new site 20 times. Estimates suggest the method saved 40 days of Quality personnel’s time, as well as further hours from the Senior Leadership Team and SMEs supporting on-site audits.
    • Redeploying staff effort – That time, coupled with hours spent on preparation and follow-ups, can now be redeployed into business growth and innovation.
    • Customer access to Saint-Gobain products – The approach enabled products from Saint-Gobain’s facility to be approved for use at a time when the pandemic was severely restricting access to audits. This supported delivery of product from many customers who wouldn’t otherwise have got access to an audit.
    • Better ‘trust’ with customers based on the quality of audit reports and the follow up process – The RX-360 provides a robust methodology for the management of audit programs, and any follow-up that may be required, in line with CAPA plans – something many customers are not able to manage as well.
    • Saint-Gobain was able to be proactive and manage the situation with an efficient approach to audit processes – offering a better overall service to its customers.

Lessons learned

Saint-Gobain Life Sciences’ team tackled several pushbacks relating to the audit program:

Lack of awareness/communication – Despite multiple communications from industry, many end users within Saint-Gobain’s supply chain were unaware of the Joint Audit Program®, or sceptical of the joint audit approach – with some major biopharmaceutical companies initially refusing to take part. There was also a lack of information sharing between different parts of complex global biopharmaceutical companies; Saint-Gobain learned that it had a part to play helping the awareness across its customers’ enterprises.

There were also internal challenges from Saint-Gobain’s own marketing team, which perceived a potential loss of opportunity to showcase its new facilities and capabilities to companies’ auditors during on-site visits. In response, the Saint-Gobain audit team clarified that executive decision makers from the supply chain would not normally attend audits, invalidating this concern.

Saint-Gobain helped to solve both of these communications issues by sharing the materials produced by members of BioPhorum’s Joint Audit Program® workstream, in partnership with Rx-360.

The audit was fantastic. From the very first one we thought ‘Wow’ – our customers can rely on this. It gave me the confidence, as a head within our organization, to feel comfortable now with encouraging our customers to accept this.

Polly Hanff, Global Regulatory Affairs and Quality Director

Rx-360

Rx-360, non-profit, is an international pharmaceutical supply chain consortium formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The organization’s mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of its materials primarily through its working group and unique audit program.