The new Third-Party Audit Report Library (3PARL®) consortium, founded by Rephine and Eurofins Healthcare, aims to set a benchmark for life sciences manufacturing supply chain Good Manufacturing Practice (GMP) audit services globally. In this interview, Adam Sherlock, CEO of Rephine, explains more about how the consortium will support high audit standards.
What was the thinking behind setting up the consortium?
The use of third-party auditors and the purchasing of library audit reports has become a standard business model for manufacturers and their customers to provide evidence of supply chain quality, assurance and regulatory compliance, to all stakeholders in the life sciences sector, specifically focussed on the GMP requirement.
However, as the niche of providers of this specialist service has rapidly expanded, and the range and type of provider has broadened, it has become obvious that not all auditors, audits and audit reports are equal. Coupled with commercial pressures, this range of provider type has driven inconsistency in behaviour within the auditing sector. This has introduced uncertainties around integrity and impartiality, which in turn adds risk to the supply chain through compromises in quality of the service being performed and the final reports which are delivered, upon which assurance and compliance are based.
To address this systemic risk, the leading, longest tenured, best reputed, competitive commercial service providers in this niche came together to create the 3PARL consortium, as a vehicle to define and adhere to a set of standard ethical behaviours, which provide our industry and all stakeholders with confidence in the performance of this scope of services and the quality of the resulting reports, upon which everyone relies.
What is the consortium’s roadmap?
The initial roadmap for the consortium is to expand its membership beyond the founding collaborators, to define a charter, to review and iteratively enhance the initial code of conduct, to meet regularly to chart the course of the consortium, and to engage manufacturers, trade associations and other key stakeholders as appropriate, to ensure our message is heard, understood and reflects the needs of the industry.
In the mid to long term, the aspiration of the consortium is to define professional standards for the performance of the scope of services covered by the group and to be able to certify and accredit members.
There is also a clear aspiration to lead the sector in terms of training, education and career development for professionals wishing to become auditors or those wanting to enhance their current credentials.
Rephine and Eurofins Healthcare are the founders of this consortium. How do you intend to bring other members on board?
We are already in advanced, direct discussions with a number of other important, well-known providers in this niche. In addition, we have made an open call to providers in the sector to apply to join the consortium.
What is the benefit of being a 3PARL audit partner and who will conduct the audits? Are they independent?
The benefit to a service provider of being a member of the 3PARL consortium is that the quality of the performance of their services will be seen to be of a consistently high quality, delivered ethically, with integrity and impartiality, fairly, according to a consistent and transparent code of conduct, to which all members have agreed to adhere and be bound.
Each organisation which becomes a member of the consortium retains its independence and continues to actively compete commercially with the other members of the consortium, but crucially, does so on the same level playing field.
For customers and manufacturers, by choosing to contract with a 3PARL consortium member, they are assured of the consistent performance of the service they need, enabling them to make their choice of whom to use based on the most important and relevant specific criteria for their requirements. There is no commercial relationship between any members of the consortium – it is not a commercial endeavour in any way.
Can you expand on the benchmark, and who will ratify it and conduct any audits?
The code of conduct is defined and monitored by the consortium members themselves. At this stage there is no external independent ratification or certification required. We expect and hope that in future, once the value of the work of the consortium has been demonstrated and is acknowledged by the industry, that some form of external ratification or certification may be possible.
All audits conducted by members of the consortium are performed by either their own internal staff or by independent auditors who have been qualified by the consortium member through a standard selection process, endorsed by the consortium.
What reception has the industry as a whole given the consortium?
The response to the announcement of the 3PARL consortium has been extremely positive across the whole life sciences product manufacturing supply chain. It is seen as a strong statement of intent on the part of the larger, professional service providers to create a standard operating model for the sector.
Adam Sherlock, a serial entrepreneur, executive business leader and experienced board member, is CEO of Rephine Ltd. He is passionate about building businesses and has a strong track record of delivering impressive growth across Life Sciences. Rephine provides bespoke technology and manufacturing supply chain compliance consultancy and third-party auditing.
