The Third-Party Audit Report Library (3PARL®) consortium was established to set global benchmarks for life sciences manufacturing supply chain GMP audit services. We talked to Adam Sherlock about the consortium and how it will drive up the standard of audits.
What led up to 3PARL’s foundation? Why was a consortium needed?
The use of third-party or purchasing of library audit reports has become a default means of providing evidence of supply chain quality, assurance, and regulatory compliance, particularly in relation to Good Manufacturing Practice (GMP) compliance. And this has become more important than ever, in a volatile market.
Third-party audit firms, by building closer relationships with suppliers, can reduce the number of audits a supplier is subjected to. This leads to greater efficiency and, when suppliers provide the reports of third-party firms to pharmaceutical companies, the audit process is expedited – without any compromise on quality.
This assumes impartiality and a consistent approach, however - to ensure that the audit is accurate and reliable. The trouble is that the spectrum of providers of associated auditing services has broadened, and the relative quality of service and output isn’t always readily apparent. Any uncertainty around supplier integrity and impartiality adds risk.
It’s in response to that risk that the longest-established and best-reputed service providers in the field came together to create the 3PARL consortium, defining a set of standards for ethical auditing behavior. This provides all industry stakeholders with confidence in auditing services and in the quality of the resulting reports.
What’s the plan for the consortium? How do you see it developing?
The immediate plan is to expand 3PARL’s membership beyond the founding collaborators and define a charter. Next, it will be to review and iteratively enhance the initial code of conduct; meet regularly to chart the course of the consortium; and 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 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. We also want to lead the sector in training, education, and career development for professionals wishing to become auditors or seeking to enhance their current credentials.
Have you added other members yet, and how are you going about this?
We’re in direct discussions with a number of other important, well-known providers in the field and have recently announced the addition of a pharma-audit. They are a brand of Heacon Service in Germany (a daughter company of the country’s Federal Association of Pharmaceutical Industry). pharma-audit conducts audits in all GxP-regulated areas - individually or as part of a shared audit.
We’ve also made an open call to providers in the sector to apply to join the consortium.
What’s the advantage of being a 3PARL audit partner?
It’s the positive associations and assumptions it creates. Essentially, those auditors’ services will be perceived to be of consistently high quality, delivered ethically, with integrity and impartiality, and fairly, according to a consistent and transparent code of conduct, to which all members have agreed to be bound.
Crucially, each member organization will retain its independence and continue to actively compete commercially with the other members of the consortium - but on a level playing field.
For customers and manufacturers, choosing to contract with a 3PARL consortium member assures them of a consistent service they need, allowing them to choose a provider based on the most relevant criteria for their requirements.
Tell us more about the benchmark, and who will ratify it.
The code of conduct is defined and monitored by the consortium members. For now, there is no external independent ratification or certification but as the value of the work of the consortium is acknowledged by the industry, we expect some form of external ratification or certification to 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.
Has 3PARL been welcomed by the industry as something of recognized value?
It has, yes. The reaction has been extremely positive, right across the Life Sciences manufacturing supply chain. It’s seen as a strong statement of intent on the part of the larger, professional service providers to create a standard operating model for GMP audits and reporting.
What lies ahead? How far could this go, in other words?
When pharma-audit recently joined our membership, its head, Bernd Hasken, cited the importance of trust between clients and auditors in the Life Sciences industry, noting that initiatives like 3PARL can strengthen the whole profession, while contributing to patient safety and ensuring product quality. That has to be the ultimate goal.
About Rephine
Rephine is a firm of deeply experienced GxP consultants, auditors, and practitioners. The company proactively helps pharmaceutical, biotech, and medical device companies with all aspects of their manufacturing and supply chain quality assurance and associated business process optimization.
Widely acknowledged to be the gold standard in its field, Rephine has been providing these specialist quality assurance services for more than 25 years. Rephine is a founding member of 3PARL®, a consortium that aims to set a new benchmark for consistent, reliable, high-quality supply chain Good Manufacturing Practice (GMP) audit services and library reports. More at www.rephine.com.
Author Details
Adam Sherlock, a serial entrepreneur, executive business leader, and experienced board member, is the CEO of Rephine Ltd. He is passionate about building businesses and has a strong track record of delivering impressive growth across Life Sciences.
Before joining Rephine as CEO in October 2021, he supported the strategic development of Biomapas, serving the international biopharma industry. Previously, he was Commercial Director at Arriello. For the last 2.5 years, Adam has also been Executive Chair of Cryoniss, a specialist in biological sample storage and specialist logistics for life sciences research and medicinal product distribution.
Publication Detail
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No. 1Jan/Feb/Mar 2024Pages: 28-29
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