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News & Views
Rephine and Eurofins spearhead 3PARL
Life sciences is set to get a boost as Rephine (www.rephine.com), the experts in quality assurance & GxP compliance across pharmaceutical, biotech & medical device manufacturing supply chains, and Eurofins Healthcare join forces to spearhead a new trailblazing international consortium that will set a clear standard for life sciences manufacturing supply chain audits globally.
The new Third-Party Audit Report Library (3PARL®) consortium aims to set a new benchmark for consistent, reliable, high-quality supply chain Good Manufacturing Practice (GMP) audit services and library reports. Several other well-known international auditing businesses will be announced as 3PARL consortium members over the coming weeks.
3PARL’s goal is to enable audit sponsors and their customers in strictly regulated markets to have the highest confidence that the auditing and qualification processes applied to suppliers and manufacturers across the whole value chain, are consistently robust and compliant with all applicable regulations.
To address this problem, and despite being commercial competitors, Rephine and Eurofins Healthcare have taken the unprecedented step of coming together to collectively make a stand and set a new benchmark for supply chain audits across the global life sciences industry. This approach assures all stakeholders of the same consistent and compliant rigour and audit quality, from raw material to finished product – whether that’s via a commissioned independent audit, or access to a valid, credible and comprehensive library report.
“In common with our respected partners around the world, we have repeatedly audited life sciences manufacturers globally for more than 25 years, giving us a strong sense of quality performance and manufacturing capabilities across the whole value chain,” says Adam Sherlock, CEO, Rephine. “All of us have become aware of a varying degree of rigour and lack of consistent ethical business practice in supplier auditing, as practised by some independent service providers. This lack of transparency and inconsistency is a risk to everyone in the industry, including patients, because ultimately it jeopardises trust in the qualification and compliance process for quality which independent auditing is designed to provide right across the value chain. Audit sponsors and the suppliers being audited have to have trust that the auditing process will assure all stakeholders of the quality of finished products and their constituent components.”
“Although the founding members of the 3PARL® consortium are competitors commercially, we are united in our concern at the less ethical practices that have unsettled our industry,” adds Corrado Lagioni, Managing Director, Eurofins Healthcare. “Together, we want to make it absolutely clear to clients what they can and should expect from an audit service or library product, and that there can be significant differences in quality depending on where they source their audits or reports. By choosing a 3PARL® audit partner, they can be assured of the highest possible standards, and that these will be observed consistently.”
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