The mutually-beneficial alliance will see Rephine take over the Dutch third-party audit service, while Ofidit’s audit reports will be featured in Rephine’s extensive library
Stevenage, UK – May 17th, 2022 – Rephine, a firm of deeply experienced GMP auditors specialising in pharma supply-chain quality assurance, has announced a new strategic partnership with Ofidit, which provides specialised GMP third-party auditing of active pharma ingredient (API) manufacturers worldwide. Ofidit, which has operations in Ter Apel, the Netherlands and Hangzhou, China, is the independent GMP audit programme of Laboratorium Ofichem BV, part of the Ofichem Group.
The mutually beneficial alliance will see Rephine take responsibility for Ofidit’s third-party audit service for customers, and in exchange Ofidit’s audit reports will be featured in Rephine’s extensive audit library, which is the largest repository of live pharma GMP audits globally.
Combined, the Rephine-Ofidit portfolio of services covers meticulous auditing of:
• API manufacture (both human and veterinary)
• Excipient manufacture
• Investigational Medicinal Product (IMP) manufacture
• All forms of secondary manufacture
• Contract Packaging Organisations
• Contract Manufacturing Organisations
• Contract Research Organisations
• Contract Laboratories
Commenting on the partnership, Adam Sherlock, CEO of Rephine, said: “We are delighted to have entered into this alliance with Ofidit, which is truly a win-win partnership, from which our pharmaceutical clients, and those of Ofidit, will benefit the most. In a world with large distances between producers of ingredients and manufacturers of medicines, building strong international bridges is vital to ensure end-to-end quality control, and that’s exactly what this powerful partnership represents.”
Alessia Cogotti, Managing Director of Ofidit, said: “We’re very much looking forward to working with Rephine. Our vision is that a safe medicine starts with high-quality raw materials. Thanks to this strategic partnership with Rephine and the presence of highly-qualified auditors in more than 40 countries, we’ll be helping to ensure that the quality of medicines is consistently as high as it should be.”
Recent research from Rephine highlighted the new appreciation for the importance of both face-to-face audits, and access to valid auditing reports, after the disruption of the pandemic which delayed site visits with the potential for quality concerns to be missed.