Ofidit forms strategic pharmaceutical audit partnership with Rephine
The mutually-beneficial alliance will see the deeply-experienced global GMP auditors assume responsibility for Ofidit’s third-party audit service and stock its audit reports in its extensive library
Ofidit, which provides specialised GMP third-party auditing of active pharmaceutical ingredient (API) manufacturers worldwide, has announced a strategic partnership with Rephine Ltd, a firm of deeply-experienced GMP auditors specialising in pharmaceutical supply-chain quality assurance.
The mutually-beneficial alliance will see Rephine assume responsibility for Ofidit’s third-party audit service for customers.
In exchange Ofidit’s audit reports will be featured in Rephine’s extensive audit library, which is the largest repository of live pharmaceutical GMP audits globally. Through the partnership, Ofidit is increasing its scope to offer and develop a broader portfolio of services, in response to the rapidly-changing pharmaceutical industry and its requirements.
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:
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.”
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.”
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.
Ofidit is the independent GMP audit programme of Laboratorium Ofichem BV, part of the Ofichem Group. Established in 2011, based in Ter Apel, the Netherlands and in Hangzhou, China, Ofidit specializes in GMP third-party auditing of API manufacturers worldwide.
The Ofichem Group of companies is committed to providing high-quality, safe raw materials for human and veterinary medicines. The various companies that make up the group are together engaged in the full range of activities around active pharmaceutical ingredients (APIs), from development and production, to the import of third-party APIs and their analysis, repacking and distribution.
Contact for Ofidit:
Phone: +31 599 583 433
About Rephine Ltd
Rephine Ltd is a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance. As well as conducting audits on an as-needed basis, Rephine offers the single largest repository of live reports (within three-year validity), spanning more than 2,500 individual products. Its new SaaS-based software solution, Rephine Catena™, provides pharmaceutical companies with clear, current, end-to-end visibility of the entire product supply chain for each of their products sold on the market.
Press contact for Rephine Ltd:
Phone: 07970 006624