News & Views
Rephine partners with Ofidit
GMP auditors, Rephine (www.rephine.com) and specialists in pharma supply-chain quality assurance, announces a new strategic partnership with Ofidit, which provides specialized GMP third-party auditing of active pharma ingredient (API) manufacturers worldwide. The mutually-beneficial alliance will see Rephine take responsibility for the Dutch third-party audit service, while Ofidit’s audit reports will be featured in Rephine’s extensive library.
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.
The combined Rephine-Ofidit portfolio of services will cover meticulous auditing of: API manufacture (both human and veterinary); Excipient manufacture; Investigational Medicinal Product (IMP) manufacture; All forms of secondary manufacture; as well as auditing of Contract organizations such as those in packaging, manufacturing, research and Contract Laboratories.
“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,” says Adam Sherlock, CEO, Rephine. “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.”
“We’re very much looking forward to working with Rephine,” adds Alessia Cogotti, Managing Director, Ofidit. “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.”