Rephine states on its About page: "We achieved ISO 9001:2015 Certificationthe world's most recognised quality management standardfor our UK (Stevenage) and Spain (Barcelona) teams." It also states: "Rephine Barcelona S.L. is now accredited to ISO/IEC 17020 as an inspection body for specific GMP and GDP audit activities." Audit and consultancy work is described against EU GMP (including Annex 11 and Annex 15)ICH Q7/Q9ICH E6 and ALCOA+ data-integrity expectations. Rephine is an auditing/consulting provider and does not claim manufacturing authorisations or inspectorate registrations of its own.
No inspection history published.
Rephine Barcelona
The Gold Standard in Life Sciences Product & Device Quality