We are proud to announce that on February 2019 IBR Inc. earned the certification for Good Manufacturing Practice (GMP) on physical/chemical analyses, bioanalytics and microbioanalytics from Swissmedic.
Beside the longstanding GLP compliance for analytical, clinical chemistry, pharmacokinetics, immunological, efficacy and potency testing, the GMP certification is an essential part of the Quality System of IBR Inc.
GMP analyses at IBR Inc. adhere to the EU GMP requirements (described in EudraLex, Volume 4, Good Manufacturing Practice guidelines) and the FDA GMP requirements (Current Good Manufacturing Practice regulation for human pharmaceuticals).
The in-house Quality Assurance Manager and Responsible Person (Fachtechnisch verantwortliche Person, FvP, for Switzerland; Qualified Person, QP, within the EU); ensure the conduction of studies in compliance with EU and FDA GMP requirements.
The GMP certification enables support of lot release of biologics, biosimilars, vaccines and small molecules by means of our broad panel of bioanalytical services.