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.
Read more about lot release services at IBR Inc. or contact us to get a more detailed description of the assays and an accurate evaluation of your requirements. The IBR Inc. experts are at your disposal for a thorough evaluation of your needs.