22.11.2013 – FDA-inspection successfully passed!
In November BioChem GmbH received the final written confirmation from the FDA, the so-called Establishment Inspection Report (EIR), about passing successfully a 4-day GMP- and Pre-Approval-Inspection in June 2013.
… is the most important passage and mirrors again, 1st FDA-inspection was passed successfully in July 2009, the high level of GMP conformity of BioChem GmbH.
The comprehensive system-inspection, performed by the experienced FDA investigator Mr. Jose R. Hernandez, was based on several license applications (NDA´s, ANDA´s und BLA´s) of our customers and focused on all operational laboratory units and their procedures as well as the quality assurance system.
Special attention was turned to e.g. gas-chromatography, photo-stability, water analysis, stability or specific rotation as well as within the microbiological area sterility and bacterial endotoxin testing, media preparation, incubators or autoclaves.
We would like to take this opportunity to say once more a very warm and sincere “THANK YOU” to all employees and participants for their dedication and professionalism.