Cerbios successfully passes a general FDA GMP inspection
It is with pleasure that we announce that on Thursday the 20th of February 2014, Cerbios-Pharma SA (from now on CERBIOS) successfully passed a general FDA GMP inspection.
Originally, the inspection was scheduled to last five days with two inspectors.
Due to the excellent results, the inspectors decided to close the audit in the middle of the fourth day, without issuing any 483 observation.
"It is the confirmation that our cGMP system is state-of-the-art and compliant with the most recent guidelines and validates our strategy of having an excellent system in place serving our partners”, says
Dr. Gabriel Haering, CEO.
The general GMP inspection covered all areas of the organisation and systems involved in the production of Active Pharmaceutical Ingredients.
Both inspectors complimented the company for the honest approach and excellent practical work (linked to the relevant SOPs) observed during the inspection in the production unit and QC laboratories. This confirms that our investments in continuous training and personnel motivation are important and rewarding.
Today’s milestone highlights that Cerbios’ strategy to pursue excellence and innovation at all levels, from manufacturing production units to quality systems and customer care, is the right and winning choice.
Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.