Cerbios successfully passes a general FDA cGMP inspection
It is with pleasure that we announce that on Friday the 27th of April 2018, Cerbios-Pharma SA (from now on CERBIOS) successfully passed a general FDA GMP inspection.
Originally, the inspection was scheduled to last five days.
Due to the excellent results, the inspector decided to close the audit in the middle of the fifth day, without issuing any 483 observation.
“Since I joined CERBIOS in 2009, this is the third FDA inspection with no 483” says Gabriel Haering, CEO.
“This 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 world-wide” .
The general cGMP inspection covered all areas of the organisation and systems involved in the production of Active Pharmaceutical Ingredients.
The inspector 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” confirms Denis Angioletti, Chief Commercial Officer.
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.