NPO Petrovax Pharm recertified for Russian GMP conformance of pharmaceutical manufacture and Quality Management System

On March 1st, 2017, NPO Petrovax Pharm was recertified by the Russian Ministry of Industry and Trade for GMP conformance of its manufacture and Quality Management System, which has proved once again a high level of the biopharmaceutical facility operations overall.

The new GMP certificate provides for certification of all production processes associated with sterile and nonsterile pharmaceuticals, vaccines, immunomodulating agents, and APIs. Besides, the certificate of conformance for the first time includes secondary packaging and release quality control of a monoclonal antibody solvent.

It is to be recalled that in June 2016, the Russian Ministry of Industry and Trade issued a Russian GMP certificate for the facility’s manufacture and Quality Management System. NPO Petrovax Pharm is the only immunobiological manufacturer in Russia that was issued international GMP certificates by the EU (Slovakia) and Iranian regulatory authorities.