Farmak has been inspected by the representatives of the regulatory authority for compliance with the GMP requirements of the Republic of Belarus and the Eurasian Economic Union (EAEU) with no critical remarks.
During the inspection which lasted for a week and a half, the representatives of the Belarusian regulatory authority had the opportunity to assess various aspects of the Company’s activities within the GMP requirements. They examined all workshops manufacturing finished medicinal products that are distributed both in Ukraine and in the EAEU countries. They also inspected the operation of the clean utility workshop, warehouses, quality control laboratories and other Farmak’s structural units. The inspectors carefully assessed the pharmaceutical quality system (PQS) implemented in the Company, personnel performance, documentation management, quality control processes, condition of the rooms etc.
At the final meeting, the inspectors highlighted Farmak’s highly qualified personnel, proper organisation of all processes and the high level of the PQS. The inspection results will be reported within 30 days.
Background information:
Farmak has developed a quality system based on European approaches. Manufacturing facilities, R&D facilities and laboratory and technological complex are internationally certified and meet the high requirements of European standards. The Company has implemented and has been constantly improving the PQS at the manufacturing facilities according to the current regulatory requirements and international standards, such as: ISO and GMP. The Company annually undergoes up to 15 international inspections and audits.
Today national GMP certificates have been issued for all lines manufacturing finished medicinal products, 14 of which are certified by the European regulatory authorities of Croatia, Poland and Germany. No other pharmaceutical company in Ukraine is recognised at such international level.
