Arterium Manufacturer Passed GMP Compliance Inspection and Received Certificates
One of the key manufacturers of Arterium products has successfully passed an inspection by the State Service of Ukraine on Medicines and Drugs Control. The inspection covered the infusion drug production site, the filling site, and the packaging site of the ampoule production facility, where sterile medicines are manufactured.
The inspection once again confirmed that Arterium products manufactured at these sites comply with the Good Manufacturing Practice (GMP) requirements, particularly the updated Annex 1 standards for sterile medicinal product manufacturing, which came into effect on 25 August 2023.
It is worth noting that Annex 1 of the Guidelines ‘Medicinal Products. Good Manufacturing Practice’ applies to the production of sterile medicines and aims to harmonise Ukrainian and European manufacturing requirements, supporting the further European integration of Ukraine’s pharmaceutical industry. The implementation of the updated requirements required significant changes to business processes, partial modernisation of equipment and facilities, and additional staff training.