Within the framework of the pharmaceutical quality system compliance in accordance with national and European requirements of GMP, the Farmak Company has successfully underwent the audit of the State Service of Ukraine on Medicinal Products and the Main Pharmaceutical Inspectorate of Poland (GIF).
The State Service of Ukraine on Medicinal Products audited warehouses, quality control laboratories and stations for finished drugs and active pharmaceutical ingredients (APIs) in terms of compliance with the Guidelines CT-N of the Ministry of Health 42 4.0: 2015 "Medicines. Good Manufacturing Practice". The audit was successfully conducted in early April. As a result of compliance with the Pharmaceutical Quality System (PQS), the Farmak Company has got 5 national GMP certificates.
In early June, the Main Pharmaceutical Inspectorate of Poland audited two stations for non-sterile drugs production in terms of compliance with the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. The Farmak Company exports these products to EU markets.
Inspectors highly appreciated PQS and logistical support of Farmak; they would recommend prolongation of GMP certificates. Currently, the Company is waiting for the audit reports and updated GMP certificates from the Polish regulator.
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