The auditors made a positive conclusion on the high level of audit organization and professionalism of Farmak personnel. Successful passing of audit gives the opportunity to enter the European Inosine Pranobex Market.
The remote audit was conducted by Aflofarm Farmacja Polska Sp. z o.o. The auditors inspected the documentation which declared the compliance of the substance manufacturing process, quality control, storage and proper functioning of the pharmaceutical quality system with the GMP requirements. During the inspection, the auditors were shown photo presentations of equipment and rooms involved in the API manufacture, quality control and storage.
At present, registration works are underway to include this API in the registration dossier of the Polish auditor’s medicinal product. The registration process simultaneously takes place in 7 European countries.
It is worth reminding that Farmak annually undergoes approximately 15 international inspections and audits. Manufacturing and research facilities, laboratory and technological complex are certified for compliance with the international standards and meet the high requirements of the European standards. The pharmaceutical quality system has been implemented and is constantly improved at the manufacturing facilities according to the current regulatory requirements and international standards, such as ISO and GMP. Today national GMP certificates have been issued to all finished products manufacturing sites, 14 of which are certified by the European regulatory authorities of Croatia, Poland and Germany. 95% of Farmak products are manufactured at these certified sites.
