Within 7 days, the Polish regulatory authority inspected Farmak’s production for compliance with the requirements of Good Manufacturing Practice (GMP) of the European Union. As a result, the company received a positive conclusion from inspectors and, accordingly, an extension of existing EU GMP compliance certificates.
Certificates are issued for 3 years. They apply to production sites for manufacturing sterile and non-sterile medicines.
In addition to the planned recertification, the company received European GMP certificates for new sites that were put into operation during 2021-2023. Among them are sections for the production of sterile medicines in ampoules and vials, medicines in the form of drops and sprays, as well as a section for the production of medicines in tablets.
The first EU GMP certificate was received by Farmak in 2005 from the Latvian regulatory authority.
“During the war, it was especially important for us to undergo European inspection. The obtained EU GMP certificates prove that in any conditions our company adheres to the highest international quality standards for the manufacture of medicines. This allows us to continue to expand Farmak’s presence in European and other foreign markets. And also export our products to more than 50 countries of the world,” said Volodymyr Kostiuk, Executive Director of Farmak.
Reference
GMP (Good Manufacturing Practice) is part of a quality assurance system that ensures that pharmaceutical products are manufactured according to quality standards in accordance with the marketing authorization and are fit for purpose. GMP principles and rules are mandatory for all EU member states.
