Darnitsa once again confirmed GMP compliance

On October 6th, 2022, the national Pharmaceutical Company Darnitsa received updated GMP certificates, which once again confirmed compliance with the requirements of Good Manufacturing Practice (GMP). The State Service of Ukraine on Medicines and Drug Control inspected the enterprise in June. Pharmaceutical companies are periodically inspected, when the previous GMP Certificate expires.

GMP is a universally recognized international standard for pharmaceutical manufacturing. It is mandatory for the European market. In Ukraine, GMP is harmonized with the current standards of the European Union.

GMP requirements apply to all processes of drug production from the final stages of development to the market entry. A GMP certificate possessed by the enterprise confirms that the products are manufactured in strictly regulated conditions excluding the ingress of foreign substances (contamination), have the necessary quantitative and qualitative composition, properly packaged (retain their properties throughout the shelf life), stored and transported in appropriate conditions, and is high-quality, safe and effective.

“On June 6 to 10, five inspectors of the State Service of Ukraine on Medicines inspected the Pharmaceutical Quality Systems at all manufacturing sites, warehouses, QC laboratories, and internal processes of the Pharmaceutical Company Darnitsa. The company was inspected without any critical observations and as a result received 5 certificates valid for two years for sterile production and three years for non-sterile production. Certificates cover all manufacturing sites for finished medicinal products. So Darnitsa once again proved the compliance of its production with international standards, which are observed even in the difficult conditions of a military state,” Olga Kramarenko, Quality Director of the Pharmaceutical Company Darnitsa says.

Darnitsa was one of the first in the country to certify production according to GMP requirements, having introduced international standards for the drugs production back in 2003. Since 2016, the company has also hold a GMP certificate issued by the regulatory authority of Lithuania, and since 2022, a certificate issued by the regulatory authority of Australia.

It is worth reminding that the Ministry of Health urges Ukrainians to support Ukrainian pharmaceutical manufacturers in order to support the Ukrainian economy and, accordingly, the Ukrainian army. After all, Ukrainian drugs undergo the same procedures of registration and quality control, and therefore are not inferior to European ones.

Reference

PJSC Pharmaceutical Company Darnitsa was founded in 1930. Since 1998, Darnitsa has been the leader in Ukraine as for drug production in physical terms. Strategic areas of products portfolio development include cardiology, neurology, and pain management. During the war, Darnitsa has passed 1.9 million packages of medicines at a cost of UAH 171 million for charitable uses to MOH, Ukrainian Armed Forces, hospitals and charity organisations.