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Darnitsa Successfully Underwent the Audit for Compliance with the Good Manufacturing Practice Requirements

08 July 2019

The Pharmaceutical Firm Darnitsa has once again confirmed its compliance with the Good Manufacturing Practice (GMP) requirements during the inspection of the State Service of Ukraine on Medicines and Drugs Control. The company has received a certificate for three years, covering all sites manufacturing finished medicinal products.

GMP is a mandatory certification standard for pharmaceutical manufacturing facilities in Europe and is universally recognized. The Ukrainian GMP standards have been harmonized with those applicable in the territory of the European Union. The GMP requirements form a part of the quality system ensuring that medicinal products are manufactured and controlled in accordance with the quality standards that correspond to their intended use and in accordance with requirements of the registration dossier and certification for the products.

Andrii Obrizan, General Director of the Pharmaceutical Firm Darnitsa:

“In 2003, the Pharmaceutical Firm “Darnitsa” received the first GMP compliance certificate for the manufacturing of sterile antibiotics. Since then, the company has been continuously improving its quality system and manufacturing conditions to ensure the consistently high quality of products. We use equipment by leading European manufacturers for the production of medicines. Darnitsa has invested more than EUR 200 million in the development of the quality system and compliance with the GMP requirements. Each year, the company allocates 10% of its gross income for R&D, production automation projects and digitalization processes. We take advantage of all the benefits of the GMP for access to foreign markets, improvements, enhancement of competitiveness and investment attractiveness”.

During the years 2016 to 2018, the Darnitsa implemented a number of projects to re-equip the main manufacturing facilities. In particular, the water treatment systems in most manufacturing facilities have been modernized and equipped with the state-of-the art equipment. Due to reengineering of the quality assurance system, in particular in the approaches to validation and qualification processes, the company has achieved steady progress in the continuous improvement of the quality of products, new products development processes and supporting the current portfolio.

In general, over the last three years Darnitsa received five positive opinions on the compliance of the conditions of manufacturing of medicinal products with the Good Manufacturing Practice requirements from the regulatory authorities of Ukraine, Belarus and the EU countries. The certificate confirms that the medicines manufactured at “Darnitsa” meet the European standard for pharmaceutical production and quality control of products.

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