Darnytsia Passed the Inspection and Confirmed Compliance With GMP Requirements

Darnytsia Pharmaceutical Company successfully passed the inspection within the framework of recertification of sterile production by inspectors of the State Service of Ukraine on Medicines and Drugs Control and confirmed compliance with standards of the Good Manufacturing Practice (GMP).

Inspectors of the State Service of Ukraine on Medicines and Drugs Control conducted a 5-day inspection of Darnytsia’s production facilities, namely:

• ampoule section;
• drops section;
• infusion solutions section;
• sterile medicinal products section for compliance with GMP requirements, including Guidance ST-N of the Ministry of Health of Ukraine 42-4.0:2023 Annex 1. “Manufacture of Sterile Medicinal Products”.

Based on the inspection results, it will be recommended to provide certificates of compliance with GMP requirements.

“We have once again confirmed that responsibility to consumers, partners and the state is in the first place for Darnytsia. Confirmation of compliance with GMP requirements opens the way for us to more effective international cooperation, achievement of new ambitious goals, and to our common Victory,” emphasized Olha Kramarenko, Quality Director of Darnytsia Pharmaceutical Company.