Production Quality at Darnytsia: Numbers, Facts, and Technologies that Impress
For 95 years, Darnytsia Pharmaceutical Company has embodied the highest standards of quality control, efficacy, and safety of medicines, annually reaffirming its leadership position in the Ukrainian pharmaceutical market.
At the core of its quality control system is a unique laboratory infrastructure that, since 2006, has provided comprehensive oversight of every stage of production on a daily basis. The laboratory complex at Darnytsia covers more than 2,300 square meters of modern facilities and features 396 pieces of state-of-the-art equipment.
Every day, the team of specialists conducts around 100 laboratory tests, with the annual total exceeding 22,000. Each sampling undergoes thorough analysis: from raw materials and packaging control to monitoring the cleanliness of premises, air, water, specialist clothing, and even employees’ hands.
Production processes are automated, and all key stages and research results are recorded in a specialized laboratory information management system. Here, the entire history of each sample is stored — no unexpected surprises: results cannot be forged or deleted, and any changes are instantly recorded, which is especially valued by European regulators when assessing quality before products enter EU markets.
Darnytsia team members undergo a multi-month training program before starting in the production areas: even before their first working day, they must fully master entry procedures for sterile zones, learn to wear multilayer protective clothing, and strictly adhere to hygiene regulations to prevent unwanted microorganisms from entering the production process.
The pharmaceutical development department is engaged in scientific research and the creation of new medicinal products. Every new formula undergoes thorough testing in special climate chambers, where product stability is verified throughout its entire shelf life.
The annual portfolio of laboratory studies, hundreds of methodologies, thousands of analyzed samples, and the yearly increase in external audits — this is the foundation upon which Darnytsia builds its reputation as a true leader in pharmaceuticals and a guarantor of trust for patients not only in Ukraine, but around the world.
“We guarantee the unquestionable quality of our medicines. Every employee, every process, and every measurement undergoes multi-stage control to ensure the safety and effectiveness of every tablet and every package. We are confident that Ukrainian pharmaceuticals can and should meet the world’s best practices,” says Olha Kramarenko, Quality Director at Darnytsia Pharmaceutical Company.