How the system for ensuring the quality of medicines’ manufacture works, what challenges inspectors face on a daily basis, and what needs improvement—these issues were discussed during a working visit by Taras Proniv, Acting Head of the SMDC of Ukraine, to the State Enterprise “Ukrainian Pharmaceutical Institute of Quality.”
The Acting Head of the SMDC of Ukraine, along with relevant staff members, got acquainted with the enterprise’s operations, spoke with its staff, and personally inspected the specialists’ working conditions.
It wasn’t a formal meeting but rather a candid conversation about the challenges that professionals face every day: working conditions, workloads, work organization, and situations that need to be resolved.
One of the key questions is how a small team manages to handle such a significant workload. After all, every inspection involves hours of preparation, document analysis, on-site work, and drafting the corresponding findings.
Inquiries and complaints from businesses were discussed with the inspectors. The causes of such situations and how to make work processes clearer and more efficient were also discussed.
Behind every medicine that reaches a Ukrainian pharmacy lies more than just the manufacturer, technology, and standards. Manufacturing facilities must comply with Good Manufacturing Practice (GMP) requirements, and this compliance must be verified and officially confirmed.
This is precisely the work carried out by specialists at the State Enterprise “Ukrainian Pharmaceutical Quality Institute.”
“The quality of an inspector’s work is not just about professional knowledge. It also involves responsibility, precision, and the ability to meet deadlines,” noted Taras Proniv.
Ukrainian Pharmaceutical Quality Institute plays a crucial role in ensuring the quality of medicines in Ukraine. After all, the government registers only those medicines whose manufacturing process meets established requirements. Manufacturing sites must undergo appropriate inspections, and their compliance with Good Manufacturing Practice (GMP) requirements must be officially confirmed. Ukrainian Pharmaceutical Quality Institute employs highly qualified and experienced specialists, including inspectors for Good Manufacturing and Distribution Practices—GMP/GDP.
The path of becoming a GMP/GDP inspector begins with the appropriate education and specialized training. Next come training sessions, participating in inspections as a junior inspector, and gaining practical experience. And even after becoming a full-fledged inspector, the learning never stops—professional knowledge must be constantly updated.
Therefore, a competent inspector is the result not of a single course or diploma, but of years of study, practice, and professional development.
Ukrainian Pharmaceutical Quality Institute plays an important role in the system of quality assurance for medicines in Ukraine. At the same time, the effectiveness of this work depends to a large extent on well-coordinated interaction with the State Service of Ukraine on Medicines and Drugs Control.
Cooperation between the State Service of Ukraine on Medicines and Drugs Control and Ukrainian Pharmaceutical Quality Institute is one of the fundamental principles of a unified system of state quality control for medicines. The outcome of their joint efforts depends on how effectively specialists collaborate, exchange information, coordinate work processes, and respond promptly to issues that arise.
The shared vision, professional dialogue, and the swift resolution of operational issues make the control system more effective and predictable.