Quality, Efficiency, Safety: Pharma Start Production Site in Ukraine Confirms EU GMP Certification
The Acino production site, Pharma Start, in Ukraine has successfully completed an EU GMP audit conducted by the State Agency of Medicines of Latvia. This audit was designed to confirm the factory’s compliance with EU Good Manufacturing Practice (GMP) standards for medicinal products and to extend the validity of the EU GMP certification.
During the audit, inspectors commended extensive upgrades to production facilities and laboratories, improvements to the energy infrastructure, and enhancements to production support systems. The audit also included a detailed examination of quality system processes, with particular attention to the validation of technological processes, data integrity, and digitalization efforts.
Based on the audit results, Pharma Start has successfully passed the certification, reaffirming its compliance with stringent EU GMP standards across quality management, personnel, equipment, production facilities, and documentation.
“Over our nine years of operations in the Ukrainian pharmaceutical market, Acino in Ukraine has continuously elevated its quality systems and introduced innovative production technologies to ensure safety, efficacy, and consistent product quality, while also maintaining production sustainability,” stated Eugene Zaika, Regional Director of Acino. “In 2019, we demonstrated that Pharma Start’s product quality meets the high regulatory standards of the European Community, supporting our ambition to expand the export potential of our portfolio. This latest certification once again validates our commitment to these rigorous standards, which are crucial for fostering global partnerships.”