State Enterprise «Ukrainian Pharmaceutical Quality Institute»

State Enterprise «Ukrainian Pharmaceutical Quality Institute» (SE «UPQI») is a state unitarily commercial enterprise that acted in the state medicines quality control sphere in accordance with the law of Ukraine «On Medicinal Products» and other regulatory acts and belongs to the management of the State Service of Ukraine on Medicines and Drugs Control.

SE «UPQI» provides a wide range of informational, consulting, scientific, technical and educational services in the area of Good Practices (GMP, GDP, GLP, GxP), ensuring the creating and development of quality systems on the enterprises of pharmaceutical industry in Ukraine. Specialists of the SE «UPQI» provided ongoing organizational, technical and professional assistance to the State Service Of Ukraine On Medicines And Drugs Control (SMDS) at all stages of its accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) from 2004 to 2010, which occurred on January, 1, 2011.

SE «UPQI» qualification in the sphere of educational process organization and conducting for pharmaceutical industry specialists, specialized assessment of the normative and technical documentation, and also specialized documents expertise and medicines manufacturing inspecting in purpose of compliance with the Good Manufacturing Practice requirements is confirmed by ISO 9001:2018 Certificate.

The main directions of activity:

• conducting training for enterprises, institutions, organizations, including civil servants, on the rules of good manufacturing and distribution practices for the manufacture of medicines and medical devices in accordance with European and world standards;

• scientific and methodological support of the educational process of specialists involved in the production, export, import, sale, circulation, storage, use, utilization and destruction of medicines and medical devices;

• conducting scientific and technical expertise and inspections to confirm the compliance of medicines manufacture condition to good manufacturing and distribution practices of enterprises, institutions and organizations, regardless of the ownership form, medicines manufacturing certification, wholesale medicines distribution organizations, medicines quality control laboratories attestation, audits, inspections, surveys, etc;

• development of proposals for the advancement and improvement of legislation in the field of medicines and medical devices production in order to harmonize it with European and global standards;

• conducting expertise of analytical regulatory projects, normative and technical documentations on compliance with applicable norms and regulations in the pharmaceutical manufacturing sphere, projects for the establishment and reconstruction of medicines manufactures, quality control laboratories for compliance with regulatory and technical documents harmonized with the relevant EU documents;

• preparation and submission for approval in accordance with the established procedure of normative documents that regulate the process of manufacture and use of medicines and medical devices, as well as control over their compliance to the requirements of national and international standards, etc.

Address: 7-A Sobornosti Ave, Office 404, Kyiv

Tel.: +38 (050) 440-40-62

E-mail: office@gmpcenter.org.ua

Website: http://gmpcenter.org.ua/