The Quality Management System (QMS) has been in place since the creation of the laboratory.
Official QMS score:
– national regulatory authorities (Ministry of Health of Ukraine, State Inspection, State Service of Ukraine on Medicines) – periodical from 2000;
– World Health Organization (WHO) – prequalification in 2010 and re-confirmation of prequalification in 2013, 2016 and 2020;
– European Directorate for the Quality of Medicines and HealthCare (EDQM) – Certification in 2012 and Continued Certification in 2016 and 2020
– National Accreditation Agency (NAAU) – accreditation of the testing laboratory for compliance with ISO/IEC 17025:2017 requirements (2018 – 2023).
Current certificates with the relevant attestation / accreditation are added.
The Laboratory has a License for the right to purchase, store, transport, import into the territory of Ukraine, destruction, use of narcotic drugs (list 1 of table II and list 1 of table III), psychotropic substances (list 2 of table II and list 2 of table III), precursors (list 1 tables IV and list 2, IV) “List of narcotic drugs, psychotropic substances and precursors” (License is valid from 20.06.2021)