The Department of Validation and Reference Standards carries out such major tasks of the Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines as the establishment, maintenance and supply of pharmacopoeial reference standards of the State Pharmacopoeia of Ukraine and conducting research on the standardisation and quality of medicines.

In accordance with their functions, the Department:

▪ develops and maintains the system of pharmacopoeial reference standards of the State Pharmacopoeia of Ukraine (SPhU RSs). It develops, maintains and distributes SPhU RSs, provides their delivery to counterparts according to the terms and quantity orders of the contracts, monitors their quality, and keeps records of their sales figures and stock level.

▪ conducts research on enhancement of SPhU RSs.

▪ issues safety data sheets for SPhU RSs in conformity with the up-to-date requirements.

▪ carries out research on validation of procedures for analysis of medicines and excipients.

▪ conducts research on standardisation and quality control of medicines, develops new and improves existing procedures for drug analysis.

▪ carries out research on validation and standardisation of technological and other processes, taking into account current requirements.

▪ participates in the development of general texts and monographs of the State Pharmacopoeia of Ukraine.

▪ designs and validates software to solve tasks of the Department.

▪ maintains and improves the quality management system according to the current standards.

▪ provides scientific and consulting assistance to organisations and enterprises as to the use of SPhU RSs, standardisation, validation, and quality control of medicines.

▪ conducts staff development and trains the employees of pharmaceutical enterprises on standardisation issues.

▪ involves in the organisation and holding of symposiums, workshops, conferences, etc., which are carried out by the Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines.

▪ participates in the development of legislative and methodological materials on standardisation and quality control of medicines.

The Department of Validation and Reference Standards comprises the following units ─ groups:

▪ SPhU RSs certification;

▪ SPhU RSs supply;

▪ Quality Management and R&D.

The organisation of the work in the Validation and Reference Standards Department is built in compliance with the current requirements of ISO and ДСТУ standards, recommendations of ICH, PIC/S and other guides related to the activities of the Department as well as the charter of the Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines.

The quality management system as to the provision of services for the establishment, maintenance and supply of pharmacopoeial reference standards of the State Pharmacopoeia of Ukraine and conducting research on the standardisation and quality of medicines is certified for compliance with the requirements of ДСТУ ISO 9001: 2009 (certificate No. UA 2.003. 08911-15 dated 11.03.2015).