Certification of the quality management system of the State Service of Ukraine on Medicines and Drugs Control

July 9, 2019

In the State Service of Ukraine on Medicines and Drugs Control the quality management system has been implemented taking into account the requirements of the national standard DSTU ISO 9001:2015 «Quality management systems – Requirements» and PIC/S recommendations, in particular the requirements of document PI 002-3 «Recommendation on Quality Systems Requirements for Pharmaceutical Inspectorates», WHO TRS 902, Annex 8 «Quality Systems Requirements for National Good Manufacturing Practice Inspectorates».

In 2014 the State Service of Ukraine on Medicines and Drugs Control has successfully passed the certification audit for compliance with the requirements of the standard ISO 9001:2008 «Quality management systems Requirements».

In 2018 the State Service of Ukraine on Medicines and Drugs Control has passed the certification audit for compliance with the requirements of the ISO 9001:2015 «Quality management systems – Requirements» conducted by the «Intersector Quality Center «PRIROST» LLC.

As a result of the audit, the State Service of Ukraine on Medicines and Drugs Control received the certificate of compliance with the requirements of the standard ISO 9001:2015 (№ 170122 QM15 dated October 12, 2018).

The quality management system of the State Service of Ukraine on Medicines and Drugs Control includes activities on the organization of state control and safety of medicines and medical products in the circulation, licensing and certification of the manufacture and import of medicines, wholesale and retail trade in pharmaceuticals.