Regarding the unscheduled inspection of the State Scientific Research Laboratory for Quality Control of Medicines at the Marzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine

As announced in the previous publication of the the State Service of Ukraine on Medicines and Drugs Control (SMDC), we would like to inform you about the results of the unscheduled inspection of the State Scientific Research Laboratory for Quality Control of Medicines at the Marzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine.

Unscheduled control measures were carried out in accordance with the Order of the Ministry of Health of Ukraine № 10 dated January 14, 2004 “On Approval of the Procedure for Sectoral Certification of Laboratories for Quality and Safety of Medicines”.

The inspection was conducted on July 18-19, 2024 according to the Order of the State Service of Ukraine on Medicines and Drugs Control № 1085 dated July 17, 2024 as a general assessment of the level of compliance of the Laboratory with the criteria of sectoral certification in regards of proper laboratory control of medicines, namely

– DSTU (National standards of Ukraine) ISO/IEC 17025 recommendations “General requirements for the competence of testing and calibration laboratories” (except for the requirements to the competence of calibration laboratories);

– PIC/S PH 2/95 recommendations “Recommendations on the quality system for official pharmaceutical control laboratories”;

– WHO recommendations “Good practices for national pharmaceutical control laboratories” (WHO TRS № 902, 2002).

During the inspection, inconsistencies were identified in the quality management system, equipment and the conducting of medicines trials.

The main findings show that numerous violations of data integrity make it impossible to properly track the conducted trials and call into question the results of quality medicines control that were tested during the inspection. In addition, it was found that trials were conducted using methods that were not specified in the quality control methods approved in Ukraine, the SMDC was not notified about the lack of resources for conducting trials and that subcontracting was not approved, violations of the handling of medicines samples, non-compliance with the internal procedures, lack of a systematic approach to the storage of primary data obtained on analytical computerised systems, etc.

The management of the National Academy of Medical Sciences of Ukraine was informed of the situation, and a copy of the Report on the unscheduled inspection with annexes (668 pages in total) has been sent to the Director of the Marzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine.

Taking into account the systematic nature of the violations that were identified, the Sectoral Certificate issued to the laboratory was suspended until shortcomings’ elimination.

Additional information on authorised laboratories by the State Service of Ukraine on Medicines and Drugs Control  

The official website of the State Service of Ukraine on Medicines and Drugs Control has published the List of Recommended Laboratories Authorised by the State Service of Ukraine on Medicines and Drugs Control to carry out quality medicines control.

In addition to this laboratory, two other state-authorised laboratories are prequalified by the World Health Organization (WHO):

– The State Enterprise “Central Laboratory for Quality Analysis of Medicines and Medical Products” is managed by the State Service of Ukraine on Medicines and Drugs Control;

– Pharmaceutical Analysis Laboratory of the State Enterprise “State Expert Centre of the Ministry of Health of Ukraine”.

Information on prequalified laboratories is publicly available on the WHO website https://extranet.who.int/prequal/medicines/prequalified/quality-control-labs

In addition, the State Enterprise ”Central Laboratory for Quality Analysis of Medicines and Medical Products” is certified by the European Directorate for the Quality of Medicines (EDQM) and is a member of the European-Network  of Official Medicines Control Laboratories (OMCL).