The State Service for Medicines and Drug Control has suspended the license of the laboratory of the Marzeyev Institute of Public Health.
“Given the systematic nature of the identified violations, the validity of the certificate of industry certification issued to the laboratory is suspended until the elimination of remarks,” – reported on the website of the State Service for Medicines and Drug Control.
The State Service noted that the certificate was suspended following the results of the survey of the general level of compliance of the laboratory with the criteria of sectoral attestation on the organization of laboratory control of medicines, conducted on July 18-19.
According to the service, the survey “identified non-compliances that relate to the quality management system, equipment and drug testing.”
“The main findings indicate that numerous data integrity violations call into question the results of quality control of medicines that were checked during the survey. It has been established that studies were conducted according to methods that are not reflected in the quality control methods approved in Ukraine,” the State Service reports.
In addition, the State Service noted that the laboratory did not inform the State Service, in particular, about the lack of resources for conducting research and failure to agree on subcontracting, violation of handling of samples of medicines.
Goslexluzhba also emphasizes that at present, apart from the laboratory of the Marzeyev Institute, two other laboratories have WHO prequalification: the Central Laboratory of Goslexluzhba and the laboratory of pharmanalysis of the State Enterprise “State Expert Center (SEC) of the Ministry of Health”. In addition, the State Enterprise “Central Laboratory for Quality Analysis of Medicines and Medical Products” is accredited by the European Directorate for Quality of Medicines (EDQM) and is part of the pan-European network of laboratories OMCL.
As reported earlier, the laboratory of the Marzeyev Institute of Public Health appealed to Ukrainian President Volodymyr Zelenskyy and Prime Minister, the leadership of the Security Service of Ukraine (SBU) and the Health Ministry with a request to prevent the transfer of the market of laboratory control of medicines into private hands. The laboratory stressed that “state control of the quality of medicines is being transferred into the hands of private business, with the State Service for Medicinal Products using for its own purposes the private authorized laboratory Dobrobut-Likilab LLC, created for itself”.
As previously reported, the laboratory of the Institute of Public Health named after Marzeyev asked Ukrainian President Volodymyr Marzeyev. Marzeyev asks the President of Ukraine Volodymyr Zelensky, the Prime Minister, the leadership of the Security Service of Ukraine (SBU) and the Ministry of Health to prevent the transfer of the market of laboratory control of medicines into private hands.
Natalia Ostanina, head of the laboratory of the Marzeyev Institute, believes that the management of the State Research Laboratory of Public Health is forcing the laboratory out of the market of quality control of medicines by transferring the directions for quality control from the State Research Laboratory of Public Health to the private laboratory Dobrobut Likilab LLC.
The State Research Laboratory for Quality Control of Medicines of the Marzeyev Institute of Drugs of the National Academy of Medical Sciences of Ukraine was established in 1996, it employs four doctors of sciences, 10 candidates of sciences and 30 researchers. It is accredited by the National Accreditation Agency of Ukraine in accordance with the requirements of DSTU EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017 IDT), certified by Gosleksluzhba, Quality Management System is certified by the Ukrainian Medical Certification Center for compliance with the requirements of DSTU EN ISO 9001:2018. The laboratory is the only one among scientific state institutions to be prequalified by WHO for the right to conduct quality control of medicines.
LABORATORY, MARZEYEV INSTITUTE, OSTANIN
