The Laboratory for Expertise and Quality Control of Medical and Pharmaceutical Products of the Public Legal Entity “Analytical Expertise Center” of the Ministry of Health, operating in the Republic of Azerbaijan, was established to ensure quality control of medicines imported into the country and used for the registration procedure in the Register of Medicines and protection of Public Health. The Center’s laboratory also carries out quality control of medicines of dubious quality on the basis of applications from citizens and legal entities to the AEC. The laboratory also examines the composition of food supplements with biological activity and conducts its own examination as to whether they are medicines or not.
In addition, in 2019, the Laboratory of the Center was accredited according to the ISO 17025 standard “General requirements for the competencies of a testing and calibration laboratory”, and after receiving the ISO/IEC 17025 accreditation certificate, it was included in the list of accredited laboratories of the Global Fund.
Since 2014, the Laboratory of the Center has been a participant in a proficiency testing project organized by the European Directorate for the Quality of Medicines and Healthcare (EDQM) in accordance with the general requirements for proficiency testing “Conformity assessment ISO/IEC 17043:2010” and participates in competitions under the Proficiency Testing Scheme (PTS). The main purpose of the Proficiency Testing Scheme is to compare the accuracy and reliability of the analyzes performed by the participating laboratories and to objectively evaluate the performance of the laboratories. For this reason, EDQM conducts annual PTSs on various methods of physico-chemical analysis. The Center’s Laboratory participates in competitions on various topics within the framework of the PTS project and achieves commendable results.
Specialists of the Laboratory for Expertise and Quality Control of Medical and Pharmaceutical Products have participated in many international trainings and courses and have been awarded the relevant certificates. Since 2021, the Laboratory has been accepted as an associate member of the WHO Network of national laboratories for the testing of biological preparations and provides uninterrupted work within the limits of its capabilities during the situation caused by the “COVID-19” pandemic in the world and in the country.
To conduct research with real precision, the laboratory uses high purity reagents, sensitive and precise equipment.
The laboratory of the Center uses modern physical and chemical research methods, such as liquid and gas chromatography, ultraviolet and infrared spectrophotometry, determination of endotoxins based on the results of microbiological studies – LAL test, determination of microbiological purity and sterility.
The equipment, consumables and devices used in the laboratory are regularly checked and qualified. In accordance with the policy of continuous improvement of the AEC, the range of services and functionality of the Laboratory is constantly expanding and developing.
Also, for students of the Azerbaijan Medical University, a production experience is held at the Laboratory of the Center and for masters and doctoral students and for teachers it is used as an experimental base for the introduction of the experimental part of scientific works and articles.
