For almost a month and a half, specialists of the Microbiology Department of the Drug Quality Control Laboratory have successfully passed international competence tests organized by the biotechnology company LGC AXIO Proficiency Testing – a division of the British National Institute of Measurement for Chemical and Bioanalytical Indicators.
A key element was the correct identification of the microorganism Enterococcus faecalis in positive samples. This bacterium, which normally lives in the intestines of humans and animals, is not normally dangerous, but can become problematic if it enters the blood, urinary tract or medical products. Moldovan specialists were 100% correct in identifying this dangerous bacterium in sterility tests. In total, representatives of 72 countries took part in the test.
Also in the test for bacterial endotoxins, the specialists of the Microbiology Department showed an outstanding result, being among the three best laboratories out of 55 participants, with a Z-factor of 0.03, which in specialized circles is an indicator of exceptionally high analytical accuracy.
These tests are an important tool for assessing the quality and accuracy of laboratory processes and are conducted in accordance with the international standards of the European Pharmacopoeia (Ph. Eur.).
The Agency’s management emphasized that the test results confirm compliance with international standards, strengthen the reputation of the laboratory and are crucial for the safety and efficacy of pharmaceutical products.
“These outstanding achievements confirm the commitment of the Agency for Medicines and Medical Devices to adhere to the strictest international standards in the field of quality control of medicines,” the Agency notes.
