Practical Aspects of Processing and Interpretation of the Results of Microbiological Analysis of the Quality of Non-Sterile Medicines

Abstract

The article presents materials on processing and interpretation of the results of microbiological analysis of the quality of medicines in accordance with the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of the Eurasian Economic Union. It exemplifies the use of the rules for processing test results and counting aerobic microorganisms and microscopic fungi on agar culture media in Petri dishes and on membrane filters. The author discusses the possibility of and prospects for applying various sample inoculation methods, as well as using calculation factors when interpreting their results. The text covers approaches to repeating microbiological testing of medicines to verify the reliability of a non-compliant first result.