Проблемы оценки «стерильности» живых бактериальных вакцин

Abstract

Objective of the study - analysis of standard indicators and methods, utilized for determination of presence of contaminating microorganisms in live bacterial vaccines. Materials and methods . We used the data from the State Pharmacopeia of the USSR, 9th-11th editions; State Pharmacopeia of the Russian Federation, 12th-14th editions; as well as regulatory documentation/manufacturer’s pharmacopoeial monographs for 9 items of live vaccines. Results and discussion . Taking into account the specificity of live vaccines, the process of their manufacturing and quality control must target elimination of the possibility of contamination with microorganisms that differ from production strains. It is established that currently there is no unified terminology for determining the indicator in the Russian Federation, as well as clear-cut criteria for interpretation of test results for quality assessment of live bacterial vaccines when testing sterility/contamination with foreign bacteria and fungi. In compliance with the requirements of the current RF Pharmacopeia editions, detection of contamination in live vaccines for parenteral administration should be carried out using various methods and assessment criteria (General Pharmacopeia Monograph (GPM) “Sterility” and GPM “Microbiological purity”). Performed investigations have revealed the necessity to enhance the regulatory framework in regard to detection of contamination with foreign bacteria and fungi. It is advised to use unified nomination of the indicator, specifically, “Absence of foreign bacteria and fungi” in the normative documents. Given are the recommendations on improvement of methods and requirements to the assessment of live bacterial vaccine contamination. Developed proposals on harmonization of the quality assessment requirements of vaccines containing other live microorganisms can be used for drawing up corresponding normative-regulatory documents (GPM, Pharmacopeia monograph, regulatory documentation et al.).