To the question of creating conditions for determining the sterility of drugs in the microbiological laboratory

Correspondence of the quality of drugs in terms of «Sterility» guarantees the safety of the use of drugs for injection and infusion, eye drops and films, pharmaceutical substances and excipients, including biological drugs and their solvents, which must be sterile in accordance with regulatory documents and pharmacopeia articles. In the article, the authors consider the necessary conditions for the organization and conduct of the sterility test of drugs. The creation, operation and maintenance of the described conditions is in the area of responsibility of production, control and expert microbiological laboratories. Among the necessary conditions, the following are highlighted: a special aseptic room with a certain confirmed purity class; microbiological monitoring; proven sterility of all consumables, solutions and culture media used; test methods used with proven applicability. Actively discusses the issue that arises when a contaminated sample is detected. The revealed fact requires an investigation of the causes of the situation and a possible further recognition of the drug as poor in terms of «Sterility». The materials are included in the draft General Pharmacopoeia Monograph «Conditions for determining the sterility of drugs», which is currently under consideration and approval in the prescribed manner for further inclusion in the State Pharmacopoeia of the Russian Federation.