Фармация
RISK MANAGEMENT AND THEIR ASSESSMENT IN THE TECHNOLOGY FOR PRODUCING A SOLUTION FOR INHALATION BASED ON RIAMILOVIR
Ju.S. Prihod'ko1, A.Yu. Petrov1, O.I. Knysh1, M.Yu. Kinev2
1. Tyumen State Medical University, Russian Federation, Tyumen
2. Ural State Medical University, Russian Federation, Yekaterinburg
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Summary:
Introduction. The technological process of drug production may be accompanied by exposure to dangerous factors. In order to correctly identify critical points, it is necessary to analyze the entire production cycle, identify the main sources of danger and develop preventive measures to eliminate them. Risk assessment is carried out using the HACCP method (Hazard Analysis and Critical Control Points), which allows you to identify dangerous factors at all stages of the technological process, as well as to establish measures to maintain the quality of the resulting product. Compliance with the principles of HACCP will allow an industrial enterprise to produce safe drugs.
The purpose of the study is to identify, using a risk management tool (HACCP method), dangerous factors and critical control points for the development of preventive and regulatory measures for the technological process.
Materials and methods. The study was conducted using a solution for inhalation administration based on the active substance riamilovir, on the experimental industrial scheme of the Laboratory of Technology Development and Scaling of the UrFU Chemical and Pharmaceutical Technologies Research Center. In order to achieve goal the HACCP method, analytical, structural and computer technologies were used.
Results and discussion. The technological scheme for the production of a solution based on riamilovir was analyzed and a block diagram was developed, with the help of which critical transition and control points were identified. The stages at which the greatest risk is observed in the production of the solution have been identified and a scoring system has been developed to assess the degree of risk. For each degree of risk, preventive measures have been developed to eliminate possible risks and adjust the technological process of drug production.
Conclusion. Thus, based on the use of a risk management tool (method HACCP) measures have been developed that allow you to modify and adjust important stages of the technological process..
Keywords inhalation dosage form; antiviral drug product; HACCP method; riamilovir; solution; technological process; production of drugs
Bibliographic reference:
Ju.S. Prihod'ko, A.Yu. Petrov, O.I. Knysh, M.Yu. Kinev, RISK MANAGEMENT AND THEIR ASSESSMENT IN THE TECHNOLOGY FOR PRODUCING A SOLUTION FOR INHALATION BASED ON RIAMILOVIR // Scientific journal «Current problems of health care and medical statistics». - 2024. - №3;
URL: http://healthproblem.ru/magazines?textEn=1369 (date of access: 31.10.2024).
URL: http://healthproblem.ru/magazines?textEn=1369 (date of access: 31.10.2024).
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