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Identification and assessment of risks arising in the process of manufacture of extraction herbal medicines have been performed. The object of research was the technological process of manufacture of multicomponent tinctures and liquid extracts. Risk analysis of production is based on the results of retrospective validation of manufacture of multicomponent extraction herbal medicines, in particular “Climased” oral drops. When conducting validation the critical stages and parameters of the technological process have been determined, acceptance criteria have been specified. Identification of the possible risks for each critical stage and critical parameter of the technological process has been conducted. Expert assessments have been recorded to the form of quality risk assessment. The results of calculations of the risk priority number (RPN) have allowed to refer possible inconsistencies of the technological process at the stage of extraction to unacceptable risks. Risks arising at the stages of the raw material preparation, purification and filtration of extracts have a great impact. In the process of the risk management at the enterprise the categorization of risks (assessed level of risk) has been carried out, the methods of monitoring, prevention and risk response have been proposed; preventive measures, as well as measures in case of risk occurrence have been developed. To prevent and minimize the possible risks of pharmaceutical production the methodological approaches to functioning of the system of the risk management have been developed taking into account the manufacture of drugs based on the medicinal plant raw material. Under market conditions any enterprise inevitably faces with extraordinary situations and unforeseen events, which should be prevented, or which should be timely responded to. Regardless of the reasons of occurrence of risk situations the desire to reduce the threat and minimize the possible financial losses is natural [9, 10]. In this regard, at present the problem of developing the management concept based on the risk management is particularly acute for all departments of a pharmaceutical enterprise, and in particular a manufacturing enterprise; this concept would take into account the latest world achievements, accumulated personal experience and the peculiarities of the domestic business environment. In this case efficient management of the organi zational structure is impossible without special methods of analysis based on the theory and practice of the risk management. Therefore, it is very important to take fully into account external and internal factors affecting the nature of the risk management organization at the enterprise, as well as to focus on some directions of development of the risk management for a particular enterprise (with consideration for business profile) [1, 7, 9].

The study of risks of herbal medicines production by the FMEA-analysis method