The study of risks of herbal medicines production by the FMEA-analysis method
Keywords:risk assessment of quality, FMEA-analysis, herbal medicines, technological process
AbstractIdentification 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.
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