Iakovenko V. The scientific-theoretical substantiation of approaches to the quality management when developing and manufacturing herbal medicines

The thesis research is devoted to the scientific substantiation of theoretical and practical approaches to the quality assurance of herbal medicines at the stages of pharmaceutical development and manufacturing. The qualitative and quantitative risk analysis of production has been conducted and the ways to minimize them have been determined. Acceptability of the offered methodology has been proved experimentally by pharmaceutical development and introduction into manufacturing of two original herbal medicines "Climased" and "Picosen". Industrial technology has developed, validation of technological process has performed, and qualification of technological equipment has conducted. The physical and chemical properties of the developed drugs have studied, the methods of qualitative and quantitative analysis of active substances have been proposed, the analytical regulatory documentation has authorized for the original drugs "Climased" and "Picosen", and their stability has studied. Documentation on quality management system has developed of input control of medicinal herbal raw material, equipment qualification, technology validation, quality risk management in production of herbal medicines.