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Information × Registration Number 0214U005857, 0110U002362 , R & D reports Title Medicines pharmaceutical research, control methods development and quality protection system at the stage of wholesale and retail distribution and medical using. popup.stage_title Head N.O.Vetyutneva, Registration Date 24-12-2014 Organization National Medical Academy of Post-Graduate Education name after P.L.Shupyk popup.description2 Aim: To study quality indicators of herbal, synthetic and biotechnological produucts, patterns of release of active substances of solid dosage drugs, development of the foundations of the quality system functioning for entities of pharmaceutical activity. There were justified and developed algorithms, diagrams, functional models of quality assurance of biological medicinal products in the chain from production to sales. There were substantiated foundations of design, implementation and operation of the quality system for entities of pharmaceutical activity engaged in wholesale and retail sale of medicinal products; there were offered methodological and practical approaches to building the quality management system. There was justified the expediency of quality management system implementation in pharmacies according to the model of ISO 90001: 20000 while meeting the requirements of GDP and GPP, which enables activity optimization based on the certified quality management system. There was offered a process model for the entity of pharmaceutical activity on the stages of wholesale and retail sale of medicinal products in terms of quality management system. The methodological approaches to the development of the structure and content of standard operating procedures were developed and the standard list for activities in corresponding areas of pharmaceutical entities practice under the conditions of the quality management system implementation was formed. Product Description popup.authors Буднікова Т.М. Марусенко Н.О. Пилипчук Л.Б. Радченко А.П. Римар М.В. Тодорова В.І. Убогов С.Г. Федорова Л.О. Шукаева Л.О. popup.nrat_date 2020-04-02 Close