Search academic texts

Information × Registration Number 0220U102256, 0115U002158 , R & D reports Title Substantiating ways of solubilisation of substances, quality control methods and methodological aspects of the integrated model of quality assuarence of medicines at the stages of implementation and medical use popup.stage_title Head Vetiutneva Nataliia O, Registration Date 11-03-2020 Organization Shupyk National Medical Academy of Postgraduate Education popup.description2 There has been substantiated and developed a standard process model of the pharmaceutical integrated quality system (PIQS) of pharmacy institutions (PI) and healthcare facilities (HF) and approaches to its regulation and documentation. The levels of responsibility and authority of the PI and HF employees within the PIQS have been determined based on the requirements of the international standards (IS) of the quality management system (QMS) ISO 9001. A structural-hierarchical model for assessing the effectiveness and improvement of the PIQS of pharmacy institutions and healthcare facilities has been built. The state of PI and HF readiness for the implementation has been investigated; positive tendencies and problematic issues have been identified in the context of the domestic pharmacies readiness for the PIQS implementation, and practical steps have been determined to increase the level of the above institutions readiness for the PIQS implementation. Tools for analysing and evaluating risks to the quality of drugs have been offered and tailored to the conditions of PI and HF activity. Organizational and applied principles of processing (control), documentation and monitoring of risks for the quality of drugs in pharmacy institutions and healthcare facilities have been substantiated. The concepts and subjects of public control over the quality assurance of drugs in the stages of their implementation and medical use in Ukraine have been justified. Product Description popup.authors popup.nrat_date 2020-04-02 Close