Artyukh T. Optimization of the authorized person activity in quality assurance of medicines

The thesis is dedicated to scientific and methodological grounds of basic approaches and practical guidelines directed at increase of efficiency of authorized person activity in quality assurance of medicines. The key aspects of formation and development of quality management system in the international science have been defined, the features of elements’ functioning of quality assurance of medicines system of different countries have been investigated. The presented results of personal investigations of authorized persons’ domestic institution functioning allowed to describe existing for today actual and top-priority tasks for scientific solution, specifically connected with absence of authorized person position in the list of pharmaceutical personnel positions in the national legislative base. The structure of specialists positions who can charge the authorized person has been defined. The modern classification of working time expenses of authorized person has been suggested. The methodology of working time autophotographing has been improved and analysis of authorized person working time expenses has been carried out. The influence of factors on content of work by quality assurance of medicines and expenses of time has been established. For the first time the model of authorized person working time distribution has been created and the methodology of authorized persons positions number determination in staff schedule of pharmaceutical organization has been elaborated. The guidelines for authorized person working place organization improvement have been grounded. The methodology of estimation of pharmaceutical organization authorized person working time use efficiency has been proposed, which allows to optimize their work through chronophages influence for the activity of this specialists overcoming or reduction.