Eiben G. Principles of the functioning of a quality system for companies in the field of pharmaceuticals

Dissertation for obtaining a scientific degree for a Candidate of Pharmaceutical Sciences under the specialization 15.00.01 - medicine technology, organisation of pharmaceutical dealings and court pharmaceuticals. - P. L. Shupik National medicinal academy of postgraduate education of the Ministry of Health of the Ukraine, Kiev, 2011. The dissertation is dedicated to scientifically justifying and structuring the main elements of a quality system in companies in the field of pharmaceuticals for wholesale and retail sales of medical goods, which is based on the theory of quality control and the GDP and GPP requirements. The situation with implementing a quality control system in companies in the field of pharmaceuticals in Kiev was analysed. It was determined that the implementation of a quality control system is carried out slowly. An algorithm for the development and implementation of a quality control system for companies in the field of pharmaceuticals was justified. In accordance with the procedural approach regarding quality control in pharmaceutical institutions, a process model for their activities in the stages of wholesale and retail sales is proposed. Methodological approaches regarding the creation of the structure and content of the subsystem of documents in the quality control system were developed: Manuals for quality and standard operational procedures. As a result of the tests carried out, instructional-methodological materials and algorithms for the principles of the realization of a quality system for the optimization of activity of a pharmaceutical company for securing quality of medical goods in the stages of wholesale and retail sales were developed and proposed. The results of the research are implemented in the activity of the regional government inspections for quality control of medical goods, companies in the field of pharmaceuticals, and the training process of pharmaceutical academic departments of the higher pharmaceutical (medical) academic institutions. Key words: quality system, quality control system, medical good, pharmacy, pharmaceutical warehouse, company with pharmaceutical activity, qualified person.