Viacheslav Lebedynets, Olena Tkachenko


The article reviews the regulatory framework in the field of regulating the activities of laboratories for quality control of medicines at the world and national levels. Taking into account the harmonization of the new version of ISO / IEC 17025 "General competence for testing and calibration laboratories" and ISO 9001: 2015 "Quality management systems. Requirements", the necessity of wide implementation of the process approach and implementation of risk-oriented thinking in the activities of laboratories has been substantiated. The general approaches to implementation of quality management systems in the activity of testing pharmaceutical laboratories are offered. In particular, a typical list of processes of the quality management system (QMS) for the laboratory for quality control of medicines has been developed, and the division of such processes into three groups is proposed: management processes, resource management processes, analytical testing processes. It is substantiated that these groups of processes should be described in the Quality Manual with a mandatory graphic representation of the structure of the process model of the QMS and the description of the conditions for the interaction of processes.

The use of the PDCA cycle within each of the processes has been proven to promote systematic measurement, analysis of activities and the development of effective corrective and preventive actions. The formation of effective QMS in state and private laboratories for quality control of medicines will help to reduce the number and significance of inconsistencies and errors in analytical work and processes, to provide proper guarantees for obtaining reliable results, to increase the awareness of staff in quality management methods and continuous improvement of activities.


quality management system; laboratory; process approach; standards; ISO 9001; ISO 17025

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ISSN 2585-6634 (Online), ISSN 2585-6626 (Print)