Abstract
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.
Highlights
Effective quality control of medicines is an obligatory component of the national securityFORMATION OF THE QUALITY MANAGEMENT SYSTEMS AT STATE LABORATORIES FOR A MEDICINES CONTROL market conditions, developments in the field of information technology, changes to the ISO 9001 standard, have led to the need for system of the state [1]
The ISO/IEC 17025 standard has become an international formation base of the research consists of scientific publications standard for the development of laboratory quality management systems (QMS)
The analysis of the QMS implementation in the pharmaceutical laboratories showed the similarity of the approaches used, despite differences in the number of personnel, assortment of methods of analysis, material resources, infrastructure [5]
Summary
FORMATION OF THE QUALITY MANAGEMENT SYSTEMS AT STATE LABORATORIES FOR A MEDICINES CONTROL market conditions, developments in the field of information technology, changes to the ISO 9001 standard, have led to the need for system of the state [1]. State laboratories for quality control of medicines should documented guarantee the correctness of the obtained results, prove their competence to their customers, and to Abstract. The general approaches to implementation of quality management systems (QMS) in the activity of testing pharmaceutical laboratories are offered. 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 to provide proper guarantees for obtaining reliable results, to increase the awareness of staff in quality management methods and continuous improvement.
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