Implementation of the good research practice principles using the example of the university quality management system

Introduction. The quality assurance of research work is a key factor in scientific discoveries, as well as the emergence of innovative high-margin products on the market. Due to the specific nature of the scientific research field, there are currently no uniform rules for organizing and conducting research that meet the needs of both scientific groups and businesses interested in the commercialization of developments, including drug developments, and individual approaches are only being formed. The set of established approaches and concepts, according to the existing system of good practices (GxP), is called "Good Research Practice" or GRP.

Аim. Generalization of existing global trends in the field of Good Research Practice and description of the implementation of GRP principles using the example of the quality management system of the Sirius University Laboratory Facility.

Materials and methods. The methods of GRP principles implementation in the Laboratory Complex are based on the requirements of ISO 9001 and ICH recommendations in such areas as document and record management, personnel and training management, audit and inspection management, risk management, analysis and evaluation of performance and efficiency.

Results and discussion. The current principles of GRP, formed within the framework of national scientific communities, individual universities and state programs, are analyzed. Using the example of the Laboratory Facility of the Sirius University, the possibilities and examples of complex implementation of GRP in such areas of the quality management system as document and record management, personnel and training management, audit and inspection management, risk management, conducting periodic analysis and assessment of the effectiveness and efficiency of activities are considered.

Conclusion. The approach to conducting scientific research work described in the article, based on the integrated implementation of GRP, is a tool for ensuring the quality of research, necessary both for purely scientific activities and for successful scientific and applied interaction between the academic environment and pharmaceutical companies in order to accelerate the launch of new drugs to the market and meet patient demand.

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