Introduction. The publication is devoted to the topical organizational and personnel issues of the implementation of the pharmaceutical quality system (PQS). The relevance of the study is due to the high importance of quality assurance in the development, production and release of drugs into circulation.Aim. The aim: to develop guidelines for organizational and personnel assistance in the implementation of pharmaceutical quality systems at enterprises of the Eurasian Union (EAEU) for the production of medicines (drugs) through the toolkit for engaging production personnel in the development of PQS.Materials and methods. Personnel engagement was assessed based on the engagement index; the benchmarking method was used when studying the impact of the engagement of production personnel on the economic indicators of corporate development (indicators of engagement and related economic indicators of “Akrikhin”, “Ozon” were compared with a panel of similar indicators for 12 pharmaceutical enterprises of the EAEU).Results and discussion. The important role of ensuring an increase in the engagement of production personnel in the development of PQS as a tool for sustainable provision of the effectiveness of the implementation of PQS and standards of good manufacturing practice (GMP) at drug production enterprises is stated. Taking into account the experience of forming quality circles in classical Japanese management, an innovative toolkit for managing the engagement of production personnel is proposed, based on the formation of employee communities, coordination and management of their engagement and development through the corporate portal of a pharmaceutical enterprise, as well as membership in closed clubs of ‘quality leaders’.Conclusion. Management of communities (small groups) of production workers is considered as a tool for improving the organizational and personnel support for the implementation and improvement of PQS / GMP at the EAEU pharmaceutical manufacturers. Through the communities, it is proposed to simultaneously manage the engagement, loyalty and job satisfaction of production personnel; community members, through the exchange of best manufacturing practices, ideas and opinions on the development of PQS and the improvement of nuclear quality assurance practices, will stimulate themselves and other production workers to consistently ensure the quality of manufactured drugs. The expected result is a steady increase in the quality of manufactured drugs, adherence of production personnel to the quality philosophy, creation of conditions for the growth of labour productivity of production personnel of pharmaceutical enterprises.
Four Generations of Quality—GxP pharmaceutical quality assurance, an alternative track?
