REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot107310.21518/1561-5936-2019-4-51-55Original ArticleCHALLENGES AND ISSUES IN OPERATING PERSONNEL MANAGEMENT DURING THE IMPLEMENTATION OF PHARMACEUTICAL QUALITY SYSTEMSMIRNOVV. A.-GORYACHKINV. V.-SHESTAKOVV. N.-ABRAMOVICHR. A.-Federal Budgetary Institution «State Institute of Drugs and Good Practices»Federal State Autonomous Education Institution for Higher Education «Peoples’ Friendship University of Russia»041220194515518032022Copyright © 2019,2019The article attempts to identify the problems in operating personnel management during the implementation of the pharmaceutical quality system (hereinafter the PQS). The problem identification activities included a survey of key personnel of the EAEU pharmaceutical manufacturers, interviews with experts, and practical experience in conducting GMP inspectorate. It was stated that personnel management remains one of the weak points in the implementation of PQS. The personnel provides low support for PQS and shows low interest in ensuring total quality management. Issues of operating personnel management in the implementation of PQS are not reflected in the personnel policies, and many enterprises have not approved any guidelines in this area. The situation is aggravated by shortages of personnel in the industry, contradictory regulatory requirements for training and staff qualifications, as well as lack of availability of educational programs. The authors came to the conclusion that a system of measures for optimizing management procedures and practices should be implemented in all key aspects of the operating personnel management during the implementation of PQS, and the existing system of operating personnel management during the implementation of PQS in EAEU pharmaceutical manufacturers can be considered nothing but satisfactory. The materials can be used to further develop recommendations for improving the operating personnel management in the implementation of PQS.pharmaceutical quality systemkey personnelauthorized personsquality of pharmaceutical productsdrug manufacturersgood manufacturing practicescommon pharmaceutical market of the EAEUpharmaceutical manufactureлекарственные препаратыфармакогенетическое тестированиефармакоэкономический анализмониторинг1.Ильинова Ю. Г. Моделирование потребности региональной экономики в фармацевтических кадрах на примере Санкт-Петербурга. СПб.; 2017.2.Об утверждении Правил надлежащей производственной практики: Приказ Минпромторга России № 916 (14 июня, 2013 в ред. от 18 декабря, 2015).3.Lin L., Yue Y., Ye L. The Study On The Personnel Qualification And Training Of Chinese Pharmaceutical Factory. Chinese Pharmaceutical Affairs. 2009;12:009.4.de Smidt J., van Rooij H. Human Resources. Practical Pharmaceutics. Springer, Cham, 2015: 537–550.5.Шестаков В. Н., Подпружников Ю. В. Что такое хорошо и что такое плохо в фармацевтическом производстве. М.: 2017.6.Горячкин B. В., Смирнов В. А., Шестаков В. Н., Абрамович Р. А., Денисова М. Н. Значение создания фармацевтической системы качества на предприятиях по выпуску лекарственных средств в контексте построения единого фармацевтического рынка ЕАЭС. Ремедиум. 2018;10:33–36.7.О порядке аттестации уполномоченных лиц производителей лекарственных средств: Решение Совета Евразийской экономической комиссии № 73 (3 ноября, 2016).