Проблемы управления производственным персоналом при внедрении фармацевтической системы качества

The 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.В статье предпринята попытка выявления проблем управления производственным персоналом при внедрении фармацевтической системы качества (далее - ФСК). С этой целью проведено анкетирование ключевого персонала фармпроизводителей ЕАЭС, интервью с экспертами, а также обобщен практический опыт работы в сфере GMP-инспектората. Констатировано, что управление персоналом остается одним из слабых мест практики внедрения ФСК. Наблюдается невысокая поддержка ФСК со стороны персонала и его низкая заинтересованность в обеспечении тотального управления качеством. Вопросы управления производственным персоналом при внедрении ФСК не находят отражения в кадровых политиках, а на многих предприятиях не утверждены методические указания в данной сфере. Ситуация усугубляется кадровым дефицитом в отрасли, противоречивыми нормативными требованиями к обучению и квалификации персонала, а также недоступностью образовательных программ. Авторы пришли к выводу, что по всем ключевым аспектам управления производственным персоналом при внедрении ФСК следует реализовать систему мер по оптимизации управленческих процедур и практик, а существующая система организации управления производственным персоналом при внедрении ФСК у фармпроизводителей ЕАЭС может быть признана не более чем удовлетворительной. Материалы могут быть использованы в целях дальнейшей разработки рекомендаций по совершенствованию управления производственным персоналом при внедрении ФСК

The Use of Digital Technologies for the Purpose of Improving Methodological Approaches to the Creation of a Pharmaceutical Quality System at Enterprises for the Production of Medicines

Introduction. The article is devoted to the aspects of improving methodological approaches to the creation of a pharmaceutical quality system (PQS) at enterprises for the production of medicines, taking into account the possibility of using tools and means of digitalization. The relevance of the study is associated with the enduring importance of comprehensive high quality assurance in the development, production and release of medicines into circulation. The implementation of PQS requires numerous transformations of management and production processes, which can be facilitated by tools and elements of digitalization. Aim. To consider the potential and specific areas of application of digital technologies to improve the methodology and practice of developing and implementing PQS. Materials and methods. The state in the subject area was assessed on the basis of the results of economic and statistical analysis and forecasting of the implementation of PQS at Russian pharmaceutical enterprises that have positive and comparatively long experience in this area: the companies LLC "OZON" and JSC "AKRIKHIN". The assessment was carried out by calculating the integral indicator of the effectiveness of the functioning of PQS, which is a set of weighted key performance indicators (KPI) for quality. Results and discussion. The importance of the introduction of PQS for the development of pharmaceutical enterprises and the presence of numerous difficulties in the implementation of PQS, which necessitates the improvement of methodological approaches in the subject area, are stated. It has been proven that even at those enterprises where PQS has been introduced with varying degrees of success, the use of digitalization tools would contribute to a faster, more systematic and high-quality implementation of PQS. Among the key areas of application of digital tools, the authors propose monitoring of quality indicators (using neural network cards) and the use of blockchain platforms and smart contracts to register the release of drugs of appropriate quality. Conclusion. Digital tools contribute to complex improvement in many areas of socio-economic activity. Their active use at pharmaceutical enterprises is intended to contribute to ensuring the proper implementation and uninterrupted functioning of pharmaceutical quality systems, through constant monitoring of the quality of manufactured products and registration of manufactured batches in high-precision information storage systems. © 2021, Center of Pharmaceutical Analytics. All rights reserved

Guidelines for promoting the implementation of pharmaceutical quality systems at eaeu enterprises through the management of the engagement of production personnel

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. © Smirnov V. A., Goryachkin V. V., Shestakov V. N., Abramovich R. A., 2021

Development of retraining systems for the implementation of the pharmaceutical quality system at pharmaceutical production enterprises of the EAEU countries

Introduction. The publication discusses the state and problems of personnel retraining in the implementation of the pharmaceutical quality system at pharmaceutical enter-prises of the Eurasian Union (EU) countries. Aim. The aim of the study is to comprehensively study the state and problems of retraining of personnel in the implementation of the pharmaceutical quality system at the enterprises of the production of medicines in the EU countries, and the development, based on its results, of scientifically grounded recommendations for the development of appropriate personnel retraining systems. Materials and methods. The research methodology is based on a comprehensive analysis of scientific literature of foreign and domestic authors on pharmaceutical quality systems and good manufacturing practices, risk management in pharmaceutical industries and personnel in the implementation of FQS, aspects of personnel training and retraining. Results and discussion. It has been proven that retraining of personnel is an important factor in promoting the introduction of FQS in pharmaceutical industries. On the example of the companies Akrikhin JSC and OZON Pharmaceuticals, aspects of advanced technologies for the development of retraining systems for production personnel in the implementation of FQS are considered. Based on the synthesis of theory and practice, practical recommendations have been prepared for the implementation and development of targeted integrated systems for retraining personnel in the context of comprehensive assistance in the implementation of FQS in pharmaceutical industries at enterprises in the countries of the Eurasian Union. Conclusion. The key role of systematic and high-quality retraining of personnel in the context of comprehensive assistance to the implementation of FQS in pharmaceutical and biopharmaceutical industries at enterprises in the EU countries was confirmed. Despite the numerous problems and contradictions that determine the low level of development of the relevant personnel retraining systems, meanwhile, when implementing a set of optimization measures, such systems can successfully function and provide the desired effect, as evidenced by the studied best practices in promoting the implementation of FQS at certain leading enterprises of the pharmaceutical industry. The recommendations presented by the authors based on the results of the study are comprehensively focused on practical implementation in order to steadily improve the theory and practice of retraining of pharmaceutical production personnel in the context of FQS implementation. © Smirnov V. A., Goryachkin V. V., Shestakov V. N., Abramovich R. A., 2021

Значение создания фармацевтической системы качества на предприятиях по выпуску лекарственных средств в контексте построения единого фармацевтического рынка ЕАЭС

The publication discusses the theoretical and regulatory aspects of a pharmaceutical quality system (PQS) design at the manufacturers, including its discussion through the prism of historical and foreign experience, and specifies the significance of single PQS design for the formation of the EAEU single pharmaceutical market. It is substantiated that the quality assurance of pharmaceutical products under current conditions should be based on an integral approach, the most important element of which is PQS, universal guidelines contained in the current GMP regulations. The authors propose the solutions of the problem, among which an important role is played by the further harmonization of PQS requirements and the unification of management and control systems in the market.В публикации рассматриваются теоретические и нормативно-правовые аспекты создания фармацевтической системы качества (ФСК) на предприятиях, в том числе через призму исторического и зарубежного опыта, и уточняется значимость для построения единой ФСК формирования единого фармацевтического рынка ЕАЭС. Обосновывается, что обеспечение качества фармацевтической продукции в современных условиях должно основываться на интегральном подходе, важнейшим элементом которого выступают ФСК, универсальные рекомендации, содержащиеся в актуальных руководящих документах по надлежащей производственной практике (GMP). Предлагаются направления решения проблемы, среди которых важное место отводится дальнейшей гармонизации требований к ФСК и унификации систем управления и контроля на рынке

The integrated model of quality management system of laboratory studies of medicines (Review)

Introduction. The publication is devoted to the role of laboratory research in ensuring the quality of domestic medicines and is a review and analysis of regulatory documents and current publications on this topic. Text. A number of different types of laboratories are involved in Drug life cycle and ensuring their effectiveness and safety. Today there are a large number of regulations governing laboratory research. Common to all types of laboratories and regulatory documents is the need to organize an effective quality management system (QMS) for the drug life cycle laboratories. The aim of this review is to analyze approaches to regulating the quality of laboratory research of domestic drugs and to consider the most effective QMS model, which is fundamental for all types of laboratories in the life cycle of drugs. Conclusion. The laboratory research quality system serves as a basic tool for achieving the ultimate goal-the clinical value of drugs and is designed to ensure that risks for patients are minimized. At the same time, each stage of the drug life cycle provides a solution to a specific problem on the way to this goal, which must be taken into account when building a QMS in each type of laboratory. The range of regulatory documents and external assessment systems (accreditation, certification, inspection control, etc.) in the field of domestic laboratory research is quite diverse. In this regard, it is advisable for the laboratory to build a harmonious QMS based on priorities in accordance with the goals and objectives. The most effective method for building such a system is an integrated management system model. © Selezneva A. I., Smirnov V. A., Goryachkin V. V., Chadova N. N., Polyakov S. V., Shestakov V. N., Abramovich R. A., 2021