scholarly journals Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel

2021 ◽  
Vol 10 (1) ◽  
pp. 136-141
Author(s):  
V. A. Smirnov ◽  
V. V. Goryachkin ◽  
V. N. Shestakov ◽  
R. A. Abramovich
Keyword(s):  
Quality Assurance ◽  
Labour Productivity ◽  
Good Manufacturing Practice ◽  
Economic Indicators ◽  
Steady Increase ◽  
Quality Systems ◽  
Pharmaceutical Quality ◽  
The Impact ◽  
Pharmaceutical Enterprises

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.

Revenue management systems and hotel performance in the economic downturn

2016 ◽  
Vol 28 (4) ◽  
pp. 658-680 ◽  
Author(s):  
Bienvenido Ortega
Keyword(s):  
Revenue Management ◽  
Unobserved Heterogeneity ◽  
Labour Productivity ◽  
Economic Conditions ◽  
Economic Downturn ◽  
Content Type ◽  
Hotel Performance ◽  
Context Specific ◽  
The Impact

Purpose The purpose of this paper is to analyse whether hotels that use a revenue management system (RMS) outperform non-RMS-users in a context of decreasing demand. Design/methodology/approach A database of chain hotels with a rating of three or more stars was used to estimate MANOVA and ANOVA models to analyse the role of RMSs in hotel performance. Findings In a context of strong competition in prices and surplus capacity, the findings suggest that RMSs have been more effective in improving occupancy than in achieving higher rates. Also, the use of RMSs did not have a significant impact on hotel labour productivity. Research limitations/implications Managers may believe that they have adopted an RMS when, in fact, they have not fully done so. In addition, establishment-level unobserved heterogeneity, such as the quality of management or unobserved quality of service, cannot be fully controlled because of the nature of the data used. The main implication of this paper is that the potential of RMSs as revenue enhancer might be influenced by unstable market and economic conditions. However, the absence of significant effects on RevPAR performance might be also the result of firms’ adopting inadequate RM strategies. Further research could investigate whether the findings are context-specific or whether firms are failing to implement effective RMSs for other reasons. Originality/value The approach used in this paper is new to the literature, given that it uses statistical methods to analyse the impact of implementing an RMS on hotel performance under specific economic conditions and using alternative indicators.

scholarly journals GMP/GACP - new standards for quality assurance of cannabis

2020 ◽  
Vol 66 (1) ◽  
pp. 91-101
Author(s):  
Mirela Ilikj ◽  
Irena Brchina ◽  
Liljana Ugrinova ◽  
Vasil Karcev ◽  
Aleksandra Grozdanova
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Standards ◽  
Quality System ◽  
Quality Systems ◽  
High Quality ◽  
Iso Standard ◽  
Continuous Quality ◽  
Medicinal Use

In 2015, in Republic of North Macedonia, a new law for narcotics has been adopted, where the changes include legal cultivation of cannabis for medicinal use as well as legal production of cannabis extracts for medicinal use. In order to gain high quality of cannabis and cannabis products for medicinal use and to meet some quality standards that will guarantee consistency, traceability and continuous quality of the product, it is necessary to implement Quality Systems. Good quality system is ISO standard system but for cannabis for medicinal use, GACP, GMP and GLC standards are used more often. Production of cannabis for medicinal use consists of: process of cultivation where GACP standards are applicable, primary processing where GMP standards are the most important and quality control of final product regulated with GLP standard. In this review, explanation of these standards as well as overview of modes of their implementation has been made. Keywords: GxP, GMP, GACP, GLP

scholarly journals Students’ Perspective on Quality Assurance in Higher Education in the Context of Sustainability: A PLS-SEM Approach

2019 ◽  
Vol 11 (17) ◽  
pp. 4793 ◽  
Author(s):  
Ana Gora ◽  
Simona Ștefan ◽  
Ștefan Popa ◽  
Cătălina Albu
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Labor Market ◽  
Higher Education Policy ◽  
Structural Equations ◽  
Educational Process ◽  
Research Activities ◽  
Higher Education Outcomes ◽  
The Impact

The purpose of this paper was to provide empirical evidence of the impact of quality assurance in higher education on two relevant higher education outcomes; students’ knowledge, skills, and competencies; and their employability. Survey data were collected from two major Romanian public universities and analyzed using a partial least-squares structural equations modeling (PLS-SEM) technique. The main results suggested that students’ competencies were positively and directly influenced by the quality of the educational process, as well as the practical and research activities. The students’ chances of employment in the labor market were positively and directly influenced only by the quality of the educational process and by the research activities. Indirect influences were also revealed. The findings of the study may be shown to have theoretical implications by proposing a model that links the features of quality management in higher education institutions with students’ competencies and chances of employment in the labor market. From a practical perspective, the results may be of interest to higher education policy makers, to evaluation and accreditation institutions, to universities, and also to students.

scholarly journals Public oversight of the audit profession – Comparison of implemented practices in the EU and the U.S.

2014 ◽  
Vol 7 (3) ◽  
Author(s):  
Maja Zaman Groff ◽  
Marko Hočevar
Keyword(s):  
Quality Assurance ◽  
External Quality Assurance ◽  
External Quality ◽  
The Public ◽  
Sarbanes Oxley ◽  
The Impact ◽  
Public Oversight ◽  
The U.S ◽  
The Eu

Following financial scandals at the turn of the century, the audit profession in the European Union, the United States and elsewhere, has undergone profound legislative and regulatory reforms, including the requirement for intense public oversight of the profession. The article provides an overview of the development of external quality assurance systems in the audit profession in the EU and the U.S. with emphasis on the system of public oversight, implemented after the passing of the Sarbanes-Oxley Act of 2002 in the U.S. and the Statutory Audit Directive of 2006 in the EU. The aims of the article are: 1) to explain different backgrounds of external quality assurance systems in the EU and the U.S., 2) to describe implemented practices related to the public oversight system in the two regions and 3) to present the main findings of the existing empirical research focusing on the impact of the newly established systems of public oversight on the quality of audit services. Our literature research reveals that the evidence on the impact of the public oversight on the ultimate audit quality in the EU has not yet been provided because the Member States have only finished the implementation of the Statutory Audit Directive requirements into national legislations by the year 2008. In the U.S., on the other hand, first empirical evidence has been presented, suggesting that the quality of auditing has improved after the passing of the Sarbanes Oxley Act of 2002. So far evidence has been provided to support the proposition that PCAOB opinions are associated with earnings quality of the audit firm’s clients, that auditors have become more conservative and that the new inspectors (as opposed to the former system of self-regulation) can hold the auditors to stricter standards by taking concrete actions against felonious auditors and imposing costly penalties.

scholarly journals The evolution of free economic zones in Russian Federation as a determinant of regional development

2020 ◽  
pp. 6-13
Author(s):  
Maria Ignatieva ◽  
Yan Shokin
Keyword(s):  
Subject Area ◽  
Steady Increase ◽  
Economic Systems ◽  
Macroeconomic Indicators ◽  
Qualitative Level ◽  
The Subject ◽  
Economic Zones ◽  
The Impact

In the context of a steady increase in the mutual dependence between the economic systems of various countries, the identification and quantitative analysis of key parameters determining the quality of development of the economic environment of individual states are becoming increasingly relevant; at the same time, it is certain that, not least, the qualitative level of the country's economic development is determined by the effective functioning of the territories of innovative development, that is, free economic zones.The report provides a detailed description of the subject area, namely, the classification of modern Russian SEZs and an overview of the main factors of their development; a set of factors is proposed for analyzing the impact of the functioning of SEZs on regional and macroeconomic indicators with the aim of further developing a methodology for assessing the effectiveness of the functioning of free economic zones.

scholarly journals Assessment of the State and Changes in the Labor Sphere, Ensuring the Quality of Working Life in the Context of Digitalization of the Economy

2021 ◽  
pp. 191-205
Author(s):  
O. Novikova ◽  
◽  
L. Shamileva ◽  
O. Khandii ◽  
◽  
...  
Keyword(s):  
Economic Development ◽  
Labor Market ◽  
Working Life ◽  
Subjective Assessment ◽  
The State ◽  
Economic Indicators ◽  
Labor Costs ◽  
Quality Of Working Life ◽  
The Impact

The article presents an assessment of the state of the labor sphere and the quality of working life in the context of digitalization of the economy and society. The general conditions for ensuring and forming a decent quality of working life are assessed on the basis of changes in macroeconomic indicators of economic development in general and the digital sector with the determination of the efficiency of living labor costs. The share of the digital sector in the structure of the national economy, labor productivity of employees in the digital sector compared to national indicators are characterized. The dynamics of changes in the main socio-economic indicators of the development of the labor sphere of Ukraine for 2013-2020 and the structural transformation of employment by type of economic activity are analyzed. Changes in precariat in Ukraine for 2013-2020 and its share in the employed population are estimated. The characteristics of the dynamics of nominal, average, minimum wages for 2013-2020 in the context of ensuring the quality of working life are given. The social orientations in the system of remuneration and changes of social and economic indicators in Ukraine for the studied period are analyzed. The results of subjective assessment of working conditions, the level of dissatisfaction with their work are presented. It is concluded that the digitalization of the economy promotes the spread of non-standard forms of employment and creates new opportunities for employment in the labor market, and at the same time generates shadowing of employment, hidden unemployment and part-time employment, which limits the impact of high quality of life. It is proved that the low level of economic development and insignificant level of ICT implementation, technical and technological backwardness of national production have not affected the labor market, so far it has not changed under the influence of digital technologies.

scholarly journals THE IMPACT OF MANAGEMENT COMMUNICATION ON THE DECISIONS TO INCREASE THE PERFORMANCE OF AN ORGANIZATION

10.26458/1624 ◽  
2016 ◽  
Vol 16 (2) ◽  
pp. 69
Author(s):  
Cezarina Adina TOFAN
Keyword(s):  
Organizational Performance ◽  
Science Communication ◽  
Labour Productivity ◽  
Professional Activity ◽  
Negative Effects ◽  
Management Communication ◽  
Raising Awareness ◽  
Real Importance ◽  
The Impact

: Many Romanian companies going through a difficult period, which makes the care of managers to materialize more on obtaining immediate profit and rarely on some less obvious aspects such as communication influence on labour productivity. Often managers do not consider communication as a factor of real importance that may affect the staff performance.The way we communicate with those around us in the professional activity, but not only, place their mark on the results. Quality of management communication influences the way how the human resource is used and the organizational performance, in particular. Each individual has a certain style of communication formed by education, skills, beliefs and personal goals. It does not always ensure the effective and efficient communication.It can be appreciated the necessity for managers to watch the subordinates, but also to themselves, the change of attitude towards "science communication" by realizing the positive and negative effects of their own style of communication and by raising awareness of the necessity to acquire some communication skills .

The Impact of the FDA GMP Regulation

1990 ◽  
Vol 9 (1) ◽  
pp. 105-106
Author(s):  
Robert N. Borghese
Keyword(s):  
Quality Assurance ◽  
Medical Devices ◽  
Good Manufacturing Practice ◽  
The Past ◽  
The Future ◽  
The Impact ◽  
Practice Regulation

The impact of the Food and Drug Administration's Good Manufacturing Practice Regulation for Medical Devices is explored ten years after its promulgation. The main purpose of the regulation was never to be specific and exacting in interpretation, but rather to serve as a framework for the development of individualized quality assurance programs. The manufacturer is ultimatelly responsible for implementation. The role of the quality assurance professional is to be a persuasive advocator of compliance. Issues which were emphasized in the past are noted. What we can expect in the future is explored.

scholarly journals INCORPORATING AN OUTSOURCING STRATEGY AND IN-HOUSE QUALITY ASSURANCE INTO THE PRODUCTION-SHIPMENT DECISION MAKING

2021 ◽  
pp. 1-9
Author(s):  
Singa Wang Chiu ◽  
Yi-Ying Li ◽  
Victoria Chiu ◽  
Hong-Dar Lin
Keyword(s):  
Quality Assurance ◽  
Real Life ◽  
Optimization Method ◽  
Batch Size ◽  
Depth Information ◽  
Business Environments ◽  
Managerial Decisions ◽  
Real Life Situation ◽  
The Impact

To stay competitive in turbulent business environments, manufacturing firms’ managers today constantly seek ways to reduce order response time, smooth production schedules, ensure the quality of their products, and lower overall making and shipping costs. This study incorporates an outsourcing strategy and in-house quality assurance into a production-shipment problem to address the aforementioned operational goals. The objectives are to simultaneously find the optimal fabrication batch size and frequency of delivery that minimize the system’s relevant costs and reveal in-depth information regarding the impact of diverse system parameters on the optimal policy and system cost. This study develops a model and uses the optimization method to resolve the problem. The research results facilitate managerial decisions in such a real-life situation.

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