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Methodical Approaches to Assessing the Performance of the Integrated System of Pharmaceutical Enterprise Management
Svitlychna K. S., Shut O. Y., Kovalenko P. V.

Svitlychna, Karina S., Shut, Oksana Yu., and Kovalenko, Polina V. (2019) “Methodical Approaches to Assessing the Performance of the Integrated System of Pharmaceutical Enterprise Management.” Business Inform 12:396–402.
https://doi.org/10.32983/2222-4459-2019-12-396-402

Section: Management and Marketing

UDC 615.12:658.310

Abstract:
The article defines that one of the promising directions of ensuring the successful functioning of enterprise in the financial, production and social environment is the introduction of the integrated management systems that combine in themselves two or three or more international standards. It is defined that in the context of implementation of the integrated management system there are issues about evaluation of the level of performance of the system’s operation. The complexity of this issue is due to the multidimensionality and multi-levelity of such an evaluation. It is proved that for a pharmaceutical enterprise, the evaluation of the performance of the entire integrated management system should be based on the evaluation of all constituent systems, i.e.: systems to ensure the quality and safety of manufactured medicines (GMP industry rules), quality management systems (international standard ISO 9001:2015) and social responsibility systems (international standard ISO 26000:2010). On this basis, a generalized evaluation system consisting of seven stages is proposed. In the initial stages, the criteria and indicators for their evaluation are defined according to each management system. The formulas for calculating the level of performance of each management system and the overall level of performance of the entire integrated management system are provided. To ensure a qualitative interpretation of the resulting values, a scale has been proposed that reflects the level of stability of the entire integrated management system.

Keywords: integrated management system, pharmaceutical enterprise, medicines, international standards, quality assurance and safety system of manufactured medicines, quality management system, system of social responsibility.

Fig.: 1. Tabl.: 7. Formulae: 2. Bibl.: 13.

Svitlychna Karina S. – Candidate of Sciences (Pharmaceutics), Associate Professor, Associate Professor, Department of Management and Public Administration, National Pharmaceutical University (53 Pushkіnska Str., Kharkіv, 61002, Ukraine)
Email: [email protected]
Shut Oksana Yu. – Candidate of Sciences (Pharmaceutics), Lecturer, Department of Management and Public Administration, National Pharmaceutical University (53 Pushkіnska Str., Kharkіv, 61002, Ukraine)
Email: [email protected]
Kovalenko Polina V. – Student, National Pharmaceutical University (53 Pushkіnska Str., Kharkіv, 61002, Ukraine)
Email: [email protected]

List of references in article

“ISO 14000 Family - Environmental management“. International Organization for Standardization. https://www.iso.org/iso-14001-environmental-management.html
“ISO 9000 Family - Quality management“. International Organization for Standardization. https://www.iso.org/iso-9001-quality-management.html
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Lyapunov, N. A., and Georgiyevskiy, V. P. Rukovodstvo 42-01-2003. Lekarstvennyye sredstva. Tekhnologicheskiy protsess. Dokumentatsiya [Guideline 42-01-2003. Medicines Technological Process. Documentation]. Kyiv: MORION, 2004.
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Kharrington, Dzh. X., Esseling, K. S., and Van, Nimvegen X. Optimizatsiya biznes-protsessov: analiz, dokumentirovaniye, upravleniye, optimizatsiya [Optimization of Business Processes: Analysis, Documentation, Management, Optimization]. St. Petersburg: Azbuka, 2002.
Shepeleva, Ye. V., and Mitaseva, Ye. V. “Integrirovannaya sistema upravleniya kachestvom i bezopasnostyu produktsii. Razrabotka i vnedreniye“ [Integrated Product Quality and Safety Management System. Development and Implementation]. Molochnaya promyshlennost, no. 10 (2010): 58-60.
Shestopal, O. A., and Pidpruzhnykov, Yu. V. “Pobudova intehrovanoi systemy upravlinnia yakistiu na suchasnomu farmatsevtychnomu pidpryiemstvi. Povidomlennia 1. Analiz standartiv ta rozrobka nastanovy z yakosti“ [Building an Integrated Quality Management System at a Modern Pharmaceutical Enterprise. Message 1. Analyze Standards and Develop Quality Guidelines]. Visnyk farmatsii, no. 2 (2008): 38-42.
Yaremchuk, A. A., and Aleksandrov, A. V. “Aktualnost vnedreniya integrirovannykh sistem menedzhmenta na farmatsevticheskikh predpriyatiyakh“ [The Relevance of Implementing Integrated Management Systems in Pharmaceutical Enterprises]. Remedium, no. 7 (2007): 20-24.

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