Rationale for ISO 22301 standard implementation in the pharmaceutical industry of Ukraine
DOI:
https://doi.org/10.24959/uekj.17.19Keywords:
business continuity management system (BCMS), pharmaceutical company, standard ISO 22301Abstract
In the recent decade Ukrainian pharmaceutical companies have been actively involved with the implementing of the quality management system (QMS), environmental management systems, systems to ensure food safety and pharmaceutical quality system (PQS) in order to improve the quality of business management and to ensure dynamic business development. The integration of the international standards, specifically the business continuity management system of (BCMS) in national production represents the requirement of the modern world.
Aim. To study the BCMS implementation at the national pharmaceutical enterprises inUkraine.
Results. The analysis of the quality management systems implementation elicited the expediency of BCMS implementation at the Ukrainian pharmaceutical enterprises. The analysis of the differences in pharmaceutical operation regulations was conducted. The benefits from the implementing of this system for the development and competitive recovery of the national enterprises have been outlined.
Conclusions. The study found trend of BCMS development worldwide. The relevance of the implementation of this standard to enhance the security of the national pharmaceutical industry has been established.
References
Gasiorowski–Denis, L. (2012). ISO opublikovala novyi standart na upravlenie nepreryvnoctiu vedeniia biznesa. Available at: http://www.iso.org/iso/ru/home/news_index/news_archive/news.htm?refid=ref1587
St–GERMAIN, R. V chem tcennost standarta ISO 22301 Sotcialnaia bezopasnost. Sistemy upravleniia nepreryvnosti biznesa. Available at: http://www.trn.ua/articles/9601/
Sytnichenko, V., Kiselova, H., Stoiakin, Ye. (2013). Standartyzatsiia, sertyfikatsiia, yakist, 2 (81), 38–44.
Yakubovskii, V. V. (2015). Aktualni problemy mizhnarodnykh vidnosyn, 126 (II), 91–100.
Shniukov, A. V., Proskurnia, O. M. (2011). Upravlinnia yakistiu v farmatsii. Kharkiv: NUPh, 144–145.
Societal security – Business continuity management systems – Requirements. Online Browsing Platform. (2012). Available at: https://www.iso.org/obp/ui/#iso:std:iso:22301:ed–1:v2:en
Liapunov, M. Bezugla, O., Tahtaulova, N. (2015). Nastanova 42–4.0:2015. Likarski zasoby. Nalezhna vyrobnycha praktyka. Kyiv, MOZ Ukrainy.
Liapunov, M. Bezugla, O., Soloviov, O. (2011). Nastanova 42–4.1:2011. Likarski zasoby. Dosie vyrobnychoi dilnytsi. Kyiv, MOZ Ukrainy.
Liapunov, M. Bezugla, O., Soloviov, O. (2011). Nastanova 42–4.3:2011. Likarski zasoby. Farmatsevtychna systema yakosti (ICH Q10). Kyiv, MOZ Ukrainy.
Savinkina V. A. (2012). Standarty i kachestvo. Available at: http://www.ria–stk.ru/mmq/adetail.php?id=65528
Gazeta Apteka (2016). Available at: http://www.apteka.ua/article/358255
Downloads
Published
Issue
Section
License
Copyright (c) 2017 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).