The study of risk management activities for quality of medicines at the wholesale stage
DOI:
https://doi.org/10.24959/sphhcj.20.194Keywords:
quality management system, quality risk management, risk-oriented thinking, wholesale trade of medicinesAbstract
Aim. To analyze the state of implementation of risk management activities for quality in domestic organizations for wholesale trade of medicines.
Materials and methods. The works of domestic and foreign authors, international professional websites, methods of survey (questionnaire), analysis, systematization, generalization were used.
Results. During 2019-2020, the sociological study was carried out among the drug distribution organizations on the activities of risk management (RM) for quality. The survey showed that 78 % of employees involved in RM activities in the distribution organizations of medicines of Ukraine were specialists in quality management (assurance) subdivisions. 17 % of the respondents were employees of various departments. 5 % of the respondents stated that RM was performed jointly by quality management (assurance) departments and other divisions of the enterprise. More than 70 % of the respondents stated that when organizing RM activities they faced the problem of insufficient information on the methodology and practical aspects of RM in the drug distribution. 33 % of the respondents believed that they received the most important information about RM during thematic workshops, trainings and from external experts, consultants. 16 % of the respondents found the useful information on RM in guidelines and methodological materials, and 11 % of the respondents - in periodicals. Accordingly, 55 % of the respondents considered it necessary to develop comprehensive guidelines for RM methodology, and 28 % of the respondents agreed that these recommendations would be useful. According to 55 % of the respondents, the greatest problems in the implementation and operation of RM procedures were related to the training of the relevant specialists. When asked about the compliance of RM results with the expectations of management 88 % of the respondents answered that management was generally skeptical about this activity, perceiving RM only as a formal job, which presence was required by regulatory requirements.
Conclusions. The main problems with the effectiveness of RM activities are related to the lack of competence of the relevant specialists and their number, the lack of time to perform procedures to identify, analyze, assess and manage risks to the quality of drugs. Based on the data obtained we plan to form a set of proposals for the optimal organization of activities with RM of medicines in the drug distribution organization, in particular, to substantiate the set of competencies of RM specialists, as well as determine scientific and methodological approaches to the regulation and documentation of RM activities.References
MOZ Ukrainy. (2011). Likarski zasoby. Upravlinnia ryzykamy dlia yakosti (ICH Q9) : 42-4.2:2011. Kyiv, 36.
MOZ Ukrainy. (2020). Likarski zasoby. Nalezhna vyrobnycha praktyka : ST-N MOZU 42-4.0:202020. Kyiv, 332.
3. Systemy upravlinnia yakistiu. Vymohy : DSTU ISO 9001:2015 (ISO 9001:2015, IDT). (2016). Kyiv: DP «UkrNDNTs», 24.
International Organization for Standardization. (2018). Risk management. Principles and guidelines : ISO 31000:2018.
Postanova Kabinetu Ministriv Ukrainy vid 30 lystopada 2016 No. 929 “Pro vprovadzhennia hospodarskoi diialnosti z vyrobnytstva likarskykh zasobiv, optovoi ta rozdribnoi torhivli likarskymy zasobamy, importu likarskykh zasobiv (krim aktyvnykh farmatsevtychnykh inhrediientiv)” (2016). Ofitsiinyi visnyk Ukrainy, 99, 19.
Lebedynets, V. O., Sukhanova, N. V. (2017). Proceeding from Sotsialna farmatsiia: stan, problemy ta perspektyvy: materialy III Mizhnar. nauk.-prakt. internet-konf. (25-28 kvit. 2017). (pр. 167–169). Kharkiv: NUPh.
Lebedynets, V. O., Kurinna, M. V. (2016). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 4, 11-20.
PE 009-14 Guide to Good Manufacturing Practice for Medicinal Products Annex 20: Quality Risk Management. Available at: https://www.picscheme.org/
Gupta, N. V. (2014). Quality Risk Management in Pharmaceutical Industry. International Journal of PharmTech Research, 6 (3), 908-914.
Waldron, K., Greene, А., Calnan, N. (2015). Quality Risk Management: State of the Industry. Part 1. Has the Industry Realized the Full Value of ICH Q9? Journal of Validation Technology, 20 (4). Available at: http://www.ivtnetwork.com/article/quality-risk-management-state-industry—part-1-has-industry-realized-full-value-ich-q9
Waldron, K. (2018). Quality Risk Management 101: A Review Of Required Reading For QRM Practitioners. Available at: https://www.pharmaceuticalonline.com/doc/quality-risk-management-a-review-of-required-reading-for-qrm-practitioners-0001.
DeSantis, Ph. (2018). A Framework For Quality Risk Management Of Facilities And Equipment. Available at: https://www.pharmaceuticalonline.com/doc/a-framework-for-quality-risk-management-of-facilities-and-equipment-0001
Jaberidoost, M., Nikfar, Sh., Abdollahiasl, A., Dinarvand, R. (2013). Pharmaceutical supply chain risks: a systematic review. DARU J. Pharm. Sci. ,21 (1).
Sandle, T. (2019). Use of Hazard Analysis and Critical Control Points (HACCP). Part 2: Determining Environmental Monitoring Locations. Available at: http://www.ivtnetwork.com/journal-gxp-compliance-vol-23-issue-5
O’Connor, T., Yang,, X., Tian, G., Chatterjee, S., Lee, S. (2017). Predictive Modeling of Pharmaceutical Unit Operations, Elsevier, Netherlands, 15-37.
Yang, Q., K.-S. Chin, Li, Y.-L (2018). A quality function deployment-based framework for the risk management of hazardous material transportation process. Journal of Loss Prevention in the Process Industries, 52, 81–92. doi: 10.1016/j.jlp.2018.02.001.
Pidpruzhnykov, Yu. V. (2015). Proceeding from Upravlinnia yakistiu v farmatsii: materialy IKh nauk.-prakt. konf. (22 trav. 2015 r.). (р.105). Kharkiv: NUPh.
Zoidze, D. R., Odynets, O. V. (2016). Proceeding from Menedzhment ta marketynh u skladi suchasnoi ekonomiky, nauky, osvity, praktyky: zb. nauk. st. IV Mizhnar. nauk.-prakt. Internet-konf. (24-25 berez. 2016 r.). (р. 243–245). Kharkiv: NUPh.
Shestopal, O. A. (2011). Optymizatsiia skladovykh systemy upravlinnia yakistiu farmatsevtychnoho pidpryiemstva z vykorystanniam otsinky ryzykiv. Doctor’s thesis. Kharkiv: NPaU, 20.
Chavda, V., Maru, S., Patel, B. (2015). How Quality Risk Management is Useful for Pharmaceuticals. G.R.J.S.N., 1 (1), 10-13.
Kumar, N., Jha, A. (2018). Quality risk management during pharmaceutical ‘good distribution practices’ A plausible solution. Bulletin of Faculty of Pharmacy, Cairo University, 56 (1), 18–25. doi:10.1016/j.bfopcu.2017.12.002.
Verbets, V. V. (2008). Metodyka orhanizatsii ta provedennia sotsiolohichnoho doslidzhennia. Berezno: RDHU, 231.
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