The analysis of the internal audit process functioning at domestic pharmaceutical companies
Keywords:quality management system, audit of the quality management system, pharmaceutical quality system, pharmaceutical company, GMP, ISO 9001
Aim. To analyze the internal audit process functioning at the domestic pharmaceutical companies by elaborating the results of a sociological survey of representatives of the profile divisions of these companies.
Materials and methods. The research objects were domestic pharmaceutical companies with the license to manufacture and sale of medicinal products on theterritory ofUkraine, and with the certificates of compliance with the requirements of the standard ISO 9001 or other standards for management systems. In the paper the information materials from the open source were also used.
Results. The topical issues of the domestic pharmaceutical companies when organizing and conducting internal audits of the quality management systems were identified, the main ways of their solution were substantiated.Conclusions. The study conducted has shown that there are facts of the insufficient effectiveness of internal audits at domestic pharmaceutical companies. This suggests that development of the scientifically based proposals for the organizational and methodological framework reform on the audit activity is a topical and important area of the future research.
Systemy upravlinnia yakistiu. Vymohy (ISO 9001:2015, IDT). (2016). DSTU ISO 9001:2015. [Na zaminu DSTU ISO 9001-2008]. Kyiv: DP “UkrNDNTs”, 22.
Systemy upravlinnia yakistiu. Osnovni polozhennia ta slovnyk terminiv (ISO 9000:2015, IDT). (2016). DSTU ISO 9000:2015. [Na zaminu DSTU ISO 9000:2007]. Kyiv: DP “UkrNDNTs”, 48.
Karamavrova, T. V., Lebedynets, V. A. (2016). Proceedings from Perspektivy razvitiia biologii, meditsiny i farmatsii. (pp. 22–23). Shimkent: OKMFA, 4 (77).
Kotvitska, A. A., Lebedynets, V. O. (2015). Orhanizatsiia vnutrishnih audytiv systemy upravlinnia yakistiu pidpriemstva z virobnytstva likarskyh zasobiv. Kharkiv: NTMT, 28.
Lebedynets, V. O. (2012). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 3 (23), 45–49.
Gorodetska, V.I., Lebedynets, V. O., Kovalenko, S. M. (2014). Prohrama pidhotovky vnutrishnikh audytoriv systemy upravlinnia yakistiu pidpryiemstv z vyrobnytstva likarskykh zasobiv v. Kharkiv: NFaU, 28.
Kachalov, V. A. (2009). Praktikum po auditu.Moscow: IzdAT, 712.
Lebedynets, V. O. (2012). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 4 (24), 32–37.
Lebedynets, V. O., Karamavrova, T. V. (2016). Proceedings from Upravlinnia yakistiu v farmatsii: materialy X Nauk.-prakt. konferentsii (20 maia 2016 roku). (p. 104). Kharkiv: NFaU.
Lebedynets, V. O., Kovalenko, S. M. (2012). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 2 (22), 21–26.
Lebedynets, V. O., Kovalenko, Sv. M. (2011). Visnyk farmatsii, 1 (65), 56–58.
Meshkovskiy, A. P. (2009). Farmateka, 2, 47–50.
Fields, T. (2008). Auditing as a Component of a Pharmaceutical Quality System. Journal of GxP Compliance, 5 (12), 61–68.
Welch, K. (2005). The Process Approach Audit Checklist for Manufacturing.Vancouver: Quality Press, 112.
Verbets, V. V. (2008). Metodyka orhanizatsii ta provedennia sotsiolohichnoho doslidzhennia. Berezno: RDGU, 231.
Struchkova-Humenna, L. B. (2015). Metody zboru sotsiolohichnoi informatsii. Ivano-Frankivsk: IFDU, 54.
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