QUALITY MANAGEMENT SYSTEM OF A PHARMACEUTICAL ORGANIZATION: CRITERIA AND IMPLEMENTATION

The aim of the study is a theoretical justification and development of a mechanism for the implementation of quality management systems (QMS) in the activities of retail trade in pharmaceutical products.

Materials and methods. The study is based on the analysis of scientific literature data and Analytical Normative Documents regulating various aspects of QMS functioning in pharmaceutical organizations. Methods of documentary content analysis of international and national ISO standards, Series 9000, were used as the basis for the development and implementation of QMS organizations despite the type of their activities.

Results. In the course of the study, the organization of the production process has been studied and the main production (business-) operations of seven structural subdivisions of “Apteka-Alex” LLC in Angarsk have been analyzed. The basic principles of QMS functioning are set forth and the author’s methodology for its development for retail trade in pharmaceutical products has been presented, taking into account the specifics of the organizational structure and production activities of pharmacy organizations. The mechanisms and successive stages of the QMS implementation have been specified and given grounds for. In accordance with the requirements of GOST R ISO 9000:2015, the definitions and classification of the main production operations (business processes) of the studied pharmacies have been made up. In addition, the list of mandatory (core) and basic standard operating procedures (SOPs), detailing the main production (business-) processes, has been made up, and an algorithm for developing and testing SOPs has been outlined.

Conclusion. The results of the study allowed us to justify and propose a step-by-step methods of QMS implementation into the work of pharmaceutical organizations in the retail sector. The first results of the approbation and use of the developed methodology show that it contributes to the rational construction and functioning of the QMS, in accordance with the requirements of the existing standards, as well as the optimization of administrative management of all production (business-) processes. 

1. Skripko AA, Geller LN. Sotsialnaya farmatsevticheskaya pomoshch v Irkutskoy oblasti: monografiya [Social pharmaceutical assistance in the Irkutsk region]. Irkutsk: Ottisk; 2014: 119 p. Russian.

2. Klimenkova AA, Geller LN, Skripko AA. Sistema dopolnitelnogo professionalnogo obrazovaniya v formate nadlezhashchey aptechnoy praktiki [System of additional professional education in the format of good pharmacy practice]. Sistema menedzhmenta kachestva: opyt i perspektivy: sbornik materialov nauchno-prakticheskoy konferentsii. Irkutsk: IGMU; 2018:130–133. Russian.

3. Diachenko RG, Andreyeva IN, Bondareva TM, Gabriyelyan NV. Kontseptualnaya model upravleniya kachestvom farmatsevticheskoy pomoshchi na regionalnom urovne [Conceptual model of quality management of pharmaceutical assistance at the regional level]. Problemy farmatsevticheskoy nauki i praktiki sbornik materialov ІІІ Vserossiyskoy nauchno-prakticheskoy konferentsii. Vladikavkaz; 2013:35–39. Russian.

4. Semenova SV. Issledovaniye dopolnitelnykh uslug predostavlyayemykh farmatsevticheskimi organizatsiyami [Research of additional services provided by pharmaceutical organizations]. Nauka molodykh (Eruditio juvenium). 2017; 5(2):306–311.Russian. doi:10.23888/HMJ20172306-311.

5. Gergiyeva IV, Andreyeva IN, Bidarova FN, Bondareva TM. Vyyavleniye prichinno-sledstvennykh svyazey mezhdu faktorami okazyvayushchimi vliyaniye na kachestvo lekarstvennoy pomoshchi na regionalnom urovne [Identification of cause-and-effect relationships between factors influencing the quality of drug care at the regional level]. Meditsinskiy vestnik Severnogo Kavkaza. Stavropol; 2015; 10(3):269– 273. Russian. doi: http://dx.doi.org/10.14300/mnnc.2015.10063.

6. Nikitin SA, Tatenko GI, Bakhtina SS, Magomedalieva OV, Kononova EE, Semenikhina AV, Morozova OI, Torgachev DN, Knyazeva VA, Laushkina NS, Kupriyanov AN, Shevtsova EA, Musatova IV, Dolgikh EL, Tronina IA, Zlobin EF. Kontseptsiya i tekhnologii menedzhmenta v otraslevom razreze: teoriya i praktika: monografiya [The concept and technology of management in the sectoral context: theory and practice]. Orel: OGU imeni Turgeneva IS; 2017:222 p. Russian.

7. Glembotskaya G. T. V labirintakh farmatsevticheskogo menedzhmenta [In the maze of pharmaceutical management]. Moscow: Litterra; 2007:225p. Russian.

8. Razdorskaya IM, Zanina IA, Plokhikh IV. Strategiya razvitiya biznes-potentsiala aptechnykh setey s uchetom sbalansirovannykh pokazateley [Development strategy for the business potential of pharmacy networks with consideration for balanced indicators]. Farmaciya, 2018; 67(2): 46–51. Russian. doi: https://doi.org/10.29296/25419218-2018-02-09.

9. Kareva NN. Perspektivnye napravleniya razvitiya sotsial’noy otvetstvennosti aptechnogo biznesa [Promising directions in the development of pharmacy business’s social responsibility]. Farmaciya, 2018; 67(5): 29–34. Russian. doi: https://doi.org/10.29296/25419218-2018-05-06.

10. Balashov AI. Nenadlezhashchaya proizvodstvennaya praktika: modernizatsiya sistemy obespecheniya kachestva proizvodstva lekarstvennykh sredstv v Rossii [Good manufacturing practice: modernization of the quality assurance system for the production of medicines in Russia]. Izvestiya vysshikh uchebnykh zavedeniy (Ekonomika, finansy i upravlenie proizvodstvom), Ivanovo.2014; 1(19):72–77. Russian.

11. Morozova TE, Khoseva EN. Organizatsiya kontrolya kachestva, effektivnosti i bezopasnosti lekarstvennykh sredstv na gosudarstvennom urovne za rubezhom i v Rossii [Organization of quality control, efficiency and safety of medicines at the state level abroad and in Russia]. Kachestvennaya klinicheskaya praktika. Moscow. 2013;2:54–59. Russian.

12. Avdoshkina OI. Kachestvo i bezopasnost’ lekarstvennykh sredstv: mezhdunarodnaya standartizatsiya i sistema gosudarstvennogo kontrolya [Quality and safety of medicines: international standardization and state control system]. Sistemnoe upravlenie. Saransk. 2014; 3(24):2–9. Russian.

13. Podpruzhnikov YuV, Nemchenko AS, Andryukova LN, Emshanova SV, Kozel’skaya TP, Chistyakova VV, Ishmukhametov AA. Khrestomatiya farmatsevticheskogo kachestva [Pharmaceutical quality reader]. Moscow: Gruppa Remedium.2015:415 p. Russian.

14. Chukreeva NV. Kontseptsiya upravleniya znaniem protsessov v organizatsiyakh sistemy tovarodvizheniya lekarstvennykh sredstv [The concept of knowledge management processes in organizations of the system of commodity circulation of medicines]. Vestnik voronezhskogo gosudarstvennogo universiteta. Seriya: khimiya. Biologiya. Farmatsiya. 2015;1:167–171. Russian.

15. Dremova NB, Ovod AI, Korzhavykh EA. Osnovy farmatsevticheskoy pomoshchi v zdravookhranenii [Fundamentals of pharmaceutical care in health care]. Kursk: GOU VPO KGMU Roszdrava.2009:412p. Russian.

16. Ryzhova OA, Moroz TL. Izmeneniya v roznichnoy realizatsii lekarstvennykh preparatov iz meditsinskikh organizatsiy [Changes in retail sales of medicines from medical organizations]. Innovatsionnye tekhnologii v farmatsii:sbornik materialov nauchno-prakticheskoy konferentsii. Irkutsk; 2017:206– 210. Russian.

17. Moroz TL, Ryzhova OA. Kak vnedrit’ sistemu obespecheniya kachestva khraneniya i perevozki lekarstvennykh preparatov [How to implement a system to ensure the quality of storage and transportation of medicines]. Zamestitel’ glavnogo vracha. 2017; 9:62–65. Russian.

18. Nevolina EV. Osnovnye podkhody k vnedreniyu SMK v apteke [Main approaches to QMS implementation in pharmacy]. Aptechnyy biznes. 2008;1:5–8. Russian.

19. Nevolina EV. Tselesoobraznost’ vnedreniya SMK v aptechnuyu praktiku [Expediency of QMS implementation in pharmacy practice]. Rossiyskie apteki. 2007;4:32–38. Russian.

20. D’yachenko RG, Andreeva IN, Bidarova FN, Bondareva TM, Gabrielyan NV. Puti sovershenstvovaniya upravleniya kachestvom aptechnykh tovarov i farmatsevticheskikh uslug v aptechnykh organizatsiyakh [Ways to improve the quality management of pharmaceutical products and pharmaceutical services in pharmacy organizations]. Sovremennye problemy nauki i obrazovaniya. 2013; 5:371–379. Russian.

21. D’yachenko, RG. Sostoyanie sistemy upravleniya kachestvom v farmatsevticheskikh organizatsiyakh Stavropol’skogo kraya [The state of the system of quality management in pharmaceutical organizations of the Stavropol territory]. Sbornik uchebno-metodicheskikh i nauchnykh trudov. Kazan’; 2014; 66–70. Russian.

22. GOST R ISO 9001-2015 Nacional’nyj standart Rossiyskoy Federatsii. Sistemy menedzhmenta kachestva. Trebovanija. Moscow:Standartinform. Russian.

23. GOST R ISO 9004-2010 Nacional’nyj standart Rossiyskoy Federatsii. Menedzhment dlja dostizhenija ustojchivogo uspeha organizacii. Podhod na osnove menedzhmenta kachestva. Moscow:Standartinform. Russian.

24. GOST R ISO 9004-2010 Natsional’nyy standart Rossiyskoy Federatsii. Menedzhment dlya dostizheniya ustoychivogo uspekha organizatsii. Podkhod na osnove menedzhmenta kachestva. Moscow: Standartinform. Russian.

25. Repin VV. Biznes-protsessy kompanii: postroenie, analiz, reglamentatsiya [Business processes of the company: construction, analysis, regulation]. Moscow: Standarty i kachestvo, 2004:398 p. Russian.

26. Kondrat’ev VV, Kuznetsov MN. Pokazyvaem biznes-protsessy ot modeli protsessov kompanii do reglamentov protsedur [We show business processes from the company’s process model to the procedures regulations]. Moscow: Eksmo; 2008:256 p. Russian.

27. Rogov OA, Davidov SB. Elementy sistemy kachestva v aptechnykh organizatsiyakh [Elements of the quality management systemin pharmacies]. Sovremennaya organizatsiya lekarstvennogo obespecheniya. Moscow; 2018(2):111–113. Russian. doi: 10.30809/solo.2.2018.35.

28. Dremova NB, Korzhavykh EA. Lekarstvennoe sredstvo kak mnogomernyy ob”ekt [Medicinal product as a multidimensional object]. Farmatsevticheskaya promyshlennost’. 2005; 5:59–69. Russian.

29. Klimenkova AA, Geller LN, Skripko AA. Razrabotka, vnedrenie i realizatsiya sistemy menedzhmenta kachestva v aptechnykh i meditsinskikh organizatsiyakh, osushchestvlyayushchikh roznichnuyu torgovlyu lekarstvennymi preparatami i tovarami aptechnogo assortimenta [Development, implementation and implementation of quality management system in pharmacy and medical organizations engaged in retail trade of medicines and pharmaceutical products]. Irkutsk: Forvard, 2018:321p.