The risk-oriented approach to the development and implementation of the pharmaceutical quality system in the production of in-bulk finished products
DOI:
https://doi.org/10.24959/uekj.21.1Keywords:
in-bulk products; medicines; drug quality; risk-based approach; pharmaceutical quality system; Good Manufacturing Practice; quality risk assessmentAbstract
Aim. To determine the areas of the risk-based approach to the development and implementation of the pharmaceutical quality system with the emphasis on the production of in-bulk finished products, identify the main factors affecting the stability of the functional characteristics of drugs in order to provide their compliance with the international quality standards, Good Manufacturing Practice and quality risk management.
Results. 29 pharmaceutical companies with the license in Ukraine for dispensing and packing of medicines from in-bulk products have been identified. The control strategy for the production of medicines for in-bulk products has been developed as a set of measures covering the incoming control of in-bulk products, the primary, secondary packing and their labeling, patient information leaflets, finished drug at release and shelf life, control of operating conditions of premises and equipment, parameters of dispensing and packing stages. The analysis of the specificity of the production of finished drugs from in-bulk products has been performed, and the areas of the risk-oriented approach have been determined to the development and implementation of the pharmaceutical quality system in this type of production based on the risk assessment of significant factors affecting the pharmaceutical production and the use of the appropriate risk management methods for quality in the production of medicines from in-bulk products.
Conclusions. It has been determined that the risk-oriented approach to the development and implementation of the pharmaceutical quality system in the production of medicines from in-bulk products is a strategic direction. It allows increasing the effectiveness of the quality management system at a qualitatively new level, achieving goals in order to prevent adverse effects on quality and safety, and it means the best possible customer satisfaction. In our research, the quality guarantees that the pharmaceutical quality system should provide in the production of medicines from in-bulk products have been identified, and the control strategy has been developed.
Key words: in-bulk products; medicines; drug quality; risk-based approach; pharmaceutical quality system; Good Manufacturing Practice; quality risk assessment
References
1. Nastanova ST-NMOZU 42-4.3:2011 (2011) Likarsʹki zasoby. Farmatsevtychna systema yakosti (ICH Q10). [Pharmaceutical quality system (ICH Q10)] Kyiv [in Ukrainian].
2. Zakon Ukrayiny «Pro likarsʹki zasoby» vid 04.04.1996 № 124/96-VR. [Law of Ukraine "On Medicinal Products" of 04.04.1996 № 124/96-VR]. (1996, 04 April). zakon.rada.gov.ua. Retrieved from https:// zakon.rada. gov.ua/laws/show/123/96-80 [in Ukrainian].
3. Postanova KMU vid 26 travnya 2005 r. № 376. Pro zatverdzhennya Poryadku derzhavnoyi reyestratsiyi (perereyestratsiyi) likarsʹkykh zasobiv i rozmiriv zboru za yikh derzhavnu reyestratsiyu (perereyestratsiyu) [On approval of the Procedure for state registration (re-registration) of medicinal products and the amount of the fee for their state registration (re-registration)]. (2005, 26 May). zakon.rada.gov.ua. Retrieved from https://zakon.rada.gov.ua/ laws/show/376-2005-%D0%BF#Text [in Ukrainian].
4. Nastanova ST-N MOZU 42-4.0:2020 (2020) Likarsʹki zasoby. Nalezhna vyrobnycha praktyka. [Good manufacturing practice] Kyiv [in Ukrainian].
5. Aleksandrov A.V. (2014) Farmatsevtycheskaya systema kachestva (ICH Q10) v alhorytmakh y skhemakh. [Pharmaceutical quality system (ICH Q10) in algorithms and schemes]. Moscow [in Russian].
6. Kotvitsʹka A.A. Lebedynetsʹ V. O., Takhtaulova N. O. (2015). Osnovni etapy formuvannya system upravlinnya yakistyu pidpryyemstv z vyrobnytstva likarsʹkykh zasobiv [The main stages of formation of quality management systems of enterprises for the production of medicines]. NTMT [in Ukrainian].
7. Lebedynetsʹ V.O. (2016) Metodolohiya formuvannya. System upravlinnya yakistyu na pidpryyemstvakh z vyrobnytstva likarsʹkykh zasobiv. dys. na zdob. Nauk. St. dok. Farm. nauk. MOZ Ukrayiny. Nats. Farm. UN-T.15.00.01 [Formation methodology. Quality management systems at drug manufacturing enterprises]. Doctor’s thesis. Kharʹkiv [in Ukrainian].
8. Baula O. V. Rozrobka pidkhodiv do formuvannja strateghiji kontrolju transdermaljnykh terapevtychnykh system . O. P. Baula, O. V. Ishhenko, S. S. Cherkas, V. I. Bessarabov, I. V. Resnycjkyj // Visnyk Kyjivsjkogho nacionaljnogho universytetu tekhnologhij ta dyzajnu. Serija Tekhnichni nauky. – 2019. – № 3 (134). – S. 79-87. DOI:10.30857/1813-6796.2019.3.8 [in Ukrainian].
9. Sukhanova, N., Lebedynets, V., & Tkachenko, O. (2020). The study of risk management activities for quality of medicines at the wholesale stage. Social Pharmacy in Health Care, 6(3), 41-48.DOI:10.24959/sphhcj.20.194[in Ukrainian].
10. Travyna O.A., Vorontsova A.A. (2017). Analyz systemy upravlenyya kachestvom, sootvet·stvuyushchey trebovanyyam standarta GMP, na predpryyatyy farmatsevtycheskoy promyshlennosty [Analysis of the quality management system that meets the requirements of the GMP standard at the pharmaceutical industry] PHTU, 2, 35-38. [in Russian].
11. Botet, J. Good Quality Practice (GQP) in Pharmaceutical Manufacturing (2015): A Handbook. Bentham Science Publishers, Sharjah (U.A.E.), 503 p.
12. O’Connor T., Yang X., Tian G., Chatterjee S., Lee S. (2017). Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations. Predictive Modeling of Pharmaceutical Unit Operations. 2017, 15-37.
13. Kumar N., Jha А. (2018). Quality risk management during pharmaceutical ‘good distribution practices’ A plausible solution. Bulletin of Faculty of Pharmacy. Vol. 56, Is. 1. Р. 18-25.
14. Reyestr diyuchykh litsenziy z vyrobnytstva likarsʹkykh zasobiv [Website of the Register of valid licenses for the production of medicines] URL:http://pub-mex.dls.gov.ua/PrcLicense/ PrcLicense List.aspx [in Ukrainian].
15. Derzhavnyy reyestr likarsʹkykh zasobiv Ukrayiny. [State Register of Medicines of Ukraine.] Retrieved from: http://www.drlz.kiev.ua [in Ukrainian].
16. DSTU ISO 9001:2015(ISO 9001:2015, IDT) Systemy upravlinnya yakistyu. Vymohy. [Quality management systems. Requirements] Kyiv, UkrNDNTS, 2016, 30p.
17. Nastanova ST-N MOZU 42-4.2-2011 (2011) Likarsʹki zasoby. Upravlinnya ryzykamy dlya yakosti (ICH Q9). [Quality risk management (ICH Q9)] Kyiv [in Ukrainian].
18. DSTU IEC/ISO 31010:2013. Keruvannya ryzykom. Metody zahalʹnoho otsinyuvannya ryzyku. [Risk management — Risk assessment techniques]. Kyiv. Publ., 2014 [in Ukrainian].
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