Application of good manufacturing practices in the production of food products for special medical purposes

Authors

DOI:

https://doi.org/10.15587/1729-4061.2023.279371

Keywords:

good manufacturing practices, good quality, food products for special medical purposes

Abstract

In order to guarantee the proper quality of medical products and medicines, the mandatory application of Good Manufacturing Practices (GMP) norms in almost all countries is provided by law. Given the importance of nutritional provision of human portrebs in emergencies, the use of GMP is also relevant in the production of food products for special medical purposes. The object of research is the methodological base, approaches, and norms of GMP application in the manufacture of this product category. It is determined that the implementation of these practices is ensured mainly through measures for raw materials, equipment, personnel, premises, compliance with hygienic requirements, journaling, internal control, response to complaints, monitoring, traceability, product recall. It is established that the basic principle of GMP application is the production of products that will meet the purpose and provisions of the registration dossier.

At the same time, ensuring product quality is a comprehensive concept of ensuring compliance with properties, combining organizational measures at all stages. This activity should be carried out taking into account risk-oriented thinking based on the control of raw materials, packaging, testing in the production and release of goods to the declared characteristics, ensuring high competence of personnel, process and analytical validation. Recommendations on a set of measures aimed at introducing good manufacturing practices at enterprises producing food products for special medical purposes have been compiled and presented. The essence of these recommendations is to identify technological processes, monitor their implementation, provide the necessary resources and measures, establish the process of documenting actions, validation at all stages, including self-inspection

Author Biographies

Nataliia Prytulska, State University of Trade and Economics

Doctor of Technical Sciences, Professor

Department of Commodity Science, Safety and Quality Management

Dmytro Antiushko, State University of Trade and Economics

PhD, Associate Professor

Department of Commodity Science, Safety and Quality Management

Victor Osyka, State University of Trade and Economics

Doctor of Technical Sciences, Professor

Department of Commodity Science, Safety and Quality Management

Liudmyla Sienohonova, Luhansk Taras Shevchenko National University

PhD, Associate Professor

Department of Commodity Science, Trade Entrepreneurship and Product Expertise

Viktoriia Volodavchyk, Luhansk Taras Shevchenko National University

PhD, Associate Professor

Department of Commodity Science, Trade Entrepreneurship and Product Expertise

Halyna Sienohonova, KROK University

Lecturer

Department of International Cooperation Management

References

  1. United Nations. Guidelines for Consumer Protection. Available at: https://unctad.org/system/files/official-document/ditccplpmisc2016d1_en.pdf
  2. Charter of Fundamental Rights of the European Union. Available at: https://www.europarl.europa.eu/charter/pdf/text_en.pdf
  3. Pro zakhyst prav spozhyvachiv: Zakon Ukrainy No. 1023-XII v red. vid 19.11.2022. Available at: https://zakon.rada.gov.ua/laws/show/1023-12#Text
  4. Food for special medical purposes. Available at: https://food.ec.europa.eu/safety/labelling-and-nutrition/specific-groups/food-special-medical-purposes_en
  5. Antiushko, D., Bozhko, T., Shapovalova, N., Fil, M., Brovenko, T., Tolok, G. et al. (2021). Nutritional value of a dry soluble gerodietetic product for enteral nutrition. Eastern-European Journal of Enterprise Technologies, 5 (11 (113)), 35–42. doi: https://doi.org/10.15587/1729-4061.2021.240175
  6. Antiushko, D. P. (2022). Interrelation of changes in amino acid composition and active acidity of whey protein concentrate. Journal of Chemistry and Technologies, 30 (1), 52–59. doi: https://doi.org/10.15421/jchemtech.v30i1.218623
  7. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32003L0094
  8. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31991L0412
  9. EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Available at: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
  10. Pro likarski zasoby: Zakon Ukrainy vid 04.04.1996 r. No. 123/96-VR. Available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text
  11. Pro zatverdzhennia Poriadku provedennia pidtverdzhennia vidpovidnosti umov vyrobnytstva likarskykh zasobiv vymoham nalezhnoi vyrobnychoi praktyky: Nakaz Ministerstva okhorony zdorovia Ukrainy No. 1130 vid 27.12.2012 r. Available at: https://zakon.rada.gov.ua/laws/show/z0133-13#Text
  12. Reis, C., Gouveia, B., Rijo, P., Gonçalo, T. (2015). Good manufacturing practices for medicinal products for human use. Journal of Pharmacy And Bioallied Sciences, 7 (2), 87. doi: https://doi.org/10.4103/0975-7406.154424
  13. Sanz-Nogués, C., O’Brien, T. (2021). Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents. Biomaterials and Biosystems, 2, 100018. doi: https://doi.org/10.1016/j.bbiosy.2021.100018
  14. Levent Alparslan, A. (2022). Basic good manufacturing practices (GMP), special conditions and inspection processes in the Covid19 (SARS-CoV-2) pandemic. Journal of Research in Pharmacy, 26 (6), 1527–1538. doi: https://doi.org/10.29228/jrp.247
  15. Covarrubias, C. E., Rivera, T. A., Soto, C. A., Deeks, T., Kalergis, A. M. (2022). Current GMP standards for the production of vaccines and antibodies: An overview. Frontiers in Public Health, 10. doi: https://doi.org/10.3389/fpubh.2022.1021905
  16. Bretaudeau, L., Tremblais, K., Aubrit, F., Meichenin, M., Arnaud, I. (2020). Good Manufacturing Practice (GMP) Compliance for Phage Therapy Medicinal Products. Frontiers in Microbiology, 11. doi: https://doi.org/10.3389/fmicb.2020.01161
  17. Tirughana, R., Metz, M. Z., Li, Z., Hall, C., Hsu, D., Beltzer, J. et al. (2018). GMP Production and Scale-Up of Adherent Neural Stem Cells with a Quantum Cell Expansion System. Molecular Therapy - Methods & Clinical Development, 10, 48–56. doi: https://doi.org/10.1016/j.omtm.2018.05.006
  18. Kovács, B., Péterfi, O., Kovács-Deák, B., Székely-Szentmiklósi, I., Fülöp, I., Bába, L.-I., Boda, F. (2021). Quality-by-design in pharmaceutical development: From current perspectives to practical applications. Acta Pharmaceutica, 71 (4), 497–526. doi: https://doi.org/10.2478/acph-2021-0039
  19. Pro zatverdzhennia dokumentiv z pytan zabezpechennia yakosti likarskykh zasobiv. Nastanova ST-N MOZU 42-4.0:2008 "Likarski zasoby. Nalezhna vyrobnycha praktyka". Available at: https://zakon.rada.gov.ua/rada/show/v0095282-09#n4777
  20. ShchO TAKE GMP? Available at: https://ifdcsms.com.ua/en/news/5/shcho-take-gm
  21. ISO 22716:2007. Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. Available at: https://www.iso.org/ru/standard/36437.html
  22. Design Space Development — How (And When) To Get Started. Available at: https://www.pharmaceuticalonline.com/doc/design-space-development-how-and-when-to-get-started-0001
  23. Current Good Manufacturing Practices (CGMP) 10 Principle’s. Available at: https://pharmabeej.com/current-good-manufacturing-practices-cgmp/#1_Standard_Operating_Procedure_SOP
  24. Iancu, E. M., Kandalaft, L. E. (2020). Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting. Current Opinion in Biotechnology, 65, 233–241. doi: https://doi.org/10.1016/j.copbio.2020.05.005
  25. GMP — shliakh do zabezpechennia dostupnosti, efektyvnosti ta bezpeky likiv. Available at: https://www.apteka.ua/article/14029
  26. Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Vol. 2. Good manufacturing practices and inspection. Available at: https://apps.who.int/iris/bitstream/handle/10665/43532/9789241547086_eng.pdf?sequence=1&isAllowed=y
Application of good manufacturing practices in the production of food products for special medical purposes

Downloads

Published

2023-06-30

How to Cite

Prytulska, N., Antiushko, D., Osyka, V., Sienohonova, L., Volodavchyk, V., & Sienohonova, H. (2023). Application of good manufacturing practices in the production of food products for special medical purposes. Eastern-European Journal of Enterprise Technologies, 3(13 (123), 52–58. https://doi.org/10.15587/1729-4061.2023.279371

Issue

Vol. 3 No. 13 (123) (2023): Transfer of technologies: industry, energy, nanotechnology

Section

Transfer of technologies: industry, energy, nanotechnology

License

Copyright (c) 2023 Nataliia Prytulska, Dmytro Antiushko, Victor Osyka, Liudmyla Sienohonova, Viktoriia Volodavchyk, Halyna Sienohonova

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

The consolidation and conditions for the transfer of copyright (identification of authorship) is carried out in the License Agreement. In particular, the authors reserve the right to the authorship of their manuscript and transfer the first publication of this work to the journal under the terms of the Creative Commons CC BY license. At the same time, they have the right to conclude on their own additional agreements concerning the non-exclusive distribution of the work in the form in which it was published by this journal, but provided that the link to the first publication of the article in this journal is preserved.

A license agreement is a document in which the author warrants that he/she owns all copyright for the work (manuscript, article, etc.).
The authors, signing the License Agreement with TECHNOLOGY CENTER PC, have all rights to the further use of their work, provided that they link to our edition in which the work was published.
According to the terms of the License Agreement, the Publisher TECHNOLOGY CENTER PC does not take away your copyrights and receives permission from the authors to use and dissemination of the publication through the world's scientific resources (own electronic resources, scientometric databases, repositories, libraries, etc.).
In the absence of a signed License Agreement or in the absence of this agreement of identifiers allowing to identify the identity of the author, the editors have no right to work with the manuscript.
It is important to remember that there is another type of agreement between authors and publishers – when copyright is transferred from the authors to the publisher. In this case, the authors lose ownership of their work and may not use it in any way.