Scientific and practical approaches to minimization of risks of cross contamination in the conditions of combined production of parenteral medicines

A. M. Goy, O. V. Posilkina, Ya. M. Derenska

Abstract


The complexity of organizing the production of high-tech parenteral medicines, as well as the need to provide their competitiveness and price affordability require the introduction of the integrated management concept that takes into account the use tools of quality management, project management and risk management.

Aim. To develop scientific and practical approaches to minimize the risks of cross contamination in the conditions of combined production of parenteral medicines in accordance with the ICH Q9 requirements.

Materials and methods. The data of scientific literature, legal acts regulating the risk management issues in the conditions of combined production were studied; Ishikawa chart, control cards were used for identification and assessment of risk.

Results. Using the control card construction the risks of cross contamination were assessed in the conditions of combined production of parenteral medicines on the example of the risk of air pollution, their causes in the critical stages were analyzed, the feasibility of the introduction of the system of the measures developed aimed at preventing and reducing the risk of cross contamination was substantiated.

Conclusions. The introduction of the system of the measures developed to prevent cross contamination risks will promote the increase of the quality level for pharmaceutical products due to the minimization of contamination of the combined production of parenteral medicines at JSC “Farmak”.

Keywords


cross contamination; control card; Ishikawa chart; system of measures for reducing risks

References


MOZ Ukrayiny. (2011). Nastanova ST-N MOZU 42-4.2:2011. Likarski zasoby. Upravlinnya ryzykamy dlya yakosti (ІCH Q9). Kyiv, 35.

MOZ Ukrayiny. (2015). Nastanova ST-N MOZU 42-4.0:2015. Likarski zasoby. Nalezhna vyrobnycha praktyka. Kyiv, 336.

Venkateswara Reddy, B., Rasmitha Reddy, B., Navaneetha. K., Sampath Kumar, V. (2013). A Review on parenteral production technology. International Journal of Pharmacy and Biological Sciences (IJPBS), 3 (1), 596–610.

John, D. L. (2010). Pharmaceutical Dosage Forms - Parenteral Medications. Formulation and Packaging. In pharma, 2 (3), 975.

Tulemisov, S. K. (2015). Vestnik KazNMU, 1. Retrieved from: https://kaznmu.kz/press/wp-content/.

Kennedy, A. (n.d.). Pharmaceutical Project Management. Retrieved from: http://books.google.com/books7id-GzQ6PvQPYC&pg:=PA120&dq=pharmaceutical+risk+management#PPPl,Mlhtp://books.google.c(lphi+method&pgis=l.

Kostiuk, G. V., Derenska, Ya. M. (2008). Proceeding of Sogodennia ta maibutnie farmatsii. (p. 534). Kharkiv: Izd-vo NFаU.

Lebedinets, V. A., Bursakov, A. V. (2008). Provisor, 17, 26–28.

Alan, M., Dempster, H. (n.d.). Risk management: value at risk and beyond. Retrieved from: http://books.google.com/books?id:=39mYKiAn5NIC&printsec=frontcover&dq^risk+management#vonepage&q=&f=false.

Bower, P. (n.d.). Risk management options. Retrieved from: https://www.projectsmart.co.uk/risk-management-options.php.

Frenkel, M., Ulrich, H. (n.d.). Risk Management: Challenge and Opportunity. Retrieved from: http://books.google.com/books?id=53HESCxwl8oC&printsec=frontcover&dq=risk+management#v=onepage&q=&f=false.

Spitskiy, O. R. (n.d.). Provedenie analiza riskov pri proektirovanii i validatsii farmatsevticheskogo proizvodstva. Retrieved from: http://www.medbusiness.ru/440.php.


GOST Style Citations


1.         Лікарські засоби. Управління ризиками для якості (ІСН Q9) : настанова СТ-Н МОЗУ 42-4.2:2011. – К. : МОЗ України, 2011. – 35 с.

 

2.         Лікарські засоби. Належна виробнича практика : настанова СТ-Н МОЗУ 42-4.0:2015. – К. : МОЗ України, 2015. – 336 с.

 

3.         A Review on parenteral production technology / B. Venkateswara Reddy, B. Rasmitha Reddy, K. Navaneetha, V. Sampath Kumar // International Journal of Pharmacy and Biological Sciences (IJPBS). – 2013. – Vol. 3, No. 1. – P. 596–610.

 

4.         John, D. L. Pharmaceutical Dosage Forms – Parenteral Medications / D. L. John,N. Sandeep// Formulation and Packaging. In pharma. – 2010. – Vol. 2, No. 3. – 975 p.

 

5.         Тулемисов, С. К. Основные аспекты проектного менеджмента в фармацевтических предприятиях [Электронный ресурс] / С. К. Тулемисов // Вестник КазНМУ. – 2015. – Вып. 1. – Режим доступа : https://kaznmu.kz/press/wp-content/.

 

6.         Kennedy, A. Pharmaceutical Project Management [Електронний ресурс] / Kennedy A. – Режим доступу : http://books.google.com/books7id-GzQ6PvQPYC&pg:=PA120&dq=pharmaceutical+risk+management#PPPl,Mlhtp://books.google.c(lphi+method&pgis=l.

 

7.         Костюк, Г. В. Шляхи регламентації процесу управління проектами в умовах інтегрованої системи управління якістю / Г. В. Костюк, Я. М. Деренська // Сьогодення та майбутнє фармації : тези доп. Всеукр. конгр., м. Харків, 16-19 квіт. 2008 р. – Х. : Вид-во НФаУ, 2008. – С. 534.

 

8.         Лебединец, В. А. Анализ актуальности интегрированных систем менеджмента в фармации / В. А. Лебединец, А. В. Бурсаков // Провизор. – 2008. – № 17. – С. 26–28.

 

9.         Alan, M. Risk management: value at risk and beyond [Internet] / M. Alan, H. Dempster. – Retrieved from :  http://books.google.com/books?id:=39mYKiAn5NIC&printsec=frontcover&dq^risk+management#vonepage&q=&f=false.

 

10.       Bower, P. Risk management options [Internet] / P. Bower. – Retrieved from: https://www.projectsmart.co.uk/risk-management-options.php.

 

11.       Frenkel, M. Risk Management: Challenge andOpportunity[Internet] / M. Frenkel, H.  Ulrich. – Available at : http://books.google.com/books?id=53HESCxwl8oC&printsec=frontcover&dq=risk+management#v=onepage&q=&f=false.

 

12.       Спицкий, О. Р. Проведение анализа рисков при проектировании и валидации фармацевтического производства [Электронный ресурс] / О. Р. Спицкий. – Режим доступа : http://www.medbusiness.ru/440.php.

 





DOI: https://doi.org/10.24959/sphhcj.17.88

Abbreviated key title: Soc. farm. ohor. zdor.

ISSN 2518-1564 (Online), ISSN 2413-6085 (Print)