Scientific and practical approaches to minimization of risks of cross contamination in the conditions of combined production of parenteral medicines
Keywords:cross contamination, control card, Ishikawa chart, system of measures for reducing risks
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”.
MOZ Ukrayiny. (2011). Nastanova ST-N MOZU 42-4.2:2011. Likars’ki zasoby. Upravlinnya ryzykamy dlya yakosti (ІCH Q9). Kyiv, 35.
MOZ Ukrayiny. (2015). Nastanova ST-N MOZU 42-4.0:2015. Likars’ki 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 S’ogodennia 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.
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