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

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”.