Approaches to increase of efficiency of processes of quality management system of the enterprise on production of medicines

The article presents approaches to improving the efficiency of the processes of the quality management system of the enterprise for the production of medicines. The article substantiates the importance of internal audit in the production of medicines, as well as the need to manage the costs associated with quality. The example of the process «Packaging» shows the use of the process approach in the audit, the identified deviations indicate a weak controllability of the process. The risk-oriented approach was applied at the stages of the «Packaging» process, which showed the most «weak» places in the process. The evaluation of the effectiveness of the «Packaging» process using the cost model and the effectiveness of the quality management system of the enterprise using the PAF model show deviations in time (unnecessary time costs), as well as returns of medicines (financial losses). According to the results of the study, measures are proposed, the use of which will allow the company to improve the structure of costs associated with quality, reduce unproductive costs, thereby increasing the efficiency of processes and all activities of the enterprise.