Vol. 8, Issue 2 (2019)

Author(s):
Alla Kotvitska, Viacheslav Lebedynets and Tetiana Karamavrova

Abstract:
At the pharmaceutical industry organizations systematic audits should be conducted. Aimed of the audit is to determining the conformity of the pharmaceutical system with the quality requirements and increasing the effectiveness of the processes. An analysis of regulatory information sources and our own sociological research was carried out, the results of which can be noted that there are problems associated with the organization of audits. Therefore, the purpose of our study was to develop a set of proposals to increase the effectiveness of the audit process at pharmaceutical companies through the implementation of the PCDA cycle. The methods used were: systematic-analytical, sociological survey, comparative analysis, structural-logical modeling, etc. The implementation of the PDCA cycle in the process of internal audit of the quality management system of the pharmaceutical company has been demonstrated. The approach to practical the PDCA cycle implementation at the organization of internal audits of the quality management system of pharmaceutical companies is proposed. The advantages that can provide this cycle in achieving the goals of continuous improvement of the quality management system effectiveness are considered.