Some aspects of activity evaluation of internal auditors of a pharmaceutical companies quality management systems

V O Lebedynets,T V Karamavrova

doi:10.24959/uekj.18.34

Abstract

An effective quality management system is a prerequisite for the effective and successful operation of any modern enterprise, including pharmaceutical companies. It is generally accepted that in such systems, the internal audit process is an important and integral part. The importance of internal audits for the diagnosis and timely adjustment of the pharmaceutical quality system is emphasized in all existing regulations from the proper practices of medicines (in particular, in the GMP and GDP) and in the national licensing conditions for the conduct of economic activities on the production, wholesale and retail sale of medicines. As for all other processes of the pharmaceutical quality system, the effectiveness of internal audits directly depends on the competence of the involved specialists. The level of auditors’ training and their personal qualities acquire special significance for auditing activities. The aim of the study was to develop approaches to assessing the activity of auditors, to determine the criteria for selecting candidates for auditors, and to determine the criteria for the audit process of the pharmaceutical companies’ quality management system. Results. The article substantiates the importance and proposed approaches to assessing the performance of internal auditors of quality management systems of pharmaceutical companies. A list of indicators and a description of the methodology for assessing the performance of internal auditors, as well as for assessing the effectiveness of the internal audit process, has been developed. Conclusions. The proposed evaluation approaches provide an opportunity to measure the effectiveness of internal audits, identify trends in its changes, and apply corrective or preventive actions to improve the audit process.

Highlights

Conclusions.The proposed evaluation approaches provide an opportunity to measure the effectiveness of internal audits, identify trends in its changes, and apply corrective or preventive actions to improve the audit process
Companies often provide training and certification for auditors themselves or invite outside experts for skills workshops and other forms of training. It accounts for lack of standardized approaches to the training of auditors and regular methods for competence assessment, which in its turn results in significantly different levels of professionalism of these audits [2]
Top management should establish a process for reviewing all internal audit results in order to identify trends that can require organization-wide corrective actions and opportunities for improvement” [7]

Summary

Introduction

Conclusions.The proposed evaluation approaches provide an opportunity to measure the effectiveness of internal audits, identify trends in its changes, and apply corrective or preventive actions to improve the audit process. Деякі аспекти оцінки діяльності внутрішніх аудиторів систем управління якістю фармацевтичних підприємств У статті обґрунтовується важливість та пропонуються підходи до оцінювання діяльності внутрішніх аудиторів систем управління якістю фармацевтичних підприємств.

Results

Conclusion