Some aspects of activity evaluation of internal auditors of a pharmaceutical companies quality management systems
DOI:
https://doi.org/10.24959/uekj.18.34Keywords:
internal audit, auditor, quality management system, pharmaceutical quality system, ISO 9001, pharmaceutical company, performance evaluationAbstract
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.
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