Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Puneet Pandey, Pankaj Singh, Mehul Saktawat

Abstract: The significance of internal audits for the pharmaceutical industry, as stated in the recommendations for excellent pharmacy practises (in particular, GMP, GDP).The topic of auditor selection, training, grading, certification, and continual development in pharmaceutical firms is relevant and vital for both local and international enterprises. The study's goal was to identify the competency of pharmacy quality system internal auditors and opportunities for growth.Materials and methods. The study's focus was on the competency of pharmaceutical quality system internal auditors. Empirical and theoretical research methodologies were employed, most notably the method of comparative analysis of scientific literature in the subject of study, as well as the method of structural and logical modelling. The terms of rules and materials available in open professional scientific literature served as the information foundation.Results The capability of the quality management system Personal attributes, professional knowledge, and abilities are required of auditors in general, and pharmaceutical quality systems in particular. The ISO 19011 standard emphasises the significance of evaluating and continuously developing auditor competence. Such an evaluation should take into consideration the audit program's requirements and objectives. The details of industrial activities should decide the areas of growth of auditors' competence. This standard requirement should be deemed significant for pharmaceutical businesses.Conclusions. We investigated the requirements for the competency of QMS internal auditors in accordance with international and industry standards. A assessment of the regulatory framework revealed a dearth of information on the research topic of choice. Defined standards for the competency of PQM audits personnel aid in the selection of specialists for the audit team so that the audit team's total competence is sufficient to meet the audit's objectives.

Keywords: internal audit, auditor, quality management system, pharmaceutical quality system, ISO 9001, ISO 19011, phar- maceutical company, auditor competence.