Abstract
The importance of internal audits for the pharmaceutical company, which is indicated in the guidelines for good practices in pharmacy (in particular, GMP, GDP).
 The issue of selection, training, grading, certification and continuous improvement of the auditor’s competence at pharmaceutical companies are relevant and important both for domestic ones, and for foreign enterprises.
 The aim of the study was to determine the competence of the pharmacy quality system internal auditors’ and the areas of its development.
 Materials and methods. The object of the study was the competence of internal auditors of pharmaceutical quality systems. Empirical and theoretical research methods were used, in particular the method of comparative analysis of scientific literature in the field of research, the method of structural and logical modeling. The information basis was the provisions of regulations and materials published in the open professional scientific literature.
 Results. The competence of quality management system auditors in general and pharmaceutical quality system in particular consists of personal qualities, professional knowledge and skills. The ISO 19011 standard highlights the importance of evaluating and continuous development of auditors’ competence. Such an assessment should take into account the needs of the audit program and its objectives. Areas of development of auditors' competence should be determined by the specifics of industry activities. This provision of the standard should be considered relevant for pharmaceutical companies.
 Conclusions. We studied the requirements for the competence of QMS internal auditors of international and industry standards. A review of the regulatory framework showed a lack of information on the chosen area of the research. Defined requirements for the competence of the PQM audits staff assists the selection of specialists to the audit team so that the overall competence of the audit team is sufficient to achieve the objectives of the audit.
Highlights
The conduct of internal audits (IA) of pharmaceutical quality system (PQS) in Ukraine is regulated by a number of regulations, in particular, the Resolution of the Cabinet of Ministers of Ukraine No 929 of November 30, 2016 «On approval of licensing conditions for business activities for the production of medicines, wholesale and retail trade in medicines» [1], Guidelines СT-Н MOH of Ukraine 42-4.0:2020 «Medicines. Good manufacturing practice» (GMP Guidelines) [2], Guidelines СТ-Н MOH of Ukraine 42-4.3:2011 «Medicines. Pharmaceutical quality system (ICH Q10)» [3].GMP Guidelines, LC regulate the availability of competent and qualified personnel to carry out all activities [1, 2]
Given that effective IA provides an opportunity to assess the functioning of a particular process, or PQS as a whole, they are of significant value to the management of the Pharmaceutical Company (PhC) [3]
First of all, such criteria should characterize the value of the audit reports for the management, which is based on the decision to optimize the company
Summary
GMP Guidelines, LC regulate the availability of competent and qualified personnel to carry out all activities [1, 2]. Such requirements apply to the IA process. Requirements for mandatory audits are set out in the standard ISO 9001:2015 «Quality Management Systems. Requirements» (paragraph 9.2) and general recommendations for audits of management systems are given in the standard ISO 19011:2018 [4, 5]
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