| Abstract [eng] |
The aim of the master's thesis is to determine how human factors influence the implementation of the requirements of good manufacturing practice according to the analyzed scientific literature and the results of semi-structured expert interviews. Tasks of the thesis: to examine and present the definitions and classification systems of the concept of human factors; examine and present the impact of human factors on quality management systems, including the application of good manufacturing practices, based on a review of the literature; to evaluate the influence of human factors on the implementation of the requirements of good manufacturing practice after conducting a qualitative research-expert survey. Methods applied: analysis of scientific literature and qualitative research - expert interviews. Good Manufacturing Practice (GMP) is a mandatory part of the processes of pharmaceutical and biotechnology organizations that manufacture medicines or their components according to the requirements and specifications so as to be safe for humans. It is critical to take human factors into account when implementing quality management systems. This work is based on human factors analysis and classification system, according to which there are four levels of human factors: organizational factors, supervision, preconditions for unsafe acts and unsafe acts. Categories of the levels of the human factors analysis and classification system have been supplemented with subcategories and interrelations between human factors, thus adapting this system to pharmaceutical and biotechnology organizations which apply GMP requirements. The work consists of two main parts: a review of the literature on human factors and good manufacturing practice and an empirical study of the impact of human factors on the implementation of good manufacturing practice requirements. |
