Optimalizace programu mikrobiologického monitoringu

Abstract

The goal of the Bachelor thesis is to estimate potential faults in the process of microbiological monitoring of a medicine during a reconstruction of a microbiological department of a medicine producer using risk analysis, attempt to propose possible solutions and discover if results of analysis can be endangered or if it can come to contamination of samples, laboratory equipment or working environment. In the theoretical part an issue of quality, its management and recent approaches to quality management are analysed. Risk analysis FMEA, theoretical basics of microbiological monitoring and microbiological quality as one of the most important parameters of inspection of medicines are described as well. The practical part introduces the department of microbiology of a medicine producer, its structure and operations held there and subsequently critical activities in the process of microbiological monitoring of a medicine are estimated using risk analysis. The conclusion contains proposal of corrective measures that could help to prevent the development of faults.