The master’s thesis dealt with the cleaning in place system in the pharmaceutical industry and analyzed the necessary procedures for documenting the qualifications of the individual stages in the development of this system. Based on the information obtained from the literature, first, the theoretical basis of the system, some different implementations of the system, and the theoretical bases of qualifications and qualification documentation in the pharmaceutical industry were presented. An analysis of the qualification documentation was made, with focus on the presentation of each stage of the qualification documentation and operation of the cleaning in place system. On the basis of the performed test procedures and the relevant worksheets, the correspondence of the documentation with the actual situation was determined. Seven test procedures were performed for installation qualification. Based on the analyzes performed, the proper installation of cleaning in place system could be confirmed.
|