Study of the Effects of Improving a Process in a Pharmaceutical Laboratory

Abstract

Improving processes has been a key focus recently, with pharmaceutical companies exploring various approaches, particularly in laboratory settings. Enhancing processes in regulated laboratories requires compliance with regulatory agencies, standard operating procedures, and the analytical methods used. Benefits include faster results, improved quality, and reduced cycle time. This study aimed to evaluate the impact of a reporting template on laboratory metrics during chromatography data reporting. Analysts' time spent generating chromatographic reports was measured and compared before and after the introduction of the template and guidelines. Additionally, errors in reports and participant feedback were analyzed. The results demonstrated significant improvements in time efficiency and a reduction in mistakes following the implementation of the template and guidelines. However, further research with a larger sample size is needed to confirm these findings, and after confirmation, it would be possible to standardize other parts of the analysis. Key Terms - Chromatographic Data, Improvement, Laboratory, Standardizing.