The Management of Process Lead Time in the Release of Sterile Pharmaceutical Batches: A Case Study of Optimization in an Official Brazilian Pharmaceutical Laboratory

Abstract

Medicines must comply with quality, safety, and efficacy pillars. Nowadays, organizations seek to incorporate new management models encouraged by quality program following the world trend regarding the technological revolution. The present research aims to improve the sterile pharmaceutical product batches release process, using the Failure Mode Effects Analysis (FMEA) method. This study addresses the gap in literature on quality risk management during batch release. The methodology uses a form adapted to the process in order to systematize the information, improving its comparison and analysis, thus estimating, the identification of potential failure modes and their effects on their performance. Made it possible to assign values for the severity, occurrence, and failure modes detection, to then determine the risk level and the priority of risk level. The results obtained showed the mitigation and elimination of failures in the process, as well as opportunities for improvement and causes of failures identification, improvement in the process performance indicators, greater reliability, and reduction in batch release time. Keywords: good manufacturing practices pharmaceutical industry, risk management, risk management tools