An overview of Risk assessment methods in pharmaceutical industries, analysis of various risk assessment techniques & applying LOPA technique in distillation operation

Abstract

The Pharmaceutical industry plays a key role in bringing new medicines to the world. While Pharma industries strive to achieve patient quality care, the operations associated with manufacturing medicines at various stages, such as research, Pilot stage, API manufacturing and Formulation, pose various hazards and risks. Therefore, it is essential to manage the risk by identifying the hazards and applying effective control measures. This paper discusses the various risk assessment tools, their suitability, and their limitations, using various case studies and an analysis of results obtained through real-time surveys. The paper also highlights the advantage of Layer of protection analysis over other tools, and its application is illustrated using distillation operation. Layer of Protection analysis is a semi-quantitative risk assessment tool to manage the risk in a better way in process Industries. LOPA provides a clear understanding of the adequacy of the safeguards suggested compared to any other qualitative risk assessment tool, such as process hazard analysis. LOPA is a systematic tool that evaluates risk by applying semi-quantitative measures to evaluate the frequency of potential incidents and the probability of failure of the protection layers. This paper will focus on various risk assessment tools available in process industries, provide a detailed overview of LOPA, and discuss the layer of protection suggested for a distillation operation in the Pharma industry