ABSTRACT RISK MANAGEMENT MODELLING FOR PRODUCT X IN THE PHARMACEUTICAL INDUSTRY Y

• Main Author: Zarkasyi, Lutfhi
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44463
• Institution: Institut Teknologi Bandung

In running the business and operational wheels of the company, pharmaceutical manufacturing deals with risks, both internal and external risk that can affect company goals and objectives. To that end, the risk needs to be managed and controlled in order not to give a broad impact for the company. In pharmaceutical manufacturing, any manufactured product will remain at risk even after applying Good Manufacturing Practice (GMP). Related risks such as risks to safety, quality and efficacy of the products produced, timely supply of products, risks from raw material suppliers to regulatory risks and other risks. Zero risk reduction is not a realistic goal but patient protection by managing these risks in the quality system and its manufacturing process becomes very important in the pharmaceutical industry. In general, risk management on a product will facilitate risk management, since each product has different characteristics and profiles and the risks that will arise will be different too. In this study, it aims to establish an integrated product risk management model that can be applied to various risk categories. This research was made by creating a risk management model, followed by model testing on backbone products in Y pharmaceutical industry. The test results showed that the Luzar 2017 model tested was able to identify 459% more risk by generating 93 improvement plans when compared to the previous model. This suggests that the Luzar 2017 model can be used for modeling the risk management of X product in the Y pharmaceutical industry