OPERATIONAL PROCESS IMPROVEMENT OF GMP AUDIT BY USING LEAN-SIX SIGMA FRAMEWORK (CASE: BADAN PENGAWAS OBAT DAN MAKANAN)

• Main Author: Wibisono, Bayu
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/63508
• Institution: Institut Teknologi Bandung

Indonesia's Badan Pengawas Obat dan Makanan (Badan POM), also known as Indonesia's National Agency for Drug and Food Control (NADFC), or Indonesia Drug and Food Control (FDA), is charged with ensuring public health safety, quality, and efficacy of pharmaceuticals and foods on the market. There is a control system in place, known as a pre-post control system, which means that before drugs and food are marketed, there will be a product and facility evaluation (pre-control), and after the product is in the market, there will be product sampling and on-site inspection to ensure that the manufacturing process and the product itself are consistent in terms of quality and safety. Due to the pandemic COVID-19 situation, there was a significant shift in terms of government services, working from an office or home, online meeting platforms, and electronic documents rather than physical ones. The regulatory inspection system was affected by the pandemic. This function is responsible for ensuring pharmaceutical manufacturers' compliance with Good Manufacturing Practices (GMP). Indonesian pharmaceutical industry with a total of around 227, is extending from Sumatra Island to Java Island, as a National Regulatory Authority (NRA) needs to enhance and innovate in terms of inspection method to ensure GMP compliance in both certification and surveillance purposes. This research aims to improve the operational efficiency of GMP inspection during pandemic COVID-19 using the Lean Six Sigma methodology of define, measure, analyze, improve, and control (DMAIC). Budget cuts, shifting from on-site to only document assessment due to travel restrictions, and the limitation of assessment on paper-based followed by fishbone analysis affected the target of GMP inspection. To overcome this problem, remote GMP inspection was introduced as an improvement with a newly added value process, and the improvement was controlled by an internal audit, an annual meeting on evaluation of GMP inspection, and a management review meeting. On the other hand, Badan POM should address internet connectivity, document security during transfer, and the guidance on remote inspection. This method should be associated with a risk-based inspection plan.