QUALITY RISK MANAGEMENT IN THE PRODUCTION PROCESS OF CHEWABLE VITAMIN C TABLETS AT PT.BNJ

• Main Author: Purnaya, Panditya
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/84957
• Institution: Institut Teknologi Bandung

A Pharmaceutical Industry that commercializes its products in Indonesia is required to implement the latest Good Manufacturing Practices (GMP. One aspect of Indonsian GMP 2024 is Quality Risk Management. To assess quality risks, one method that can be used is FMEA (Failure Mode and Effect Analysis). Through the FMEA method, it is expected that the purpose of this study is able to provide an overview of the elements studied at each stage of the production process, identify risks in each process and assess risks, also provide information on preventive and corrective actions against risks so that they can be used as guidelines for company management. The study began with a focused group discussion to discuss the documents needed to make a risk assessment in the vitamin C tablet production process, make FMEA, determine mitigation actions and make an action priority matrix and a system for monitoring the effectiveness of mitigation actions. Based on the results of the study of the vitamin C chewable tablet production process, a total of 300 failure modes were produced, consisting of 237 low risks, 57 medium risks, and 6 high risks. Based on the quality risk assessment, 10 types of mitigation actions were obtained which will be carried out consisting of 1 quick wins, 3 major projects, and 6 actions as fill ins. The quality risk assessment using the FMEA method has been designed in accordance with the stages of vitamin C lozenges production. Risks during the entire production process can be identified early to obtain a reliable production process so the recurring deviations and complaints are able to be prevented.