SAGITHA DEVINA WIJAYA
Prof. Ir. Suparno MSIE.
PT. XYZ is one of the pharmaceutical companies located in East Java region. PT. XYZ produces various pharmaceutical dosage forms, one of which is AN tablet. In its implementation, PT. XYZ implements a quality management system as a fulfillment of current Good Manufacturing Practice called Cara Pembuatan Obat yang Baik (CPOB). One function of quality management is evaluating products to guarantee three aspects, namely quality, efficacy and safety.
Pharmaceutical companies record product-testing deviation in reports called Out-of-Spesification Form. From the results of studies conducted, it was found that AN tablets had the highest percentage of 28.95%. This study aims to find the cause of the test results outside the specifications of AN tablets and make recommendations for corrective actions. This research is applied research. This study used the six sigma method (Define, Measure, Analyze, Improve & Control) followed by analysis using Failure Mode and Effect Analysis to determine the priority of corrective actions through the Focus Group Discussion method to collect data.
Based on the analysis, the results of the study showed that the causes of the deviation of tablet AN hardness came from aspect material, man, machine and method. From the analysis carried out, the corrective action recommended to management is recalculating the number of coating agent material ratios used in the AN tablet coating process, making an information system as communication tool which is involving each batch of products, updating the spray gun space in coating process, the method of putting the coating agent into coating pan and the length of the coating process.
Keywords: Pharmaceutical company, Tablet, DMAIC, FMEA.
Sumber : http://mm.feb.unair.ac.id/id/kemahasiswaan/artikel/artikel-ilmiah/913-penerapan-failure-mode-and-effect-analysis-fmea-dalam-rangka-perbaikan-proses-produksi-tablet-an-studi-kasus-di-pt-xyz.html