Upaya Peningkatan Efisiensi dan Akurasi Pengecekan Dokumen Batch pada Produksi Obat Liquid di PT Kalbe Farma Tbk

Abstract

This study discusses efforts to improve efficiency and accuracy in the batch document review process within the liquid drug production division at PT Kalbe Farma Tbk. Batch documentation plays a crucial role in quality management systems and compliance with Good Manufacturing Practice (GMP). However, manual execution often leads to delays and recording errors. This research employs a Lean Six Sigma approach combined with the implementation of a digital Electronic Batch Record (EBR) system as a process improvement solution. Through literature review and direct observation, the findings indicate that digitalization and Lean Six Sigma application can improve work efficiency by up to 30% and significantly reduce human error. Therefore, this study demonstrates that the integration of these two approaches is effective in enhancing the accuracy and efficiency of documentation processes in the pharmaceutical industry.