Impact Stories

Building pharmaceutical regulations into the system

Weighing, production, sorting, and packaging, all on a GMP-compliant electronic record system

• The pharmaceutical industry has complex process standards and strict regulations, making manufacturing and production management highly demanding
• Quality control areas requiring specialized knowledge are hard to automate, making large-scale investment difficult
• Weighing and dispensing management were recorded by hand, causing human error and review burden
• The MES introduced in 2011 had to be upgraded without interrupting operations

• Fast process preparation: MBR (Master Batch Record)-based potency calculation, automatic allocation of raw materials and supplies, and electronic approval of production order instructions
• Work quality and data integrity: automatic transmission of input results through ERP integration, barcode-based prevention of material mis-loading with automatic entry of input details, and controls that block progression to the next step if quantities do not match the standard
• Management visibility and audit readiness: real-time monitoring of production results by line and automatic generation of process work result summary reports, shortening the lead time for shipment approval
• Embedding global regulations: manufacturing records and review and approval system based on GAMP guidelines, compliant with FDA 21 CFR Part 11 and GMP
• Zero-downtime transition: switched to the new MES sequentially over approx. 20 days without stopping production (a first in the pharmaceutical industry)

• Approx. 50% improvement in dispensing efficiency by digitizing manual tasks such as weighing and dispensing
• Converted production data to an electronic record and signature system, achieving over 90% company-wide paperless operations
• Switched to the new MES in approx. 20 days without stopping production
• Systemized all processes from raw material management to packaging, enabling global-level production and quality management through compliance with international regulations