Establishing GMP for specialized Korea pharma company using MES

Dong-A ST is a specialized pharmaceutical company that develops ethical drugs (ETC) and supports the oldest pharmaceutical company, Dong-A Group, in Korea. Dong-A ST is now able to verify its global standard manufacturing environment and quality by introducing Manufacturing Execution Systems (MES). In addition, by applying a Warehouse Management System (WMS), Supervisory Control and Data Acquisition system (SCADA), and PTC solution, it became possible to automate the manufacturing record system, manage product quality, and realize data integrity business intelligence.

Seeking Opportunities Beyond Domestic Market

Due to a lack of original technologies developed locally in Korea, there were many cases paying royalties for new drugs or widely sold products and brought Korean domestic copyrights from abroad. As for the overseas pharmaceutical companies, they had to manufacture their medicines in a production environment based on international good manufacturing practices (GMP) standards. Korean pharmaceutical companies do not fully comply with global manufacturing environment regulations since their focus are mainly on the Korean domestic market and meeting Korea good manufacturing practice (KGMP) set by the country’s Ministry of Food and Drug Safety.

However, Korean companies that focused on the domestic market have experienced limitations in the domestic market due to several circumstances including a steadily declining population. As such, they seek to enter overseas markets to overcome these limits and grow. One way to enable this is to build a production environment and system that complies with global standards.

Global pharmaceutical companies supply pharmaceutical products to countries around the world based on mass production of small items. However, unlike global pharmaceutical companies, Korean pharmaceutical companies are engaged in multi-product productions and produce various products at their manufacturing facilities. This multi-product production method requires a robust and efficient management system to meet quality standards in the manufacturing environment, and there is a requirement to strengthen data integrity for multi-product quality management. To achieve data integrity, MES can help from an IT system perspective to better manage quality requirements. This led Dong-A to start a large-scale project across three years from 2020 to 2022 at its Cheonan plant.
 

Boosting Data Integrity with MES, WMS and SCADA

Dong-A is the oldest pharmaceutical company in Korea, and Dong-A ST, a subsidiary that produces specialty pharmaceuticals, sought FactoryTalk PharmaSuite, FactoryTalk ProductionCentre and Enterprise Integration Hub (EIhub) to strengthen data integrity considering its expansion into the global market. Pharmaceutical companies must keep manufacturing records as certificates that contain information on all drugs manufactured in production facilities, but the existing manual paper-based method is prone to human errors . Dong-A ST integrated MES (FactoryTalk PharmaSuite, FactoryTalk® ProductionCentre and EIhub) and WMS (FactoryTalk Warehouse) to build automatic data capture functions and integrated label applications, through which it is making improvements to increase operational efficiency. The digitization of manufacturing records also makes it easier to review compliance.

When a product-related problem occurs after product shipment, MES automatically traces back the recorded data to take appropriate follow-up actions, facilitate the COPA (Computer Operator and Programming Assistant) process, and provide reference materials when corrective action is required. By introducing MES into its production environment, Dong-A ST was able to further strengthen its data integrity.

In addition, the combination of IT (Information Technology) and OT (Operational technology) by using ThingWorx was applied to make quality control and product maintenance easier by allowing operators to see data in real-time as they work. Advanced analytics and optimization solutions that integrate disparate devices, applications, and data sources increased productivity and improved overall operational efficiency. By connecting smart tools and facilities, workers can more securely access data in real time and monitor it remotely in a timely manner.

With FactoryTalk Analytics DataView, decision makers can intuitively see factory metrics and conditions, realize business intelligence to make data-driven decisions, and accurately measure KPIs.
 

Fewer Human Errors, Better Outcomes

With Rockwell Automation’s MES, WMS, SCADA, and PTC solutions, they enabled Dong-A ST to validate the manufacturing environment and quality, and data sorting and analysis. This helped decision-makers make more immediate business decisions. Through system automation, regulatory reporting and compliance became much easier with fewer human errors. Above all, the successful establishment of GMP global regulations in the company’s production environment and system enabled Dong-A ST to carve out a competitive advantage in the fierce global pharmaceutical market.

Building on experiences and technology obtained from this project, Rockwell Automation Korea is committed to actively supporting foreign market entry by providing global competitive solutions to manufacturers in various industries as well as the pharmaceutical industry.