Korea Innovative Pharmaceuticals Consortium Drives Pharmaceutical Bio Quality Innovation with Smart Factories and QbD

Selection of Service Providers for Projects Supported by the Ministry of SMEs and Startups and the Ministry of Food and Drug Safety

[Asia Economy Reporter Kim Ji-hee] The Korea Innovative Medicines Consortium (KIMCo) announced on the 18th that it was recently selected as the operating agency for the Ministry of SMEs and Startups' "Pharmaceutical Specialized Smart Factory Construction Support Project" and as the service provider for the Ministry of Food and Drug Safety's "Pharmaceutical Quality by Design (QbD) System Implementation Foundation Project." Through this, KIMCo will be able to support 1.995 billion KRW for smart factory construction support in the domestic pharmaceutical bio industry and 273 million KRW for the introduction of QbD in production sites.

QbD is a pharmaceutical development method integrated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to ensure excellent drug development and quality management by combining manufacturing processes and quality control. It is characterized by analyzing and focusing on managing risk factors that may occur from raw materials to manufacturing and distribution processes of pharmaceuticals. By adopting QbD, the traditional method of releasing products if they meet standard manufacturing processes and test methods, or discarding them if they do not, is replaced by optimizing processes using statistical techniques. This can lead to ▲establishment of scientific manufacturing strategies ▲reduction of defect rates and improvement of product productivity ▲increased success rates of marketing authorization through submission of QbD-based research data when entering overseas markets.

A smart factory installs sensors on equipment and machines to collect and analyze data in real time, allowing clear understanding and control according to the analyzed objectives. It applies information and communication technologies (ICT) such as the Internet of Things (IoT), big data, cloud computing, and robotics, enhancing productivity and enabling customized production.

KIMCo plans to go beyond simple financial support by identifying the status and requirements of different types of companies and acting as a service provider connecting companies and government support. It will reduce cost burdens by providing differential construction costs according to the smart factory construction target level and support QbD adoption through on-site consulting tailored to demand and expert training programs.

Heo Kyung-hwa, CEO of KIMCo, stated, "Through this project, we will support the construction of smart factories applying QbD to pharmaceutical manufacturing facilities and enhance pharmaceutical quality competitiveness to narrow the technological gap with advanced countries." She added, "Innovation in pharmaceutical productivity and quality will lead to the stable supply of high-quality medicines, contributing to securing public health rights and advancing Korea as a strong pharmaceutical bio nation."