Hanmi Pharmaceutical is set to integrate artificial intelligence (AI) into its quality assurance (QA) processes, fully automating quality documentation tasks.
On September 7, Hanmi Pharmaceutical announced that it has been selected as a recipient of the 'AX (AI Transformation) One-Stop Voucher Support Project' for the pharmaceutical and bio sectors, led by the Ministry of Science and ICT. The company will begin implementing AI solutions and conducting validation work.
The official name of the project is 'Hanmi Q-Agent.' In line with the government's initiative, it will be conducted as a consortium composed solely of domestic infrastructure.
Hanmi Pharmaceutical will oversee the project, which includes linking internal standard operating procedures (SOPs), quality documents, IT governance, information security, and core systems (MES, LIMS, QMS). Samsung SDS will handle the establishment of the AX infrastructure, while Megazone Cloud will be responsible for implementing and tuning the AI solutions. SelectStar will play a role in building datasets and conducting third-party verification through AI reliability assessments.
Through the 'Hanmi Q-Agent' project, Hanmi Pharmaceutical aims to elevate its QA processes to a global standard smart lab. The project commenced in July and will span two years, concluding in December of next year. The total budget for the first year is approximately 1.7 billion won, with around 1 billion won provided by the government.
Hanmi Pharmaceutical plans to enhance its QA capabilities over the two-year project, using its Pyeongtaek bio plant as a base. In the first year, AI will learn from approximately 4,000 SOPs at the Pyeongtaek facility to provide evidence-based accurate responses. In the second year, a system will be established to automatically draft reports for the Annual Product Quality Review (APQR) based on the learned data.
The focus will be on developing a 'Hanmi-specific language model' through fine-tuning based on Upstage's 'Solar' model, rather than using a general-purpose AI. This fine-tuned model will be utilized exclusively for enhancing quality assurance and quality control for innovative drug development at Hanmi Pharmaceutical.
Additionally, Hanmi Pharmaceutical aims to transition from manual quality documentation tasks to an AI collaborative process, reducing workload and allowing employees to focus on high-value tasks such as drug development and global business.
The initiative will also expand beyond the Pyeongtaek facility to other sites, including the R&D center, extending its reach to quality control (QC) and research and development (R&D) across the organization.
Hanmi Pharmaceutical CEO Hwang Sang-yeon stated, "Through the Hanmi Q-Agent project, we will not only support the quality assurance of Epe, which is set to launch in the second half of the year, but also spread a successful AI innovation model throughout the group, enhancing the global export competitiveness of K-pharmaceuticals."
Meanwhile, Hanmi Pharmaceutical is working on developing the country's first digital convergence medicine, combining the obesity drug Epe with a digital platform. Digital convergence medicine integrates pharmaceuticals with digital medical devices or health support devices, adding patient management functions through digital technology to the biological therapeutic effects of the drug.
Hanmi Pharmaceutical envisions a system where patients prescribed Epe can record their weight, meals, exercise, and medication information in a dedicated application, allowing AI to analyze the data and provide personalized health management services.
* This article has been translated by AI.
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