Hanmi Pharmaceutical is bringing artificial intelligence into its quality assurance operations to automate the search, analysis and drafting of a vast body of quality documents.
The company said on the 7th that it had been selected as a pharmaceutical and biotech recipient under the AX One-Stop Voucher Program run by the Ministry of Science and ICT, and has begun deploying and testing AI solutions.
The project, named Hanmi Q-Agent, involves Samsung SDS, Megazone Cloud and Selectstar. Hanmi Pharmaceutical is overseeing the integration of standard operating procedures, quality documents and core systems including MES, LIMS and QMS. Samsung SDS is building the AX infrastructure, Megazone Cloud is implementing and tuning the AI solution, and Selectstar handles dataset construction and AI reliability verification.
The project runs over two years through December next year, centered on the company's Pyeongtaek bio plant. First-year spending totals about 1.7 billion won, including roughly 1 billion won in government funding.
This year, the company will train AI on some 4,000 standard operating procedures at the Pyeongtaek site for use in document searches and analysis of gaps against regulations. In the second year, it plans to build a system that automatically drafts sections of annual product quality reviews based on that foundation.
Rather than using a general-purpose AI, the company is building its own language model by tuning Upstage's Solar model for its operations. It plans to apply the system to quality assurance work for Efe, an obesity treatment tailored to Korean patients that is set for launch in the second half of the year.
The model validated at Pyeongtaek will later expand to the Paltan site and the R&D center, with applications broadening beyond quality assurance to quality control, R&D and clinical work, and regulatory affairs and pharmacovigilance. It will also extend to affiliates including Hanmi Science, Hanmi Fine Chemical and Beijing Hanmi Pharmaceutical.
"Quality assurance, which handles an enormous volume of documents, has been constrained by manual work and after-the-fact responses," Hanmi Pharmaceutical CEO Hwang Sang-yeon said. "Through Hanmi Q-Agent, we will support quality assurance for Efe and spread this AI innovation model across the group."
