Hanmi Pharmaceutical(128940) will introduce artificial intelligence (AI) to quality control document work at pharmaceutical and bio plants. The goal is for AI to learn about 4,000 types of standard operating procedures (SOPs) at the Pyeongtaek site to find relevant regulations and documents, and starting next year to draft annual product quality review (APQR) reports.
Hanmi Pharmaceutical said on the 7th it was selected as a supported corporations in the pharmaceutical and bio institutional sector of the "AX One-Stop Voucher Support Project," overseen by the Ministry of Science and ICT and the National IT Industry Promotion Agency (NIPA), and has begun building an AI quality control system.
The project is called "Hanmi Q-Agent." Hanmi Pharmaceutical is leading the project, with Samsung SDS, Megazone Cloud, Selectstar, and Upstage participating. It will run for two years, and the first-year budget is about 1.7 billion won. Of that, about 1.0 billion won will come from government support.
Hanmi Pharmaceutical will enable AI to search and analyze in-house SOPs and quality documents, and will link it with existing systems such as the manufacturing execution system (MES), laboratory information management system (LIMS), and quality management system (QMS).
In the first-year project this year, the focus is on having AI learn about 4,000 types of SOPs at the Pyeongtaek site. When employees ask for required quality standards or work procedures, it will answer based on relevant documents and analyze whether there are gaps between actual regulations and current practices.
In the second-year project, a function will be added for AI to draft each section of the annual product quality review (APQR). The aim is to reduce the time people spend searching through massive quality data, comparing them one by one, and documenting them.
Instead of using a general-purpose AI model as-is, the "Solar" model from Upstage will be adjusted for Hanmi Pharmaceutical's quality work. The plan is to build a model specialized for internal quality control and new drug quality assurance.
Hanmi Pharmaceutical plans to first validate the system at the Pyeongtaek site and then expand it to the Paltan site and the research and development center. After that, it will broaden AI coverage to other tasks such as quality control (QC), research and development (R&D), regulatory affairs (RA), and pharmacovigilance (PV), and extend it to group companies including Hanmi Science, Hanmi Fine Chemical, and Beijing Hanmi Pharmaceutical.
Hanmi Pharmaceutical expects the AI rollout to also be used for quality assurance of "eppe," an obesity treatment set for release in the second half. Eppe is an obesity treatment independently developed by Hanmi Pharmaceutical and is set to begin production at the Pyeongtaek site.
Hwang Sang-yeon, CEO of Hanmi Pharmaceutical, said, "QA work that handles quality documents has so far relied on manual processes and after-the-fact responses," and added, "starting with Pyeongtaek, we will spread a successful AI innovation model across the group."