AI

MegazoneCloud Launches Hanmi Pharmaceutical Quality Assurance AI Agent Project

TECHWORLD ·

At the “2026 AX One-Stop Voucher Support Project Hanmi Pharmaceutical Consortium Launch Ceremony” held on August 28, the attendees pose for a commemorative photo. From right to left in the front row: MegazoneCloud Vice President Seo Min-taek, SelectStar CEO Kim Se-yeob, Samsung SDS Managing Director Park Chang-hong, Hanmi Growth Support Division Vice President Sim Byeong-hwa, Hanmi Pyeongtaek Manufacturing Center Director Jeon Dong-seon, and Upstage Division Head Byun Jae-kyung. [Photo: MegazoneCloud]

✦ AI Summary

MegazoneCloud announced that it has begun building an AI agent for Hanmi Pharmaceutical to support quality document search and regulatory review.

The target is Hanmi Q-Agent, a QA workflow automation AI agent based on AIR Studio, with Hanmi Pharmaceutical overseeing the project and MegazoneCloud handling AI solution implementation and fine-tuning.

Hanmi Q-Agent will support search and analysis of more than 4,000 quality documents and comparison with the latest regulations, and will use RAG technology to identify discrepancies and help correct documents.

MegazoneCloud announced on the 7th that it has begun building an AI agent for Hanmi Pharmaceutical to support quality document search and regulatory review. The underlying technology is AIR Studio, an enterprise AI operating system (OS), and the target is the quality assurance (QA) workflow automation AI agent Hanmi Q-Agent.

The project is part of the Ministry of Science and ICT and the National IT Industry Promotion Agency (NIPA)'s AX One-stop Voucher Support Project. Hanmi Pharmaceutical is overseeing the overall project, while MegazoneCloud is responsible for AI solution implementation and fine-tuning. Samsung SDS is handling the AX infrastructure, and SelectStar is responsible for data processing and third-party verification, respectively.

Hanmi Q-Agent will support search and analysis of more than 4,000 quality documents accumulated by Hanmi Pharmaceutical, as well as comparisons with the latest regulations. It will also apply retrieval-augmented generation (RAG) technology to identify newly added or changed regulations and discrepancies in documents, and help correct the documents.

Through this, MegazoneCloud aims to reduce related work time by more than 40%.

Pharmaceutical quality documents are used to prove compliance and consistent manufacturing of medicines, and they typically include tables, figures, and formulas, with a mix of Korean and English. For that reason, workers previously had to review documents manually, and comparing the latest regulations with internal guidelines also took a great deal of time.

To reflect these work characteristics, MegazoneCloud will fine-tune Upstage's domestic AI model Solar for Hanmi Pharmaceutical's GMP field. It also plans to deploy the fine-tuned Solar in an AIR Studio-based agent to improve the accuracy and expertise of pharmaceutical quality assurance work.

Once the system is completed, it will be possible to continuously compare regulatory changes with quality documents and identify potentially problematic items in advance. Whereas the existing approach was to supplement regulatory compliance after inspections, the goal of this build is to establish a preventive quality management system.

MegazoneCloud, Hanmi Pharmaceutical, Samsung SDS, and SelectStar held the launch ceremony for the Hanmi Pharmaceutical consortium for the 2026 AX One-stop Voucher Support Project on the 28th of last month, and the Hanmi Pharmaceutical consortium began project execution after the ceremony.

MegazoneCloud Vice President Seomin Taek said that the pharmaceutical quality field is a difficult area for AI application because it has strict requirements for accuracy and traceability, to the extent that even one word can determine a regulatory judgment. He added that through this project, the company intends to accelerate the spread of domain AI in regulated industries.

Source: TECHWORLD · Kim Seung-gi
Original: https://www.epnc.co.kr/news/articleView.html?idxno=406618

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Source: TECHWORLD

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