Humedics Selected for MFDS Support Project to Advance Pharmaceutical Quality
[Asia Economy Reporter Lee Chun-hee] Humedix is accelerating quality management through the establishment of a Quality by Design (QbD) system based on pharmaceutical design.
On the 26th, Humedix announced that it has been selected as a target company for the "Customized QbD Technology Consulting Support" program, conducted as part of the "Establishment of a Foundation for Introducing the Pharmaceutical QbD System" project supported by the Ministry of Food and Drug Safety and operated by the Korea Innovative Medicines Consortium (KIMCo).
The QbD approach integrates and unifies manufacturing processes and quality control, managing manufacturing and quality based on scientific and statistical verification through risk assessment. Advanced pharmaceutical countries such as the United States and Europe already operate QbD systems, and other countries are expanding the adoption of QbD systems. As the number of countries worldwide requiring QbD data increases, the Ministry of Food and Drug Safety has been continuously conducting consulting support projects for pharmaceutical and bio companies since 2020 to introduce the QbD system domestically.
Through this consulting support from the Ministry of Food and Drug Safety, Humedix will receive about three months of QbD technical support for 'HMC2-092,' which is currently under development. By receiving expert advice, the company plans to establish a QbD system and apply it from the early stages of product development. Additionally, QbD will be applied to future improved new drug products to enhance the efficiency of the pharmaceutical development process, reduce the time and cost required for commercialization, and improve product quality, thereby increasing international competitiveness.
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A Humedix representative said, "Based on being selected for this consulting support from the Ministry of Food and Drug Safety, we expect to improve the quality of products in the development stage through internalization of the QbD system and accelerate future exports," adding, "We will continue to do our best to improve quality continuously and enhance global competitiveness."
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