Ildong Pharmaceutical Selected for MFDS 'Pharmaceutical Quality Advancement' Technology Support Project
"Establishment of Advanced Quality Control System for Targeted Anticancer Drug 'Venetafalib'"
[Asia Economy Reporter Kim Ji-hee] Ildong Pharmaceutical announced on the 6th that it has been selected as a target company for the Ministry of Food and Drug Safety's 'Customized Pharmaceutical Quality Advancement System (QbD) Support Consulting' and has begun full-scale technology transfer work.
The Ministry of Food and Drug Safety is implementing a customized innovative technology consulting support project for pharmaceutical companies promoting the introduction of QbD necessary for building smart factories. QbD refers to a manufacturing quality management system designed based on scientific and statistical verification through unified pharmaceutical manufacturing processes and quality control, and risk assessment.
In advanced pharmaceutical countries such as the United States and Europe, the QbD system is already introduced and operated, and other countries are also expanding the adoption of QbD. Ildong Pharmaceutical stated, "We applied for the technology support project under the judgment that proactive measures are necessary to enhance global competitiveness in quality levels," adding, "Going forward, Ildong Pharmaceutical will receive QbD technology support for the manufacturing processes of candidate substances related to ongoing new drug development projects."
In particular, the affiliate IDIANS plans to establish an advanced quality management system that meets global standards for IDX-1197 (Venadafarib), a targeted anticancer drug candidate under development. Venadafarib is currently undergoing clinical trials in Korea and the United States.
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To improve quality management levels, Ildong Pharmaceutical has been operating a task force team (TFT) to establish the QbD process even before applying for the support project. It is expected that a more strengthened internal QbD process can be established through this consulting. The company also plans to expand this to various R&D pipelines.
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An Ildong Pharmaceutical official emphasized, "Through the Ministry of Food and Drug Safety's technology support project, we will be able to enhance the quality management level during the new drug development process, thereby increasing the success potential of global new drug development," and added, "In the future, we plan to expand the application of QbD to various processes to further elevate the quality management level related to new drug R&D."
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