November 1, 2019 – SEOUL, South Korea – The International Vaccine Institute (IVI), an international organization for vaccine development and delivery headquartered in Seoul, has been granted Good Clinical Laboratory Practice (GCLP) certification by the Korean Ministry of Food and Drug Safety (KMFDS).
This designation denotes that a given institution is certified to conduct bioanalytical tests on samples such as blood, feces and urine collected from human subjects participating in clinical research trials. Obtaining GCLP certification requires that an institution meets strict requirements regarding laboratory systems and controls, including: organization and personnel qualifications, facilities, quality management equipment and reagent management, established standard operating procedures, systems for analyzing and archiving clinical trial samples, and systems supporting controls and the reporting of data. Additionally, KMFDS requires that all laboratories within Korea which perform bioanalytical analysis of human clinical research samples must hold GCLP certification. The GCLP certification is described in and required by the Korean Pharmaceutical Affairs Act (in effect since October 2018).
IVI submitted an application to the KMFDS to acquire GCLP certification in May 2019, and the ministry visited IVI in July 2019 to conduct a formal inspection of the institute to assess qualification for GCLP laboratory designation. The on-site inspection covered verification of and compliance to Korean GCLP standards.
IVI has made significant investment in Quality Management over the past 2 years, securing related facilities and systems, and training personnel – all in the effort to further raise the quality of GCLP-related activities. The certification granted by KMFDS confirmed that the IVI GCLP laboratory is aligned with globally recognized GCLP standards, as well as the KMFDS regulatory requirements in South Korea.
“By acquiring GCLP certification from KMFDS, IVI has secured the necessary basis of safety and reliability for the process of bioanalytical analysis of human samples in support of vaccine clinical trials,” said Dr. Jerome Kim, Director General of IVI. “With IVI’s continuously expanding cooperation with domestic and overseas institutions in vaccine clinical trials, we will now be able to play a more significant role and increase our contribution to vaccine development activities in Korea and around the world.”
Tae Kyung Byun, Head of Government & PR, IVI
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