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Regulator grants certification to global vaccine organ

Lee Han-soo  Published 2019.11.01  16:07  Updated 2019.11.01 16:07

공유
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The International Vaccine Institute (IVI), an international organization for vaccine development and delivery headquartered in Seoul, said it has received a Good Clinical Laboratory Practice (GCLP) certification from the Ministry of Food and Drug Safety.

This designation certifies an institution to conduct bioanalytical tests on samples such as blood, feces, and urine collected from human subjects participating in clinical research trials.

To obtain GCLP certification, an institution should meet strict requirements regarding laboratory systems and controls, including organization and personnel qualifications, facilities, quality management equipment, and reagent management, established standard operating procedures, methods for analyzing and archiving clinical trial samples, and systems supporting controls and the reporting of data.

Also, the ministry requires that all laboratories in Korea, which perform bioanalytical analysis of human clinical research samples, must hold GCLP certification.

IVI applied to the ministry in May, and the ministry visited IVI in July, conducting a formal inspection of the institute to assess qualification for GCLP laboratory designation. The on-site inspection covered verification of and compliance with Korean GCLP standards.

IVI has made a significant investment in quality management over the past two years, securing related facilities and systems, and training personnel. The certification granted by the ministry confirmed that the IVI GCLP laboratory is aligned with globally recognized GCLP standards, as well as the regulatory requirements in Korea, according to the institute.

"By acquiring GCLP certification, 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," IVI Director General Jerome Kim said. "IVI is continuously expanding cooperation with domestic and overseas institutions in vaccine clinical trials, and we will be able to play a more significant role in and increase our contribution to vaccine development activities in Korea and the world."

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