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KMID : 1142220160110010065
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.65 ~ p.72
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Stability Testing of National Reference Standards for Vaccines
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Bae Min-Seok
Choi Chan-Woong
Kim Jae-Ok
Kim Byung-Kuk
Kang Hyun-Kyung
Park Sang-Jin
Kim So-Young
Ban Sang-Ja
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Abstract
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National biological reference standards established by the National Institute of Food and Drug Safety Evaluation are used in national lot release and quality control testing of biologics. Stability is a critical factor to ensure the quality of reference standards and should be monitored at all stages from production to storage. The aim of this study is to perform stability testing for 9 national reference standards for vaccines to ensure the reliability of standards. The in-vivo/in-vitro potency testing and statistical analysis were conducted to monitor changes in the stability of each national reference standard. The results of statistical analysis have shown that stability was well maintained for most of the products, except for certain products that require continuous monitoring due to the short testing period. The results of this study will be used in establishing policies for the management of national reference standards and therefore, expected to contribute to the supply of high quality biologics.
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KEYWORD
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National Reference Standard, Stability Testing, Biologics, Vaccine
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