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KMID : 1142220210160010019
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.19 ~ p.25
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On the Operation of OECD GLP Guideline No. 17 (Application of GLP Principles to Computerised Systems)
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Shin Jae-Ho
Kim Geon-A
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Abstract
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Most of the GLP facilities are introducing various types of computer systems centering on the toxicity test data collection system. In general, considering the ongoing computerization of various tasks and measurements, this trend is expected to continue to increase in the future. As the number of test facilities adopting large-scale computer systems worldwide increases, the OECD GLP Guideline No. 17 was published by the OECD in 2016 as the Guideline No. 10’s update. Foreign government agencies and testing institutions used No. 17 as a guideline for test facilities to introduce, operate, and abolish computer systems, and thought as the basis for pointing out and providing guidance in GLP investigations. In this report, we described the parts that researchers who are interested in each GLP facility and computerization should understand, even if they are not operators, along with related items of the guideline. At present, there is a possibility that the interpretation may change in the future depending on the situation change and various GLP documents issued by the OECD in the future, but it is thought that it can be referred to when introducing and verifying the computerized system in the future.
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KEYWORD
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GLP, OECD guideline, Computerised system
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