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KMID : 1142220200150010009
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Regulatory Research on Food, Drug & Cosmetic
2020 Volume.15 No. 1 p.9 ~ p.18
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A Study on Establishment of Good Laboratory Practice Guidebook
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Hwang Jin-Ah
Kim Dong-Hwan
Shin Chun-Chul
Lee Eun-Ji
Choi Nam-Song
Gam Jong-Sik
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Abstract
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Ministry of Food and Drug Safety (MFDS) has revised notification of KGLP (MFDS 2017-32, 2017.5.1) to harmonize international regulations on non-clinical testing of medical devices and to ensure the reliability of the study procedures and results of non-clinical study. Therefore, the need to establish GLP guidebook has increased so that the GLP personnels can easily understand the revised GLP regulations and settle the system early. The GLP guidebook consists of general rules with the purpose of enactment and the definition of terms, evaluation of agency designation requirements/application for designation, management of non-clinical study, performance of the study/storage and retention of records and materials, multi-site study as shown in the table of contents of KGLP(MFDS 2017-32, 2017.5.1). Contents regarding master schedule, multi-site study, reference item and test item, computerised system were added after the latest domestic and international GLP regulations for medical devices, Q&A, GLP handbook, and advisory documents of the working group on GLP were comprehensively reviewed. In addition, the Q&A section was supplemented in the GLP guidebook to help the GLP personnel to understand the amendment.
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KEYWORD
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GLP Guidebook, Nonclinical study, Drugs, Quasi-Drugs, Cosmeceutical, Medical Device
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