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KMID : 0861020230380060061
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Korea Journal of Herbology
2023 Volume.38 No. 6 p.61 ~ p.71
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A Study on the Comparison of Korea Good Manufacturing Practice (KGMP) Evaluation Criteria with Certification Criteria of Extramural Herbal Dispensaries
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Kim Hyeong-Gi
Hwang Eui-Hyoung
Lee Eun-Gyeong
Lim Byung-Mook
Shin Young-Jae
Park Sun-Young
Shin Byung-Cheul
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Abstract
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Objectives : This study aimed to find out the future direction of accreditation system of Extramural herbal dispensaries
(EHD) by comparing the current criteria of EHD and the existing Korea good manufacturing practice (GMP) regulations.
Methods : Among the accreditation criteria of EHD, criteria of general herbal medicine was compared with the
pharmaceutical GMP of Korea. The regulations of the accreditation of EHD and the regulations of KGMP were compared and organized with similar things based on the index of KGMP. All criteria from both were extracted for each element, classified into key-words and evaluated by dividing them into the same, similar one and no-matching.
Results : Among the 189 criteria of KGMP, 77 criteria were consistent with the accreditation of EHD, and 15 criteria were similar. Based on the accreditation of EHD, 70.4% of the criteria were consistent or similar to KGMP. There were a total of 27 key-words only in the GMP criteria and not in the EHD one. Hence, a total of 25 key-words only in the EHD criteria and not in the GMP one. There were 12 similar key-words, and among them, there were 4 keywords in which accreditation of EHD was more specific than the KGMP.
Conclusions : The criteria of general herbal medicine in EHD showed a similar or equivalent level of accreditation criteria compared to that of pharmaceutical GMP in Korea, and it ts believed that it should be considered at the current level to reflect the characteristics of herbal medicine.
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KEYWORD
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Herbal Dispensary, Extramural Herbal Dispensaries, Korea GMP, Good Manufacturing Practices, accreditation
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