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KMID : 1142220230180020135
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 2 p.135 ~ p.142
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A Study on the Practical Issues of Herbal Good Manufacturing Practice (hGMP) and then Solutions for Further Advancement Directions
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Kim Su-Eon
Park Jae-Hwi
Ji Han-Se
Jeong Chang-Min
Ryu Jong-Hoon
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Abstract
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With the advances of modern living standards and the continuous extension of life expectancy, the increasing interest in health has led to an increase in the consumption of herbal medicines, which can be expected to have a simultaneous effect on the treatment and prevention of diseases. Therefore, the safety issues of herbal medicines have been raised. This study examined the herbal Good Manufacturing Practice (hGMP) and other domestic regulations and management systems for safe herbal medicine production, and we analyzed the reasons for noncompliance of herbal medicine safety issues that occurred before and after the implementation and mandate of hGMP. Despite the mandatory application of hGMP to herbal medicine manufacturing facilities and the continuous improvement of various management systems for herbal medicine, problems with foreign substances and purity still occurred at a high rate. We confirmed that the occurrence of such problems was due to the lack of a management system for cultivation and collection outside the scope of hGMP, and suggested that herbal medicines be managed at a level comparable to that of drug substance. This study is expected to contribute to the improvement of public health by suggesting directions for the development of hGMP to improve the production of high-quality herbal medicines.
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KEYWORD
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herbal Good Manufacturing Practice, Good Manufacturing Practice, Good Agricultural Practice, Safety of herbal medicine, Quality control
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