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KMID : 1142220070020010035
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Regulatory Research on Food, Drug & Cosmetic
2007 Volume.2 No. 1 p.35 ~ p.40
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An Understanding of the Guideline for Common Technical Document-III. Quality
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Hong Chong-Hui
Kim Dong-Sup
Kim Eun-Jung
Kim Mi-Jeong
Park In-Sook
Jung Joo-Yeon
Song Yun-Kyoung
Park Hyo-Min
Park Eun-Hye
Chae Gyu-Han
Lee Sun-Hee
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Abstract
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With the recent flow, the quality control of medicinal products demand more than just meeting the requirements on the specification of the finished products. Therefore, the “Guideline for Common Technical Document-III. Quality” was in need in order to improve the quality of the medicinal products. This guideline for registration of pharmaceuticals includes the manufacturing environment and process such as manufacturing process control (3.2.S.2, 3.2.P.3) and container closure system (3.2.S.6, 3.2.P.7) for the drug substance and drug products. In conclusion, this guideline would provide a way to manufacture good quality products with competitiveness in the Korean pharmaceutical companies which mostly depend on manufacturing generic drugs.
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KEYWORD
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ICH CTD quality, quality control, common technical document, manufacturing process
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