{"id":48859,"date":"2026-11-02T12:37:01","date_gmt":"2026-11-02T11:37:01","guid":{"rendered":"https:\/\/kymos.com\/news\/%ec%9d%b4%eb%ac%bc-%ec%9e%85%ec%9e%90-%eb%b6%84%ec%84%9d-%ec%98%88%ec%83%81%ec%b9%98-%eb%aa%bb%ed%95%9c-%ec%9a%94%ec%86%8c-%ec%8b%9d%eb%b3%84\/"},"modified":"2026-11-02T12:37:01","modified_gmt":"2026-11-02T11:37:01","slug":"%ec%9d%b4%eb%ac%bc-%ec%9e%85%ec%9e%90-%eb%b6%84%ec%84%9d-%ec%98%88%ec%83%81%ec%b9%98-%eb%aa%bb%ed%95%9c-%ec%9a%94%ec%86%8c-%ec%8b%9d%eb%b3%84","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%ec%9d%b4%eb%ac%bc-%ec%9e%85%ec%9e%90-%eb%b6%84%ec%84%9d-%ec%98%88%ec%83%81%ec%b9%98-%eb%aa%bb%ed%95%9c-%ec%9a%94%ec%86%8c-%ec%8b%9d%eb%b3%84\/","title":{"rendered":"\uc774\ubb3c \uc785\uc790 \ubd84\uc11d: \uc608\uc0c1\uce58 \ubabb\ud55c \uc694\uc18c \uc2dd\ubcc4"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\uc758\uc57d\ud488\uc5d0\uc11c \uc608\uc0c1\uce58 \ubabb\ud55c \uc785\uc790\uac00 \ubc1c\uacac\ub418\uba74 \uc81c\ud488 \ud488\uc9c8\uc774 \uc800\ud558\ub418\uace0 \ud658\uc790 \uc548\uc804\uc774 \uc704\ud611\ubc1b\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc758\uc57d\ud488\uc5d0\uc11c \uc608\uc0c1\uce58 \ubabb\ud55c \uc774\ubb3c \uc785\uc790\ub97c \uc2dd\ubcc4\ud558\ub294 \uac83\uc740 \ucca0\uc800\ud55c \ud488\uc9c8 \uc77c\ud0c8(Deviation) \uc870\uc0ac\uc640 \ud6a8\uacfc\uc801\uc778 \uadfc\ubcf8 \uc6d0\uc778 \ubd84\uc11d(Root-cause analysis)\uc744 \uc218\ud589\ud558\ub294 \ub370 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \uc678\uad00\ub9cc\uc73c\ub85c \ud310\ub2e8\ud558\ub294 \uac83\uc740 \ucda9\ubd84\ud558\uc9c0 \uc54a\uc73c\uba70, \uc624\uc5fc\uc6d0\uc744 \ud2b9\uc815\ud558\uace0 \uc81c\ud488 \ud488\uc9c8\uc744 \ubcf4\ud638\ud558\uba70 \uaddc\uc81c \uc694\uac74\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574\uc11c\ub294 \uc815\ud655\ud55c \ud654\ud559\uc801\u00b7\ubb3c\ub9ac\uc801 \ud2b9\uc131\ud654\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \ucd5c\uadfc FDA \ub9ac\ucf5c\uacfc \uacbd\uace0 \uc11c\ud55c\uc740 \uc140\ub8f0\ub85c\uc624\uc2a4, \uc720\ub9ac\uc12c\uc720, \uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15, \uace0\ubb34 \uc6a9\uae30-\ub9c8\uac1c(container-closure) \ud30c\ud3b8 \ub4f1 \ub2e4\uc591\ud55c \uc785\uc790\uc131 \ubb3c\uc9c8\uc744 \uc5b8\uae09\ud558\uba70 \uc774\ub7ec\ud55c \ud544\uc694\uc131\uc744 \uac15\uc870\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc774\ubb3c \uc785\uc790 \uc870\uc0ac\ub97c \ud1b5\ud574 \ubb34\uc5c7\uc744 \uc54c \uc218 \uc788\uc744\uae4c\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc774\ubb3c \uc785\uc790\ub294 \uc870\uc131\uacfc \uae30\uc6d0\uc774 \ub2e4\uc591\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc6d0\ub8cc, \uc81c\uc870 \uc7a5\ube44, \ud3ec\uc7a5 \uad6c\uc131\ud488, \uc0dd\uc0b0 \ud658\uacbd \ub610\ub294 \uae30\ud0c0 \ucd9c\ucc98\uc640 \uc5f0\uad00\ub420 \uc218 \uc788\uc73c\uba70, \uacbd\uc6b0\uc5d0 \ub530\ub77c\uc11c\ub294 \uc81c\ud488 \uc790\uccb4\uc5d0\uc11c \uc720\ub798\ud558\uac70\ub098 \uc81c\ud615 \uc131\ubd84\uacfc \ud3ec\uc7a5 \uc7ac\ub8cc \uac04 \uc0c1\ud638\uc791\uc6a9\uc744 \ud1b5\ud574 \ud615\uc131\ub418\uae30\ub3c4 \ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc678\uad00\ub9cc\uc73c\ub85c\ub294 \ud655\uc815\uc801\uc778 \ub2f5\uc744 \uc5bb\uae30 \uc5b4\ub824\uc6b4 \uacbd\uc6b0\uac00 \ub300\ubd80\ubd84\uc785\ub2c8\ub2e4. \uc12c\uc720\ucc98\ub7fc \ubcf4\uc774\uac70\ub098 \uae08\uc18d \ud30c\ud3b8, \uc791\uc740 \uc720\ub9ac \uc870\uac01\ucc98\ub7fc \ubcf4\uc774\ub294 \uc785\uc790\ub77c\ub3c4, \uc2e0\ub8b0\ud560 \uc218 \uc788\uac8c \uc815\uccb4\ub97c \ud655\ub9bd\ud558\ub824\uba74 \uba3c\uc800 \ud2b9\uc131\ud654\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. 2025\ub144\uacfc 2026\ub144\uc5d0 FDA\ub294 \uc0dd\uc0b0 \uacfc\uc815\uc5d0\uc11c \uc774\ubb3c \uc870\uc0ac \ubbf8\uc644\ub8cc\uc640 \uad00\ub828\ub41c \uacbd\uace0 \uc11c\ud55c\uacfc 483 \uad00\ucc30(Observation) \uc591\uc2dd\uc744 \uc810\uc810 \ub354 \ub9ce\uc774 \ubc1c\ud589\ud574 \uc654\uc73c\uba70, \uc774\ub294 \uc774 \uc8fc\uc81c\uac00 \uaddc\uc81c \ub2f9\uad6d\uc5d0\ub3c4 \uc911\uc694\ud574\uc84c\uc74c\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \uc870\uc131\uc744 \uc774\ud574\ud558\uba74 \ud300\uc774 \uc7a0\uc7ac\uc801 \uc624\uc5fc\uc6d0\uc744 \ud3c9\uac00\ud558\uace0 \uc77c\ud0c8\uc744 \uc870\uc0ac\ud558\uba70 \ucd94\uac00\ub85c \uc5b4\ub5a4 \uadfc\uac70\uac00 \ud544\uc694\ud55c\uc9c0 \ud310\ub2e8\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uad6c\ubd84\uc774 \uc911\uc694\ud55c \uc774\uc720\ub294, \ubb3c\uc9c8\uc758 \uc815\uccb4\uac00 \uc7a0\uc7ac\uc801 \ucd9c\ucc98\ub97c \uc881\ud788\uace0 \ud6c4\uc18d \uc870\uc0ac\uc758 \ubc29\ud5a5\uc744 \uc81c\uc2dc\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub418\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\uc81c\ud488 vs. \ud658\uacbd:<\/strong> \uc785\uc790\uac00 \uc6d0\ub8cc, \uc7a5\ube44 \ub9c8\ubaa8, \ud3ec\uc7a5 \uc694\uc18c, \ud658\uacbd \ub178\ucd9c \ub610\ub294 \uc81c\ud615-\ud3ec\uc7a5 \uc0c1\ud638\uc791\uc6a9 \uc911 \uc5b4\ub514\uc5d0\uc11c \uae30\uc6d0\ud588\ub294\uc9c0 \uad6c\ubd84\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ud45c\uc801\ud654\ub41c \uc870\uc0ac:<\/strong> \ud3f4\ub9ac\uba38\ub97c \ud655\uc778\ud588\uc744 \ub54c\uc758 \uc870\uc0ac \uacbd\ub85c\ub294 \uae08\uc18d \ud30c\ud3b8\uc774\ub098 \ubb34\uae30 \uc624\uc5fc\ubb3c\uc744 \ubc1c\uacac\ud588\uc744 \ub54c\uc640 \ub2e4\ub974\uac8c \uc804\uac1c\ub429\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc608\ub97c \ub4e4\uc5b4, \ud3f4\ub9ac\uba38\uc131 \uc785\uc790\ub97c \uc2dd\ubcc4\ud588\uc744 \ub54c\uc758 \uc870\uc0ac \ubc29\ud5a5\uc740 \uae08\uc18d \ud30c\ud3b8\uc774\ub098 \ubb34\uae30 \uc785\uc790\ub97c \ubc1c\uacac\ud588\uc744 \ub54c\uc640 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4\uc774 \uc5b4\ub824\uc6b4 \uc774\uc720\ub294 \ubb34\uc5c7\uc778\uac00\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\ubd84\uc11d\uc774 \ud56d\uc0c1 \ub2e8\uc21c\ud558\uac8c \uc9c4\ud589\ub418\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4. \uc785\uc790\ub294 \ub9e4\uc6b0 \uc791\uc744 \uc218 \uc788\uace0, \uc874\uc7ac\ub7c9\uc774 \uc81c\ud55c\uc801\uc774\uac70\ub098 \uc8fc\ubcc0 \uc81c\ud488 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0\uc11c \ubd84\ub9ac\ud558\uae30 \uc5b4\ub824\uc6b8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uc870\uc131\uc774 \ubcf5\uc7a1\ud560 \uc218 \uc788\uc73c\uba70, \uc11c\ub85c \ub2e4\ub978 \uc7ac\ub8cc\uac00 \uc720\uc0ac\ud55c \uc2dc\uac01\uc801 \ud2b9\uc131\uc744 \ubcf4\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub2e8\uc77c \ubd84\uc11d \uae30\ubc95\ub9cc\uc73c\ub85c \ubaa8\ub4e0 \uc9c8\ubb38\uc5d0 \ub2f5\ud560 \uc218 \uc788\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \ud604\ubbf8\uacbd\uc740 \uc785\uc790\uc758 \ud615\ud0dc\ud559\uc801 \uc815\ubcf4(morphology)\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc9c0\ub9cc, \uc721\uc548\/\uc2dc\uac01\uc801 \uac80\uc0ac\ub9cc\uc73c\ub85c\ub294 \ud654\ud559\uc801 \uc870\uc131\uc744 \ud655\uc815\ud558\uae30 \uc5b4\ub824\uc6b8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ubd84\uad11\ud559 \uae30\ubc95\uc740 \ubd84\uc790 \uc218\uc900\uc758 \uc815\ubcf4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uace0, \uc6d0\uc18c \ubd84\uc11d\uc740 \ubb34\uae30 \ubb3c\uc9c8\uc758 \ud2b9\uc131\ud654\uc5d0 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubd84\uc11d \uc811\uadfc\ubc95\uc758 \uc120\ud0dd\uc740 \uc785\uc790 \uc790\uccb4\uc640 \uc870\uc0ac \uc911\uc778 \uc9c8\ubb38\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4. \ub2e8\uc77c \uad00\ucc30\uc774\ub098 \uce21\uc815\uc5d0 \uc758\uc874\ud558\uae30\ubcf4\ub2e4 \uc0c1\ud638\ubcf4\uc644\uc801 \uae30\ubc95\uc744 \uacb0\ud569\ud558\uba74 \ub354 \uc644\uc804\ud55c \ud2b9\uc131\ud654\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc2dc\ub8cc \ucde8\uae09\ub3c4 \uc911\uc694\ud569\ub2c8\ub2e4. \uc0ac\uc6a9 \uac00\ub2a5\ud55c \ubb3c\uc9c8\uc774 \uc18c\ub7c9\uc77c \ub54c\ub294, \ud6c4\uc18d \uc870\uc0ac\uc5d0 \ud544\uc694\ud55c \uc815\ubcf4\ub97c \ubcf4\uc874\ud558\uba74\uc11c\ub3c4 \uc2dc\ub8cc\ub97c \ud6a8\uacfc\uc801\uc73c\ub85c \ud65c\uc6a9\ud560 \uc218 \uc788\ub3c4\ub85d \ubd84\uc11d \uc804\ub7b5\uc744 \uc218\ub9bd\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc5b4\ub5a4 \ubd84\uc11d \uae30\ubc95\uc73c\ub85c \uc774\ubb3c \uc785\uc790\ub97c \uc2dd\ubcc4\ud560 \uc218 \uc788\ub098\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\ud604\ubbf8\uacbd, \ubd84\uad11\ud559, \uc6d0\uc18c \ubd84\uc11d\uc744 \uc870\ud569\ud558\uba74 \uc758\uc57d\ud488 \ub0b4 \uc774\ubb3c \uc785\uc790\ub97c \ud2b9\uc131\ud654\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4. \uac01 \uae30\ubc95\uc740 \uc11c\ub85c \ub2e4\ub978 \uc815\ubcf4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h3><span style=\"font-size: 14pt;\"><strong>\uad11\ud559 \ubc0f \ud3b8\uad11 \ud604\ubbf8\uacbd<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\ud604\ubbf8\uacbd\uc740 \uc885\uc885 \uc911\uc694\ud55c \ucd9c\ubc1c\uc810\uc785\ub2c8\ub2e4. \ubd84\uc11d\uac00\ub294 \uc774\ub97c \ud1b5\ud574 \uc785\uc790\uc758 \ud06c\uae30, \ud615\ud0dc, \uc0c9\uc0c1 \ubc0f \uae30\ud0c0 \ud615\ud0dc\ud559\uc801 \ud2b9\uc131\uc744 \uad00\ucc30\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud3b8\uad11 \ud604\ubbf8\uacbd(PLM)\uc740 \uad11\ud559\uc801 \ud2b9\uc131\uc5d0 \ub300\ud55c \ucd94\uac00 \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\uc5ec \uc7ac\ub8cc \ud2b9\uc131\ud654\ub97c \ub3d5\uace0 \ub2e4\uc74c \ubd84\uc11d \ub2e8\uacc4\uc758 \ubc29\ud5a5\uc744 \uc81c\uc2dc\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h3><span style=\"font-size: 14pt;\"><strong>\ub77c\ub9cc \ud604\ubbf8\uacbd<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\ub77c\ub9cc \ubd84\uad11\ubc95\uc740 \ud2b9\uc720\uc758 \uc9c4\ub3d9 \uc2e0\ud638\ub97c \uae30\ubc18\uc73c\ub85c \ubb3c\uc9c8\uc744 \uc2dd\ubcc4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub418\ub294 \ubd84\uc790 \uc9c0\ubb38(molecular fingerprint) \uc815\ubcf4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub97c \ud604\ubbf8\uacbd\uc801\uc73c\ub85c \uc801\uc6a9\ud558\uba74 \uac1c\ubcc4 \uc785\uc790 \ubd84\uc11d\uc5d0 \uc720\uc6a9\ud558\uba70, \ubb3c\uc9c8\uc758 \ud2b9\uc131\uacfc \uce21\uc815 \uc870\uac74\uc5d0 \ub530\ub77c \ub9ce\uc740 \uc720\uae30\ubb3c \ubc0f \uc77c\ubd80 \ubb34\uae30\ubb3c\uc744 \uc2dd\ubcc4\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uc758\uc2ec\ub418\ub294 \uae30\uc900\/\ucd9c\ucc98 \ubb3c\uc9c8(reference\/source material)\ub3c4 \ub77c\ub9cc\uc73c\ub85c \ubd84\uc11d\ud574 \uc870\uc0ac\uc5d0 \ub9de\ucd98 \ub9de\ucda4\ud615 \ub808\ud37c\ub7f0\uc2a4 \ub370\uc774\ud130\ubca0\uc774\uc2a4\ub97c \uad6c\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h3><span style=\"font-size: 14pt;\"><strong>\uc5d0\ub108\uc9c0 \ubd84\uc0b0\ud615 X\uc120 \ubd84\uad11\ubc95(SEM-EDX)\uc744 \uacb0\ud569\ud55c \uc8fc\uc0ac\uc804\uc790\ud604\ubbf8\uacbd<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">SEM\uc740 \uc785\uc790 \ud45c\uba74\uacfc \ud615\ud0dc\uc5d0 \ub300\ud55c \uace0\ud574\uc0c1\ub3c4 \uc774\ubbf8\uc9c0\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0 \uc5d0\ub108\uc9c0 \ubd84\uc0b0\ud615 X\uc120 \ubd84\uad11\ubc95\uc744 \uacb0\ud569\ud558\uba74 \uc6d0\uc18c \uc870\uc131\uc5d0 \ub300\ud55c \uc815\ubcf4\ub3c4 \uc5bb\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ubb34\uae30 \uc785\uc790\ub97c \ud2b9\uc131\ud654\ud558\uace0 \uae08\uc18d, \uc720\ub9ac, \uad11\ubb3c\uc131 \uc624\uc5fc\ubb3c\uacfc \uac19\uc740 \ubb3c\uc9c8\uc744 \uc870\uc0ac\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \ubc29\ubc95\ub4e4\uc740 \ub300\uccb4 \uad00\uacc4\uac00 \uc544\ub2c8\ub77c \uc0c1\ud638\ubcf4\uc644\uc801\uc785\ub2c8\ub2e4. \ud604\ubbf8\uacbd \uc774\ubbf8\uc9c0, \ubd84\uc790 \uc2a4\ud399\ud2b8\ub7fc, \uc6d0\uc18c \ud504\ub85c\ud30c\uc77c\uc740 \uac01\uac01 \uc11c\ub85c \ub2e4\ub978 \uadfc\uac70\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub97c \uc885\ud569\uc801\uc73c\ub85c \ud574\uc11d\ud558\uba74 \uc785\uc790\uac00 \ubb34\uc5c7\uc778\uc9c0, \uadf8\ub9ac\uace0 \uadf8 \ud2b9\uc131\uc774 \uc758\uc2ec\ub418\ub294 \ubb3c\uc9c8 \ub610\ub294 \ucd9c\ucc98\uc640 \uc77c\uce58\ud558\ub294\uc9c0 \ud310\ub2e8\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc785\uc790 \uc2dd\ubcc4\uc740 \uadfc\ubcf8 \uc6d0\uc778 \uc870\uc0ac\uc5d0 \uc5b4\ub5bb\uac8c \ub3c4\uc6c0\uc774 \ub418\ub098\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc785\uc790\ub97c \uc2dd\ubcc4\ud558\ub294 \uac83\uc740 \uc911\uc694\ud55c \ub2e8\uacc4\uc774\uc9c0\ub9cc, \uadf8\uac83\ub9cc\uc73c\ub85c \uc785\uc790\uac00 \uc5b8\uc81c \ub610\ub294 \uc5b4\ub5bb\uac8c \uc81c\ud488\uc5d0 \uc720\uc785\ub418\uc5c8\ub294\uc9c0\ub97c \uc790\ub3d9\uc73c\ub85c \ud655\uc815\ud560 \uc218\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. \uadf8 \uacb0\ub860\uc744 \uc704\ud574\uc11c\ub294 \uc81c\uc870 \uacf5\uc815, \uc7a5\ube44, \uc6d0\ub8cc \ubc0f \ud3ec\uc7a5 \uad6c\uc131\ud488\uc5d0 \ub300\ud55c \uc815\ubcf4\ub97c \ud3ec\ud568\ud55c \ucd94\uac00 \uadfc\uac70\uac00 \ud544\uc694\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uadf8\ub7fc\uc5d0\ub3c4 \ubd84\uc11d\uc801 \ud2b9\uc131\ud654\ub294 \uc870\uc0ac\ub97c \ubcf4\ub2e4 \uc9d1\uc911\uc801\uc73c\ub85c \uc9c4\ud589\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc608\ub97c \ub4e4\uc5b4, \uc77c\uc0c1\uc801\uc778 \ud488\uc9c8 \uad00\ub9ac \uc911 \uc608\uc0c1\uce58 \ubabb\ud55c \uc785\uc790\uac00 \ubc1c\uacac\ub418\uba74 \uadf8 \uc870\uc131\uc740 \uc5b4\ub5a4 \uc7a0\uc7ac\uc801 \ucd9c\ucc98\ub97c \uc6b0\uc120\uc801\uc73c\ub85c \ucd94\uac00 \uac80\ud1a0\ud574\uc57c \ud558\ub294\uc9c0 \ud310\ub2e8\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc77c\ud0c8 \ub610\ub294 \uaddc\uaca9 \uc77c\ud0c8(Out-of-Specification, OOS) \uacb0\uacfc\ub85c \uc870\uc0ac\uac00 \ud544\uc694\ud560 \ub54c\ub3c4, \uc785\uc790 \uc2dd\ubcc4\uc740 \ud3c9\uac00\ub97c \ub4b7\ubc1b\uce68\ud558\ub294 \ucd94\uac00 \uadfc\uac70\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uacf5\uae09\uc5c5\uccb4 \ubcc0\uacbd \uc774\ud6c4 \uc608\uc0c1\uce58 \ubabb\ud55c \uacb0\uacfc\uac00 \ubc1c\uacac\ub420 \ub54c\ub3c4 \ucd94\uac00 \uc870\uc0ac\uac00 \ucd09\ubc1c\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc81c\uc57d\uc0ac\uac00 API, \ubd80\ud615\uc81c \ub610\ub294 \uae30\ud0c0 \uc6d0\ub8cc \uacf5\uae09\uc5c5\uccb4\ub97c \ubcc0\uacbd\ud558\uba74 \ubb3c\uc131 \ucc28\uc774\ub85c \uc778\ud574 \ucd94\uac00 \ud2b9\uc131\ud654\uac00 \ud544\uc694\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc124\uba85\ub418\uc9c0 \uc54a\ub294 \uc785\uc790\uac00 \uac80\ucd9c\ub418\uba74, \uadf8 \uc870\uc131\uacfc \uac00\ub2a5\ud55c \uae30\uc6d0\uc744 \uc870\uc0ac\ud558\uc5ec \uc2e0\uaddc \uc6d0\ub8cc, \uadf8 \ucde8\uae09 \ubc29\uc2dd \ub610\ub294 \uc81c\uc870 \uacf5\uc815\uc758 \ub2e4\ub978 \ubd80\ubd84\uacfc \uad00\ub828\uc774 \uc788\ub294\uc9c0 \ud310\ub2e8\ud574\uc57c \ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc785\uc790\uc758 \ud2b9\uc131\uc744 \uc7a0\uc7ac\uc801 \ucd9c\ucc98 \ubb3c\uc9c8\uc758 \ud2b9\uc131\uacfc \ube44\uad50\ud558\uba74, \uacf5\uae09\uc5c5\uccb4 \ubcc0\uacbd\uc774 \ud574\ub2f9 \uc774\uc288\uc640 \uad00\ub828\uc774 \uc788\ub294\uc9c0 \ud3c9\uac00\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub9c8\ucc2c\uac00\uc9c0\ub85c \ud3ec\uc7a5 \ub610\ub294 \uc81c\uc870 \uc7a5\ube44\uac00 \uc758\uc2ec\ub418\ub294 \uacbd\uc6b0\uc5d0\ub3c4, \uc785\uc790\uc758 \ud2b9\uc131\uc744 \ud6c4\ubcf4 \ubb3c\uc9c8\uacfc \ube44\uad50\ud558\uba74 \uac00\ub2a5\ud55c \uc124\uba85\uc744 \ud3c9\uac00\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uc815\ubcf4\ub294 \uadfc\ubcf8 \uc6d0\uc778 \uc870\uc0ac, \uc77c\ud0c8 \ud3c9\uac00 \ubc0f \uc801\uc808\ud55c \uc2dc\uc815 \ubc0f \uc608\ubc29 \uc870\uce58(CAPA) \uc815\uc758\ub97c \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud575\uc2ec \uac00\uce58\ub294 \uc678\uad00\uc5d0 \uae30\ubc18\ud55c \ucd94\uc815\uc744, \ub2e4\ub978 \uc870\uc0ac \uacb0\uacfc\uc640 \ud568\uaed8 \ud3c9\uac00\ud560 \uc218 \uc788\ub294 \ubd84\uc11d\uc801 \uadfc\uac70\ub85c \ub300\uccb4\ud558\ub294 \ub370 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub530\ub77c\uc11c \ucd08\uae30 \uad00\ucc30\uc774 \uc81c\ud55c\uc801\uc774\uac70\ub098 \ub2e8\ubc1c\uc131\uc73c\ub85c \ubcf4\uc774\ub354\ub77c\ub3c4 \uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4\uc740 \uad00\ub828\uc131\uc774 \uc788\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc804\ubb38 \ubd84\uc11d\uc758 \ud544\uc694\uc131\uc740 \ub300\uac1c \uc785\uc790\uac00 \uac80\ucd9c\ub41c \ub4a4\uc5d0\ub3c4 \uc815\uccb4\uac00 \ubd88\ud655\uc2e4\ud558\uac8c \ub0a8\uc544 \uc788\uc744 \ub54c \ube44\ub85c\uc18c \ubd84\uba85\ud574\uc9d1\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc81c\uc57d\uc0ac\ub294 \uc5b8\uc81c \uc804\ubb38 \uc785\uc790 \ubd84\uc11d\uc744 \uace0\ub824\ud574\uc57c \ud558\ub098\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\ub2e4\uc74c\uacfc \uac19\uc740 \uacbd\uc6b0\uc5d0\ub294 \uc804\ubb38 \uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4\uc774 \ud56d\uc0c1 \uc694\uad6c\ub418\uba70 \ud544\uc694\ud569\ub2c8\ub2e4:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uc758\uc57d\ud488\uc5d0\uc11c \uc608\uc0c1\uce58 \ubabb\ud55c \uac00\uc2dc \ub610\ub294 \ube44\uac00\uc2dc(subvisible) \uc785\uc790\uac00 \uac80\ucd9c\ub41c \uacbd\uc6b0.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ucd08\uae30 \uac80\uc0ac\ub85c \uc785\uc790\uc758 \uc815\uccb4\uac00 \ud655\ub9bd\ub418\uc9c0 \uc54a\ub294 \uacbd\uc6b0.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc77c\ud0c8, OOS \uacb0\uacfc \ub610\ub294 \uc624\uc5fc \uc758\uc2ec \uc0ac\uac74\uc5d0 \ub300\ud574 \ucd94\uac00 \uc870\uc0ac\uac00 \ud544\uc694\ud55c \uacbd\uc6b0.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uacf5\uae09\uc5c5\uccb4 \ubcc0\uacbd \uc774\ud6c4, \ud2b9\ud788 \uc785\uc790\uac00 \uac80\ucd9c\ub41c \uc0c1\ud669\uc5d0\uc11c \uc870\uc0ac\uac00 \ud544\uc694\ud55c \uc608\uc0c1\uce58 \ubabb\ud55c \uacb0\uacfc\uac00 \ub4a4\ub530\ub974\ub294 \uacbd\uc6b0.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc6d0\ub8cc, \uc7a5\ube44, \ud3ec\uc7a5 \ub610\ub294 \uc0dd\uc0b0 \ud658\uacbd\uacfc \uad00\ub828\ub41c \uc7a0\uc7ac\uc801 \ucd9c\ucc98\ub97c \ud3c9\uac00\ud574\uc57c \ud558\ub294 \uacbd\uc6b0.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ud488\uc9c8 \uc870\uc0ac\ub97c \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 \ucd94\uac00\uc801\uc778 \ud654\ud559\uc801 \ub610\ub294 \uc6d0\uc18c \ud2b9\uc131\ud654\uac00 \ud544\uc694\ud55c \uacbd\uc6b0.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc0c1\ud669\uc740 \ub2e4\uc591\ud55c \uc758\uc57d\ud488\uacfc \uc18c\uc7ac \uc804\ubc18\uc5d0\uc11c \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc785\uc790\uac00 \ubd84\ub9ac\ud558\uae30 \uc5b4\ub835\uac70\ub098 \uc870\uc131\uc774 \ubd88\uba85\ud655\ud558\uac70\ub098 \uc0ac\uc6a9 \uac00\ub2a5\ud55c \uc2dc\ub8cc\uac00 \uc81c\ud55c\uc801\uc77c \ub54c, \uc804\ubb38 \ubd84\uc11d \uae30\ubc95\uacfc \uc219\ub828\ub41c \uacfc\ud559\uc790\uc5d0 \ub300\ud55c \uc811\uadfc\uc131\uc740 \ud2b9\ud788 \ud070 \uac00\uce58\ub97c \uac00\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Kymos Denmark\uc758 \uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Kymos Group\uc758 \ub374\ub9c8\ud06c \uc0ac\uc774\ud2b8\uc5d0\uc11c\ub294, \ub2e4\uc591\ud55c \uc81c\uc57d \uc2dc\ub8cc\uc640 \uc18c\uc7ac\ub97c \ub300\uc0c1\uc73c\ub85c \uc785\uc790 \ubd84\uc11d\uc744 \uc218\ud589\ud574 \uc628 20\ub144 \uc774\uc0c1\uc758 \uacbd\ud5d8\uc744 \ubc14\ud0d5\uc73c\ub85c \ud300\uc774 \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ub2f9\uc0ac\uc758 GMP \uc900\uc218 \uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4 \uc11c\ube44\uc2a4\ub294 \u201c\ud615\ud0dc\ud559\uc801, \ud654\ud559\uc801, \uc6d0\uc18c\u201d \ud2b9\uc131\ud654 \uc6cc\ud06c\ud50c\ub85c\ub97c \ud3ec\uad04\uc801\uc73c\ub85c \uc81c\uacf5\ud558\uc5ec \ucd94\uce21\uc744 \ubc30\uc81c\ud569\ub2c8\ub2e4. \ubbf8\ub7c9 \uc624\uc5fc\uc6d0\uc744 \ubd84\ub9ac\u00b7\ubd84\uc11d\ud574 \uc81c\ud488 \ud488\uc9c8\uc744 \ubcf4\ud638\ud558\uace0 OOS \uc870\uc0ac \ubc29\uc5b4\ub97c \uc9c0\uc6d0\ud558\uba70 \ud658\uc790 \uc548\uc804\uc744 \ud655\ubcf4\ud569\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubaa8\ub4e0 \uc2dc\ub8cc\ub294 \uace0\uc720\ud55c \uacfc\uc81c\ub97c \uc81c\uc2dc\ud569\ub2c8\ub2e4. \ub2f9\uc0ac\uc758 \uae30\uc220 \uc804\ubb38\uac00\ub294 \ud68d\uc77c\uc801\uc778 \uc811\uadfc\uc744 \uc0ac\uc6a9\ud558\uc9c0 \uc54a\uc73c\uba70, \ub300\uc2e0 \uace0\uac1d\uc758 \ud2b9\uc815 \uc2dc\ub8cc \ub9e4\ud2b8\ub9ad\uc2a4\uc640 \uc870\uc0ac \ubaa9\ud45c\uc5d0 \ub530\ub77c \uac00\uc7a5 \uc801\ud569\ud55c \uc9c1\uad50(orthogonal) \uc2dc\ud5d8 \uc2dc\ud000\uc2a4\ub97c \uc2e0\uc911\ud558\uac8c \uc120\ud0dd\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uae4a\uc774 \uc788\ub294 \uaddc\uc81c \ubc0f \ubd84\uc11d \uc804\ubb38\uc131\uc740 \uc81c\ud488 \ub77c\uc774\ud504\uc0ac\uc774\ud074 \uc804\ubc18\uc5d0\uc11c \uc81c\uc57d\uc0ac\ub97c \ub2e4\uc74c\uacfc \uac19\uc774 \uc9c0\uc6d0\ud569\ub2c8\ub2e4:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\uc608\uc0c1\uce58 \ubabb\ud55c \uc785\uc790 \uc870\uc0ac:<\/strong> \uc0dd\uc0b0 \ud604\uc7a5 \ub610\ub294 \ud3ec\uc7a5 \uacfc\uc815\uc5d0\uc11c \ubc1c\uacac\ub41c \ub3cc\ubc1c \uc624\uc5fc \uc0ac\uac74\uc774\ub098 \uc774\uc0c1 \uc785\uc790\ub97c \uc2e0\uc18d\ud558\uac8c \ubd84\uc11d\ud569\ub2c8\ub2e4.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc624\uc5fc\uc6d0 \ub9e4\ud551 &#038; \uadfc\ubcf8 \uc6d0\uc778 \ubd84\uc11d:<\/strong> \uc678\uad00\uc5d0 \uae30\ubc18\ud55c \uac00\uc815\uc744 \uacbd\ud5d8\uc801 \ub370\uc774\ud130\ub85c \ub300\uccb4\ud558\uc5ec \uc624\uc5fc\uc6d0\uc744 \uae30\uacc4\uc801 \ub9c8\ubaa8, \uc6d0\ub8cc \ub610\ub294 \ud658\uacbd\uc801 \ucd9c\ucc98\ub85c \ucd94\uc801\ud558\uace0, \ud300\uc774 \uaddc\uaca9 \uc77c\ud0c8(OOS) \uc77c\ud0c8\uc744 \uc885\uacb0\ud558\uba70 \ud6a8\uacfc\uc801\uc778 CAPA \uacc4\ud68d\uc744 \uc218\ub9bd\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><strong>\uc804\ubb38 \uc785\uc790 \ubd84\uc11d \uc9c0\uc6d0\uc774 \ud544\uc694\ud558\uc2e0\uac00\uc694?<\/strong><\/h3>\n<p><span style=\"font-size: 14pt;\">\uc9c0\uc18d\uc801\uc778 \ubd84\uc11d \uc9c0\uc6d0\uc774 \ud544\uc694\ud558\ub4e0, \uc608\uc0c1\uce58 \ubabb\ud55c \uc785\uc790\uc758 \ud2b9\uc131\ud654\uac00 \ud544\uc694\ud558\ub4e0, \ub2f9\uc0ac \ud300\uc774 \uc694\uad6c\uc0ac\ud56d\uc744 \ub17c\uc758\ud558\uace0 \uc801\uc808\ud55c \ubd84\uc11d \uc811\uadfc\ubc95\uc744 \uc81c\uc548\ud574 \ub4dc\ub9b4 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><a href=\"https:\/\/kymos.com\/ko\/%ec%84%9c%eb%b9%84%ec%8a%a4\/%ea%b3%a0%ec%b2%b4-%ec%83%81%ed%83%9c-%eb%b6%84%ec%84%9d\/%ec%9d%b4%eb%ac%bc-%ec%9e%85%ec%9e%90-%ec%8b%9d%eb%b3%84\/\" data-wpel-link=\"internal\"><strong>Kymos Group\uc758 \uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4 \uc11c\ube44\uc2a4 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uae30<\/strong><\/a><strong>.<\/strong><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc758\uc57d\ud488\uc5d0\uc11c \uc608\uc0c1\uce58 \ubabb\ud55c \uc785\uc790\uac00 \ubc1c\uacac\ub418\uba74 \uc81c\ud488 \ud488\uc9c8\uc774 \uc800\ud558\ub418\uace0 \ud658\uc790 \uc548\uc804\uc774  [&#8230;]<\/p>\n","protected":false},"author":8,"featured_media":48836,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[261],"tags":[],"class_list":["post-48859","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-261"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\uc774\ubb3c \uc785\uc790 \ubd84\uc11d: \uc608\uc0c1\uce58 \ubabb\ud55c \uc694\uc18c \uc2dd\ubcc4 | Kymos<\/title>\n<meta name=\"description\" content=\"\uc774\ubb3c \uc785\uc790 \uc2dd\ubcc4\uc774 \ucca8\ub2e8 \ubd84\uc11d \uae30\ubc95\uc744 \ud1b5\ud574 \uc758\uc57d\ud488\uc5d0\uc11c \uc608\uc0c1\uce58 \ubabb\ud55c \uc785\uc790\ub97c \ud2b9\uc131\ud654\ud558\uace0 \ud488\uc9c8 \uc870\uc0ac(Investigation)\ub97c \uc9c0\uc6d0\ud558\ub294 \ubc29\ubc95\uc744 \uc54c\uc544\ubcf4\uc138\uc694.\" 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