\n\u2018\ub610 \uad50\uc721\ud574\uc57c \ud55c\ub2e4\uace0?\u2019 \u2018\ubb34\uc2a8 SOP\uac00 \uc774\ub807\uac8c \uc790\uc8fc \ubc14\ub00c\ub294\uac70\uc57c?\u2019
\nGMP \ud604\uc7a5\uc5d0\uc11c \uc790\uc8fc \ub4e4\ub9ac\ub294 \uc18c\ub9ac\ub2e4. \uc801\uc751\ud560 \ub9cc\ud558\uba74 \ubc14\ub00c\ub294 SOP \ud0d3\uc5d0 \uc5c5\ubb34\uc5d0 \uc9d1\uc911\uc774 \uc5b4\ub835\ub2e4\ub294 \uc774\uc57c\uae30\ub9c8\uc800 \ub4e4\ub824\uc628\ub2e4. \ubb38\uc11c\ub97c \ubc14\uafb8\ub294 \uc785\uc7a5\uc5d0\uc11c\ub3c4 \uc27d\uc9c0 \uc54a\uc740 \uc0c1\ud669\uc774\ub77c\uace0 \ud55c\ub2e4. \uc218\ub9ce\uc740 \uaddc\uc81c\ub97c \ud0c4\ub825\uc801\uc73c\ub85c \ubc18\uc601\ud558\ub824\uace0 \ubb38\uc11c\ub97c \ub9cc\ub4e4\uc5c8\uc9c0\ub9cc, \uaddc\uc815 \ud639\uc740 \uad00\ub828 \uc2dc\uc2a4\ud15c\uc758 \ubcc0\uacbd\uc73c\ub85c \ubb38\uc11c\ub97c \ubcc0\uacbd\ud558\uc9c0 \uc54a\uc744 \uc218 \uc5c6\uace0, \ubb38\uc11c\ubcc0\uacbd\uc774 \ub418\uc5c8\uc73c\ub2c8 \uad50\uc721\uc744 \uc9c4\ud589\ud574\uc57c \ud55c\ub2e4. \uc815\ub9d0 GMP \uad50\uc721\uc740 \uacfc\uc5f0 \ubaa8\ub450\uc5d0\uac8c \uadc0\ucc2e\uace0 \ud798\ub4e4\uae30\ub9cc \ud574\uc57c \ud560\uae4c? \uadf8\ubcf4\ub2e4 \uba3c\uc800 \uc774\ub7f0 \ud798\ub4e0 GMP \uad50\uc721\uc744 \uc65c \ud574\uc57c \ud558\ub294 \uac83\uc77c\uae4c?\n<\/p>\n
\nGMP\ub294 \uc9c0\ub8e8\ud558\ub2e4. \ud0dc\uc0dd\uc774 \uadf8\ub7ec\ud558\ub2e4. \uc0ac\ub78c\uc5d0\uac8c \uae30\uacc4\ucc98\ub7fc \uc815\ud655\ud558\uace0 \ubc18\ubcf5\uc801\uc778 \ud589\ub3d9\uc744 \uc694\uad6c\ud55c\ub2e4. \uba3c\uc9c0 \ud55c \ud1a8 \uc5c6\ub294 \uc791\uc5c5\ubcf5\uc744 \uc785\uace0, \uadfc\ubb34\uc2dc\uac04 \ub0b4\ub0b4 \uc815\ud574\uc9c4 \ub3d9\uc120\uacfc \ubc29\ubc95\ub300\ub85c \ucc9c\ucc9c\ud788 \uc6c0\uc9c1\uc5ec\uc57c \ud55c\ub2e4. \uc544\uc9c1\uae4c\uc9c0 \uae30\uacc4\ub098 \uc790\ub3d9\uc124\ube44\ub85c \uc5c5\ubb34\ub97c \ub300\uccb4\ud558\uae30 \ubcf4\ub2e4\ub294 \uc0ac\ub78c\uc774 \ubcf4\ub2e4 \ud6a8\uc728\uc801\uc774\uae30 \ub54c\ubb38\uc5d0, GMP \ud604\uc7a5\uc5d0 \uc0ac\ub78c\uc774 \ud544\uc694\ud558\ub2e4. \uadf8\ub9ac\uace0 \uc791\uc5c5\uc790\uc758 \uc815\ud655\ud558\uace0 \ubc18\ubcf5\uc801\uc778 \ud589\ub3d9\uc744 \uc704\ud55c \uad50\uc721\uc774 \uc218\ubc18\ub418\uc5b4\uc57c \ud55c\ub2e4. \uadf8\ub807\ub2e4\uba74 \uc5f4\uc2ec\ud788 \uad50\uc721\ud558\uba74 \ub418\ub294 \uac83 \uc544\ub2cc\uac00?<\/p>\n
\ud604\uc2e4\uc744 \ub4e4\uc5ec\ub2e4\ubcf4\uba74 \u2018\uc5f4\uc2ec\ud788 \uad50\uc721\ud55c\ub2e4\u2019\uace0 \ub420 \uc218 \uc788\ub294 \uc0c1\ud669\uc774 \uc544\ub2c8\ub2e4. GMP \uad50\uc721\uc5d0 \ub300\ud55c \uc778\uc801, \ubb3c\uc801 \ud22c\uc790\uac00 \ub9e4\uc6b0 \ubd80\uc871\ud558\uae30 \ub54c\ubb38\uc774\ub2e4. \uc5b4\ub5a0\ud55c \uc0c1\ud669\uc778\uc9c0 \ud55c\ubc88 \ub4e4\uc5ec\ub2e4 \ubcf4\ub3c4\ub85d \ud558\uc790. \uad6d\ub0b4\uc758 \uc81c\uc870\ud604\uc7a5 \ub2f9 \ud559\uc2b5\uc790 \uc218\ub294 \ubcf4\ud1b5 300~500\uc5ec \uba85\uc774\ub2e4. \uadf8\ub7ec\ub098 \uc774\ub97c \uc804\uccb4\uc801\uc73c\ub85c \uad00\ub9ac\ud574 \uc904 \uad50\uc721\uad00\ub9ac \ub2f4\ub2f9\uc790\ub294 1\uba85 \uc815\ub3c4\uc778 \uacbd\uc6b0\uac00 \ub9ce\ub2e4. \ubb3c\ub860 \ubaa8\ub4e0 \uc778\uc6d0\uc758 \uad50\uc721\uae30\ub85d\uc744 \ub2e8\ub3c5\uc73c\ub85c \uad00\ub9ac\ud560 \uc218 \uc5c6\uae30\uc5d0, \uac01 \ubd80\uc11c\ub9c8\ub2e4 \uc9c0\uc815\ub41c \uad50\uc721\uad00\ub9ac\ub2f4\ub2f9\uc790\uac00 \uad50\uc721\uc5c5\ubb34\ub97c \uc9c0\uc6d0\ud55c\ub2e4. \uc77c\ubc18\uc801\uc778 GMP \uad50\uc721\uc758 \uc6b4\uc601\uc774 \uc774\ub7ec\ud55c\ub370, \uad50\uc721\uc744 \uc9c4\ud589\ud558\uba74 \ubaa8\ub450\uac00 \ubd88\ub9cc\uc774 \uac00\ub4dd\ud558\ub2e4.\n<\/p>\n
\n\uc6b0\uc120, \ubd80\uc11c \uad50\uc721\uad00\ub9ac\ub2f4\ub2f9\uc790\uc758 \ub3d9\uae30\uac00 \ubd80\uc871\ud558\ub2e4. \uadf8\ub4e4\uc758 \uc131\uacfc\ub294 \uad50\uc721\uad00\ub9ac\uac00 \uc544\ub2cc \ubcf8\uc5f0\uc758 \uc5c5\ubb34\uc640 \uad00\ub828\ub418\uae30 \ub54c\ubb38\uc774\ub2e4. \ubcf8\uc5f0\uc758 \uc5c5\ubb34\ub9cc\uc73c\ub85c\ub3c4 \ucda9\ubd84\ud788 \ubc14\uc05c \uc0c1\ud669\uc5d0\uc11c, \uc9c0\uc6d0\ud574\uc57c \ud560 \uad50\uc721\uc740 \ub9ce\uace0 \ud559\uc2b5\uc790\ub294 \uc5b4\ub514 \uc788\ub294\uc9c0 \ucc3e\ub294 \uac83\ub3c4 \uc5b4\ub835\uace0, \uc11c\uba85\uacfc \uae30\ub85d\uc740 \ubc1b\uc544\uc57c \ud558\uace0, \uc2dc\uac04\uc774 \uc9c0\ub0a0 \uc218\ub85d \uad50\uc721\uc5c5\ubb34\uc5d0 \ub300\ud55c \ubd80\ub2f4\uc774 \ucee4\uc838\ub9cc \uac04\ub2e4. <\/p>\n
\ud559\uc2b5\uc790\ub294 \ud559\uc2b5\uc790\ub300\ub85c \ubd88\ub9cc\uc774 \ub9ce\ub2e4. \uc55e\uc11c \uc774\uc57c\uae30\ud55c \uc774\uc720\ub85c \uc810\ucc28 \uc7a6\uc544\uc9c0\ub294 \uad50\uc721 \uc77c\uc815\uc5d0, \uad50\uc721\ub9c8\ub2e4 \uc791\uc131\ud558\uace0 \uc11c\uba85\ud560 \uac83\ub4e4\uc774 \ubb34\ucc99 \ub9ce\ub2e4. \ud604\uc7a5\uc0c1\ud669 \ub54c\ubb38\uc5d0 \uc790\ub9ac\ub97c \ube44\uc6b8 \uc218 \uc5c6\uac70\ub098 \ud639\uc740 \uad50\uc721\uc5d0 \uc2dc\uac04\uc744 \ud560\uc560\ud558\uae30 \uc5b4\ub824\uc6b4 \uc2dc\uc810\uc774 \uc788\ub2e4. \ub180\ub78d\uc9c0 \uc54a\uac8c\ub3c4 \uaf2d \uadf8\ub7f0 \uc2dc\uac04\uc5d0 \uad50\uc721\uc744 \ud55c\ub2e4\uace0 \ud55c\ub2e4. \uc5b4\ub835\uac8c \ucc38\uc11d\ud55c \uad50\uc721\uc5d0\uc11c\ub294 \uad50\uc721\ub0b4\uc6a9 \ubcf4\ub2e4\ub294 \uc5b4\ub514\uc5d0 \ubb34\uc5c7\uc744 \uc791\uc131\ud558\uace0 \uc11c\uba85\ud574\uc57c \ud558\ub294\uc9c0\uc5d0\ub9cc \uad00\uc2ec\uc774 \uac04\ub2e4. \uad50\uc721\uc744 \ube68\ub9ac \ub05d\ub0b4\uace0 \ub0b4 \uc77c\uc744 \ud574\uc57c \ud558\uae30 \ub54c\ubb38\uc774\ub2e4. \uc5ec\uae30\uc5d0 \ud559\uc2b5\uc790\ub294 \uad50\uc721\uc744 \ubc1b\uc9c0 \uc54a\ub354\ub77c\ub3c4 \ud2b9\ubcc4\ud55c \ud328\ub110\ud2f0\uac00 \uc5c6\ub2e4. \uadf8\ub798\uc11c GMP \uad50\uc721\uc5d0 \uc801\uadf9\uc131\uc744 \ubcf4\uc774\uba70 \ucc38\uc11d\ud558\uae30 \ubcf4\ub2e4\ub294 \uad00\ub828\ub41c \uc0ac\ud56d\uc744 \ub0b4\uac00 \uc544\ub2cc \ub204\uad70\uac00\uac00 \uc900\ube44\ud574 \uc8fc\uace0, \uc2ec\uc9c0\uc5b4 \uc774\ub04c\uc5b4 \uc904 \ub54c\uae4c\uc9c0 \uae30\ub2e4\ub9b0\ub2e4. <\/p>\n
\ud55c\ud3b8, \uad50\uc721\uad00\ub9ac \ub2f4\ub2f9\uc790\ub294 \ub2f5\ub2f5\ud558\uae30\ub9cc \ud558\ub2e4. \ub9ce\uc740 \ucc38\uace0\uc790\ub8cc\ub97c \uc0b4\ud3b4\ubcf4\uc558\uace0, \uc2ec\uc9c0\uc5b4 \ucee8\uc124\ud305\uae4c\uc9c0 \ubc1b\uc544\uc11c \uad50\uc721 \ud504\ub85c\uadf8\ub7a8\uc744 \uad6c\ucd95\ud588\uace0, \ub9ce\uc740 \uc778\uc6d0\uc774 \uace0\uc0dd\ud558\uace0 \uc788\ub294\ub370\ub3c4, \uc5ec\uae30\uc800\uae30 \ubd88\ub9cc\uc774 \uc18d\ucd9c\ud558\uace0 \uad50\uc721 \ud504\ub85c\uadf8\ub7a8\uc774 \uc6d0\ud65c\ud788 \uc9c4\ud589\ub418\uae30\uae4c\uc9c0\ub294 \uc544\uc9c1 \uba40\uae30\ub9cc \ud558\ub2e4. \ud604\uc7ac\uc758 \uad50\uc721 \uc774\uc218\uc0c1\ud669\uc744 \uc0b4\ud3b4 \ubcf4\uc544\uc57c \ud560 \ub54c\uc5d0\ub3c4 \ud574\ub2f9 \ubd80\uc11c\ub97c \ucc3e\uc544\uac00\uc11c \uad50\uc721\uae30\ub85d\uc744 \ucc3e\uc544\uc11c \ud655\uc778\ud574\uc57c \uc870\uae08\uc740 \uc815\ubcf4\ub97c \uc5bb\uac8c \ub41c\ub2e4. \uac8c\ub2e4\uac00 \uc790\uc728\uc810\uac80\uc774\ub098 \uc2e4\uc0ac \uc9c0\uc801\uc0ac\ud56d\uc73c\ub85c\ub294, \uad50\uc721\uc744 \ubc1b\uc9c0 \uc54a\uc558\ub2e4\ub294 \uc778\uc6d0\uc774 \ubc1c\uc0dd\ud558\uace0, \uc77c\ubd80 \uae30\ub85d\uc740 \ub3c4\uc800\ud788 \ucc3e\uc544\ubcfc \uc218\uac00 \uc5c6\ub2e4. \uadf8\ub807\uac8c \uc5ec\ub7ec\ucc28\ub840 \ud655\uc778\ud588\ub294\ub370\ub3c4 \ub9d0\uc774\ub2e4! \uc815\ub9d0\ub85c \u2018\uc5f4\uc2ec\ud788 \uad50\uc721\ud55c\ub2e4\u2019\uace0 \ud574\uacb0\ub420 \uac83\uc774 \uc544\ub2cc \uc0c1\ud669\uc774\ub2e4.\n<\/p>\n
\n\ub300\ubd80\ubd84\uc758 \uc81c\uc57d\ud68c\uc0ac\ub294 \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc73c\ub85c \ub208\uc744 \ub3cc\ub9ac\uace0 \uc788\ub2e4. \uad6d\ub0b4 \uc2dc\uc7a5\ub9cc \ubc14\ub77c\ubcf4\uae30\uc5d0\ub294 \ud30c\uc774 \ud06c\uae30\uc758 \ud55c\uacc4\ub97c \uc54c\uae30 \ub54c\ubb38\uc774\ub2e4. \uadf8\ub798\uc11c \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc744 \ubaa9\ud45c\ud558\ub294 \uc88b\uc740 \uc0dd\uc0b0 \uc2dc\uc124\uc744 \uad6c\ucd95\ud558\ub294 \uac83\uc5d0 \ub9ce\uc740 \ud22c\uc790\ub97c \ud558\uace0 \uc788\uc9c0\ub9cc, \uadf8\ubcf4\ub2e4 \uc911\uc694\ud55c \uac83\uc740 \uc2dc\uc124\uc744 \uc6b4\uc601\ud558\uace0 \uc81c\ud488\uc744 \uc0dd\uc0b0\ud558\ub294 \u2018\uc0ac\ub78c\u2019\uc5d0 \ub300\ud55c \uad00\ub9ac\uc774\ub2e4. 4M (Man, Machine, Method, Meterial) \uc911\uc5d0 \uac00\uc7a5 \ud1b5\uc81c\ud558\uae30 \ud798\ub4e0 \uac83\uc740 Man \uc774\uba70, \uc774\ub97c \uc798 \uc778\uc9c0\ud558\uace0 \uc788\ub294 \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc5d0\uc11c\ub294 \uc774\ubbf8 \uad50\uc721\uad00\ub9ac\uc5d0 \ub300\ud55c \uc911\uc694\uc131\uc744 \ub9ce\uc774 \uac15\uc870\ud558\uace0 \uc788\ub2e4. \ub610\ud55c \ubbf8\uad6d FDA\uac00 2006\ub144 \ubc1c\ud45c\ud55c \uac00\uc774\ub358\uc2a4 \uc911 \u201c\uc81c\ud488\uc5d0 \ud488\uc9c8\uc774 \ud1b5\ud569\ub418\uc5b4\uc57c \ud558\uba70, \uc2dc\ud5d8\ub9cc\uc73c\ub85c\ub294 \uc81c\ud488 \ud488\uc9c8\uc744 \ubcf4\uc99d\ud560 \uc218 \uc5c6\ub2e4\u201d (Quality should be built into the product, and testing alone cannot be relied on to ensure product quality.)1<\/sup> \ub77c\ub294 \uad6c\uc808\uc740 \uc774\uc81c \uad50\uc721\uae30\ub85d\uc73c\ub85c\ub9cc \uad50\uc721 \uc9c4\ud589 \uc5ec\ubd80\ub97c \uc99d\uba85\ud558\ub294 \uac83\uc740 \ubd80\uc871\ud558\uba70, \uad50\uc721\uad00\ub9ac \uc808\ucc28 \ubc0f \ub17c\ub9ac\ub85c \uc678\ubd80 \uc2e4\uc0ac\uc790\ub4e4\uc5d0\uac8c \uad50\uc721\uad00\ub9ac \uc2dc\uc2a4\ud15c\uc774 \ud488\uc9c8\uc5d0 \ubb38\uc81c\uc5c6\uc74c\uc744 \uc99d\uba85\ud574\uc57c \ud55c\ub2e4\uace0 \ud574\uc11d\ub41c\ub2e4. <\/p>\n \uacb0\uad6d \uad6d\ub0b4 \uc81c\uc57d\uc5c5\uacc4\ub85c\uc11c\ub294 \ud604\uc7ac\uc758 \uad50\uc721 \uad00\ub9ac\ub3c4\ub97c \ub192\uc5ec\uc57c \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc73c\ub85c\uc758 \uc9c4\ucd9c\uc5d0 \uc5b4\ub824\uc6c0\uc774 \uc5c6\uc744 \uac83\uc73c\ub85c \ubcf4\uc5ec\uc9c4\ub2e4. \uadf8\ub807\ub2e4\uba74, \uad50\uc721 \uad00\ub9ac\ub3c4\ub97c \ub192\uc774\uae30 \uc704\ud574\uc11c\ub294 \uc5b4\ub5a4 \uc810\ub4e4\uc744 \uace0\ub824\ud574\uc57c \ud560\uae4c? <\/p>\n \uc6b0\uc120 GMP \uad50\uc721\uc5d0 \ub300\ud55c \uc778\uc2dd\uc758 \ubcc0\ud654\uac00 \ud544\uc694\ud558\ub2e4. \uc55e\uc11c \ub9d0\ud588\ub4ef GMP\uc758 \uad50\uc721\uc740 \uc6b0\ub9ac\uac00 \ud559\uad50\uc5d0\uc11c \ubc30\uc6cc\uc654\ub358 \uad50\uc721\uacfc \uacb0\uc774 \ub2e4\ub974\ub2e4. \uad50\uc721\uc744 \ubc1b\uace0 \ub0b4\uc6a9\uc774 \uc798 \uae30\uc5b5\ub098\uc9c0 \uc54a\uac70\ub098, \uc774\ud574\ub418\uc9c0 \uc54a\uc740 \uac83\uc744 \uadf8\ub300\ub85c \ub450\uace0 \ub2e4\uc74c\uc744 \uae30\uc57d\ud558\ub294 \uac83\uc740 \ud5c8\uc6a9\ub418\uc9c0 \uc54a\ub294\ub2e4. \uc0dd\uc0b0\ud604\uc7a5\uc744 \ub2f4\ub2f9\ud558\ub294 \ub098\uc758 \ubb34\uc9c0 \ub610\ub294 \ubb34\uac10\uac01\uc774 \ucd5c\uc885\uc801\uc73c\ub85c \ud658\uc790\uc5d0\uac8c\ub294 \uc5c4\uccad\ub09c \uc601\ud5a5\uc744 \ub07c\uce60 \uc218 \uc788\uae30 \ub54c\ubb38\uc5d0, GMP \uad50\uc721\uc740 \ud604\uc7a5\uc5d0\uc11c \uc5c5\ubb34\ub97c \ud560 \uc218 \uc788\ub294 \uba74\ud5c8\ub97c \ucde8\ub4dd\ud558\ub294 \uac83\uc73c\ub85c \uc778\uc2dd\ud574\uc57c \ud55c\ub2e4. \ub2e8\uc21c\ud788 \uad50\uc721\uae30\ub85d\uc744 \ub0a8\uae30\ub294 \uacfc\uac70\uc758 \uc778\uc2dd\uacfc\ub294 \ub2ec\ub9ac, \ud604\uc7a5\uc5d0 \ud22c\uc785 \uac00\ub2a5\ud55c \uba74\ud5c8\ucde8\ub4dd \ubc0f \uc9c0\uc18d\uc801 \uac31\uc2e0\uc744 \uc704\ud55c \uac83\uc73c\ub85c GMP \uad50\uc721 \uac1c\ub150\uc744 \ubcc0\ud654\ud574\uc57c \ud55c\ub2e4. <\/p>\n \uad50\uc721\uc5d0 \ub300\ud55c \ud22c\uc790\ub3c4 \ud544\uc694\ud558\ub2e4. \uc624\ub298\ub0a0\uc758 \uad50\uc721\uc778\uc6d0\uc73c\ub85c\ub294 \uad50\uc721\uad00\ub9ac \ubc0f \uc6b4\uc601\uc5d0 \ud55c\uacc4\uac00 \uc788\uc74c\uc774 \uba85\ud655\ud558\uba70, \uad50\uc721\uad00\ub9ac\uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \ud22c\uc790\uac00 \ud544\uc694\ud558\ub2e4. GMP\uad50\uc721\uad00\ub9ac\uc758 \uae30\ubcf8\uc740 \ub2e8\uc21c\ud558\ub2e4. \ud604\uc7a5\uc5d0 \ud22c\uc785\ub418\ub294 \uc778\uc6d0\uc774 \uc5c5\ubb34\ub97c \ud558\uae30 \uc704\ud574 \uc5b4\ub5a4 \ubb38\uc11c\ub97c \uc219\uc9c0\ud574\uc57c \ud558\ub294\uc9c0 \uc815\uc758\ud558\uace0, \uc791\uc5c5 \uc804\uc5d0 \ucd5c\uc2e0 \ubb38\uc11c\ub97c \uc798 \uc774\ud574\ud558\uace0 \uc788\ub2e4\ub294 \uac83\uc744 \uad50\uc721\uae30\ub85d\uc73c\ub85c \uc99d\uba85\ud574\ub0b4\uba74 \ub41c\ub2e4. \ud558\uc9c0\ub9cc \uc774\ub807\uac8c \ub2e8\uc21c\ud558\uac8c \ubcf4\uc774\ub294 \uacfc\uc815\uc774 \uc5b4\ub824\uc6b4 \uc774\uc720\ub294 \uc774\ub7ec\ud55c \uad50\uc721\uad00\ub9ac\uac00 \uc9c0\uc18d\uc801\uc73c\ub85c \uc774\ub8e8\uc5b4\uc838\uc57c \ud558\uae30 \ub54c\ubb38\uc774\uace0, \uc55e\uc11c \uc5b8\uae09\ud55c \ub300\ub85c \ub04a\uc784\uc5c6\uc774 \uad00\ub828 \ubb38\uc11c\uac00 \uac1c\uc815\ub418\uae30 \ub54c\ubb38\uc774\ub2e4. \ub2e8\uc21c \ubc18\ubcf5\uc774 \ub9ce\uc740 \ub0b4\uc6a9\uc774\uba70, \uc774\ub97c \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294 \uad50\uc721\uad00\ub9ac \uc194\ub8e8\uc158\uc744 \uc774\uc6a9\ud558\uc5ec \ubcf4\ub2e4 \uc774\ub97c \ubcf4\ub2e4 \ud6a8\uc728\uc801\uc73c\ub85c \ucc98\ub9ac\ud558\ub294 \uac83\uc774 \ud544\uc694\ud558\ub2e4. <\/p>\n \ub2e4\ub9cc, \uc5ec\uae30\uc11c \uc8fc\uc758\ud560 \uac83\uc740 GMP \uad50\uc721\uad00\ub9ac\uc194\ub8e8\uc158\uc740 \uc77c\ubc18 \uad50\uc721\uad00\ub9ac\uc2dc\uc2a4\ud15c\uacfc\ub294 \ub2e4\ub974\ub2e4\ub294 \uac83\uc774\ub2e4. GMP \uc5d0\uc11c \uc0ac\uc6a9\ud558\ub294 \uc804\uc790\uc2dc\uc2a4\ud15c\uc774\ubbc0\ub85c \ucef4\ud4e8\ud130\ud654\uc2dc\uc2a4\ud15c\ubc38\ub9ac\ub370\uc774\uc158 (CSV)\uc744 \uace0\ub824\ud55c \uc2dc\uc2a4\ud15c\uc774\uc5ec\uc57c \ud558\uba70, \uc804\uc790\uae30\ub85d\uacfc \uc804\uc790\uc11c\uba85 (ERES) \uaddc\uc815 \ubc0f \ub370\uc774\ud130 \uc644\uc804\uc131 (Data Integrity) \ub4f1 \uad6d\ub0b4 \uc678 \uc81c\uc57d\uc5c5\uacc4 \uaddc\uc815\uc900\uc218\ub97c \uace0\ub824\ud558\uc5ec \uc6b4\uc601\uc774 \uac00\ub2a5\ud55c\uc9c0\uc5d0 \ub300\ud574\uc11c\ub3c4 \ud655\uc778\ud574\uc57c \ud55c\ub2e4. \uae30\uc874\uc758 e-learning \ud504\ub85c\uadf8\ub7a8\uc774\ub098 HR \ud504\ub85c\uadf8\ub7a8\uc5d0\uc11c \uad00\ub9ac\ud558\ub294 \uad50\uc721\uad00\ub9ac\uc640 \uac19\uc774 \uc77c\ubc18\uc801\uc778 \uad50\uc721\uad00\ub9ac \uc194\ub8e8\uc158\uacfc\uc758 \ucc28\uc774\uc810\ub3c4 \ubc14\ub85c \uc5ec\uae30\uc5d0\uc11c \ubc1c\uc0dd\ud55c\ub2e4. \ub610\ud55c \uc2dc\uc2a4\ud15c \uad6c\uc131 \uce21\uba74\uc73c\ub85c\ub3c4 GMP \uad50\uc721\uad00\ub9ac \uc2dc\uc2a4\ud15c\uc740 \ubb38\uc11c\uad00\ub9ac\uc2dc\uc2a4\ud15c\uacfc \ubc00\uc811\ud558\uac8c \uad00\ub828\ub418\uc5b4 \uc788\uc5b4\uc57c \ud55c\ub2e4. \uad50\uc721\uc744 \ubc1b\ub294 \ub0b4\uc6a9\uc740 1\ud68c\uc131 \uc790\ub8cc\uac00 \uc544\ub2cc, \uc8fc\ub85c SOP \ub4f1 \ud604\uc7a5\uc5d0\uc11c \ub0b4\uac00 \uc5b8\uc81c, \uc5b4\ub5bb\uac8c \ud574\uc57c \ud558\ub294\uc9c0\ub97c \uc124\uba85\ud558\ub294 \ubb38\uc11c\uc774\ub2e4. \ub530\ub77c\uc11c \uc778\uc6d0 \ubcc4\ub85c \uc5b4\ub5a0\ud55c \ubb38\uc11c\ub97c \ubd10\uc57c \ud558\ub294\uc9c0, \ucd5c\uc2e0 \ubb38\uc11c\uac00 \ubb34\uc5c7\uc778\uc9c0\ub97c \uc27d\uac8c \ud30c\uc545\ud558\uace0 \ud604\ud669\uc744 \uad00\ub9ac\ud558\uae30 \uc704\ud574 \ubb38\uc11c\uad00\ub9ac\uc2dc\uc2a4\ud15c\uacfc\uc758 \uae34\ubc00\uc131\uc744 \ud655\uc778\ud574\uc57c \ud55c\ub2e4.<\/p>\n \n1<\/sup> Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations, 2006, FDA \n\uae00\ub85c\ubc8c \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc704\ud574 \uc81c\uc57d\ud68c\uc0ac\uc5d0\uc11c\ub294 \ub9ce\uc740 \ud22c\uc790\uc640 \ub178\ub825\uc744 \uae30\uc6b8\uc774\uace0 \uc788\ub2e4. \uadf8\ub7ec\ub098 \uc720\ub3c5 \uad50\uc721\uad00\ub9ac \uc601\uc5ed\uc5d0\uc11c\ub294 \ud22c\uc790\uac00 \ubd80\uc871\ud574 \ubcf4\uc600\ub358 \uac83\ub3c4 \uc0ac\uc2e4\uc774\ub2e4. \ud558\ub098\uc758 \ud488\ubaa9\ud5c8\uac00\ub97c \ubc1b\ub294 \ub370\uc5d0 \uc3df\uc558\ub358 \uc218\ub9ce\uc740 \uac1c\ubc1c\uacfc \uc5f0\uad6c\ube44\uc6a9\uc744 \uc0dd\uac01\ud55c\ub2e4\uba74, \uadf8\uac83\uc744 \uc77c\uc815\ud558\uace0 \uc62c\ubc14\ub974\uac8c \uc0dd\uc0b0\ud558\uace0 \uad00\ub9ac\ud558\ub294 \uc778\uc6d0\uc5d0 \ub300\ud55c \ud22c\uc790\ub294 \ub2f9\uc5f0\uc2dc \ub418\uc5b4\uc57c \ud560 \uac83 \uc774\ub2e4. \uc774\uc81c \uad50\uc721\uc740 \ub2e8\uc21c\ud788 \uc2e4\uc0ac\ub300\uc751\uc744 \uc704\ud55c \uad50\uc721\uae30\ub85d\ud655\ubcf4\uc758 \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c, \ud604\uc7a5\uc5d0 \ud22c\uc785\ud560 \uc218 \uc788\ub294 \uc758\uc57d\ud488 \uc81c\uc870\uba74\ud5c8\ub97c \uad00\ub9ac\ud558\ub294 \uac83\uc73c\ub85c \uc778\uc2dd\uc744 \uc804\ud658\ud574\uc57c \ud55c\ub2e4. \uba74\ud5c8\uac00 \uc5c6\uac70\ub098 \uc720\ud6a8\ud558\uc9c0 \uc54a\uc73c\uba74 \uc81c\uc870\ub098 \uc2dc\ud5d8\ud604\uc7a5\uc5d0 \ud22c\uc785\ub418\uc9c0 \ubabb\ud558\ub294 \uac83\uc774\ub2e4. \uc885\uc774\uae30\ubc18\uc758 \uad50\uc721\ub85c\ub294 \uc774\ub7ec\ud55c \uad00\ub9ac\uac00 \ud604\uc2e4\uc801\uc73c\ub85c \ubd88\uac00\ud558\uba70, \uad50\uc721\uad00\ub9ac\uc2dc\uc2a4\ud15c\uc758 \ub3c4\uc6c0\uc744 \ubc1b\uc544\uc57c \ud55c\ub2e4. GMP \uaddc\uc815\uc744 \uc900\uc218\ud558\uace0, \ubb38\uc11c\uad00\ub9ac\uc2dc\uc2a4\ud15c\uacfc \uae34\ubc00\ud55c \uc5f0\uacb0\uc774 \uac00\ub2a5\ud55c \uad50\uc721\uad00\ub9ac \uc2dc\uc2a4\ud15c\uc774\ub77c\uba74 \ubcf4\ub2e4 \ud6a8\uc728\uc801\uc774\uace0 \ud0c4\ub825\uc801\uc778 \uad50\uc721\uad00\ub9ac \ubc0f \uc6b4\uc601 \uc5c5\ubb34\uad6c\ud604\uc774 \uac00\ub2a5\ud560 \uac83\uc774\ub2e4.<\/p>\n \n2022\ub144 7\uc6d4 \uae00\ub85c\ubc8c \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc704\ud574 \uc81c\uc57d\ud68c\uc0ac\uc5d0\uc11c\ub294 \ub9ce\uc740 \ud22c\uc790\uc640 \ub178\ub825\uc744 \uae30\uc6b8\uc774\uace0 \uc788\ub2e4. \uadf8\ub7ec\ub098 \uc720\ub3c5 \uad50\uc721\uad00\ub9ac \uc601\uc5ed\uc5d0\uc11c\ub294 \ud22c\uc790\uac00 \ubd80\uc871\ud574 \ubcf4\uc600\ub358 \uac83\ub3c4 \uc0ac\uc2e4\uc774\ub2e4. \ud558\ub098\uc758 \ud488\ubaa9\ud5c8\uac00\ub97c \ubc1b\ub294 \ub370\uc5d0 \uc3df\uc558\ub358 \uc218\ub9ce\uc740 \uac1c\ubc1c\uacfc \uc5f0\uad6c\ube44\uc6a9\uc744 \uc0dd\uac01\ud55c\ub2e4\uba74, \uadf8\uac83\uc744 \uc77c\uc815\ud558\uace0 \uc62c\ubc14\ub974\uac8c \uc0dd\uc0b0\ud558\uace0 \uad00\ub9ac\ud558\ub294 \uc778\uc6d0\uc5d0 \ub300\ud55c \ud22c\uc790\ub294 \ub2f9\uc5f0\uc2dc \ub418\uc5b4\uc57c \ud560 \uac83 \uc774\ub2e4. \uc774\uc81c \uad50\uc721\uc740 \ub2e8\uc21c\ud788 \uc2e4\uc0ac\ub300\uc751\uc744 \uc704\ud55c \uad50\uc721\uae30\ub85d\ud655\ubcf4\uc758 \ubaa9\uc801\uc774 \uc544\ub2c8\ub77c, \ud604\uc7a5\uc5d0 \ud22c\uc785\ud560 \uc218 \uc788\ub294 \uc758\uc57d\ud488 \uc81c\uc870\uba74\ud5c8\ub97c \uad00\ub9ac\ud558\ub294 \uac83\uc73c\ub85c \uc778\uc2dd\uc744 \uc804\ud658\ud574\uc57c \ud55c\ub2e4. <\/p>\n","protected":false},"author":230,"featured_media":30375,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-30370","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","blog-area-vault-quality","blog-product-quality"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/posts\/30370"}],"collection":[{"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/users\/230"}],"replies":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/comments?post=30370"}],"version-history":[{"count":13,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/posts\/30370\/revisions"}],"predecessor-version":[{"id":30705,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/posts\/30370\/revisions\/30705"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/media\/30375"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/media?parent=30370"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/categories?post=30370"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.veeva.com\/kr\/wp-json\/wp\/v2\/tags?post=30370"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n<\/span>\n<\/p>\n\ub9c8\ubb34\ub9ac\ud558\uba70<\/h2>\n
\n
\nVeeva Systems
\nQuality Strategy \u2013 Korea
\n\ubd80\uc7a5 \uc774\uc815\ud658<\/p>\n","protected":false},"excerpt":{"rendered":"