{"id":20998,"date":"2024-06-09T23:05:41","date_gmt":"2024-06-10T02:05:41","guid":{"rendered":"http:\/\/fromtv.com.br\/web\/?p=20998"},"modified":"2024-06-09T23:05:41","modified_gmt":"2024-06-10T02:05:41","slug":"%eb%b8%8c%eb%9d%bc%ec%a7%88-%ed%95%9c%ea%b5%ad-%eb%93%b1-42%ea%b0%9c%ea%b5%ad-gmp-%ec%9d%b8%ec%a0%95%ec%9c%bc%eb%a1%9c-%ec%9d%b8%ec%a6%9d%ec%a0%88%ec%b0%a8-%ea%b0%84%ec%86%8c%ed%99%94-%ec%b6%94","status":"publish","type":"post","link":"http:\/\/fromtv.com.br\/web\/2024\/06\/09\/%eb%b8%8c%eb%9d%bc%ec%a7%88-%ed%95%9c%ea%b5%ad-%eb%93%b1-42%ea%b0%9c%ea%b5%ad-gmp-%ec%9d%b8%ec%a0%95%ec%9c%bc%eb%a1%9c-%ec%9d%b8%ec%a6%9d%ec%a0%88%ec%b0%a8-%ea%b0%84%ec%86%8c%ed%99%94-%ec%b6%94\/","title":{"rendered":"\ube0c\ub77c\uc9c8, \ud55c\uad6d \ub4f1 42\uac1c\uad6d GMP \uc778\uc815\uc73c\ub85c \uc778\uc99d\uc808\ucc28 \uac04\uc18c\ud654 \ucd94\uc9c4\u2026 6\uc6d41\uc77c\ubd80\ud130 \uc2dc\ud589 \uc608\uc815."},"content":{"rendered":"\n

<\/p>\n\n\n\n

\uace0\uad6d \uc815\ubcf4 : 2024.05.31<\/p>\n\n\n\n

\ube0c\ub77c\uc9c8\uc774 \ud55c\uad6d \ub4f1 42\uac1c\uad6d\uc758 \uc6b0\uc218\uc81c\uc870\uad00\ub9ac\uae30\uc900(GMP)\uc744 \uc778\uc815\ud574 \uc790\uad6d \ub0b4 \uc778\uc99d\uc808\ucc28\uc758 \uac04\uc18c\ud654\ub97c \ucd94\uc9c4\ud55c\ub2e4. \ud55c\uad6d\ubc14\uc774\uc624\ud611\ud68c \ubc14\uc774\uc624\uacbd\uc81c\uc5f0\uad6c\uc13c\ud130\ub294 17\uc77c \ubc1c\ud589\ud55c \uc774\uc288 \ube0c\ub9ac\ud551\uc744 \ud1b5\ud574 \uc774\uac19\uc774 \uc804\ud588\ub2e4.<\/p>\n\n\n\n

\ube0c\ub77c\uc9c8 \uad6d\uac00\ubcf4\uac74\uaddc\uc81c\uccad(ANVISA)\uc740 \ucd5c\uadfc \uc6b0\uc218\uc81c\uc870\uad00\ub9ac\uae30\uc900(GMP) \uc778\uc99d \uc808\ucc28\ub97c \uc2e0\uc18d\ud558\uac8c \uc9c4\ud589\ud558\uae30 \uc704\ud55c \uc0c8\ub85c\uc6b4 \uc774\ub2c8\uc154\ud2f0\ube0c\ub97c \ubc1c\ud45c\ud588\ub2e4. \uaddc\uc81c \uc758\uc874\ub3c4\ub97c \ub192\uc774\uae30 \uc704\ud574 ANVISA\ub294 \uc774\uc81c \ub3d9\ub4f1\ud55c \uc678\uad6d \uaddc\uc81c \uae30\uad00(equivalent foreign regulatory bodies, AREE)\uc73c\ub85c \uc778\uc815\ub41c 42\uac1c\uad6d\uc5d0\uc11c \uc218\ud589\ub41c GMP \uac80\uc0ac\ub97c \uace0\ub824\ud560 \uc608\uc815\uc774\ub2e4.<\/p>\n\n\n\n

\uc774 \uad6d\uac00\ub4e4\uc740 \uc758\uc57d\ud488\uc2e4\uc2dc\uc0c1\ud638\ud611\ub825\uae30\uad6c(PIC\/S) \ubc0f \uc758\uc57d\ud488\uad6d\uc81c\uc870\ud654\ud68c\uc758(ICH) \ud68c\uc6d0\uad6d\uc73c\ub85c \ub300\ubd80\ubd84 \uc720\ub7fd, \ubd81\ubbf8, \ud55c\uad6d\uc744 \ud3ec\ud568\ud55c \uc544\uc2dc\uc544 \uad6d\uac00\ub4e4\uc774\uba70 \ub77c\ud2f4\uc544\uba54\ub9ac\uce74\uc5d0\uc11c\ub294 \uba55\uc2dc\ucf54\uac00 \uc720\uc77c\ud558\uac8c \ud3ec\ud568\ub410\ub2e4. 2024\ub144 4\uc6d4 3\uc77c\uc5d0 \ubc1c\ud45c\ub41c \uaddc\ubc94 \uc9c0\uce68(IN) 292\/2024\uc5d0 \ub530\ub978 \uc774 \uc0c8\ub85c\uc6b4 \uc811\uadfc \ubc29\uc2dd\uc740 \uc2e0\uccad\uc11c \ucc98\ub9ac \uc2dc\uac04\uc744 \ud06c\uac8c \ub2e8\ucd95\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uba70, 2024\ub144 6\uc6d4 1\uc77c\ubd80\ud130 \uc2dc\ud589\ub420 \uc608\uc815\uc774\ub2e4.<\/p>\n\n\n\n

\uaddc\uc81c \uc758\uc874\ub3c4\ub294 \ud3c9\ud310\uc774 \uc88b\uc740 \uc678\uad6d \uaddc\uc81c \uae30\uad00\uc758 GMP \ud3c9\uac00\uacb0\uacfc\ub97c \ud65c\uc6a9\ud55c\ub2e4. \ud574\uc678 \uaddc\uc81c\uae30\uad00\uc5d0\uc11c \uc218\ud589\ub41c \ud3c9\uac00\ub97c \uc2e0\ub8b0\ud568\uc73c\ub85c\uc368 ANVISA\ub294 \ud2b9\uc815 \uc81c\ud488\uc5d0 \ub300\ud55c \uc790\uccb4 \uac80\uc0ac \uc808\ucc28\ub97c \uac04\uc18c\ud654\ud560 \uc218 \uc788\ub2e4. \uc774\ub807\uac8c \ud558\uba74 \uc911\ubcf5 \uc791\uc5c5\uc774 \uc904\uc5b4\ub4e4\uace0 \uc804\uccb4 \uc778\uc99d \ud504\ub85c\uc138\uc2a4\uac00 \ube68\ub77c\uc9c0\ub294 \ud6a8\uacfc\uac00 \uc0dd\uae30\uac8c \ub41c\ub2e4.<\/p>\n\n\n\n

\uc758\uc57d\ud488, \ubc14\uc774\uc624\uc758\uc57d\ud488, \uc758\ub8cc\uc6a9 \ub300\ub9c8\ucd08 \ubc0f \ud65c\uc131 \uc758\uc57d\ud488 \uc131\ubd84(API)\uc5d0 \ub300\ud55c GMP \uc778\uc99d\uc744 \uc6d0\ud558\ub294 \ud68c\uc0ac\ub294 \uc774 \uc0c8\ub85c\uc6b4 \uc811\uadfc \ubc29\uc2dd\uc758 \uc774\uc810\uc744 \ub204\ub9b4 \uc218 \uc788\uc744 \uac83\uc73c\ub85c \uc804\ub9dd\ub41c\ub2e4. \uacf5\uc778\ub41c AREE\uc5d0\uc11c \uc774\ubbf8 \uc2b9\uc778\ud55c \uc81c\ud488\uacfc \uad00\ub828\ub41c \uaddc\uc81c\ud5c8\uac00\uc2e0\uccad\uc740 \uc7a0\uc7ac\uc801\uc73c\ub85c \ucc98\ub9ac \uc2dc\uac04\uc774 \ub354 \ube68\ub77c\uc9c8 \uc218 \uc788\ub2e4.<\/p>\n\n\n\n

\uaddc\ubc94\uc9c0\uce68(IN 292\/2024)\uc740 \uc138 \uac00\uc9c0 \uc758\uc874\ub3c4 \ub808\ubca8\uc744 \uc124\uc815\ud558\uc5ec ANVISA\uac00 \uad00\ub828\ub41c \ud2b9\uc815 AREE\ub97c \uae30\ubc18\uc73c\ub85c \uac80\ud1a0 \ud504\ub85c\uc138\uc2a4\ub97c \uc870\uc815\ud560 \uc218 \uc788\ub3c4\ub85d \ud558\uace0 \uc788\ub2e4. 42\uac1c\uad6d\uc774 \uc5b4\ub5a4 \uc2e0\ub8b0\ub3c4\ub85c \uad6c\ubd84\ub418\ub294\uc9c0\ub294 \uacf5\uac1c\ub418\uc9c0 \uc54a\uc558\ub2e4. \uba3c\uc800 *\ubd80\ubd84\uc801 \uc758\uc874 \uad6d\uac00\ub294 GMP \uc900\uc218 \uc5ec\ubd80\ub97c \ud3c9\uac00\ud558\uae30 \uc704\ud574 AREE\uac00 \ubc1c\ud589\ud55c \uc2e4\uc0ac \ubcf4\uace0\uc11c\uc5d0 \ub300\ud55c \uc644\uc804\ud55c \ubd84\uc11d\uc774 \uc218\ud589\ub41c\ub2e4. Anvisa\ub294 \uc870\uc0ac \uacb0\uacfc\ub97c \uc77c\ubc29\uc801\uc73c\ub85c \ucc44\ud0dd\ud560 \uc218 \uc788\ub2e4. \ub2e4\uc74c\uc73c\ub85c *\uc644\uc804\ud55c \uc758\uc874 \uad6d\uac00\ub294 AREE\uc758 GMP \uc2e4\uc0ac \ubcf4\uace0\uc11c\uc5d0 \ub300\ud55c \uac04\uc18c\ud654\ub41c \uac80\ud1a0\uac00 \uc218\ud589\ub41c\ub2e4. ANVISA\ub294 \uc774 \uac80\ud1a0\uacb0\uacfc\ub97c \uae30\ubc18\uc73c\ub85c \uc77c\ubc29\uc801\uc778 \uacb0\uc815\uc744 \ub0b4\ub9b4 \uc218 \uc788\ub294 \uad8c\ud55c\uc744 \ubcf4\uc720\ud558\uace0 \uc788\ub2e4. \ub9c8\uc9c0\ub9c9\uc73c\ub85c * \uc0c1\ud638 \uc778\uc815 \uad6d\uac00\ub294 \uacf5\uc2dd \uacc4\uc57d \ubc0f \ud655\ub9bd\ub41c \uaddc\uc81c \uc758\uc874 \ud504\ub85c\uadf8\ub7a8\uc744 \ud1b5\ud574 ANVISA\uc640 AREE\ub294 \uc11c\ub85c\uc758 GMP \uc2e4\uc0ac \ubc0f \uc778\uc99d\uc11c\ub97c \uc644\uc804\ud788 \uc778\uc815\ud558\uac8c \ub41c\ub2e4.<\/p>\n\n\n\n

GMP \uc778\uc99d \uac04\uc18c\ud654\uc5d0 \ub530\ub77c ANVISA\ub294 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc678\uad6d \ub2f9\uad6d\uc758 \uc804\ubb38 \uc9c0\uc2dd\uc744 \ud65c\uc6a9\ud558\uc5ec \uc5c4\uaca9\ud55c \ud488\uc9c8 \ud45c\uc900\uacfc \uc778\uc99d \ud504\ub85c\uc138\uc2a4\uc758 \ud6a8\uc728\uc131\uc744 \ub192\uc774\uace0 \uc788\uc73c\uba70, \uc774\ub2c8\uc154\ud2f0\ube0c\ub97c \ud1b5\ud574 \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc758\ub8cc \uc81c\ud488\uc5d0 \ub300\ud55c \uc811\uadfc\uc744 \uac00\uc18d\ud654\ud568\uc73c\ub85c\uc368 \uae30\uc5c5\uacfc \uc18c\ube44\uc790 \ubaa8\ub450\uc5d0\uac8c \ud61c\ud0dd\uc744 \uc904 \uac83\uc73c\ub85c \uae30\ub300\ud558\uace0 \uc788\ub2e4.<\/p>\n\n\n\n

\/ \ub9e4\ub4dc\uc6d4\ub4dc \uc774\uacc4\uc7ac \uae30\uc790<\/p>\n\n\n\n

\"\"<\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"

\uace0\uad6d \uc815\ubcf4 : 2024.05.31 \ube0c\ub77c\uc9c8\uc774 \ud55c\uad6d \ub4f1 42\uac1c\uad6d\uc758 \uc6b0\uc218\uc81c\uc870\uad00\ub9ac\uae30\uc900(GMP)\uc744 \uc778\uc815\ud574 \uc790\uad6d \ub0b4 \uc778\uc99d\uc808\ucc28\uc758 \uac04\uc18c\ud654\ub97c \ucd94\uc9c4\ud55c\ub2e4. \ud55c\uad6d\ubc14\uc774\uc624\ud611\ud68c \ubc14\uc774\uc624\uacbd\uc81c\uc5f0\uad6c\uc13c\ud130\ub294 17\uc77c \ubc1c\ud589\ud55c \uc774\uc288 \ube0c\ub9ac\ud551\uc744 \ud1b5\ud574 \uc774\uac19\uc774 \uc804\ud588\ub2e4. \ube0c\ub77c\uc9c8 \uad6d\uac00\ubcf4\uac74\uaddc\uc81c\uccad(ANVISA)\uc740 \ucd5c\uadfc \uc6b0\uc218\uc81c\uc870\uad00\ub9ac\uae30\uc900(GMP) \uc778\uc99d \uc808\ucc28\ub97c \uc2e0\uc18d\ud558\uac8c \uc9c4\ud589\ud558\uae30 \uc704\ud55c \uc0c8\ub85c\uc6b4 \uc774\ub2c8\uc154\ud2f0\ube0c\ub97c \ubc1c\ud45c\ud588\ub2e4. \uaddc\uc81c \uc758\uc874\ub3c4\ub97c \ub192\uc774\uae30 \uc704\ud574 ANVISA\ub294 \uc774\uc81c \ub3d9\ub4f1\ud55c \uc678\uad6d \uaddc\uc81c \uae30\uad00(equivalent foreign regulatory bodies, AREE)\uc73c\ub85c \uc778\uc815\ub41c 42\uac1c\uad6d\uc5d0\uc11c \uc218\ud589\ub41c GMP \uac80\uc0ac\ub97c […]<\/p>\n","protected":false},"author":3,"featured_media":20999,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[3842,3844,3846,24,1727,58,3845,1422,256,2065],"_links":{"self":[{"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/posts\/20998"}],"collection":[{"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/comments?post=20998"}],"version-history":[{"count":1,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/posts\/20998\/revisions"}],"predecessor-version":[{"id":21000,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/posts\/20998\/revisions\/21000"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/media\/20999"}],"wp:attachment":[{"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/media?parent=20998"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/categories?post=20998"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/fromtv.com.br\/web\/wp-json\/wp\/v2\/tags?post=20998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}