{"id":30078,"date":"2026-01-31T09:01:13","date_gmt":"2026-01-31T00:01:13","guid":{"rendered":"https:\/\/blog.agentsoft.co.kr\/index.php\/2026\/01\/31\/30078\/"},"modified":"2026-01-31T09:01:13","modified_gmt":"2026-01-31T00:01:13","slug":"gmp-%ed%92%88%ec%a7%88%ea%b2%bd%ec%98%81%ec%8b%9c%ec%8a%a4%ed%85%9c-%ea%b8%b0%ec%a4%80%ec%84%9c","status":"publish","type":"post","link":"https:\/\/blog.agentsoft.co.kr\/index.php\/2026\/01\/31\/30078\/","title":{"rendered":"GMP \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c \uae30\uc900\uc11c"},"content":{"rendered":"

<\/p>\n

\ubaa9\ucc28<\/strong><\/p>\n

1.\t\ubaa9\uc801 (Purpose)<\/p>\n

2.\t\uc801\uc6a9\ubc94\uc704 (Scope)<\/p>\n

3.\t\uc6a9\uc5b4\uc758 \uc815\uc758(Glossary)
\n3.1.\t\ud488\uc9c8 \uc2dc\uc2a4\ud15c \uad00\ub9ac \uc9c0\ud45c
\n3.2.\t\ubd80\uc7ac\uc911 \uad8c\ud55c \uc704\uc784
\n3.3.\t\uc81c\uc870<\/p>\n

4.\t\ud488\uc9c8\uacbd\uc601 \uc6d0\uce59 (Principle of Quality Management)<\/p>\n

5.\t\ucc45\uc784 \ubc0f \uad8c\ud55c(Responsibility and Authority)
\n5.1.\t\ub300\ud45c
\n5.2.\t\uacbd\uc601\uc9c4
\n5.3.\t\ud488\uc9c8\uad00\ub9ac\uc790(\ud488\uc9c8\ubcf4\uc99d\ucc45\uc784\uc790)<\/p>\n

6.\t\ud488\uc9c8 \ud504\ub85c\uadf8\ub7a8 \ubb38\uc11c \uad6c\uc870(Quality Program Document Structure)<\/p>\n

7.\t\ud488\uc9c8\ubcf4\uc99d\uc2dc\uc2a4\ud15c(Quality System)
\n7.1.\t\ud488\uc9c8\uacbd\uc601 \ubaa9\uc801
\n7.2.\t\uc2dc\uc2a4\ud15c \uc694\uad6c\uc0ac\ud56d
\n7.3.\t\ubb38\uc11c\uc758 \uad6c\uc131<\/p>\n

8.\t\uc124\ube44 \ubc0f \uae30\uacc4\uc7a5\uce58 \uc2dc\uc2a4\ud15c(Facility & Equipment System)<\/p>\n

9.\t\ud488\uc9c8\uacbd\uc601 \ubc29\ud5a5 (Quality Management Direction)
\n9.1.\t\uc5c5\ubb34 \ud750\ub984\ub3c4
\n9.2.\t\uae30\uc900\uc11c \uc791\uc131
\n9.3.\t\uacc4\ud68d\uc218\ub9bd
\n9.4.\t\uc0ac\uc5c5\uc804\ub7b5<\/p>\n

10.\t\ucc38\uace0\ubb38\ud5cc (Reference)<\/p>\n

\ubcf8\ubb38\ub0b4\uc6a9<\/strong><\/p>\n

1.\t\ubaa9\uc801 (Purpose)
\n\ubcf8 \uaddc\uc815\uc740 \u3147\u3147\uc81c\uc57d\uc758 GMP\uacf5\uc7a5\uc5d0\uc11c \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c\uc774 \uc801\uc808\ud55c \uae30\ub2a5\uc744 \uc218\ud589\ud560 \uc218 \uc788\ub3c4\ub85d \ud544\uc694\ud55c \uc808\ucc28\ub97c \ub9c8\ub828\ud558\uace0, \uc790\uc6d0\uc744 \uc801\uc808\ud788 \ud655\ubcf4\/\ubc30\ubd84\ud558\uc5ec \uc8fc\uae30\uc801\uc73c\ub85c \uc774\ud589 \uc0c1\ud0dc\ub97c \ud3c9\uac00\ud558\uace0 \uc801\uc808\ud55c \uc870\uce58\ub97c \ucde8\ud558\uc5ec GMP \uc900\uc218\uc0ac\ud56d\uc774 \uc9c0\ucf1c\uc9c0\uace0 \uc788\uc74c\uc744 \ud655\uc2e0\ud558\uae30 \uc704\ud568\uc774\ub2e4. <\/p>\n

2.\t\uc801\uc6a9\ubc94\uc704 (Scope)
\n\uc774 \uaddc\uc815\uc740 \u321coo\uc81c\uc57d\uc758 GMP \uacf5\uc7a5\uc5d0\uc11c \uac1c\ubc1c \ub610\ub294 \uc81c\uc870\ud558\ub294 \uc0c1\uc5c5 \ubaa9\uc801\uc758 \uc758\uc57d\ud488\uc758 \ud488\uc9c8\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\ub294 \ubaa8\ub4e0 \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c \ud65c\ub3d9\uc5d0 \uc801\uc6a9\ud55c\ub2e4.<\/p>\n

3.\t\uc6a9\uc5b4\uc758 \uc815\uc758(Glossary)
\n3.1.\t\ud488\uc9c8 \uc2dc\uc2a4\ud15c \uad00\ub9ac \uc9c0\ud45c
\n\ud488\uc9c8\uc2dc\uc2a4\ud15c\uc774 \uc6b4\uc601\ub418\uace0 \uc788\ub294\uc9c0\ub97c \ud655\uc778\ud558\uae30 \uc704\ud55c \uad00\ub9ac\uc9c0\ud45c\ub97c \ub9d0\ud55c\ub2e4.(\uc608\ub97c \ub4e4\uba74, \uc885\ub8cc\uc2dc\uac04, \ucd1d \uc2e4\uc218\ud55c \ud69f\uc218, \ucd1d \uc2dc\ud5d8\uc218, \uc2e4\uc218\uc758 \uc885\ub958 \ub4f1)
\n3.2.\t\ubd80\uc7ac\uc911 \uad8c\ud55c \uc704\uc784
\n\ucc9c\uc7ac\uc9c0\ubcc0, \uc2b9\uc9c4 \ub610\ub294 \ud1f4\uc0ac \ub4f1\uc73c\ub85c \ubd80\uc7ac\uc911\uc778 \uacbd\uc6b0\uc5d0\ub294 \uc8fc\uc694 \uc5ed\ud560 \uc744 \uc815\uc758\ud558\uace0 \uc774\ub97c \uc704\uc784 \ubc1b\uc744 \uc218 \uc788\ub3c4\ub85d \ud558\uae30 \uc704\ud558 \uacc4\ud68d\uc744 \ub9d0\ud55c\ub2e4.
\n3.3.\t\uc81c\uc870
\n\uc81c\uc870, \ud3ec\uc7a5 \ubc0f \ud45c\uc2dc\uc791\uc5c5\uc744 \ud3ec\ud568\ud558\uc5ec \uc758\uc57d\ud488\uc744 \uc0dd\uc0b0\ud558\uae30 \uc704\ud558\uc5ec \ud558\ub294 \ubaa8\ub4e0 \uc791\uc5c5\uc744 \ub9d0\ud55c\ub2e4.<\/p>\n

4.\t\ud488\uc9c8\uacbd\uc601 \uc6d0\uce59 (Principle of Quality Management)
\n4.1.\t\uc758\uc57d\ud488 \ud488\uc9c8\uc740 \uc81c\uc870\uc5d0 \uad00\ub828\ub41c \ubaa8\ub4e0 \uc0ac\ub78c\uc758 \ucc45\uc784\uc774\ub2e4.
\n4.2.\t\uc758\uc57d\ud488 \uc81c\uc870\uc5c5\uc790\ub294 \uacbd\uc601\uc9c4\uacfc \uc791\uc5c5\uc6d0\uc774 \ucc38\uc5ec\ud558\ub294 \ud6a8\uacfc\uc801\uc778 \ud488\uc9c8\uacbd\uc601 \uc2dc\uc2a4\ud15c\uc744 \uc218\ub9bd\ud558\uace0 \uc774\ub97c \ubb38\uc11c\ud654\ud558\uc5ec \uc2dc\ud589\ud558\uc5ec\uc57c \ud55c\ub2e4.
\n4.3.\t\ud488\uc9c8\uacbd\uc601 \uc2dc\uc2a4\ud15c\uc740 \uc758\uc57d\ud488 \ud488\uc9c8\uc758 \uc2e0\ub8b0\uc131\uc744 \ubcf4\uc99d\ud558\uae30 \uc704\ud558\uc5ec \ud544\uc694\ud55c \ud65c\ub3d9\uacfc \uc870\uc9c1, \uc808\ucc28, \uacf5\uc815 \ub4f1\uc744 \ud3ec\ud568\ud558\uc5ec, \ubaa8\ub4e0 \ud488\uc9c8\uad00\ub828 \ud65c\ub3d9\uc744 \uaddc\uc815\ud558\uace0 \ubb38\uc11c\ud654\ud558\uc5ec\uc57c \ud55c\ub2e4.
\n4.4.\t\uc81c\uc870\uc18c\uc5d0\uc11c \uc11c\ub85c \ub3c5\ub9bd\ub41c \uc81c\uc870\ubd80\uc11c\uc640 \ud488\uc9c8(\ubcf4\uc99d)\ubd80\uc11c\ub97c \ub450\uace0 \uac01\uac01 \ucc45\uc784\uc790\ub97c \ub450\uc5b4\uc57c \ud558\uba70, \uc774 \uacbd\uc6b0 \uacb8\uc9c1\ud558\uc5ec\uc11c\ub294 \uc544\ub2c8\ub41c\ub2e4.
\n4.5.\t\uc704 4.4.\uc758 \ucc45\uc784\uc790\ub294 \uc57d\uc0ac\ubc95 36\uc870 \uc81c3\ud56d\uc5d0 \ub530\ub978 \uc81c\uc870\uad00\ub9ac\uc790\ub85c\uc11c \uc774 \uae30\uc900\uc5d0 \uad00\ud55c \ucda9\ubd84\ud55c \uc9c0\uc2dd\uc744 \uac00\uc9c4 \uc0ac\ub78c\uc774\uc5b4\uc57c \ud55c\ub2e4.<\/p>\n

5.\t\ucc45\uc784 \ubc0f \uad8c\ud55c(Responsibility and Authority)
\n5.1.\t\ub300\ud45c
\n\ubcf8 \uc0f9\uadf8\ub9ac\ub77c\ubc14\uc774\uc624\uc758 \uc758\uc57d\ud488 \uc81c\uc870\uc5c5\uccb4\uc758 \ub300\ud45c\ub85c\uc11c..<\/p>\n

<\uc911 \ub7b5><\/p>\n

\ucd9c\ucc98 : \ud574\ud53c\ucea0\ud37c\uc2a4<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\ubaa9\ucc28 1. \ubaa9\uc801 (Purpose) 2. \uc801\uc6a9\ubc94\uc704 (Scope) 3. \uc6a9\uc5b4\uc758 \uc815\uc758(Glossary) 3.1. \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uad00\ub9ac \uc9c0\ud45c 3.2. \ubd80\uc7ac\uc911 \uad8c\ud55c \uc704\uc784 3.3. \uc81c\uc870 4. \ud488\uc9c8\uacbd\uc601 \uc6d0\uce59 (Principle of Quality Management) 5. \ucc45\uc784 \ubc0f \uad8c\ud55c(Responsibility and Authority) 5.1. \ub300\ud45c 5.2. \uacbd\uc601\uc9c4 5.3. \ud488\uc9c8\uad00\ub9ac\uc790(\ud488\uc9c8\ubcf4\uc99d\ucc45\uc784\uc790) 6. \ud488\uc9c8 \ud504\ub85c\uadf8\ub7a8 \ubb38\uc11c \uad6c\uc870(Quality Program Document Structure) 7. \ud488\uc9c8\ubcf4\uc99d\uc2dc\uc2a4\ud15c(Quality System) 7.1. \ud488\uc9c8\uacbd\uc601 \ubaa9\uc801 7.2. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[23994,28628,37543,1094],"class_list":["post-30078","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-fmea---","tag-gmp","tag-37543","tag-1094"],"_links":{"self":[{"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/posts\/30078","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/comments?post=30078"}],"version-history":[{"count":0,"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/posts\/30078\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/media?parent=30078"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/categories?post=30078"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.agentsoft.co.kr\/index.php\/wp-json\/wp\/v2\/tags?post=30078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}