{"id":9160,"date":"2026-02-07T04:53:57","date_gmt":"2026-02-07T04:53:57","guid":{"rendered":"https:\/\/sepro.vn\/?p=9160"},"modified":"2026-02-07T04:53:57","modified_gmt":"2026-02-07T04:53:57","slug":"gmp-eu-vs-gmp-who-huong-dan-nha-may","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/gmp-eu-vs-gmp-who-huong-dan-nha-may\/","title":{"rendered":"GMP EU vs GMP WHO: H\u01b0\u1edbng D\u1eabn L\u1ef1a Ch\u1ecdn Cho Doanh Nghi\u1ec7p"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">B\u00e0i vi\u1ebft mang t\u00ednh tham kh\u1ea3o \u0111\u1ec3 \u0111\u1ecbnh h\u01b0\u1edbng so s\u00e1nh <strong><a href=\"https:\/\/sepro.vn\/gmp-eu-vs-gmp-who-huong-dan-nha-may\/\">GMP EU vs GMP WHO<\/a><\/strong>. Khi \u00e1p d\u1ee5ng th\u1ef1c t\u1ebf, lu\u00f4n \u01b0u ti\u00ean \u0111\u1ecdc b\u1ea3n h\u01b0\u1edbng d\u1eabn ch\u00ednh th\u1ed1ng v\u00e0 y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd n\u01a1i b\u1ea1n \u0111\u0103ng k\u00fd ho\u1eb7c cung \u1ee9ng s\u1ea3n ph\u1ea9m.<\/span><\/p>\n<h2><b>GMP EU vs GMP WHO: Gi\u1ed1ng v\u00e0 kh\u00e1c nhau, n\u00ean ch\u1ecdn chu\u1ea9n n\u00e0o cho nh\u00e0 m\u00e1y<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Nhi\u1ec1u nh\u00e0 m\u00e1y b\u1eaft \u0111\u1ea7u v\u1edbi GMP WHO \u0111\u1ec3 chu\u1ea9n h\u00f3a h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng, sau \u0111\u00f3 c\u00e2n nh\u1eafc GMP EU khi m\u1ee5c ti\u00eau l\u00e0 th\u1ecb tr\u01b0\u1eddng EU ho\u1eb7c kh\u00e1ch h\u00e0ng y\u00eau c\u1ea7u ti\u00eau chu\u1ea9n chi ti\u1ebft h\u01a1n. \u0110\u1ec3 ch\u1ecdn \u0111\u00fang, b\u1ea1n c\u1ea7n hi\u1ec3u b\u1ed1i c\u1ea3nh qu\u1ea3n l\u00fd, m\u1ee9c \u0111\u1ed9 chi ti\u1ebft c\u1ee7a h\u01b0\u1edbng d\u1eabn, kh\u1ea3 n\u0103ng ch\u1ee9ng minh tu\u00e2n th\u1ee7 v\u00e0 m\u1ee9c \u0111\u1ed9 k\u1ef3 v\u1ecdng v\u1ec1 d\u1eef li\u1ec7u, th\u1ea9m \u0111\u1ecbnh, gi\u00e1m s\u00e1t.<\/span><\/p>\n<h2><b>GMP WHO l\u00e0 g\u00ec<\/b><\/h2>\n<figure id=\"attachment_9167\" aria-describedby=\"caption-attachment-9167\" style=\"width: 847px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-large wp-image-9167\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-1024x928.png\" alt=\"gmp-who-la-gi-tong-quan\" width=\"847\" height=\"768\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-1024x928.png 1024w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-300x272.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-768x696.png 768w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-1536x1393.png 1536w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-2048x1857.png 2048w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/who-logo-600x544.png 600w\" sizes=\"(max-width: 847px) 100vw, 847px\" \/><figcaption id=\"caption-attachment-9167\" class=\"wp-caption-text\"><em>GMP WHO l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<h3><b>GMP WHO l\u00e0 ti\u00eau chu\u1ea9n hay h\u01b0\u1edbng d\u1eabn<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">GMP WHO l\u00e0 <strong><a href=\"https:\/\/www.who.int\/publications\/m\/item\/trs986-annex2#:~:text=Annex%202%20of%20the%20WHO%20Technical%20Report,of%20pharmaceutical%20products%20moving%20in%20international%20commerce.\" target=\"_blank\" rel=\"noopener\">b\u1ed9 h\u01b0\u1edbng d\u1eabn th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t<\/a><\/strong> do WHO ban h\u00e0nh, \u0111\u1eb7t tr\u1ecdng t\u00e2m v\u00e0o vi\u1ec7c \u0111\u1ea3m b\u1ea3o s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t \u1ed5n \u0111\u1ecbnh theo m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 y\u00eau c\u1ea7u c\u1ee7a h\u1ed3 s\u01a1 c\u1ea5p ph\u00e9p. WHO c\u0169ng nh\u1ea5n m\u1ea1nh GMP nh\u1eb1m gi\u1ea3m c\u00e1c r\u1ee7i ro v\u1ed1n c\u00f3 trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c, nh\u01b0 nhi\u1ec5m ch\u00e9o, nh\u1ea7m l\u1eabn v\u00e0 ghi nh\u00e3n sai.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">T\u00e0i li\u1ec7u n\u1ec1n t\u1ea3ng th\u01b0\u1eddng \u0111\u01b0\u1ee3c tham chi\u1ebfu l\u00e0 WHO TRS 986 Annex 2, n\u00eau c\u00e1c nguy\u00ean t\u1eafc ch\u00ednh c\u1ee7a GMP WHO cho s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c.<\/span><\/p>\n<h3><b>Ti\u00eau chu\u1ea9n GMP WHO th\u01b0\u1eddng t\u1eadp trung v\u00e0o nh\u1eefng g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">\u1ede m\u1ee9c khung h\u1ec7 th\u1ed1ng, GMP WHO th\u01b0\u1eddng bao ph\u1ee7 c\u00e1c nh\u00f3m n\u1ed9i dung c\u1ed1t l\u00f5i nh\u01b0:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nh\u00e2n s\u1ef1 v\u00e0 \u0111\u00e0o t\u1ea1o<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nh\u00e0 x\u01b0\u1edfng, thi\u1ebft b\u1ecb<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u00e0i li\u1ec7u v\u00e0 h\u1ed3 s\u01a1<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t trong qu\u00e1 tr\u00ecnh<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ki\u1ec3m nghi\u1ec7m ch\u1ea5t l\u01b0\u1ee3ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u1ef1 thanh tra v\u00e0 c\u1ea3i ti\u1ebfn<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">C\u00e1ch ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp nh\u01b0 m\u1ed9t nguy\u00ean t\u1eafc tri\u1ec3n khai, nh\u01b0ng th\u01b0\u1eddng \u1edf m\u1ee9c h\u01b0\u1edbng d\u1eabn chung \u0111\u1ec3 c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd qu\u1ed1c gia v\u00e0 doanh nghi\u1ec7p n\u1ed9i lu\u1eadt h\u00f3a v\u00e0 \u00e1p d\u1ee5ng theo b\u1ed1i c\u1ea3nh.<\/span><\/p>\n<h2><b>GMP EU l\u00e0 g\u00ec<\/b><\/h2>\n<figure id=\"attachment_9140\" aria-describedby=\"caption-attachment-9140\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/sepro.vn\/gmp-eu-la-gi\/\"><img decoding=\"async\" class=\"wp-image-9140 size-full\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2.png\" alt=\"gmp-eu-la-gi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><figcaption id=\"caption-attachment-9140\" class=\"wp-caption-text\"><em>GMP EU l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<h3><b>GMP EU n\u1eb1m trong h\u1ec7 th\u1ed1ng quy \u0111\u1ecbnh n\u00e0o<\/b><\/h3>\n<p><span style=\"font-weight: 400;\"><strong><a href=\"https:\/\/sepro.vn\/gmp-eu-la-gi\/\">GMP EU<\/a><\/strong> l\u00e0 h\u01b0\u1edbng d\u1eabn GMP c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u, \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong <strong><a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noopener\">EudraLex Volume 4<\/a><\/strong>, \u00e1p d\u1ee5ng cho thu\u1ed1c d\u00f9ng cho ng\u01b0\u1eddi v\u00e0 th\u00fa y theo khung ph\u00e1p l\u00fd c\u1ee7a EU.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m th\u1ef1c ti\u1ec5n r\u1ea5t quan tr\u1ecdng: m\u1ecdi nh\u00e0 s\u1ea3n xu\u1ea5t thu\u1ed1c d\u1ef1 ki\u1ebfn cung \u1ee9ng cho th\u1ecb tr\u01b0\u1eddng EU \u0111\u1ec1u ph\u1ea3i tu\u00e2n th\u1ee7 GMP EU, kh\u00f4ng ph\u1ee5 thu\u1ed9c nh\u00e0 m\u00e1y \u0111\u1eb7t \u1edf \u0111\u00e2u.<\/span><\/p>\n<h3><b>EU GMP Annex l\u00e0 g\u00ec v\u00e0 v\u00ec sao quan tr\u1ecdng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Annex l\u00e0 c\u00e1c ph\u1ee5 l\u1ee5c b\u1ed5 sung y\u00eau c\u1ea7u theo ch\u1ee7 \u0111\u1ec1 ho\u1eb7c lo\u1ea1i h\u00ecnh s\u1ea3n xu\u1ea5t. V\u00ed d\u1ee5 Annex 1 v\u1ec1 s\u1ea3n xu\u1ea5t thu\u1ed1c v\u00f4 tr\u00f9ng \u0111\u01b0a nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng \u00e1p d\u1ee5ng xuy\u00ean su\u1ed1t thi\u1ebft k\u1ebf v\u00e0 ki\u1ec3m so\u00e1t, \u0111\u1ed3ng th\u1eddi nh\u1ea5n m\u1ea1nh chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m, c\u00f4ng ngh\u1ec7 h\u00e0ng r\u00e0o nh\u01b0 RABS ho\u1eb7c isolator, v\u00e0 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng, gi\u00e1m s\u00e1t quy tr\u00ecnh.<\/span><\/p>\n<h2><b>S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa GMP EU vs GMP WHO<\/b><\/h2>\n<figure id=\"attachment_9161\" aria-describedby=\"caption-attachment-9161\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9161\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/1.png\" alt=\"gmp-eu-vs-gmp-who\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/1.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/1-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/1-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/1-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9161\" class=\"wp-caption-text\"><em>GMP EU vs GMP WHO<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">GMP WHO vs GMP EU, c\u00f9ng h\u01b0\u1edbng t\u1edbi m\u1ee5c ti\u00eau c\u1ed1t l\u00f5i l\u00e0 b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n v\u00e0 t\u00ednh nh\u1ea5t qu\u00e1n trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, nh\u01b0ng kh\u00e1c nhau \u0111\u00e1ng k\u1ec3 v\u1ec1 b\u1ed1i c\u1ea3nh qu\u1ea3n l\u00fd v\u00e0 c\u00e1ch \u00e1p d\u1ee5ng. GMP WHO \u0111\u00f3ng vai tr\u00f2 nh\u01b0 b\u1ed9 h\u01b0\u1edbng d\u1eabn mang t\u00ednh to\u00e0n c\u1ea7u, nh\u1ea5n m\u1ea1nh c\u00e1c nguy\u00ean t\u1eafc n\u1ec1n t\u1ea3ng \u0111\u1ec3 c\u00e1c qu\u1ed1c gia linh ho\u1ea1t tri\u1ec3n khai theo \u0111i\u1ec1u ki\u1ec7n qu\u1ea3n l\u00fd n\u1ed9i \u0111\u1ecba. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Trong khi \u0111\u00f3, GMP EU g\u1eafn ch\u1eb7t v\u1edbi h\u1ec7 th\u1ed1ng ph\u00e1p l\u00fd v\u00e0 c\u01a1 ch\u1ebf thanh tra c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u, th\u01b0\u1eddng chi ti\u1ebft h\u01a1n nh\u1edd c\u1ea5u tr\u00fac EudraLex Volume 4, h\u1ec7 th\u1ed1ng Annex v\u00e0 kh\u1ea3 n\u0103ng tra c\u1ee9u minh b\u1ea1ch tr\u00ean EudraGMDP. \u0110\u1eb7c bi\u1ec7t \u1edf l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng, Annex 1 c\u1ee7a EU \u0111\u1eb7t ra k\u1ef3 v\u1ecdng r\u1ea5t r\u00f5 v\u1ec1 qu\u1ea3n l\u00fd r\u1ee7i ro, chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m v\u00e0 gi\u00e1m s\u00e1t theo xu h\u01b0\u1edbng, t\u1ea1o kh\u00e1c bi\u1ec7t th\u1ef1c d\u1ee5ng khi doanh nghi\u1ec7p h\u01b0\u1edbng t\u1edbi m\u1ee5c ti\u00eau \u0111\u01b0a s\u1ea3n ph\u1ea9m v\u00e0o th\u1ecb tr\u01b0\u1eddng EU.<\/span><\/p>\n<h3><b>Kh\u00e1c nhau v\u1ec1 m\u1ee5c ti\u00eau v\u00e0 b\u1ed1i c\u1ea3nh qu\u1ea3n l\u00fd<\/b><\/h3>\n<p><span style=\"font-weight: 400;\"><strong>GMP WHO<\/strong> l\u00e0 h\u01b0\u1edbng d\u1eabn mang t\u00ednh to\u00e0n c\u1ea7u, d\u00f9ng l\u00e0m n\u1ec1n t\u1ea3ng \u0111\u1ec3 gi\u1ea3m r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c v\u00e0 h\u1ed7 tr\u1ee3 h\u00e0i h\u00f2a th\u1ef1c h\u00e0nh GMP.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"><strong>GMP EU<\/strong> g\u1eafn ch\u1eb7t v\u1edbi h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd c\u1ee7a EU, c\u00f3 c\u1ea5u tr\u00fac EudraLex Volume 4 v\u00e0 c\u01a1 ch\u1ebf thanh tra, gi\u00e1m s\u00e1t tu\u00e2n th\u1ee7 ph\u1ee5c v\u1ee5 vi\u1ec7c \u0111\u01b0a s\u1ea3n ph\u1ea9m v\u00e0o th\u1ecb tr\u01b0\u1eddng EU.<\/span><\/p>\n<h3><b>Kh\u00e1c nhau v\u1ec1 m\u1ee9c \u0111\u1ed9 chi ti\u1ebft v\u00e0 c\u00e1ch tri\u1ec3n khai<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">GMP EU th\u01b0\u1eddng chi ti\u1ebft h\u01a1n nh\u1edd h\u1ec7 th\u1ed1ng Annex, Q&amp;A v\u00e0 c\u00e1c k\u1ef3 v\u1ecdng r\u00f5 v\u1ec1 thi\u1ebft k\u1ebf, v\u1eadn h\u00e0nh, ki\u1ec3m so\u00e1t thay \u0111\u1ed5i, th\u1ea9m \u0111\u1ecbnh, gi\u00e1m s\u00e1t v\u00e0 c\u00e1ch ch\u1ee9ng minh tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> GMP WHO v\u1eabn bao tr\u00f9m c\u00e1c tr\u1ee5 c\u1ed9t t\u01b0\u01a1ng t\u1ef1, nh\u01b0ng c\u00e1ch th\u1ec3 hi\u1ec7n th\u01b0\u1eddng \u1edf m\u1ee9c nguy\u00ean t\u1eafc v\u00e0 h\u01b0\u1edbng d\u1eabn, \u0111\u1ec3 linh ho\u1ea1t \u00e1p d\u1ee5ng theo \u0111i\u1ec1u ki\u1ec7n t\u1eebng h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd qu\u1ed1c gia.<\/span><\/p>\n<h3><b>Kh\u00e1c nhau v\u1ec1 kh\u1ea3 n\u0103ng tra c\u1ee9u v\u00e0 ch\u1ee9ng nh\u1eadn<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">M\u1ed9t kh\u00e1c bi\u1ec7t th\u1ef1c d\u1ee5ng c\u1ee7a GMP EU l\u00e0 t\u00ednh minh b\u1ea1ch tra c\u1ee9u: EudraGMDP l\u00e0 c\u01a1 s\u1edf d\u1eef li\u1ec7u c\u1ed9ng \u0111\u1ed3ng v\u1ec1 gi\u1ea5y ph\u00e9p s\u1ea3n xu\u1ea5t, nh\u1eadp kh\u1ea9u v\u00e0 ch\u1ee9ng th\u01b0 GMP ho\u1eb7c GDP; b\u1ea3n c\u00f4ng khai c\u00f3 t\u1eeb n\u0103m 2011.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"> Ngo\u00e0i ch\u1ee9ng th\u01b0 tu\u00e2n th\u1ee7, c\u00e1c th\u00f4ng b\u00e1o kh\u00f4ng tu\u00e2n th\u1ee7 GMP c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c c\u00f4ng khai trong EudraGMDP, gi\u00fap b\u00ean li\u00ean quan \u0111\u00e1nh gi\u00e1 r\u1ee7i ro chu\u1ed7i cung \u1ee9ng v\u00e0 n\u0103ng l\u1ef1c tu\u00e2n th\u1ee7 c\u1ee7a m\u1ed9t site.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u1edbi GMP WHO, vi\u1ec7c tra c\u1ee9u ch\u1ee9ng nh\u1eadn th\u01b0\u1eddng ph\u1ee5 thu\u1ed9c c\u01a1 quan qu\u1ea3n l\u00fd c\u1ee7a t\u1eebng qu\u1ed1c gia v\u00e0 kh\u00f4ng c\u00f3 m\u1ed9t c\u01a1 s\u1edf d\u1eef li\u1ec7u to\u00e0n c\u1ea7u th\u1ed1ng nh\u1ea5t t\u01b0\u01a1ng t\u1ef1 EudraGMDP.<\/span><\/p>\n<h3><b>Kh\u00e1c nhau n\u1ed5i b\u1eadt v\u1edbi s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u1edbi v\u00f4 tr\u00f9ng, GMP EU Annex 1 nh\u1ea5n m\u1ea1nh qu\u1ea3n l\u00fd r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng \u00e1p d\u1ee5ng cho to\u00e0n b\u1ed9 h\u1ec7 th\u1ed1ng v\u00e0 y\u00eau c\u1ea7u c\u00e1c bi\u1ec7n ph\u00e1p tr\u1ecdng t\u00e2m nh\u01b0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m, c\u00f4ng ngh\u1ec7 h\u00e0ng r\u00e0o \u0111\u1ec3 gi\u1ea3m r\u1ee7i ro t\u1eeb con ng\u01b0\u1eddi v\u00e0 m\u00f4i tr\u01b0\u1eddng, c\u00f9ng gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng v\u00e0 gi\u00e1m s\u00e1t quy tr\u00ecnh theo xu h\u01b0\u1edbng.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">GMP WHO c\u0169ng c\u00f3 h\u01b0\u1edbng d\u1eabn cho v\u00f4 tr\u00f9ng v\u00e0 c\u00f3 b\u1ea3n c\u1eadp nh\u1eadt g\u1ea7n \u0111\u00e2y, trong \u0111\u00f3 WHO n\u00eau r\u00f5 t\u00e0i li\u1ec7u v\u00f4 tr\u00f9ng \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i v\u1edbi s\u1ef1 h\u1ee3p t\u00e1c c\u1ee7a EU v\u00e0 PIC\/S, ph\u1ea3n \u00e1nh xu h\u01b0\u1edbng h\u00e0i h\u00f2a.<\/span><\/p>\n<h3><b>B\u1ea3ng so s\u00e1nh t\u00f3m t\u1eaft GMP EU vs GMP WHO<\/b><\/h3>\n<p><b>B\u1ea3ng so s\u00e1nh t\u00f3m t\u1eaft GMP EU vs GMP WHO<\/b><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Ti\u00eau ch\u00ed<\/b><\/td>\n<td><b>GMP WHO <\/b><b><br \/>\n<\/b><b>(T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi)<\/b><\/td>\n<td><b>GMP EU <\/b><b><br \/>\n<\/b><b>(Li\u00ean minh Ch\u00e2u \u00c2u)<\/b><\/td>\n<\/tr>\n<tr>\n<td><b>Ph\u1ea1m vi<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u0110\u01b0\u1ee3c \u00e1p d\u1ee5ng r\u1ed9ng r\u00e3i t\u1ea1i h\u01a1n 100 qu\u1ed1c gia, \u0111\u1eb7c bi\u1ec7t ph\u1ed5 bi\u1ebfn \u1edf c\u00e1c n\u01b0\u1edbc \u0111ang ph\u00e1t tri\u1ec3n.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Th\u01b0\u1eddng \u0111\u01b0\u1ee3c xem l\u00e0 \u0111i\u1ec1u ki\u1ec7n quan tr\u1ecdng \u0111\u1ec3 ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng Ch\u00e2u \u00c2u, M\u1ef9 v\u00e0 c\u00e1c th\u1ecb tr\u01b0\u1eddng c\u00f3 y\u00eau c\u1ea7u kh\u1eaft khe.<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>T\u00ednh ch\u1ea5t ch\u1ebf<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u0110\u01b0a ra nguy\u00ean t\u1eafc chung; c\u00e1ch tri\u1ec3n khai c\u00f3 th\u1ec3 kh\u00e1c nhau gi\u1eefa c\u00e1c qu\u1ed1c gia.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Y\u00eau c\u1ea7u ch\u1eb7t ch\u1ebd h\u01a1n, \u0111\u1eb7c bi\u1ec7t v\u1ec1 th\u1ea9m \u0111\u1ecbnh v\u00e0 ki\u1ec3m so\u00e1t.<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>D\u1eef li\u1ec7u<\/b><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3 th\u1ec3 d\u1ef1a nhi\u1ec1u v\u00e0o h\u1ed3 s\u01a1 gi\u1ea5y, vi\u1ec7c ch\u1ec9nh s\u1eeda\/ki\u1ec3m so\u00e1t thay \u0111\u1ed5i t\u00f9y quy \u0111\u1ecbnh t\u1eebng qu\u1ed1c gia.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ki\u1ec3m so\u00e1t d\u1eef li\u1ec7u nghi\u00eam ng\u1eb7t; nh\u1ea5n m\u1ea1nh \u0111\u1ea3m b\u1ea3o to\u00e0n v\u1eb9n d\u1eef li\u1ec7u \u0111i\u1ec7n t\u1eed (data integrity).<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Thi\u1ebft b\u1ecb<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u00cdt t\u1eadp trung v\u00e0o giai \u0111o\u1ea1n \u0111\u1ea7u nh\u01b0 thi\u1ebft k\u1ebf v\u00e0 l\u1ef1a ch\u1ecdn v\u1eadt t\u01b0\/thi\u1ebft b\u1ecb.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Y\u00eau c\u1ea7u cao: c\u00f3 kh\u1ea3 n\u0103ng l\u01b0u tr\u1eef d\u1eef li\u1ec7u v\u1eadn h\u00e0nh, h\u1ed3 s\u01a1, t\u00e0i li\u1ec7u \u0111\u1ea7y \u0111\u1ee7 t\u1eeb URS \u0111\u1ebfn nghi\u1ec7m thu.<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>M\u1ee5c ti\u00eau<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u0110\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n thu\u1ed1c cho c\u00e1c th\u1ecb tr\u01b0\u1eddng n\u1ed9i \u0111\u1ecba\/\u0111ang ph\u00e1t tri\u1ec3n.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">N\u00e2ng cao uy t\u00edn, t\u0103ng c\u01a1 h\u1ed9i v\u00e0o th\u1ecb tr\u01b0\u1eddng cao c\u1ea5p v\u00e0 tham gia \u0111\u1ea5u th\u1ea7u.<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Ngu\u1ed3n g\u1ed1c<\/b><\/td>\n<td><span style=\"font-weight: 400;\">Ban h\u00e0nh b\u1edfi WHO.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ban h\u00e0nh b\u1edfi C\u01a1 quan Qu\u1ea3n l\u00fd D\u01b0\u1ee3c ph\u1ea9m Ch\u00e2u \u00c2u (EMA).<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><b>Nh\u00e0 m\u00e1y n\u00ean theo GMP EU hay GMP WHO<\/b><\/h2>\n<h3><b>Ch\u1ecdn theo m\u1ee5c ti\u00eau th\u1ecb tr\u01b0\u1eddng v\u00e0 m\u00f4 h\u00ecnh kinh doanh<\/b><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">N\u1ebfu m\u1ee5c ti\u00eau l\u00e0 cung \u1ee9ng v\u00e0o EU ho\u1eb7c l\u00e0m vi\u1ec7c v\u1edbi \u0111\u1ed1i t\u00e1c y\u00eau c\u1ea7u chu\u1ea9n EU, GMP EU th\u01b0\u1eddng l\u00e0 \u0111\u00edch c\u1ea7n h\u01b0\u1edbng t\u1edbi, v\u00ec nh\u00e0 s\u1ea3n xu\u1ea5t cho th\u1ecb tr\u01b0\u1eddng EU ph\u1ea3i tu\u00e2n th\u1ee7 GMP EU.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">N\u1ebfu m\u1ee5c ti\u00eau l\u00e0 chu\u1ea9n h\u00f3a n\u1ec1n t\u1ea3ng h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng theo khung qu\u1ed1c t\u1ebf v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c th\u1ecb tr\u01b0\u1eddng tham chi\u1ebfu WHO, GMP WHO l\u00e0 l\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p \u0111\u1ec3 x\u00e2y h\u1ec7 th\u1ed1ng c\u1ed1t l\u00f5i v\u00e0 t\u1ea1o \u0111i\u1ec3m t\u1ef1a cho n\u00e2ng c\u1ea5p sau.<\/span><\/li>\n<\/ul>\n<h3><b>Ch\u1ecdn theo danh m\u1ee5c s\u1ea3n ph\u1ea9m v\u00e0 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro<\/b><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nh\u00f3m s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng, ti\u00eam truy\u1ec1n, sinh h\u1ecdc th\u01b0\u1eddng k\u00e9o theo k\u1ef3 v\u1ecdng cao v\u1ec1 ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m, c\u00f4ng ngh\u1ec7 h\u00e0ng r\u00e0o, gi\u00e1m s\u00e1t v\u00e0 b\u1eb1ng ch\u1ee9ng tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t; v\u00ec v\u1eady l\u1ed9 tr\u00ecnh l\u00ean GMP EU th\u01b0\u1eddng \u0111\u00f2i h\u1ecfi \u0111\u1ea7u t\u01b0 h\u1ec7 th\u1ed1ng s\u00e2u h\u01a1n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nh\u00f3m kh\u00f4ng v\u00f4 tr\u00f9ng v\u1eabn c\u1ea7n h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng m\u1ea1nh, nh\u01b0ng tr\u1ecdng t\u00e2m \u0111\u1ea7u t\u01b0 c\u00f3 th\u1ec3 kh\u00e1c, \u01b0u ti\u00ean thi\u1ebft k\u1ebf ki\u1ec3m so\u00e1t nhi\u1ec5m ch\u00e9o, ki\u1ec3m so\u00e1t quy tr\u00ecnh v\u00e0 d\u1eef li\u1ec7u.<\/span><\/li>\n<\/ul>\n<h3><b>L\u1ed9 tr\u00ecnh th\u1ef1c t\u1ebf n\u1ebfu \u0111ang \u1edf WHO GMP v\u00e0 mu\u1ed1n n\u00e2ng l\u00ean EU GMP<\/b><\/h3>\n<figure id=\"attachment_9163\" aria-describedby=\"caption-attachment-9163\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9163\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-2.png\" alt=\"lo-trinh-nang-cap-who-gmp-len-eu-gmp\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-2.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-2-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-2-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-2-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9163\" class=\"wp-caption-text\"><em>3 giai \u0111o\u1ea1n n\u00e2ng c\u1ea5p t\u1eeb GMP WHO l\u00ean GMP EU, k\u00e8m c\u00e1c h\u1ea1ng m\u1ee5c \u01b0u ti\u00ean theo r\u1ee7i ro<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">M\u1ed9t l\u1ed9 tr\u00ecnh th\u1ef1c t\u1ebf th\u01b0\u1eddng \u0111i theo 3 c\u1ee5m c\u00f4ng vi\u1ec7c:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Giai \u0111o\u1ea1n 1: \u0111\u00e1nh gi\u00e1 kho\u1ea3ng c\u00e1ch v\u00e0 ch\u1ed1t ph\u1ea1m vi EU GMP c\u1ea7n \u0111\u1ea1t, \u0111\u1ed1i chi\u1ebfu v\u1edbi EudraLex Volume 4 v\u00e0 Annex li\u00ean quan<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Giai \u0111o\u1ea1n 2: n\u00e2ng h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 b\u1eb1ng ch\u1ee9ng v\u1eadn h\u00e0nh, t\u1eadp trung th\u1ea9m \u0111\u1ecbnh, ki\u1ec3m so\u00e1t thay \u0111\u1ed5i, d\u1eef li\u1ec7u v\u00e0 gi\u00e1m s\u00e1t<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Giai \u0111o\u1ea1n 3: ch\u1ea1y \u0111\u00e1nh gi\u00e1 th\u1eed, r\u00e0 so\u00e1t theo xu h\u01b0\u1edbng d\u1eef li\u1ec7u, \u0111\u00f3ng h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba tr\u01b0\u1edbc thanh tra<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Khung th\u1eddi gian ph\u1ee5 thu\u1ed9c hi\u1ec7n tr\u1ea1ng, ph\u1ea1m vi s\u1ea3n ph\u1ea9m v\u00e0 m\u1ee9c \u0111\u1ea7u t\u01b0, n\u00ean t\u1ed1t nh\u1ea5t b\u1ea1n x\u00e2y k\u1ebf ho\u1ea1ch theo r\u1ee7i ro v\u00e0 theo giai \u0111o\u1ea1n thay v\u00ec c\u1ed1 \u00e9p m\u1ed9t m\u1ed1c c\u1ed1 \u0111\u1ecbnh.<\/span><\/p>\n<h2><b>K\u1ebft lu\u1eadn<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">GMP EU vs GMP WHO kh\u00e1c nhau ch\u1ee7 y\u1ebfu \u1edf 3 \u0111i\u1ec3m: b\u1ed1i c\u1ea3nh qu\u1ea3n l\u00fd, m\u1ee9c \u0111\u1ed9 chi ti\u1ebft v\u00e0 m\u1ee5c ti\u00eau th\u1ecb tr\u01b0\u1eddng. N\u1ebfu m\u1ee5c ti\u00eau l\u00e0 EU, b\u1ea1n c\u1ea7n b\u00e1m GMP EU trong EudraLex Volume 4 v\u00e0 c\u00e1c Annex li\u00ean quan, Theo <a href=\"https:\/\/sepro.vn\/\"><strong>Sepro<\/strong><\/a> n\u1ebfu m\u1ee5c ti\u00eau l\u00e0 x\u00e2y n\u1ec1n t\u1ea3ng qu\u1ed1c t\u1ebf linh ho\u1ea1t, GMP WHO l\u00e0 \u0111i\u1ec3m kh\u1edfi \u0111\u1ea7u t\u1ed1t. B\u01b0\u1edbc ti\u1ebfp theo mang t\u00ednh gi\u00e1o d\u1ee5c v\u00e0 th\u1ef1c d\u1ee5ng nh\u1ea5t l\u00e0 \u0111\u1ecdc t\u00e0i li\u1ec7u g\u1ed1c, l\u1eadp checklist gap theo r\u1ee7i ro, v\u00e0 \u01b0u ti\u00ean c\u00e1c m\u1ea3ng th\u01b0\u1eddng t\u1ea1o kho\u1ea3ng c\u00e1ch l\u1edbn nh\u01b0 v\u00f4 tr\u00f9ng, th\u1ea9m \u0111\u1ecbnh v\u00e0 d\u1eef li\u1ec7u.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ngu\u1ed3n ch\u00ednh th\u1ed1ng n\u00ean \u0111\u1ecdc:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><strong><a href=\"https:\/\/www.who.int\/publications\/m\/item\/trs986-annex2#:~:text=Annex%202%20of%20the%20WHO%20Technical%20Report,of%20pharmaceutical%20products%20moving%20in%20international%20commerce.\" target=\"_blank\" rel=\"noopener\">WHO TRS 986 Annex 2 v\u1ec1 GMP WHO<\/a><\/strong><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><strong><a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noopener\">EU EudraLex Volume 4<\/a><\/strong><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><strong><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/20220825_gmp-an1_en_0.pdf\" target=\"_blank\" rel=\"noopener\">EU GMP Annex 1 b\u1ea3n 2022\u00a0<\/a><\/strong><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>B\u00e0i vi\u1ebft mang t\u00ednh tham kh\u1ea3o \u0111\u1ec3 \u0111\u1ecbnh h\u01b0\u1edbng so s\u00e1nh GMP EU vs GMP WHO. Khi \u00e1p d\u1ee5ng th\u1ef1c t\u1ebf, lu\u00f4n \u01b0u ti\u00ean \u0111\u1ecdc b\u1ea3n h\u01b0\u1edbng d\u1eabn ch\u00ednh th\u1ed1ng v\u00e0 y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd n\u01a1i b\u1ea1n \u0111\u0103ng k\u00fd ho\u1eb7c cung \u1ee9ng s\u1ea3n ph\u1ea9m. GMP EU vs GMP WHO: Gi\u1ed1ng v\u00e0 kh\u00e1c &hellip; <a href=\"https:\/\/sepro.vn\/vi\/gmp-eu-vs-gmp-who-huong-dan-nha-may\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">GMP EU vs GMP WHO: H\u01b0\u1edbng D\u1eabn L\u1ef1a Ch\u1ecdn Cho Doanh Nghi\u1ec7p<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":9175,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9160","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9160","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9160"}],"version-history":[{"count":3,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9160\/revisions"}],"predecessor-version":[{"id":9174,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9160\/revisions\/9174"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9175"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9160"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9160"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9160"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}