{"id":9127,"date":"2026-02-03T10:14:59","date_gmt":"2026-02-03T10:14:59","guid":{"rendered":"https:\/\/sepro.vn\/?p=9127"},"modified":"2026-07-23T06:33:23","modified_gmt":"2026-07-22T23:33:23","slug":"gmp-eu-annex-1-la-gi","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/","title":{"rendered":"GMP EU Annex 1 L\u00e0 G\u00ec? Nh\u1eefng \u0110i\u1ec1u Nh\u00e0 M\u00e1y D\u01b0\u1ee3c C\u1ea7n Bi\u1ebft"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_62 ez-toc-wrap-center counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#GMP_EU_La_Gi_Va_Nam_O_Dau_Trong_He_Thong_Quy_Dinh_EU\" title=\"GMP EU L\u00e0 G\u00ec V\u00e0 N\u1eb1m \u1ede \u0110\u00e2u Trong H\u1ec7 Th\u1ed1ng Quy \u0110\u1ecbnh EU\">GMP EU L\u00e0 G\u00ec V\u00e0 N\u1eb1m \u1ede \u0110\u00e2u Trong H\u1ec7 Th\u1ed1ng Quy \u0110\u1ecbnh EU<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#GMP_EU_Annex_1_La_Gi_Va_Lien_Quan_Gi_Den_San_Xuat_Vo_Trung\" title=\"GMP EU Annex 1 L\u00e0 G\u00ec V\u00e0 Li\u00ean Quan G\u00ec \u0110\u1ebfn S\u1ea3n Xu\u1ea5t V\u00f4 Tr\u00f9ng\">GMP EU Annex 1 L\u00e0 G\u00ec V\u00e0 Li\u00ean Quan G\u00ec \u0110\u1ebfn S\u1ea3n Xu\u1ea5t V\u00f4 Tr\u00f9ng<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#EMA_La_Gi_Va_Vai_Tro_Cua_EMA_Trong_Hoat_Dong_GMP\" title=\"EMA L\u00e0 G\u00ec V\u00e0 Vai Tr\u00f2 C\u1ee7a EMA Trong Ho\u1ea1t \u0110\u1ed9ng GMP\">EMA L\u00e0 G\u00ec V\u00e0 Vai Tr\u00f2 C\u1ee7a EMA Trong Ho\u1ea1t \u0110\u1ed9ng GMP<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#FDA_La_Gi_Va_Vai_Tro_Cua_FDA_Trong_Hoat_Dong_GMP\" title=\"FDA L\u00e0 G\u00ec V\u00e0 Vai Tr\u00f2 C\u1ee7a FDA Trong Ho\u1ea1t \u0110\u1ed9ng GMP ?\">FDA L\u00e0 G\u00ec V\u00e0 Vai Tr\u00f2 C\u1ee7a FDA Trong Ho\u1ea1t \u0110\u1ed9ng GMP ?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#Chung_Nhan_GMP_EU_Va_Chung_Chi_GMP_La_Gi\" title=\"Ch\u1ee9ng Nh\u1eadn GMP EU V\u00e0 Ch\u1ee9ng Ch\u1ec9 GMP L\u00e0 G\u00ec\">Ch\u1ee9ng Nh\u1eadn GMP EU V\u00e0 Ch\u1ee9ng Ch\u1ec9 GMP L\u00e0 G\u00ec<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#Cach_De_Dat_GMP_EU_Cho_Nha_May_GMP\" title=\"C\u00e1ch \u0110\u1ec3 \u0110\u1ea1t GMP EU Cho Nh\u00e0 M\u00e1y GMP\">C\u00e1ch \u0110\u1ec3 \u0110\u1ea1t GMP EU Cho Nh\u00e0 M\u00e1y GMP<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#Hay_Chuan_Bi_Cac_Nhom_Ho_So_Sau\" title=\"H\u00e3y Chu\u1ea9n B\u1ecb C\u00e1c Nh\u00f3m H\u1ed3 S\u01a1 Sau\">H\u00e3y Chu\u1ea9n B\u1ecb C\u00e1c Nh\u00f3m H\u1ed3 S\u01a1 Sau<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#GMP_WHO_Va_GMP_EU_Khac_Nhau_The_Nao\" title=\"GMP WHO V\u00e0 GMP EU Kh\u00e1c Nhau Th\u1ebf N\u00e0o\">GMP WHO V\u00e0 GMP EU Kh\u00e1c Nhau Th\u1ebf N\u00e0o<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#Loi_The_Cua_Nha_May_Dat_Chung_Nhan_GMP_EU\" title=\"L\u1ee3i Th\u1ebf C\u1ee7a Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU\">L\u1ee3i Th\u1ebf C\u1ee7a Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#Danh_Sach_Nha_May_Dat_GMP_EU_O_Viet_Nam_Va_Cach_Tra_Cuu\" title=\"Danh S\u00e1ch Nh\u00e0 M\u00e1y \u0110\u1ea1t GMP EU \u1ede Vi\u1ec7t Nam V\u00e0 C\u00e1ch Tra C\u1ee9u\">Danh S\u00e1ch Nh\u00e0 M\u00e1y \u0110\u1ea1t GMP EU \u1ede Vi\u1ec7t Nam V\u00e0 C\u00e1ch Tra C\u1ee9u<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#FAQ_%E2%80%93_GMP_EU_Good_Manufacturing_Practices_%E2%80%93_European_Union_Annex_1\" title=\"FAQ &#8211; GMP EU (Good Manufacturing Practices \u2013 European Union) Annex 1\">FAQ &#8211; GMP EU (Good Manufacturing Practices \u2013 European Union) Annex 1<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/#Tam_Ket\" title=\"T\u1ea1m K\u1ebft\">T\u1ea1m K\u1ebft<\/a><\/li><\/ul><\/nav><\/div>\n<p>GMP EU l\u00e0 b\u1ed9 ti\u00eau chu\u1ea9n Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u, \u00e1p d\u1ee5ng cho m\u1ecdi nh\u00e0 m\u00e1y d\u01b0\u1ee3c mu\u1ed1n cung \u1ee9ng v\u00e0o th\u1ecb tr\u01b0\u1eddng EU \u2013 b\u1ea5t k\u1ec3 \u0111\u1eb7t \u1edf qu\u1ed1c gia n\u00e0o.<\/p>\n<p>\u1ede b\u00e0i vi\u1ebft n\u00e0y <a href=\"https:\/\/sepro.vn\/\"><strong>Sepro<\/strong><\/a> gi\u1ea3i th\u00edch GMP EU Annex 1 l\u00e0 g\u00ec, vai tr\u00f2 c\u1ee7a EMA,vai tr\u00f2 c\u1ee7a FDA, \u0111i\u1ec3m m\u1ea5u ch\u1ed1t trong Annex 1 v\u1ec1 s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng (CCS, QRM), c\u00e1ch ph\u00e2n bi\u1ec7t v\u1edbi GMP WHO, l\u1ed9 tr\u00ecnh 6 b\u01b0\u1edbc \u0111\u1ec3 \u0111\u1ea1t ch\u1ee9ng nh\u1eadn, c\u00f9ng c\u00e1ch tra c\u1ee9u ch\u1ee9ng th\u01b0 GMP EU tr\u00ean EudraGMDP cho c\u00e1c nh\u00e0 m\u00e1y t\u1ea1i Vi\u1ec7t Nam.<\/p>\n<h2 data-path-to-node=\"4\"><span class=\"ez-toc-section\" id=\"GMP_EU_La_Gi_Va_Nam_O_Dau_Trong_He_Thong_Quy_Dinh_EU\"><\/span>GMP EU L\u00e0 G\u00ec V\u00e0 N\u1eb1m \u1ede \u0110\u00e2u Trong H\u1ec7 Th\u1ed1ng Quy \u0110\u1ecbnh EU<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9140\" aria-describedby=\"caption-attachment-9140\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9140\" 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\" \/><figcaption id=\"caption-attachment-9140\" class=\"wp-caption-text\"><em>GMP EU l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<p><strong><a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noopener\">GMP &#8211; EU (Good Manufacturing Practices \u2013 European Union)<\/a><\/strong><span style=\"font-weight: 400;\"> l\u00e0 b\u1ed9 h\u01b0\u1edbng d\u1eabn Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t theo ti\u00eau chu\u1ea9n c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u, d\u00f9ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o thu\u1ed1c \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng m\u1ed9t c\u00e1ch ch\u1eb7t ch\u1ebd v\u00e0 nh\u1ea5t qu\u00e1n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m quan tr\u1ecdng v\u1edbi nh\u00e0 m\u00e1y l\u00e0 GMP &#8211; EU kh\u00f4ng ch\u1ec9 \u00e1p d\u1ee5ng cho c\u01a1 s\u1edf trong EU\/EEA. <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>EMA n\u00eau r\u00f5<\/strong> 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, d\u00f9 \u0111\u1eb7t \u1edf b\u1ea5t k\u1ef3 qu\u1ed1c gia n\u00e0o.<\/span><\/p>\n<h2 data-path-to-node=\"9\"><span class=\"ez-toc-section\" id=\"GMP_EU_Annex_1_La_Gi_Va_Lien_Quan_Gi_Den_San_Xuat_Vo_Trung\"><\/span>GMP EU Annex 1 L\u00e0 G\u00ec V\u00e0 Li\u00ean Quan G\u00ec \u0110\u1ebfn S\u1ea3n Xu\u1ea5t V\u00f4 Tr\u00f9ng<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9128\" aria-describedby=\"caption-attachment-9128\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9128\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3.png\" alt=\"gmp-eu-annex-1-la-gi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9128\" class=\"wp-caption-text\"><em>GMP EU Annex 1 l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\"><strong>GMP EU Annex 1<\/strong> l\u00e0 ph\u1ee5 l\u1ee5c h\u01b0\u1edbng d\u1eabn ri\u00eang cho s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c v\u00f4 tr\u00f9ng l\u00e0 phi\u00ean b\u1ea3n m\u1edbi nh\u1ea5t m\u00e0 <strong>Sepro <\/strong>thu th\u1eadp \u0111\u01b0\u1ee3c.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Trang th\u00f4ng b\u00e1o c\u1ee7a \u1ee6y ban ch\u00e2u \u00c2u cho bi\u1ebft <strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/revision-manufacture-sterile-medicinal-products-2022-08-25_en\" target=\"_blank\" rel=\"noopener\">Annex 1 (phi\u00ean b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ec9nh s\u1eeda)<\/a><\/strong><\/span><span style=\"font-weight: 400;\">:<\/span><\/p>\n<blockquote>\n<ul>\n<li>H\u1ea7u h\u1ebft c\u00e1c quy \u0111\u1ecbnh trong t\u00e0i li\u1ec7u n\u00e0y b\u1eaft \u0111\u1ea7u c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb ng\u00e0y <strong>25 th\u00e1ng 8 n\u0103m 2023<\/strong><\/li>\n<li>Ri\u00eang m\u1ee5c<strong> 8.123 (v\u1ec1 vi\u1ec7c \u0111\u00f4ng kh\u00f4)<\/strong> \u0111\u01b0\u1ee3c ho\u00e3n th\u1eddi h\u1ea1n \u00e1p d\u1ee5ng \u0111\u1ebfn ng\u00e0y<strong> 25 th\u00e1ng 8 n\u0103m 2024<\/strong><\/li>\n<\/ul>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Tr\u1ecdng t\u00e2m c\u1ee7a Annex 1 l\u00e0 \u00e1p d\u1ee5ng nguy\u00ean t\u1eafc <\/span><b>Qu\u1ea3n l\u00fd r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng (QRM)<\/b><span style=\"font-weight: 400;\"> l\u00e0m n\u1ec1n t\u1ea3ng \u0111\u1ec3 x\u00e2y d\u1ef1ng m\u1ed9t <\/span><b>Chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m (CCS)<\/b><span style=\"font-weight: 400;\"> to\u00e0n di\u1ec7n cho to\u00e0n b\u1ed9 c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng. <\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">CCS (Contamination Control Strategy) kh\u00f4ng ch\u1ec9 l\u00e0 1 lo\u1ea1i t\u00e0i li\u1ec7u m\u00e0 c\u00f2n l\u00e0 1 b\u1ed9 khung qu\u1ea3n tr\u1ecb v\u1eadn h\u00e0nh gi\u00fap c\u00e1c nh\u00e0 m\u00e1y \u0111\u1ea1t \u0111\u01b0\u1ee3c m\u1ee5c ti\u00eau: ki\u1ec3m so\u00e1t ngu\u1ed3n \u00f4 nhi\u1ec5m t\u1eeb con ng\u01b0\u1eddi, m\u00f4i tr\u01b0\u1eddng, thi\u1ebft b\u1ecb, nguy\u00ean li\u1ec7u v\u00e0 quy tr\u00ecnh.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">V\u00ec v\u1eady 1 CCS \u0111\u1ea1t chu\u1ea9n c\u1ea7n: <\/span><br \/>\n<blockquote><p><span style=\"font-weight: 400;\">X\u00e1c \u0111\u1ecbnh \u0111i\u1ec3m c\u1ea7n ki\u1ec3m so\u00e1t \u0111\u00e3 \u0111\u1ea1t t\u1edbi gi\u1edbi h\u1ea1n &#8211; Ch\u1ee9ng minh hi\u1ec7u l\u1ef1c b\u1eb1ng d\u1eef li\u1ec7u &#8211; R\u00e0 so\u00e1t \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 c\u1ea3i ti\u1ebfn.<\/span><\/p><\/blockquote>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Nh\u1eefng ch\u1ee7 \u0111\u1ec1 th\u01b0\u1eddng \u0111\u01b0\u1ee3c \u0111o\u00e0n thanh tra ho\u1eb7c \u0111\u1ed1i t\u00e1c th\u1ea9m \u0111\u1ecbnh t\u1eadp trung \u0111\u00e1nh gi\u00e1 (\u00e1p d\u1ee5ng cho QA, s\u1ea3n xu\u1ea5t, k\u1ef9 thu\u1eadt, vi sinh, validation, qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 c\u1ea3 ban \u0111i\u1ec1u h\u00e0nh) g\u1ed3m:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><strong>CCS v\u00e0 s\u1ef1 li\u00ean k\u1ebft h\u1ec7 th\u1ed1ng<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CCS c\u1ea7n k\u1ebft n\u1ed1i v\u1edbi :<\/span>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u00e1c thi\u1ebft k\u1ebf nh\u00e0 x\u01b0\u1edfng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">HVAC<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lu\u1ed3ng ng\u01b0\u1eddi v\u1eadt<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V\u1ec7 sinh kh\u1eed khu\u1ea9n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng theo xu h\u01b0\u1edbng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ch\u01b0\u01a1ng tr\u00ecnh m\u00f4 ph\u1ecfng quy tr\u00ecnh v\u00f4 tr\u00f9ng (APS)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Qu\u1ea3n l\u00fd sai l\u1ec7ch<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CAPA. <\/span><\/li>\n<\/ol>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u1ee5c ti\u00eau l\u00e0 ch\u1ee9ng minh ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m kh\u00f4ng n\u1eb1m r\u1eddi r\u1ea1c \u1edf <a href=\"https:\/\/sepro.vn\/vi\/sop-la-gi-trong-nganh-duoc-dinh-nghia\/\"><strong>t\u1eebng SOP<\/strong><\/a>, m\u00e0 v\u1eadn h\u00e0nh nh\u01b0 m\u1ed9t h\u1ec7 th\u1ed1ng th\u1ed1ng nh\u1ea5t.<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><strong>Gi\u1ea3i ph\u00e1p ph\u00f2ng s\u1ea1ch v\u00e0 gi\u1ea3m thi\u1ec3u s\u1ef1 can thi\u1ec7p c\u1ee7a con ng\u01b0\u1eddi<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Annex 1 khuy\u1ebfn kh\u00edch c\u00e2n nh\u1eafc c\u00e1c gi\u1ea3i ph\u00e1p nh\u01b0 RABS, isolator v\u00e0 t\u1ef1 \u0111\u1ed9ng h\u00f3a <strong>nh\u1eb1m gi\u1ea3m r\u1ee7i ro t\u1eeb thao t\u00e1c c\u1ee7a con ng\u01b0\u1eddi v\u00e0 bi\u1ebfn \u0111\u1ed9ng m\u00f4i tr\u01b0\u1eddng<\/strong><\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tr\u1ecdng t\u00e2m l\u00e0 gi\u1ea3m can thi\u1ec7p, t\u1ef1 \u0111\u1ed9ng h\u00f3a v\u00e0 c\u00f3 c\u01a1 s\u1edf <strong>\u0111\u00e1nh gi\u00e1 r\u1ee7i ro r\u00f5 r\u00e0ng khi ch\u1ecdn thi\u1ebft k\u1ebf v\u00e0 c\u00e1ch v\u1eadn h\u00e0nh.<\/strong><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><strong>Gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng v\u00e0 gi\u00e1m s\u00e1t quy tr\u00ecnh<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u1ea7n thi\u1ebft l\u1eadp ng\u01b0\u1ee1ng c\u1ea3nh b\u00e1o v\u00e0 ng\u01b0\u1ee1ng h\u00e0nh \u0111\u1ed9ng, c\u00f3 c\u00e1ch ph\u1ea3n \u1ee9ng khi v\u01b0\u1ee3t ng\u01b0\u1ee1ng ki\u1ec3m so\u00e1t v\u00e0 <strong>quan tr\u1ecdng l\u00e0 c\u00f3 ph\u00e2n t\u00edch xu h\u01b0\u1edbng<\/strong> theo th\u1eddi gian \u0111\u1ec3 ph\u00e1t hi\u1ec7n v\u1ea5n \u0111\u1ec1 tr\u01b0\u1edbc khi th\u00e0nh sai l\u1ec7ch l\u1edbn.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2 data-path-to-node=\"22\"><span class=\"ez-toc-section\" id=\"EMA_La_Gi_Va_Vai_Tro_Cua_EMA_Trong_Hoat_Dong_GMP\"><\/span>EMA L\u00e0 G\u00ec V\u00e0 Vai Tr\u00f2 C\u1ee7a EMA Trong Ho\u1ea1t \u0110\u1ed9ng GMP<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9130\" aria-describedby=\"caption-attachment-9130\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9130\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4.png\" alt=\"ema-vai-tro-thanh-tra-gmp\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9130\" class=\"wp-caption-text\"><em>EMA ph\u1ed1i h\u1ee3p thanh tra GMP c\u00f9ng c\u01a1 quan th\u1ea9m quy\u1ec1n qu\u1ed1c gia EU<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\"><strong><a href=\"https:\/\/sepro.vn\/vi\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/\">EMA (European Medicines Agency)<\/a><\/strong> l\u00e0 C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m ch\u00e2u \u00c2u. V\u1edbi GMP, EMA c\u00f3 vai tr\u00f2 \u0111i\u1ec1u ph\u1ed1i to\u00e0n b\u1ed9 ho\u1ea1t \u0111\u1ed9ng h\u1ec7 th\u1ed1ng GMP \u1edf c\u1ea5p EU.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ngo\u00e0i ra, EMA duy tr\u00ec nh\u00f3m l\u00e0m vi\u1ec7c GMP\/GDP Inspectors Working Group, n\u01a1i th\u1ed1ng nh\u1ea5t di\u1ec5n gi\u1ea3i v\u00e0 Q&amp;A nh\u1eb1m gi\u1ea3i quy\u1ebft c\u00e1c v\u1ea5n \u0111\u1ec1 c\u1ee7a nh\u00e0 m\u00e1y.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FDA_La_Gi_Va_Vai_Tro_Cua_FDA_Trong_Hoat_Dong_GMP\"><\/span>FDA L\u00e0 G\u00ec V\u00e0 Vai Tr\u00f2 C\u1ee7a FDA Trong Ho\u1ea1t \u0110\u1ed9ng GMP ?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_13716\" aria-describedby=\"caption-attachment-13716\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13716\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/Tieu-chuan-vi-sinh-phong-sach.png\" alt=\"Tr\u1ee5 s\u1edf FDA Hoa K\u1ef3 minh h\u1ecda vai tr\u00f2 qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m v\u00e0 GMP\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/Tieu-chuan-vi-sinh-phong-sach.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/Tieu-chuan-vi-sinh-phong-sach-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/Tieu-chuan-vi-sinh-phong-sach-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/Tieu-chuan-vi-sinh-phong-sach-80x80.png 80w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/Tieu-chuan-vi-sinh-phong-sach-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-13716\" class=\"wp-caption-text\">FDA l\u00e0 c\u01a1 quan qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m, sinh ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3<\/figcaption><\/figure>\n<p><strong><a href=\"https:\/\/sepro.vn\/vi\/fda-la-gi-vai-tro-va-quy-dinh-trong-nganh-duoc\/\">FDA (U.S. Food and Drug Administration) <\/a><\/strong>l\u00e0 C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3. FDA ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng th\u00f4ng qua vi\u1ec7c qu\u1ea3n l\u00fd thu\u1ed1c, sinh ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, th\u1ef1c ph\u1ea9m, m\u1ef9 ph\u1ea9m v\u00e0 m\u1ed9t s\u1ed1 nh\u00f3m s\u1ea3n ph\u1ea9m kh\u00e1c t\u1ea1i th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n<p>Trong b\u1ed1i c\u1ea3nh GMP, FDA c\u00f3 vai tr\u00f2 thanh tra, gi\u00e1m s\u00e1t v\u00e0 \u0111\u00e1nh gi\u00e1 vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u s\u1ea3n xu\u1ea5t, ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 d\u1eef li\u1ec7u c\u1ee7a nh\u00e0 m\u00e1y n\u1ebfu s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u1ebfn th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n<p>N\u00f3i ng\u1eafn g\u1ecdn, <strong>EMA g\u1eafn v\u1edbi h\u1ec7 th\u1ed1ng EU, c\u00f2n FDA g\u1eafn v\u1edbi th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3<\/strong>.<\/p>\n<h2 data-path-to-node=\"26\"><span class=\"ez-toc-section\" id=\"Chung_Nhan_GMP_EU_Va_Chung_Chi_GMP_La_Gi\"><\/span>Ch\u1ee9ng Nh\u1eadn GMP EU V\u00e0 Ch\u1ee9ng Ch\u1ec9 GMP L\u00e0 G\u00ec<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9132\" aria-describedby=\"caption-attachment-9132\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9132\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5.png\" alt=\"chung-nhan-chung-chi-gmp-eu\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9132\" class=\"wp-caption-text\"><em>Ch\u1ee9ng nh\u1eadn &amp; Ch\u1ee9ng Ch\u1ec9 GMP EU<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Ch\u1ee9ng nh\u1eadn GMP EU th\u01b0\u1eddng \u0111\u01b0\u1ee3c hi\u1ec3u \u0111\u01a1n gi\u1ea3n l\u00e0 <strong>m\u1ed9t GMP certificate<\/strong> c\u1ea5p cho t\u1eebng nh\u00e0 m\u00e1y sau khi \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n thanh tra v\u00e0 x\u00e1c nh\u1eadn tu\u00e2n th\u1ee7. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Tr\u00ean ch\u1ee9ng nh\u1eadn n\u00e0y s\u1ebd ghi r\u00f5 \u0111\u1ecba \u0111i\u1ec3m, ph\u1ea1m vi ho\u1ea1t \u0111\u1ed9ng \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 <\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">V\u00ed d\u1ee5: s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i, ki\u1ec3m nghi\u1ec7m, d\u1ea1ng b\u00e0o ch\u1ebf\u2026 v\u00e0 th\u00f4ng tin li\u00ean quan \u0111\u1ebfn \u0111\u1ee3t thanh tra. <\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">C\u00e1c d\u1eef li\u1ec7u n\u00e0y \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt v\u00e0 l\u01b0u tr\u00ean c\u01a1 s\u1edf d\u1eef li\u1ec7u <strong>EudraGMDP<\/strong> (h\u1ec7 th\u1ed1ng tra c\u1ee9u gi\u1ea5y ph\u00e9p s\u1ea3n xu\u1ea5t\/nh\u1eadp kh\u1ea9u v\u00e0 ch\u1ee9ng th\u01b0 GMP\/GDP).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m c\u1ea7n nh\u1edb \u0111\u1ec3 tr\u00e1nh hi\u1ec3u nh\u1ea7m:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Ch\u1ee9ng ch\u1ec9 GMP kh\u00f4ng \u00e1p d\u1ee5ng chung cho to\u00e0n doanh nghi\u1ec7p.<\/strong> N\u00f3 g\u1eafn v\u1edbi t\u1eebng \u0111\u1ecba \u0111i\u1ec3m c\u1ee5 th\u1ec3 v\u00e0 ph\u1ea1m vi c\u1ee5 th\u1ec3 \u0111\u00e3 \u0111\u01b0\u1ee3c thanh tra.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>N\u1ebfu doanh nghi\u1ec7p c\u00f3 nhi\u1ec1u nh\u00e0 m\u00e1y<\/strong>, m\u1ed7i nh\u00e0 m\u00e1y c\u00f3 th\u1ec3 c\u00f3 c\u00e1c ch\u1ee9ng nh\u1eadn v\u00e0 ph\u1ea1m vi kh\u00e1c nhau.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>N\u1ebfu c\u01a1 s\u1edf kh\u00f4ng \u0111\u00e1p \u1ee9ng \u0111\u1ee7 c\u00e1c y\u00eau c\u1ea7u<\/strong>, c\u01a1 quan thanh tra c\u00f3 th\u1ec3 ban h\u00e0nh th\u00f4ng b\u00e1o kh\u00f4ng tu\u00e2n th\u1ee7 v\u00e0 th\u00f4ng tin n\u00e0y c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ghi nh\u1eadn trong h\u1ec7 th\u1ed1ng.<\/span><\/li>\n<\/ul>\n<blockquote><p><b data-path-to-node=\"7,0\" data-index-in-node=\"1\">Tips nh\u1ecf:<\/b> Nh\u1eadn ch\u1ee9ng ch\u1ec9 m\u1edbi ch\u1ec9 l\u00e0 b\u01b0\u1edbc \u0111\u1ea7u, vi\u1ec7c duy tr\u00ec tu\u00e2n th\u1ee7 li\u00ean t\u1ee5c theo \u0111\u00fang tinh th\u1ea7n cGMP m\u1edbi l\u00e0 y\u1ebfu t\u1ed1 quy\u1ebft \u0111\u1ecbnh. B\u1ea1n c\u00f3 th\u1ec3 xem th\u00eam b\u00e0i vi\u1ebft <a href=\"https:\/\/sepro.vn\/vi\/cgmp-la-gi-tu-dinh-nghia-den-van-hanh-thuc-te\/\"><b data-path-to-node=\"7,0\" data-index-in-node=\"158\">cGMP L\u00e0 G\u00ec? T\u1eeb \u0110\u1ecbnh Ngh\u0129a \u0110\u1ebfn V\u1eadn H\u00e0nh Th\u1ef1c T\u1ebf<\/b><\/a> \u0111\u1ec3 n\u1eafm tr\u1ecdn b\u1ed9 b\u1ee9c tranh v\u1eadn h\u00e0nh nh\u00e9!<\/p><\/blockquote>\n<h2 data-path-to-node=\"32\"><span class=\"ez-toc-section\" id=\"Cach_De_Dat_GMP_EU_Cho_Nha_May_GMP\"><\/span>C\u00e1ch \u0110\u1ec3 \u0110\u1ea1t GMP EU Cho Nh\u00e0 M\u00e1y GMP<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9134\" aria-describedby=\"caption-attachment-9134\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9134\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6.png\" alt=\"cach-dat-chung-chi-gmp-eu\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9134\" class=\"wp-caption-text\"><em>C\u00e1ch \u0111\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c ch\u1ee9ng ch\u1ec9 GMP EU<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\"><strong>L\u1ed9 tr\u00ecnh \u0111\u1ea1t GMP EU kh\u00f4ng c\u00f3 b\u01b0\u1edbc t\u1eaft<\/strong>, nh\u01b0ng th\u1ef1c t\u1ebf th\u01b0\u1eddng \u0111i theo 6 b\u01b0\u1edbc sau \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o l\u00e0m \u0111\u00fang v\u00e0 \u0111\u1ee7 b\u1eb1ng ch\u1ee9ng.<\/span><\/p>\n<h3 data-path-to-node=\"34\">L\u1ed9 Tr\u00ecnh 6 B\u01b0\u1edbc \u0110\u1ec3 H\u01b0\u1edbng T\u1edbi GMP EU<\/h3>\n<ol>\n<li><b>X\u00e1c \u0111\u1ecbnh ph\u1ea1m vi m\u1ee5c ti\u00eau<\/b>\n<ul>\n<li><span style=\"font-weight: 400;\"><strong>L\u00e0m r\u00f5 nh\u00e0 m\u00e1y c\u1ea7n \u0111\u00e1p \u1ee9ng GMP EU<\/strong> cho d\u1ea1ng thu\u1ed1c n\u00e0o, c\u00f3 s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng hay kh\u00f4ng, m\u1ee5c ti\u00eau l\u00e0 xu\u1ea5t kh\u1ea9u v\u00e0o EU hay ch\u1ec9 ph\u1ee5c v\u1ee5 h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd v\u00e0 th\u1ea9m \u0111\u1ecbnh c\u1ee7a \u0111\u1ed1i t\u00e1c.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><b>\u0110\u00e1nh gi\u00e1 kho\u1ea3ng c\u00e1ch so v\u1edbi y\u00eau c\u1ea7u GMP EU<\/b>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c t\u1ebf c\u1ee7a nh\u00e0 m\u00e1y so v\u1edbi EudraLex Volume 4<\/b><span style=\"font-weight: 400;\"> v\u00e0 c\u00e1c ph\u1ee5 l\u1ee5c li\u00ean quan \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh nh\u1eefng \u0111i\u1ec3m nh\u00e0 m\u00e1y c\u00f2n thi\u1ebfu ho\u1eb7c ch\u01b0a \u0111\u00e1p \u1ee9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>N\u1ebfu c\u00f3 s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng, c\u1ea7n \u01b0u ti\u00ean Annex 1<\/b><span style=\"font-weight: 400;\"> v\u00ec y\u00eau c\u1ea7u c\u1ee7a ph\u1ee5 l\u1ee5c n\u00e0y \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn thi\u1ebft k\u1ebf khu v\u1ef1c s\u1ea1ch, c\u00e1ch v\u1eadn h\u00e0nh d\u00e2y chuy\u1ec1n v\u00e0 ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t, ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n<\/span><\/li>\n<\/ul>\n<\/li>\n<li><b>L\u1eadp k\u1ebf ho\u1ea1ch t\u1ed5ng th\u1ec3 theo r\u1ee7i ro<\/b>\n<ul>\n<li><span style=\"font-weight: 400;\">X\u00e2y d\u1ef1ng k\u1ebf ho\u1ea1ch t\u1ed5ng th\u1ec3, bao qu\u00e1t c\u00e1c h\u1ea1ng m\u1ee5c tr\u1ecdng y\u1ebfu g\u1ed3m:<\/span>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Thi\u1ebft k\u1ebf nh\u00e0 x\u01b0\u1edfng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng HVAC<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng n\u01b0\u1edbc<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ch\u01b0\u01a1ng tr\u00ecnh v\u1ec7 sinh v\u00e0 kh\u1eed khu\u1ea9n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u00e0o t\u1ea1o nh\u00e2n s\u1ef1<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Qu\u1ea3n l\u00fd nh\u00e0 cung c\u1ea5p<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ki\u1ec3m so\u00e1t thay \u0111\u1ed5i<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">X\u1eed l\u00fd sai l\u1ec7ch<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tri\u1ec3n khai CAPA<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Ho\u00e0n thi\u1ec7n h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 t\u00e0i li\u1ec7u tr\u1ecdng y\u1ebfu<\/b>\n<ul>\n<li><b>Chu\u1ea9n h\u00f3a h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng PQS v\u00e0 b\u1ed9 t\u00e0i li\u1ec7u n\u1ec1n t\u1ea3ng theo GMP EU Guide<\/b><span style=\"font-weight: 400;\"> bao g\u1ed3m qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng, nh\u00e2n s\u1ef1, c\u01a1 s\u1edf v\u1eadt ch\u1ea5t, h\u1ec7 th\u1ed1ng t\u00e0i li\u1ec7u, ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m nghi\u1ec7m ch\u1ea5t l\u01b0\u1ee3ng.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><b>Th\u1ef1c hi\u1ec7n th\u1ea9m \u0111\u1ecbnh v\u00e0 ch\u1ee9ng minh v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh<\/b>\n<ul>\n<li><span style=\"font-weight: 400;\">Ho\u00e0n th\u00e0nh c\u00e1c b\u01b0\u1edbc th\u1ea9m \u0111\u1ecbnh v\u00e0 x\u00e1c nh\u1eadn \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a thi\u1ebft b\u1ecb v\u00e0 quy tr\u00ecnh khi v\u1eadn h\u00e0nh. \u01afu ti\u00ean ho\u00e0n thi\u1ec7n b\u1ed9 h\u1ed3 s\u01a1 th\u1ea9m \u0111\u1ecbnh g\u1ed3m:<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>URS (User Requirement Specification) &#8211; Y\u00eau c\u1ea7u c\u1ee7a ng\u01b0\u1eddi s\u1eed d\u1ee5ng<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>DQ (Design Qualification) &#8211; Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>IQ (Installation Qualification) &#8211; Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>OQ (Operational Qualification) &#8211; Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>PQ (Performance Qualification) &#8211; Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u0110\u1ed3ng th\u1eddi ki\u1ec3m so\u00e1t to\u00e0n v\u1eb9n d\u1eef li\u1ec7u \u0111\u1ec3 m\u1ecdi k\u1ebft qu\u1ea3 \u0111\u1ec1u \u0111\u00e1ng tin c\u1eady, c\u00f3 nh\u1eadt k\u00fd thay \u0111\u1ed5i r\u00f5 r\u00e0ng v\u00e0 truy xu\u1ea5t \u0111\u01b0\u1ee3c khi ki\u1ec3m tra.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><b>T\u1ed5 ch\u1ee9c \u0111\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9 v\u00e0 c\u1ea3i ti\u1ebfn tr\u01b0\u1edbc thanh tra<\/b>\n<ul>\n<li><b>H\u00e3y t\u1ef1 gi\u1ea3 l\u1eadp nh\u01b0 \u0111ang c\u00f3 m\u1ed9t cu\u1ed9c thanh tra th\u1eadt:<\/b>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">R\u00e0 so\u00e1t chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m n\u1ebfu c\u00f3 s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ph\u00e2n t\u00edch v\u00e0 gi\u00e1m s\u00e1t xu h\u01b0\u1edbng thay \u0111\u1ed5i c\u1ee7a m\u00f4i tr\u01b0\u1eddng theo th\u1eddi gian<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u1ed5ng h\u1ee3p, x\u00e1c \u0111\u1ecbnh v\u00e0 gi\u1ea3i quy\u1ebft c\u00e1c sai l\u1ec7ch v\u1ec1 m\u1eb7t ch\u1ec9 s\u1ed1 c\u1ee7a nh\u00e0 m\u00e1y<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<h2 data-path-to-node=\"36\"><span class=\"ez-toc-section\" id=\"Hay_Chuan_Bi_Cac_Nhom_Ho_So_Sau\"><\/span>H\u00e3y Chu\u1ea9n B\u1ecb C\u00e1c Nh\u00f3m H\u1ed3 S\u01a1 Sau<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><b>T\u00e0i li\u1ec7u t\u1ed5ng quan nh\u00e0 m\u00e1y v\u00e0 s\u01a1 \u0111\u1ed3 lu\u1ed3ng<\/b><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">M\u00f4 t\u1ea3 c\u01a1 s\u1edf v\u00e0 lu\u1ed3ng di chuy\u1ec3n c\u1ee7a ng\u01b0\u1eddi, nguy\u00ean li\u1ec7u, s\u1ea3n ph\u1ea9m v\u00e0 ch\u1ea5t th\u1ea3i <strong>\u0111\u1ec3 ch\u1ee9ng minh kh\u1ea3 n\u0103ng ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n v\u00e0 nhi\u1ec5m ch\u00e9o<\/strong>.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><b>Chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m n\u1ebfu c\u00f3 v\u00f4 tr\u00f9ng<\/b><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/h3>\n<p><span style=\"font-weight: 400;\"><strong>T\u00e0i li\u1ec7u t\u1ed5ng th\u1ec3 v\u1ec1 c\u00e1ch nh\u00e0 m\u00e1y c\u1ee7a b\u1ea1n<\/strong> ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m t\u1eeb con ng\u01b0\u1eddi, m\u00f4i tr\u01b0\u1eddng, thi\u1ebft b\u1ecb, nguy\u00ean li\u1ec7u v\u00e0 quy tr\u00ecnh, k\u00e8m b\u1eb1ng ch\u1ee9ng r\u00e0 so\u00e1t v\u00e0 c\u1eadp nh\u1eadt \u0111\u1ecbnh k\u1ef3.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><b>H\u1ed3 s\u01a1 \u0111\u00e0o t\u1ea1o v\u00e0 \u0111\u00e1nh gi\u00e1 n\u0103ng l\u1ef1c<\/b><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/h3>\n<p><span style=\"font-weight: 400;\"><strong>Ch\u1ee9ng minh nh\u00e2n s\u1ef1 c\u1ee7a nh\u00e0 m\u00e1y \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o \u0111\u1ee7 n\u0103ng l\u1ef1c<\/strong> \u0111\u1ec3 l\u00e0m vi\u1ec7c trong v\u1ecb tr\u00ed \u0111\u01b0\u1ee3c ph\u00e2n b\u1ed1, c\u00f3 b\u1ea3ng \u0111\u00e1nh gi\u00e1 n\u0103ng l\u1ef1c v\u00e0 \u0111\u00e0o t\u1ea1o l\u1ea1i khi c\u1ea7n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><b>H\u1ed3 s\u01a1 v\u1eadn h\u00e0nh v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng theo d\u1eef li\u1ec7u g\u1ed3m<\/b><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b><\/b><span style=\"font-weight: 400; font-size: 16px;\">Nh\u1eadt k\u00fd thi\u1ebft b\u1ecb v\u1eadn h\u00e0nh \u1edf nh\u00e0 m\u00e1y<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; font-size: 16px;\">D\u1eef li\u1ec7u gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng, sai l\u1ec7ch<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; font-size: 16px;\">K\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m khi ph\u00e1t hi\u1ec7n \u0111i\u1ec3m b\u1ea5t th\u01b0\u1eddng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; font-size: 16px;\">H\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400; font-size: 16px;\">H\u1ed3 s\u01a1 ki\u1ec3m so\u00e1t thay \u0111\u1ed5i v\u00e0 \u0111\u00e1nh gi\u00e1 c\u00e1c t\u00e1c \u0111\u1ed9ng.<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">\n<h3><b>H\u1ed3 s\u01a1 gia c\u00f4ng v\u00e0 qu\u1ea3n l\u00fd nh\u00e0 cung c\u1ea5p g\u1ed3m<\/b><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b><\/b><span style=\"font-weight: 400;\">Th\u1ecfa thu\u1eadn \u0111\u1ea3m b\u1ea3o v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng nh\u00e0 cung c\u1ea5p \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o chu\u1ed7i cung \u1ee9ng kh\u00f4ng c\u00f3 l\u1ed7 h\u1ed5ng v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<blockquote><p><b data-path-to-node=\"5,0\" data-index-in-node=\"1\">Tips nh\u1ecf:<\/b> \u0110\u1ec3 \u0111\u1ea3m b\u1ea3o nh\u00e0 m\u00e1y \u0111\u00e3 \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c n\u1ec1n t\u1ea3ng k\u1ef9 thu\u1eadt tr\u01b0\u1edbc khi b\u01b0\u1edbc v\u00e0o l\u1ed9 tr\u00ecnh tri\u1ec3n khai, b\u1ea1n c\u00f3 th\u1ec3 tham kh\u1ea3o th\u00eam b\u00e0i vi\u1ebft <a href=\"https:\/\/sepro.vn\/vi\/dieu-kien-de-nha-may-dat-chung-nhan-gmp-eu\/\"><b data-path-to-node=\"5,0\" data-index-in-node=\"145\">\u0110i\u1ec1u Ki\u1ec7n \u0110\u1ec3 Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU<\/b><\/a> nh\u00e9!<\/p><\/blockquote>\n<h2 data-path-to-node=\"39\"><span class=\"ez-toc-section\" id=\"GMP_WHO_Va_GMP_EU_Khac_Nhau_The_Nao\"><\/span>GMP WHO V\u00e0 GMP EU Kh\u00e1c Nhau Th\u1ebf N\u00e0o<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.who.int\/teams\/health-product-policy-and-standards\/standards-and-specifications\/norms-and-standards\/gmp\" target=\"_blank\" rel=\"noopener\"><strong>GMP WHO (WHO &#8211; Good Manufacturing Practices)<\/strong><\/a> l\u00e0 h\u01b0\u1edbng d\u1eabn GMP do WHO ban h\u00e0nh, v\u00ed d\u1ee5 t\u00e0i li\u1ec7u Main principles trong WHO TRS 986 Annex 2.<\/span><a href=\"https:\/\/www.who.int\/publications\/m\/item\/trs986-annex2?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\"><br \/>\n<\/span><\/a><span style=\"font-weight: 400;\"><strong> Kh\u00e1c bi\u1ec7t c\u1ed1t l\u00f5i th\u01b0\u1eddng n\u1eb1m \u1edf h\u1ec7 th\u1ed1ng ph\u00e1p l\u00fd v\u00e0 c\u00e1ch tri\u1ec3n khai:<\/strong> <\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"><strong>GMP EU g\u1eafn v\u1edbi khung qu\u1ea3n l\u00fd EU<\/strong>, c\u01a1 ch\u1ebf thanh tra v\u00e0 ghi nh\u1eadn GMP certificates tr\u00ean EudraGMDP<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>WHO GMP th\u01b0\u1eddng \u0111\u01b0\u1ee3c qu\u1ed1c gia tham kh\u1ea3o<\/strong> khi x\u00e2y d\u1ef1ng quy \u0111\u1ecbnh n\u1ed9i \u0111\u1ecba ho\u1eb7c trong c\u00e1c ch\u01b0\u01a1ng tr\u00ecnh li\u00ean quan WHO.<\/span><\/li>\n<\/ul>\n<h3><strong>B\u1ea3ng so s\u00e1nh nhanh GMP EU v\u00e0 WHO GMP<\/strong><\/h3>\n<table>\n<tbody>\n<tr>\n<td><b>Ti\u00eau ch\u00ed<\/b><\/td>\n<td><b>GMP EU<\/b><\/td>\n<td><b>GMP WHO<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">C\u01a1 quan \u0111i\u1ec1u ph\u1ed1i<\/span><\/td>\n<td><span style=\"font-weight: 400;\">EMA ph\u1ed1i h\u1ee3p ho\u1ea1t \u0111\u1ed9ng GMP \u1edf c\u1ea5p EU<\/span><\/td>\n<td><span style=\"font-weight: 400;\">WHO ban h\u00e0nh h\u01b0\u1edbng d\u1eabn, h\u1ed7 tr\u1ee3 h\u1ed9i t\u1ee5 quy \u0111\u1ecbnh<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">C\u00e1ch tra c\u1ee9u ch\u1ee9ng th\u01b0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">EudraGMDP c\u00f4ng khai GMP certificates<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/eudragmdp-database?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/a><\/td>\n<td><span style=\"font-weight: 400;\">T\u00f9y c\u01a1 quan qu\u1ea3n l\u00fd t\u1eebng n\u01b0\u1edbc, kh\u00f4ng c\u00f3 d\u1eef li\u1ec7u to\u00e0n c\u1ea7u th\u1ed1ng nh\u1ea5t<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">V\u00f4 tr\u00f9ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Annex 1 quy \u0111\u1ecbnh chi ti\u1ebft, b\u1eaft bu\u1ed9c CCS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3 n\u1ed9i dung v\u00f4 tr\u00f9ng trong h\u1ec7 h\u01b0\u1edbng d\u1eabn WHO, m\u1ee9c chi ti\u1ebft t\u00f9y b\u1ed9 t\u00e0i li\u1ec7u<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p data-path-to-node=\"44\"><strong>Tips nh\u1ecf:<\/strong> \u0110\u1ec3 bi\u1ebft ti\u00eau chu\u1ea9n n\u00e0o ph\u00f9 h\u1ee3p nh\u1ea5t v\u1edbi quy m\u00f4 v\u00e0 l\u1ed9 tr\u00ecnh ph\u00e1t tri\u1ec3n hi\u1ec7n t\u1ea1i c\u1ee7a nh\u00e0 m\u00e1y, b\u1ea1n c\u00f3 th\u1ec3 xem th\u00eam b\u00e0i vi\u1ebft <strong><a href=\"https:\/\/sepro.vn\/vi\/gmp-eu-vs-gmp-who-huong-dan-nha-may\/\">GMP EU vs GMP WHO: H\u01b0\u1edbng D\u1eabn L\u1ef1a Ch\u1ecdn Cho Doanh Nghi\u1ec7p<\/a><\/strong> nh\u00e9!<\/p>\n<\/blockquote>\n<h2 data-path-to-node=\"44\"><span class=\"ez-toc-section\" id=\"Loi_The_Cua_Nha_May_Dat_Chung_Nhan_GMP_EU\"><\/span>L\u1ee3i Th\u1ebf C\u1ee7a Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9136\" aria-describedby=\"caption-attachment-9136\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9136\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/7.png\" alt=\"loi-the-nha-may-dat-eu-gmp\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/7.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/7-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/7-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/7-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9136\" class=\"wp-caption-text\"><em>Nh\u00e0 m\u00e1y d\u01b0\u1ee3c chu\u1ea9n GMP EU v\u1edbi ph\u00f2ng s\u1ea1ch v\u00e0 khu v\u1ef1c v\u00f4 tr\u00f9ng minh h\u1ecda<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">V\u1edbi vi\u1ec7c \u0111\u1ea1t ch\u1ee9ng nh\u1eadn GMP EU gi\u00fap nh\u00e0 m\u00e1y:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>D\u1ec5 tham gia chu\u1ed7i cung \u1ee9ng cho th\u1ecb tr\u01b0\u1eddng<\/strong> c\u00f3 y\u00eau c\u1ea7u m\u00f4i tr\u01b0\u1eddng <\/span><b>ph\u00f2ng s\u1ea1ch<\/b><span style=\"font-weight: 400;\"> cao<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Chu\u1ea9n h\u00f3a h\u1ec7 th\u1ed1ng PQS, \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng nh\u00e0 cung c\u1ea5p, <strong>gi\u1ea3m r\u1ee7i ro sai l\u1ec7ch l\u1eb7p l\u1ea1i<\/strong><\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V\u1edbi s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng, chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m v\u00e0 c\u00e1ch thi\u1ebft k\u1ebf m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch k\u1ebft h\u1ee3p gi\u00e1m s\u00e1t li\u00ean t\u1ee5c gi\u00fap gi\u1ea3m nguy c\u01a1 nhi\u1ec5m b\u1ea9n, \u0111\u1ed3ng th\u1eddi <strong>h\u1ed7 tr\u1ee3 \u0111i\u1ec1u tra s\u1ef1 c\u1ed1 theo d\u1eef li\u1ec7u v\u00e0 theo quy tr\u00ecnh r\u00f5 r\u00e0ng h\u01a1n<\/strong><\/span><\/li>\n<\/ul>\n<h2 data-path-to-node=\"48\"><span class=\"ez-toc-section\" id=\"Danh_Sach_Nha_May_Dat_GMP_EU_O_Viet_Nam_Va_Cach_Tra_Cuu\"><\/span>Danh S\u00e1ch Nh\u00e0 M\u00e1y \u0110\u1ea1t GMP EU \u1ede Vi\u1ec7t Nam V\u00e0 C\u00e1ch Tra C\u1ee9u<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">V\u00ec danh s\u00e1ch thay \u0111\u1ed5i theo th\u1eddi gian, c\u00e1ch \u0111\u00e1ng tin nh\u1ea5t l\u00e0 tra c\u1ee9u tr\u1ef1c ti\u1ebfp tr\u00ean <\/span><a href=\"https:\/\/eudragmdp.ema.europa.eu\/inspections\/exc\/sites\" target=\"_blank\" rel=\"noopener\"><b>EudraGMDP<\/b><\/a><span style=\"font-weight: 400;\"> b\u1ea3n c\u00f4ng khai do EMA v\u1eadn h\u00e0nh.<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/eudragmdp-database?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\"><br \/>\n<\/span><\/a><strong> H\u00e3y th\u1eed l\u00e0m nh\u01b0 sau:<\/strong><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V\u00e0o m\u1ee5c GMP Certificates ho\u1eb7c Search GMP Compliance<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u1ede tr\u01b0\u1eddng Country ch\u1ecdn Vietnam, r\u1ed3i l\u1ecdc th\u00eam theo ph\u1ea1m vi ho\u1eb7c ng\u00e0y n\u1ebfu c\u1ea7n<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">V\u00ed d\u1ee5 m\u1ed9t s\u1ed1 doanh nghi\u1ec7p t\u1ea1i Vi\u1ec7t Nam c\u00f4ng b\u1ed1 \u0111\u1ea1t GMP EU:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Imexpharm c\u00f3 th\u00f4ng tin truy\u1ec1n th\u00f4ng v\u1ec1 c\u00e1c d\u00e2y chuy\u1ec1n\/nh\u00e0 m\u00e1y \u0111\u1ea1t GMP EU.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">United International Pharma UIP c\u00f4ng b\u1ed1 \u0111\u1ea1t GMP EU trong 01\/2025.<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"FAQ_%E2%80%93_GMP_EU_Good_Manufacturing_Practices_%E2%80%93_European_Union_Annex_1\"><\/span><b>FAQ &#8211; GMP EU (Good Manufacturing Practices \u2013 European Union) Annex 1<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<blockquote>\n<h3>GMP EU l\u00e0 g\u00ec v\u00e0 kh\u00e1c GMP n\u1ed9i \u0111\u1ecba \u1edf \u0111i\u1ec3m n\u00e0o?<\/h3>\n<p><span style=\"font-weight: 400;\">GMP EU l\u00e0 h\u01b0\u1edbng d\u1eabn GMP theo khung EU (EudraLex Volume 4), th\u01b0\u1eddng chi ti\u1ebft h\u01a1n v\u1ec1 h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 c\u00e1ch thanh tra, \u0111\u1ed3ng th\u1eddi ch\u1ee9ng th\u01b0 \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean EudraGMDP.<\/span><\/p>\n<h3>GMP EU Annex 1 \u00e1p d\u1ee5ng cho nh\u1eefng nh\u00e0 m\u00e1y n\u00e0o?<\/h3>\n<p><span style=\"font-weight: 400;\">Annex 1 \u00e1p d\u1ee5ng cho s\u1ea3n xu\u1ea5t thu\u1ed1c v\u00f4 tr\u00f9ng v\u00e0 c\u1ea3 c\u00e1c b\u1ed1i c\u1ea3nh c\u1ea7n ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n nghi\u00eam ng\u1eb7t; hi\u1ec7u l\u1ef1c 25\/08\/2023, ri\u00eang m\u1ee5c 8.123 \u0111\u1ebfn 25\/08\/2024.<\/span><\/p>\n<h3>EMA l\u00e0 g\u00ec trong c\u00e2u chuy\u1ec7n GMP EU?<\/h3>\n<p><span style=\"font-weight: 400;\">EMA ph\u1ed1i h\u1ee3p ho\u1ea1t \u0111\u1ed9ng thanh tra GMP v\u00e0 h\u00e0i h\u00f2a th\u1ef1c h\u00e0nh \u1edf c\u1ea5p EU, \u0111\u1ed3ng th\u1eddi v\u1eadn h\u00e0nh EudraGMDP b\u1ea3n c\u00f4ng khai.<\/span><\/p>\n<h3>C\u00e1ch \u0111\u1ec3 \u0111\u1ea1t GMP EU th\u01b0\u1eddng m\u1ea5t bao l\u00e2u?<\/h3>\n<p><span style=\"font-weight: 400;\">T\u00f9y ph\u1ea1m vi v\u00e0 m\u1ee9c \u0111\u1ed9 n\u00e2ng c\u1ea5p nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng PQS v\u00e0 validation.<\/span><\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Tam_Ket\"><\/span><b>T\u1ea1m K\u1ebft<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><strong>GMP EU Annex 1<\/strong> l\u00e0 ti\u00eau chu\u1ea9n quan tr\u1ecdng \u0111\u1ed1i v\u1edbi nh\u00e0 m\u00e1y d\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng, \u0111\u1eb7c bi\u1ec7t trong ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m, qu\u1ea3n l\u00fd r\u1ee7i ro v\u00e0 duy tr\u00ec m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch \u0111\u1ea1t chu\u1ea9n.<\/li>\n<li><strong>Vi\u1ec7c hi\u1ec3u v\u00e0 \u00e1p d\u1ee5ng \u0111\u00fang Annex 1<\/strong> gi\u00fap nh\u00e0 m\u00e1y n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, gi\u1ea3m nguy c\u01a1 nhi\u1ec5m b\u1ea9n v\u00e0 s\u1eb5n s\u00e0ng h\u01a1n cho c\u00e1c y\u00eau c\u1ea7u th\u1ea9m \u0111\u1ecbnh, thanh tra ho\u1eb7c m\u1edf r\u1ed9ng th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>GMP EU l\u00e0 b\u1ed9 ti\u00eau chu\u1ea9n Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u, \u00e1p d\u1ee5ng cho m\u1ecdi nh\u00e0 m\u00e1y d\u01b0\u1ee3c mu\u1ed1n cung \u1ee9ng v\u00e0o th\u1ecb tr\u01b0\u1eddng EU \u2013 b\u1ea5t k\u1ec3 \u0111\u1eb7t \u1edf qu\u1ed1c gia n\u00e0o. \u1ede b\u00e0i vi\u1ebft n\u00e0y Sepro gi\u1ea3i th\u00edch GMP EU Annex 1 l\u00e0 g\u00ec, vai tr\u00f2 c\u1ee7a EMA,vai &hellip; <a href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">GMP EU Annex 1 L\u00e0 G\u00ec? Nh\u1eefng \u0110i\u1ec1u Nh\u00e0 M\u00e1y D\u01b0\u1ee3c C\u1ea7n Bi\u1ebft<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9138,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9127","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\/9127","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9127"}],"version-history":[{"count":54,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9127\/revisions"}],"predecessor-version":[{"id":13779,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9127\/revisions\/13779"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9138"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9127"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9127"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9127"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}