{"id":9239,"date":"2026-03-01T20:26:10","date_gmt":"2026-03-01T20:26:10","guid":{"rendered":"https:\/\/sepro.vn\/?p=9239"},"modified":"2026-03-01T20:27:59","modified_gmt":"2026-03-01T20:27:59","slug":"dos-donts-phong-sach-gmp-eu-annex-1","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/dos-donts-phong-sach-gmp-eu-annex-1\/","title":{"rendered":"Dos &#038; Don\u2019ts Trong Ph\u00f2ng S\u1ea1ch: H\u01b0\u1edbng D\u1eabn Chu\u1ea9n GMP \u0110\u1ec3 Ng\u0103n Ng\u1eeba Nhi\u1ec5m B\u1ea9n"},"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\/dos-donts-phong-sach-gmp-eu-annex-1\/#Cac_nguyen_tac_bat_buoc_Dos_trong_phong_sach\" title=\"C\u00e1c nguy\u00ean t\u1eafc b\u1eaft bu\u1ed9c (Dos) trong ph\u00f2ng s\u1ea1ch\">C\u00e1c nguy\u00ean t\u1eafc b\u1eaft bu\u1ed9c (Dos) trong ph\u00f2ng s\u1ea1ch<\/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\/dos-donts-phong-sach-gmp-eu-annex-1\/#Nhung_dieu_tuyet_doi_khong_duoc_lam_Donts\" title=\"Nh\u1eefng \u0111i\u1ec1u tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng \u0111\u01b0\u1ee3c l\u00e0m (Don\u2019ts)\">Nh\u1eefng \u0111i\u1ec1u tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng \u0111\u01b0\u1ee3c l\u00e0m (Don\u2019ts)<\/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\/dos-donts-phong-sach-gmp-eu-annex-1\/#Yeu_to_con_nguoi_trong_kiem_soat_nhiem_ban\" title=\"Y\u1ebfu t\u1ed1 con ng\u01b0\u1eddi trong ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n\">Y\u1ebfu t\u1ed1 con ng\u01b0\u1eddi trong ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n<\/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\/dos-donts-phong-sach-gmp-eu-annex-1\/#FAQs\" title=\"FAQs\">FAQs<\/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\/dos-donts-phong-sach-gmp-eu-annex-1\/#Ket_luan\" title=\"K\u1ebft lu\u1eadn\">K\u1ebft lu\u1eadn<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\">Trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf, ph\u00f2ng s\u1ea1ch l\u00e0 m\u00f4i tr\u01b0\u1eddng y\u00eau c\u1ea7u m\u1ee9c \u0111\u1ed9 ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n nghi\u00eam ng\u1eb7t. Con ng\u01b0\u1eddi l\u00e0 ngu\u1ed3n ch\u00ednh c\u1ee7a vi\u1ec7c ph\u00e1t t\u00e1n b\u1ee5i, v\u00ec v\u1eady h\u00e0nh vi c\u1ee7a nh\u00e2n s\u1ef1 c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m.<\/span>Vi\u1ec7c tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 <a href=\"https:\/\/sepro.vn\/dos-dont-phong-sach-gmp-eu-annex-1\/\"><strong data-start=\"432\" data-end=\"465\">Dos &amp; Don\u2019ts trong ph\u00f2ng s\u1ea1ch<\/strong><\/a> gi\u00fap duy tr\u00ec \u0111i\u1ec1u ki\u1ec7n v\u00f4 tr\u00f9ng, \u1ed5n \u0111\u1ecbnh d\u00f2ng kh\u00ed (airflow) v\u00e0 gi\u1eef ch\u00eanh \u00e1p (differential pressure) trong gi\u1edbi h\u1ea1n an to\u00e0n.<\/p>\n<p><span style=\"font-weight: 400;\">Theo ti\u00eau chu\u1ea9n GMP EU Annex 1 cho th\u1ea5y h\u01a1n 70% s\u1ef1 c\u1ed1 nhi\u1ec5m b\u1ea9n \u0111\u1ebfn t\u1eeb h\u00e0nh vi con ng\u01b0\u1eddi (human factors). Nh\u1eefng h\u00e0nh vi t\u01b0\u1edfng ch\u1eebng nh\u1ecf nh\u01b0 ch\u1ea1m v\u00e0o m\u1eb7t, m\u1edf c\u1eeda sai quy tr\u00ecnh airlock ho\u1eb7c di chuy\u1ec3n qu\u00e1 nhanh \u0111\u1ec1u c\u00f3 th\u1ec3 l\u00e0m t\u0103ng l\u01b0\u1ee3ng ti\u1ec3u ph\u00e2n trong kh\u00f4ng kh\u00ed v\u00e0 ph\u00e1 v\u1ee1 d\u00f2ng kh\u00ed t\u1ea7ng (laminar airflow), d\u1eabn \u0111\u1ebfn \u00f4 nhi\u1ec5m ph\u00f2ng s\u1ea1ch. V\u00ec v\u1eady, m\u1ecdi thao t\u00e1c trong ph\u00f2ng s\u1ea1ch \u0111\u1ec1u c\u1ea7n \u0111\u01b0\u1ee3c chu\u1ea9n h\u00f3a v\u00e0 th\u1ef1c hi\u1ec7n c\u00f3 ch\u1ee7 \u0111\u00edch.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Cac_nguyen_tac_bat_buoc_Dos_trong_phong_sach\"><\/span><b>C\u00e1c nguy\u00ean t\u1eafc b\u1eaft bu\u1ed9c (Dos) trong ph\u00f2ng s\u1ea1ch<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9241\" aria-describedby=\"caption-attachment-9241\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9241\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2.png\" alt=\"what-we-do-in-cleanroom\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9241\" class=\"wp-caption-text\"><em>Nh\u1eefng nguy\u00ean t\u1eafc b\u1eaft bu\u1ed9c trong Ph\u00f2ng S\u1ea1ch<\/em><\/figcaption><\/figure>\n<h3><b>Tu\u00e2n th\u1ee7 \u0111\u00fang quy tr\u00ecnh m\u1eb7c ph\u00f2ng s\u1ea1ch (gowning)<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Gowning l\u00e0 r\u00e0o ch\u1eafn quan tr\u1ecdng gi\u1eefa c\u01a1 th\u1ec3 con ng\u01b0\u1eddi v\u00e0 m\u00f4i tr\u01b0\u1eddng s\u1ea1ch. Trang ph\u1ee5c ph\u1ea3i bao ph\u1ee7 to\u00e0n b\u1ed9 da v\u00e0 t\u00f3c, \u0111\u1ea3m b\u1ea3o kh\u00f4ng \u0111\u1ec3 l\u1ea1i \u0111i\u1ec3m h\u1edf. Ch\u00fang ta c\u1ea7n tu\u00e2n th\u1ee7:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/sepro.vn\/product-category\/cleanroom-ppe-2\/\"><b>M\u1eb7c \u0111\u1ea7y \u0111\u1ee7 b\u1ed9 \u0111\u1ed3 ph\u00f2ng s\u1ea1ch g\u1ed3m coverall, hood, mask, goggles, gloves v\u00e0 shoe covers.<\/b><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u1ea3m b\u1ea3o kh\u00f4ng \u0111\u1ec3 l\u1ed9 t\u00f3c ho\u1eb7c da.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Thay ngay trang ph\u1ee5c n\u1ebfu b\u1ea9n, r\u00e1ch ho\u1eb7c nghi ng\u1edd b\u1ecb nhi\u1ec5m.<\/span><\/li>\n<\/ul>\n<h3><b>Di chuy\u1ec3n ch\u1eadm v\u00e0 c\u00f3 ki\u1ec3m so\u00e1t<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Di chuy\u1ec3n nhanh t\u1ea1o ra nhi\u1ec5u lo\u1ea1n d\u00f2ng kh\u00ed (turbulence), khi\u1ebfn ti\u1ec3u ph\u00e2n lan r\u1ed9ng trong kh\u00f4ng gian. M\u1ecdi chuy\u1ec3n \u0111\u1ed9ng ph\u1ea3i nh\u1eb9 nh\u00e0ng, c\u00f3 ki\u1ec3m so\u00e1t v\u00e0 gi\u1eef tay g\u1ea7n c\u01a1 th\u1ec3 \u0111\u1ec3 h\u1ea1n ch\u1ebf rung l\u1eafc.Quy t\u1eafc quan tr\u1ecdng:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Kh\u00f4ng ch\u1ea1y ho\u1eb7c chuy\u1ec3n h\u01b0\u1edbng \u0111\u1ed9t ng\u1ed9t.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lu\u00f4n gi\u1eef b\u01b0\u1edbc \u0111i \u1ed5n \u0111\u1ecbnh v\u00e0 \u0111\u1ec1u.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Th\u1ef1c hi\u1ec7n c\u00e1c thao t\u00e1c ch\u1eadm r\u00e3i, c\u00f3 ch\u1ee7 \u0111\u00edch.<\/span><\/li>\n<\/ul>\n<h3><b>Duy tr\u00ec k\u1ef7 lu\u1eadt thao t\u00e1c khi l\u00e0m vi\u1ec7c d\u01b0\u1edbi LAF\/BSC<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khi l\u00e0m vi\u1ec7c d\u01b0\u1edbi t\u1ee7 d\u00f2ng kh\u00ed t\u1ea7ng (LAF \u2013 Laminar Air Flow) ho\u1eb7c t\u1ee7 an to\u00e0n sinh h\u1ecdc (BSC \u2013 Biological Safety Cabinet), nh\u00e2n s\u1ef1 c\u1ea7n tu\u00e2n th\u1ee7 \u0111\u00fang v\u00f9ng l\u00e0m vi\u1ec7c s\u1ea1ch \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o hi\u1ec7u qu\u1ea3 b\u1ea3o v\u1ec7. Nguy\u00ean t\u1eafc c\u1ea7n nh\u1edb:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u1eef tay trong khu v\u1ef1c l\u00e0m vi\u1ec7c \u0111\u01b0\u1ee3c b\u1ea3o v\u1ec7.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tr\u00e1nh \u0111\u01b0a tay ra v\u00e0o li\u00ean t\u1ee5c g\u00e2y r\u1ed1i lo\u1ea1n d\u00f2ng kh\u00ed.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u1eef b\u1ec1 m\u1eb7t thao t\u00e1c g\u1ecdn, t\u1ed1i gi\u1ea3n v\u1eadt th\u1ec3.<\/span><\/li>\n<\/ul>\n<h3><b>Th\u1ef1c h\u00e0nh v\u1ec7 sinh c\u00e1 nh\u00e2n t\u1ed1t<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u1ec7 sinh c\u00e1 nh\u00e2n gi\u00fap gi\u1ea3m \u0111\u00e1ng k\u1ec3 s\u1ed1 l\u01b0\u1ee3ng vi sinh v\u00e0 ti\u1ec3u ph\u00e2n ph\u00e1t sinh. N\u00ean th\u1ef1c hi\u1ec7n:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u1eef m\u00f3ng tay ng\u1eafn, s\u1ea1ch.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Bu\u1ed9c t\u00f3c g\u1ecdn tr\u01b0\u1edbc khi gowning.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tr\u00e1nh d\u00f9ng lotion, ph\u1ea5n ho\u1eb7c n\u01b0\u1edbc hoa v\u00ec ch\u00fang t\u1ea1o th\u00eam b\u1ee5i v\u00e0 h\u1ea1t.<\/span><\/li>\n<\/ul>\n<h3><b>Tu\u00e2n th\u1ee7 quy tr\u00ecnh v\u00e0o \u2013 ra (entry &amp; exit protocol)<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Airlock ho\u1ea1t \u0111\u1ed9ng d\u1ef1a tr\u00ean ch\u00eanh \u00e1p. M\u1ed9t h\u00e0nh vi sai c\u00f3 th\u1ec3 ph\u00e1 h\u1ee7y c\u1ea5u tr\u00fac ph\u00f2ng s\u1ea1ch. Quy \u0111\u1ecbnh b\u1eaft bu\u1ed9c:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ch\u1ec9 m\u1edf m\u1ed9t c\u1eeda t\u1ea1i m\u1ed9t th\u1eddi \u0111i\u1ec3m.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u1ea3m b\u1ea3o c\u1eeda \u0111\u00f3ng ho\u00e0n to\u00e0n tr\u01b0\u1edbc khi m\u1edf c\u1eeda ti\u1ebfp theo.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Th\u00e1o g\u0103ng ngo\u00e0i khi r\u1eddi khu v\u1ef1c aseptic.<\/span><\/li>\n<\/ul>\n<h3><b>Ch\u1ec9 s\u1eed d\u1ee5ng v\u1eadt t\u01b0 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t cho ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u1eadt t\u01b0 kh\u00f4ng \u0111\u1ea1t chu\u1ea9n c\u00f3 th\u1ec3 ph\u00e1t sinh s\u1ee3i, b\u1ee5i ho\u1eb7c ti\u1ec3u ph\u00e2n. Y\u00eau c\u1ea7u:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ch\u1ec9 mang v\u00e0o d\u1ee5ng c\u1ee5 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn cleanroom-compatible.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lau s\u1ea1ch b\u1eb1ng<\/span><a href=\"https:\/\/sepro.vn\/why-is-ipa-a-powerful-assistant-in-pharmaceutical-factory\/\"> <b>IPA 70%<\/b><\/a><span style=\"font-weight: 400;\"> ho\u1eb7c ch\u1ea5t kh\u1eed khu\u1ea9n \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/span><\/li>\n<\/ul>\n<h3><b>V\u1ec7 sinh v\u00e0 kh\u1eed khu\u1ea9n \u0111\u00fang quy tr\u00ecnh<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u1ec7 sinh sai k\u1ef9 thu\u1eadt c\u00f3 th\u1ec3 l\u00e0m t\u00e1i nhi\u1ec5m b\u1ea9n b\u1ec1 m\u1eb7t. Nguy\u00ean t\u1eafc:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">L\u00e0m s\u1ea1ch t\u1eeb s\u1ea1ch \u0111\u1ebfn b\u1ea9n (clean to dirty).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lau t\u1eeb tr\u00ean xu\u1ed1ng d\u01b0\u1edbi (top to bottom). V\u00ed d\u1ee5: tr\u1ea7n &#8211; t\u01b0\u1eddng &#8211; khu v\u1ef1c thao t\u00e1c &#8211; s\u00e0n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh (validated disinfectant) v\u00e0 cung c\u1ea5p b\u1edfi nh\u1eefng<\/span><a href=\"https:\/\/sepro.vn\/\"> <b>\u0111\u01a1n v\u1ecb uy t\u00edn<\/b><\/a><\/li>\n<\/ul>\n<h3><b>Duy tr\u00ec d\u00f2ng kh\u00ed v\u00e0 ch\u00eanh \u00e1p<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">D\u00f2ng kh\u00ed t\u1ea7ng l\u00e0 l\u1edbp \u201ch\u00e0ng r\u00e0o v\u00f4 h\u00ecnh\u201d b\u1ea3o v\u1ec7 s\u1ea3n ph\u1ea9m. Tu\u00e2n th\u1ee7:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lu\u00f4n gi\u1eef c\u1eeda \u0111\u00f3ng.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Kh\u00f4ng \u0111\u1eb7t h\u1ed9p, t\u00e0i li\u1ec7u ho\u1eb7c v\u1eadt c\u1ea3n tr\u01b0\u1edbc HEPA filter, supply vent ho\u1eb7c return grill.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110i\u1ec1u ch\u1ec9nh sash c\u1ee7a LAF\/BSC \u0111\u00fang chi\u1ec1u cao \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh.<\/span><\/li>\n<\/ul>\n<h3><b>B\u00e1o c\u00e1o sai l\u1ec7ch ngay l\u1eadp t\u1ee9c<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Sai l\u1ec7ch nh\u1ecf c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn nhi\u1ec5m b\u1ea9n nghi\u00eam tr\u1ecdng n\u1ebfu kh\u00f4ng \u0111\u01b0\u1ee3c x\u1eed l\u00fd k\u1ecbp th\u1eddi. C\u1ea7n b\u00e1o c\u00e1o khi th\u1ea5y:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">G\u0103ng tay r\u00e1ch.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u1ea3m ch\u00eanh \u00e1p b\u1ea5t th\u01b0\u1eddng.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ti\u1ebfng \u1ed3n l\u1ea1 t\u1eeb HEPA ho\u1eb7c thi\u1ebft b\u1ecb.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Particle count t\u0103ng \u0111\u1ed9t bi\u1ebfn.<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Nhung_dieu_tuyet_doi_khong_duoc_lam_Donts\"><\/span><b>Nh\u1eefng \u0111i\u1ec1u tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng \u0111\u01b0\u1ee3c l\u00e0m (Don\u2019ts)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9243\" aria-describedby=\"caption-attachment-9243\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9243\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3.png\" alt=\"what-we-don't-in-cleanroom\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9243\" class=\"wp-caption-text\"><em>Nh\u1eefng \u0111i\u1ec1u tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng \u0111\u01b0\u1ee3c l\u00e0m trong Ph\u00f2ng S\u1ea1ch<\/em><\/figcaption><\/figure>\n<h3><b>Kh\u00f4ng ch\u1ea1y ho\u1eb7c di chuy\u1ec3n g\u1ea5p<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">H\u00e0nh vi n\u00e0y t\u1ea1o turbulence, ph\u00e1 v\u1ee1 h\u01b0\u1edbng d\u00f2ng kh\u00ed v\u00e0 mang theo ti\u1ec3u ph\u00e2n v\u00e0o khu v\u1ef1c quan tr\u1ecdng.<\/span><\/p>\n<h3><b>Kh\u00f4ng ch\u1ea1m v\u00e0o m\u1eb7t, t\u00f3c ho\u1eb7c \u0111i\u1ec1u ch\u1ec9nh kh\u1ea9u trang<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khu\u00f4n m\u1eb7t v\u00e0 t\u00f3c l\u00e0 ngu\u1ed3n vi sinh l\u1edbn nh\u1ea5t tr\u00ean c\u01a1 th\u1ec3. Ch\u1ea1m v\u00e0o nh\u1eefng v\u00f9ng n\u00e0y r\u1ed3i ti\u1ebfp x\u00fac b\u1ec1 m\u1eb7t s\u1ea1ch d\u1ec5 g\u00e2y nhi\u1ec5m ch\u00e9o (cross-contamination).<\/span><\/p>\n<h3><b>Kh\u00f4ng t\u1ef1a t\u01b0\u1eddng, ng\u1ed3i s\u00e0n ho\u1eb7c t\u1ef1a v\u00e0o thi\u1ebft b\u1ecb<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u00e1c b\u1ec1 m\u1eb7t n\u00e0y c\u00f3 th\u1ec3 ch\u1ee9a b\u1ee5i ho\u1eb7c t\u1ea1p ch\u1ea5t kh\u00f4ng \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t. Vi\u1ec7c ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp s\u1ebd l\u00e0m b\u1ea9n trang ph\u1ee5c s\u1ea1ch.<\/span><\/p>\n<h3><b>Kh\u00f4ng mang \u0111\u1ed3 c\u00e1 nh\u00e2n v\u00e0o ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec7n tho\u1ea1i, v\u00ed, ch\u00eca kh\u00f3a, trang s\u1ee9c hay m\u1ef9 ph\u1ea9m l\u00e0 ngu\u1ed3n t\u1ea1o ti\u1ec3u ph\u00e2n v\u00e0 vi sinh kh\u00f4ng th\u1ec3 ki\u1ec3m so\u00e1t.<\/span><\/p>\n<h3><b>Kh\u00f4ng m\u1edf hai c\u1eeda c\u00f9ng l\u00fac<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">H\u00e0nh vi n\u00e0y l\u00e0m s\u1ee5p ch\u00eanh \u00e1p (pressure collapse), k\u00e9o kh\u00f4ng kh\u00ed b\u1ea9n v\u00e0o khu v\u1ef1c s\u1ea1ch.<\/span><\/p>\n<h3><b>Kh\u00f4ng ph\u1edbt l\u1edd c\u00e1c d\u1ea5u hi\u1ec7u b\u1ea5t th\u01b0\u1eddng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">M\u1ed9t v\u1ebft r\u00e1ch nh\u1ecf tr\u00ean g\u0103ng hay ti\u1ebfng gi\u00f3 l\u1ea1 \u1edf c\u1eeda c\u0169ng c\u00f3 th\u1ec3 l\u00e0 d\u1ea5u hi\u1ec7u nhi\u1ec5m b\u1ea9n ho\u1eb7c r\u00f2 kh\u00ed c\u1ea7n x\u1eed l\u00fd ngay.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Yeu_to_con_nguoi_trong_kiem_soat_nhiem_ban\"><\/span><b>Y\u1ebfu t\u1ed1 con ng\u01b0\u1eddi trong ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9245\" aria-describedby=\"caption-attachment-9245\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9245\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4.png\" alt=\"personal-control-in-cleanroom\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9245\" class=\"wp-caption-text\"><em>Ki\u1ec3m so\u00e1t y\u1ebfu t\u1ed1 Con Ng\u01b0\u1eddi trong Ph\u00f2ng S\u1ea1ch<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Y\u1ebfu t\u1ed1 con ng\u01b0\u1eddi bao g\u1ed3m s\u1ef1 t\u1eadp trung, th\u00e1i \u0111\u1ed9, t\u00ednh nh\u1ea5t qu\u00e1n v\u00e0 vi\u1ec7c tu\u00e2n th\u1ee7 SOP. Nh\u00e2n s\u1ef1 c\u1ea7n l\u00e0m vi\u1ec7c b\u00ecnh t\u0129nh, kh\u00f4ng n\u00f3i chuy\u1ec7n kh\u00f4ng c\u1ea7n thi\u1ebft, lu\u00f4n \u0111eo kh\u1ea9u trang \u0111\u00fang c\u00e1ch v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c l\u00e0m vi\u1ec7c khi \u0111ang b\u1ec7nh. M\u1ed9t h\u00e0nh vi nh\u1ecf c\u0169ng c\u00f3 th\u1ec3 l\u00e0m thay \u0111\u1ed5i m\u00f4i tr\u01b0\u1eddng v\u00f4 tr\u00f9ng, do \u0111\u00f3 v\u0103n h\u00f3a tu\u00e2n th\u1ee7 ph\u1ea3i \u0111\u01b0\u1ee3c duy tr\u00ec m\u1ed7i ng\u00e0y.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FAQs\"><\/span><b>FAQs<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><b>1. V\u00ec sao con ng\u01b0\u1eddi l\u00e0 ngu\u1ed3n g\u00e2y nhi\u1ec5m l\u1edbn nh\u1ea5t trong ph\u00f2ng s\u1ea1ch?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Do c\u01a1 th\u1ec3 li\u00ean t\u1ee5c ph\u00e1t t\u00e1n ti\u1ec3u ph\u00e2n v\u00e0 vi sinh t\u1eeb da, t\u00f3c, qu\u1ea7n \u00e1o v\u00e0 h\u01a1i th\u1edf. Chuy\u1ec3n \u0111\u1ed9ng m\u1ea1nh l\u00e0m t\u0103ng l\u01b0\u1ee3ng ph\u00e1t th\u1ea3i n\u00e0y.<\/span><\/p>\n<h3><b>2. V\u00ec sao kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea1y ho\u1eb7c di chuy\u1ec3n nhanh trong ph\u00f2ng s\u1ea1ch?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Di chuy\u1ec3n nhanh t\u1ea1o turbulence v\u00e0 ph\u00e1 v\u1ee1 h\u01b0\u1edbng d\u00f2ng kh\u00ed laminar, khi\u1ebfn ti\u1ec3u ph\u00e2n lan v\u00e0o khu v\u1ef1c quan tr\u1ecdng.<\/span><\/p>\n<h3><b>3. T\u1ea1i sao ph\u1ea3i \u0111\u00f3ng c\u1eeda airlock ho\u00e0n to\u00e0n tr\u01b0\u1edbc khi m\u1edf c\u1eeda ti\u1ebfp theo?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 duy tr\u00ec ch\u00eanh \u00e1p gi\u1eefa c\u00e1c khu v\u1ef1c v\u00e0 ng\u0103n kh\u00f4ng kh\u00ed b\u1ea9n t\u1eeb zone c\u00f3 c\u1ea5p \u0111\u1ed9 th\u1ea5p x\u00e2m nh\u1eadp zone s\u1ea1ch h\u01a1n.<\/span><\/p>\n<h3><b>4. V\u00ec sao kh\u00f4ng \u0111\u01b0\u1ee3c mang \u0111\u1ed3 c\u00e1 nh\u00e2n v\u00e0o ph\u00f2ng s\u1ea1ch?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">\u0110\u1ed3 c\u00e1 nh\u00e2n l\u00e0 ngu\u1ed3n ti\u1ec3u ph\u00e2n v\u00e0 vi sinh kh\u00f4ng th\u1ec3 ki\u1ec3m so\u00e1t, c\u00f3 th\u1ec3 l\u00e0m nhi\u1ec5m b\u1ea9n khu v\u1ef1c s\u1ea3n xu\u1ea5t.<\/span><\/p>\n<h3><b>5. Khi n\u00e0o c\u1ea7n b\u00e1o c\u00e1o sai l\u1ec7ch trong ph\u00f2ng s\u1ea1ch?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">B\u1ea5t c\u1ee9 khi n\u00e0o xu\u1ea5t hi\u1ec7n d\u1ea5u hi\u1ec7u b\u1ea5t th\u01b0\u1eddng nh\u01b0 g\u0103ng r\u00e1ch, thi\u1ebft b\u1ecb ph\u00e1t ti\u1ebfng l\u1ea1, t\u1ee5t ch\u00eanh \u00e1p ho\u1eb7c particle count t\u0103ng.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ket_luan\"><\/span><b>K\u1ebft lu\u1eadn<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Dos &amp; Don\u2019ts kh\u00f4ng ch\u1ec9 l\u00e0 quy \u0111\u1ecbnh m\u00e0 l\u00e0 n\u1ec1n t\u1ea3ng b\u1ea3o v\u1ec7 s\u1ea3n ph\u1ea9m v\u00e0 m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t. Khi hi\u1ec3u r\u00f5 nguy\u00ean t\u1eafc v\u00e0 \u00e1p d\u1ee5ng \u0111\u00fang c\u00e1ch, nh\u00e2n s\u1ef1 c\u00f3 th\u1ec3 duy tr\u00ec tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng \u1ed5n \u0111\u1ecbnh, \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n<\/span><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/20220825_gmp-an1_en_0.pdf\" target=\"_blank\" rel=\"noopener\"> <b>GMP-EU<\/b><\/a><span style=\"font-weight: 400;\"> v\u00e0 ISO 14644, \u0111\u1ed3ng th\u1eddi gi\u1ea3m thi\u1ec3u t\u1ed1i \u0111a nguy c\u01a1 nhi\u1ec5m b\u1ea9n xu\u1ea5t ph\u00e1t t\u1eeb ch\u00ednh con ng\u01b0\u1eddi.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf, ph\u00f2ng s\u1ea1ch l\u00e0 m\u00f4i tr\u01b0\u1eddng y\u00eau c\u1ea7u m\u1ee9c \u0111\u1ed9 ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n nghi\u00eam ng\u1eb7t. Con ng\u01b0\u1eddi l\u00e0 ngu\u1ed3n ch\u00ednh c\u1ee7a vi\u1ec7c ph\u00e1t t\u00e1n b\u1ee5i, v\u00ec v\u1eady h\u00e0nh vi c\u1ee7a nh\u00e2n s\u1ef1 c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m.Vi\u1ec7c tu\u00e2n th\u1ee7 &hellip; <a href=\"https:\/\/sepro.vn\/vi\/dos-donts-phong-sach-gmp-eu-annex-1\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Dos &#038; Don\u2019ts Trong Ph\u00f2ng S\u1ea1ch: H\u01b0\u1edbng D\u1eabn Chu\u1ea9n GMP \u0110\u1ec3 Ng\u0103n Ng\u1eeba Nhi\u1ec5m B\u1ea9n<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":9247,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9239","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\/9239","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9239"}],"version-history":[{"count":2,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9239\/revisions"}],"predecessor-version":[{"id":9249,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9239\/revisions\/9249"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9247"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}