{"id":18994,"date":"2026-11-11T22:50:40","date_gmt":"2026-11-11T21:50:40","guid":{"rendered":"https:\/\/www.s-vt.net\/oq-tham-dinh-van-hanh-operational-qualification\/"},"modified":"2026-11-11T23:20:19","modified_gmt":"2026-11-11T22:20:19","slug":"operational-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/vi\/operational-qualification\/","title":{"rendered":"OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (Operational Qualification)"},"content":{"rendered":"<div style='' class=''><section class='page-content' style=''  ><section class='container'><div style='' class=''><div class='row' style=''><div style='' class=''><div class='col-md-12 ' style=''><div style='' class=''><div class='cma-wysiwyg-editor'><p class=\"svt-lead2\">Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ) l\u00e0 b\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb, \u1edf tr\u1ea1ng th\u00e1i \u0111\u00e3 l\u1eafp \u0111\u1eb7t ho\u1eb7c \u0111\u00e3 s\u1eeda \u0111\u1ed5i, ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang quy \u0111\u1ecbnh trong to\u00e0n b\u1ed9 d\u1ea3i v\u1eadn h\u00e0nh d\u1ef1 ki\u1ebfn.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><strong>Ki\u1ec3m tra ch\u1ee9c n\u0103ng<\/strong><span>S\u1ef1 ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c ch\u1ee9c n\u0103ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u trong b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tachometer\" aria-hidden=\"true\"><\/i><strong>Hi\u1ec7u chu\u1ea9n<\/strong><span>Hi\u1ec7u chu\u1ea9n c\u00e1c \u0111i\u1ec3m \u0111o v\u00e0 x\u00e1c \u0111\u1ecbnh chu k\u1ef3 hi\u1ec7u chu\u1ea9n.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Bi\u00ean b\u1ea3n &amp; b\u00e1o c\u00e1o<\/strong><span>Bi\u00ean b\u1ea3n ki\u1ec3m tra, s\u1ed5 nh\u1eadt k\u00fd v\u00e0 b\u00e1o c\u00e1o OQ.<\/span><\/div><\/div><h2>\u0110\u1ecbnh ngh\u0129a th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/h2><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Aide Memoire GMP<\/h3><p>\u201cB\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb, \u1edf tr\u1ea1ng th\u00e1i \u0111\u00e3 l\u1eafp \u0111\u1eb7t ho\u1eb7c \u0111\u00e3 s\u1eeda \u0111\u1ed5i, ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang quy \u0111\u1ecbnh trong to\u00e0n b\u1ed9 d\u1ea3i v\u1eadn h\u00e0nh d\u1ef1 ki\u1ebfn.\u201d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>H\u01b0\u1edbng d\u1eabn EU-GMP, Ph\u1ee5 l\u1ee5c 15<\/h3><p>\u201cVi\u1ec7c x\u00e1c nh\u1eadn b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb, nh\u01b0 \u0111\u00e3 \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t ho\u1eb7c s\u1eeda \u0111\u1ed5i, ho\u1ea1t \u0111\u1ed9ng nh\u01b0 mong \u0111\u1ee3i trong to\u00e0n b\u1ed9 c\u00e1c d\u1ea3i v\u1eadn h\u00e0nh d\u1ef1 ki\u1ebfn.\u201d<\/p><\/div><\/div><h2>N\u1ed9i dung c\u1ee7a OQ<\/h2><p class=\"svt-knote\"><strong>\u0110i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft:<\/strong> B\u01b0\u1edbc <a href=\"https:\/\/www.s-vt.net\/vi\/installation-qualification\/\">IQ<\/a> \u0111\u00e3 \u0111\u01b0\u1ee3c ho\u00e0n t\u1ea5t th\u00e0nh c\u00f4ng. Ti\u1ebfp theo, OQ ki\u1ec3m tra xem ch\u1ee9c n\u0103ng c\u1ee7a h\u1ec7 th\u1ed1ng k\u1ef9 thu\u1eadt c\u00f3 \u0111\u00e1p \u1ee9ng c\u00e1c ch\u1ee9c n\u0103ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u trong <a href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#lastenheft\">b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt<\/a> hay kh\u00f4ng.<\/p><div class=\"svt-kgrid svt-kgrid-3\"><div class=\"svt-kcard\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><h3>L\u1eadp k\u1ebf ho\u1ea1ch &amp; h\u1ed3 s\u01a1<\/h3><ul class=\"svt-klist\"><li>K\u1ebf ho\u1ea1ch th\u1ef1c hi\u1ec7n OQ<\/li><li>Bi\u00ean b\u1ea3n ki\u1ec3m tra cho t\u1eebng ph\u00e9p th\u1eed ch\u1ee9c n\u0103ng<\/li><li>L\u1eadp s\u1ed5 nh\u1eadt k\u00fd thi\u1ebft b\u1ecb<\/li><li>Ki\u1ec3m tra t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt c\u1ee7a nh\u00e0 cung c\u1ea5p<\/li><li>Ki\u1ec3m tra t\u00ednh \u0111\u1ea7y \u0111\u1ee7<\/li><li>B\u00e1o c\u00e1o th\u1ef1c hi\u1ec7n OQ<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><h3>Ki\u1ec3m tra ch\u1ee9c n\u0103ng<\/h3><ul class=\"svt-klist\"><li>Ki\u1ec3m tra t\u1eebng ch\u1ee9c n\u0103ng ri\u00eang l\u1ebb<\/li><li>X\u00e1c \u0111\u1ecbnh v\u00e0 ki\u1ec3m tra c\u00e1c ch\u1ee9c n\u0103ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng<\/li><li>Ki\u1ec3m tra c\u00e1c th\u00f4ng s\u1ed1 hi\u1ec7u n\u0103ng<\/li><li>Ki\u1ec3m tra \u0111i\u1ec1u ki\u1ec7n m\u00f4i tr\u01b0\u1eddng<\/li><li>Ki\u1ec3m tra t\u01b0\u01a1ng th\u00edch \u0111i\u1ec7n t\u1eeb<\/li><li>R\u00e0 so\u00e1t ph\u00e2n t\u00edch r\u1ee7i ro<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-wrench\" aria-hidden=\"true\"><\/i><h3>Hi\u1ec7u chu\u1ea9n &amp; v\u1eadn h\u00e0nh<\/h3><ul class=\"svt-klist\"><li>Hi\u1ec7u chu\u1ea9n c\u00e1c \u0111i\u1ec3m \u0111o v\u00e0 x\u00e1c \u0111\u1ecbnh chu k\u1ef3 hi\u1ec7u chu\u1ea9n<\/li><li>H\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c b\u1ed5 sung cho s\u00e1ch h\u01b0\u1edbng d\u1eabn v\u1eadn h\u00e0nh<\/li><li>\u0110i\u1ec1u ch\u1ec9nh h\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c cho hi\u1ec7u chu\u1ea9n v\u00e0 b\u1ea3o tr\u00ec<\/li><\/ul><\/div><\/div><h2>T\u1ed5ng quan quy tr\u00ecnh th\u1ea9m \u0111\u1ecbnh<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 Ph\u00e2n t\u00edch r\u1ee7i ro<\/strong><span class=\"svt-step-tx\">Nh\u1eadn di\u1ec7n v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro tr\u01b0\u1edbc khi ch\u1ed1t thi\u1ebft k\u1ebf.<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/vi\/design-qualification\/\">DQ \u2013 Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/a><\/strong><span class=\"svt-step-tx\">B\u1eb1ng ch\u1ee9ng r\u1eb1ng thi\u1ebft k\u1ebf ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng.<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/vi\/installation-qualification\/\">IQ \u2013 Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t<\/a><\/strong><span class=\"svt-step-tx\">Ki\u1ec3m tra vi\u1ec7c l\u1eafp \u0111\u1eb7t so v\u1edbi h\u1ed3 s\u01a1 \u0111\u1eb7t h\u00e0ng.<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong>OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (trang n\u00e0y)<\/strong><span class=\"svt-step-tx\">Ki\u1ec3m tra ch\u1ee9c n\u0103ng ho\u1ea1t \u0111\u1ed9ng theo d\u1ef1 ki\u1ebfn.<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong><a href=\"https:\/\/www.s-vt.net\/vi\/process-qualification\/\">PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng<\/a><\/strong><span class=\"svt-step-tx\">B\u1eb1ng ch\u1ee9ng v\u1ec1 hi\u1ec7u n\u0103ng y\u00eau c\u1ea7u khi v\u1eadn h\u00e0nh.<\/span><\/li><\/ol><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-ghost\" style=\"flex:0 0 auto\" href=\"https:\/\/www.s-vt.net\/vi\/process-qualification\/\">Ti\u1ebfp theo: PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng <i class=\"fa fa-arrow-right\" aria-hidden=\"true\"><\/i><\/a><\/div><p>B\u01b0\u1edbc <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> h\u1ed7 tr\u1ee3 Qu\u00fd kh\u00e1ch l\u1eadp h\u1ed3 s\u01a1 v\u00e0 ki\u1ec3m tra th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh.<\/p><h2>C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ)<\/h2><h3>Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ) l\u00e0 g\u00ec?<\/h3><p>OQ l\u00e0 b\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb \u1edf tr\u1ea1ng th\u00e1i \u0111\u00e3 l\u1eafp \u0111\u1eb7t ho\u1ea1t \u0111\u1ed9ng nh\u01b0 mong \u0111\u1ee3i trong to\u00e0n b\u1ed9 d\u1ea3i v\u1eadn h\u00e0nh d\u1ef1 ki\u1ebfn (H\u01b0\u1edbng d\u1eabn EU-GMP, Ph\u1ee5 l\u1ee5c 15).<\/p><h3>\u0110i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft cho OQ l\u00e0 g\u00ec?<\/h3><p>Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t (IQ) ph\u1ea3i \u0111\u01b0\u1ee3c ho\u00e0n t\u1ea5t th\u00e0nh c\u00f4ng.<\/p><h3>OQ ki\u1ec3m tra nh\u1eefng g\u00ec?<\/h3><p>Ki\u1ec3m tra xem c\u00e1c ch\u1ee9c n\u0103ng c\u1ee7a h\u1ec7 th\u1ed1ng c\u00f3 \u0111\u00e1p \u1ee9ng c\u00e1c ch\u1ee9c n\u0103ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u trong b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt hay kh\u00f4ng \u2013 bao g\u1ed3m t\u1eebng ch\u1ee9c n\u0103ng ri\u00eang l\u1ebb, ch\u1ee9c n\u0103ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng, th\u00f4ng s\u1ed1 hi\u1ec7u n\u0103ng, \u0111i\u1ec1u ki\u1ec7n m\u00f4i tr\u01b0\u1eddng, hi\u1ec7u chu\u1ea9n \u0111i\u1ec3m \u0111o v\u00e0 t\u01b0\u01a1ng th\u00edch \u0111i\u1ec7n t\u1eeb.<\/p><h3>OQ t\u1ea1o ra nh\u1eefng t\u00e0i li\u1ec7u n\u00e0o?<\/h3><p>K\u1ebf ho\u1ea1ch OQ, bi\u00ean b\u1ea3n ki\u1ec3m tra, chu k\u1ef3 hi\u1ec7u chu\u1ea9n, h\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c cho v\u1eadn h\u00e0nh, hi\u1ec7u chu\u1ea9n v\u00e0 b\u1ea3o tr\u00ec, s\u1ed5 nh\u1eadt k\u00fd v\u00e0 b\u00e1o c\u00e1o OQ cu\u1ed1i c\u00f9ng.<\/p><h2 class=\"svt-pcta-h\">H\u00e3y li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">Ch\u00fang t\u00f4i s\u1eb5n l\u00f2ng t\u01b0 v\u1ea5n cho Qu\u00fd kh\u00e1ch v\u1ec1 th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh \u2013 qua \u0111i\u1ec7n tho\u1ea1i theo s\u1ed1 <a href=\"tel:+494203789492\">+49 4203 789492<\/a> ho\u1eb7c qua email <a href=\"mailto:in&#102;o&#64;&#115;-vt&#46;&#110;et\">i&#110;&#102;o&#64;s-&#118;&#116;&#46;ne&#116;<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/vi\/contact\/?produkt=Verfahrenstechnische%20Beratung\">G\u1eedi y\u00eau c\u1ea7u<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#planung\">T\u1ea5t c\u1ea3 d\u1ecbch v\u1ee5<\/a><\/div><\/div><h2>C\u00e1c d\u1ecbch v\u1ee5 kh\u00e1c<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#planung\"><span>Thi\u1ebft k\u1ebf<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#basic-engineering\"><span>Basic engineering (thi\u1ebft k\u1ebf c\u01a1 s\u1edf)<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#konstruktion\"><span>H\u1ed7 tr\u1ee3 thi\u1ebft k\u1ebf chi ti\u1ebft<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#beschaffung\"><span>H\u1ed7 tr\u1ee3 mua s\u1eafm<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#lastenheft\"><span>B\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt cho h\u1ec7 th\u1ed1ng c\u00f4ng ngh\u1ec7<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#terminplanung\"><span>L\u1eadp v\u00e0 ki\u1ec3m so\u00e1t ti\u1ebfn \u0111\u1ed9<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#bauueberwachung\"><span>Gi\u00e1m s\u00e1t thi c\u00f4ng<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/design-qualification\/\"><span>DQ \u2013 Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/installation-qualification\/\"><span>IQ \u2013 Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/process-qualification\/\"><span>PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/vi\/process-optimisation\/\"><span>T\u1ed1i \u01b0u h\u00f3a qu\u00e1 tr\u00ecnh<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Service\",\"name\":\"OQ \u2013 Th\u1ea9m \u0111\u1ecbnh 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c\u00f9ng.\"}}]}]}<\/script><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/section><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"rs_blank_template":"","rs_page_bg_color":"","slide_template_v7":"","footnotes":""},"class_list":["post-18994","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh theo EU-GMP Ph\u1ee5 l\u1ee5c 15<\/title>\n<meta name=\"description\" content=\"Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ) cho h\u1ec7 th\u1ed1ng GMP: \u0111i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft, ph\u1ea1m vi ki\u1ec3m tra, hi\u1ec7u chu\u1ea9n, bi\u00ean b\u1ea3n ki\u1ec3m tra v\u00e0 b\u00e1o c\u00e1o OQ \u2013 h\u1ed7 tr\u1ee3 t\u1eeb 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