{"id":18990,"date":"2026-11-11T22:50:29","date_gmt":"2026-11-11T21:50:29","guid":{"rendered":"https:\/\/www.s-vt.net\/pq-tham-dinh-hieu-nang-performance-qualification\/"},"modified":"2026-11-11T23:20:08","modified_gmt":"2026-11-11T22:20:08","slug":"process-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/vi\/process-qualification\/","title":{"rendered":"PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (Performance 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 hi\u1ec7u n\u0103ng (PQ) l\u00e0 vi\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, khi \u0111\u01b0\u1ee3c k\u1ebft n\u1ed1i v\u1edbi nhau, v\u1eadn h\u00e0nh hi\u1ec7u qu\u1ea3 v\u00e0 c\u00f3 t\u00ednh l\u1eb7p l\u1ea1i d\u1ef1a tr\u00ean ph\u01b0\u01a1ng ph\u00e1p quy tr\u00ecnh v\u00e0 ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-link\" aria-hidden=\"true\"><\/i><strong>H\u1ec7 th\u1ed1ng li\u00ean k\u1ebft<\/strong><span>V\u00ed d\u1ee5 d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t, m\u00e1y chi\u1ebft r\u00f3t ho\u1eb7c h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-flask\" aria-hidden=\"true\"><\/i><strong>Th\u1eed nghi\u1ec7m placebo<\/strong><span>Ki\u1ec3m tra d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m v\u00e0 b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>B\u00e1o c\u00e1o th\u1ea9m \u0111\u1ecbnh<\/strong><span>B\u00e1o c\u00e1o t\u1ed5ng k\u1ebft v\u1ec1 t\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc th\u1ea9m \u0111\u1ecbnh.<\/span><\/div><\/div><div class=\"svt-kgrid svt-kgrid-2\"><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, khi \u0111\u01b0\u1ee3c k\u1ebft n\u1ed1i v\u1edbi nhau, c\u00f3 th\u1ec3 v\u1eadn h\u00e0nh hi\u1ec7u qu\u1ea3 v\u00e0 c\u00f3 t\u00ednh l\u1eb7p l\u1ea1i d\u1ef1a tr\u00ean ph\u01b0\u01a1ng ph\u00e1p quy tr\u00ecnh v\u00e0 ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.\u201d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-clock-o\" aria-hidden=\"true\"><\/i><h3>Th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n PQ<\/h3><p>PQ \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n sau khi ho\u00e0n t\u1ea5t <a href=\"https:\/\/www.s-vt.net\/vi\/operational-qualification\/\">OQ<\/a>. V\u1ec1 th\u1eddi gian, PQ lu\u00f4n di\u1ec5n ra tr\u01b0\u1edbc th\u1ea9m \u0111\u1ecbnh quy tr\u00ecnh ho\u1eb7c th\u1ea9m \u0111\u1ecbnh v\u1ec7 sinh. Th\u00f4ng th\u01b0\u1eddng, PQ \u00e1p d\u1ee5ng cho c\u00e1c h\u1ec7 th\u1ed1ng ph\u1ee9c t\u1ea1p, li\u00ean k\u1ebft v\u1edbi nhau \u2013 ch\u1eb3ng h\u1ea1n d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, m\u00e1y chi\u1ebft r\u00f3t ho\u1eb7c <a href=\"https:\/\/www.s-vt.net\/vi\/di-water-plants\/\">h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft<\/a>.<\/p><\/div><\/div><h2>Ti\u00eau ch\u00ed ki\u1ec3m tra trong PQ<\/h2><p>C\u01a1 s\u1edf cho vi\u1ec7c ki\u1ec3m tra l\u00e0 ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t v\u00e0 <a href=\"https:\/\/www.s-vt.net\/vi\/plant-engineering-project-execution\/#lastenheft\">b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt<\/a>. Tr\u00ean c\u01a1 s\u1edf \u0111\u00f3, ch\u1eb3ng h\u1ea1n, m\u1ed9t th\u1eed nghi\u1ec7m placebo \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh. Ti\u00eau ch\u00ed l\u00e0 c\u00e1c th\u00f4ng s\u1ed1 hi\u1ec7u n\u0103ng v\u1edbi kho\u1ea3ng gi\u00e1 tr\u1ecb c\u00f9ng gi\u1edbi h\u1ea1n tr\u00ean v\u00e0 d\u01b0\u1edbi, v\u00ed d\u1ee5:<\/p><ul class=\"svt-tags\"><li>gi\u1edbi h\u1ea1n nhi\u1ec7t \u0111\u1ed9<\/li><li>d\u1ea3i t\u1ed1c \u0111\u1ed9 quay<\/li><li>d\u1ea3i \u00e1p su\u1ea5t<\/li><li>l\u01b0u l\u01b0\u1ee3ng<\/li><li>th\u00f4ng s\u1ed1 hi\u1ec7u n\u0103ng v\u00e0 s\u1ea3n l\u01b0\u1ee3ng \u0111\u00e3 th\u1ecfa thu\u1eadn<\/li><li>s\u1ed1 l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m<\/li><li>\u0111\u1ed9 ch\u00ednh x\u00e1c v\u00e0 dung sai<\/li><\/ul><h2>Ho\u00e0n t\u1ea5t th\u1ea9m \u0111\u1ecbnh<\/h2><p>Khi k\u1ebft th\u00fac c\u00f4ng vi\u1ec7c th\u1ea9m \u0111\u1ecbnh, th\u00f4ng th\u01b0\u1eddng s\u1ebd l\u1eadp m\u1ed9t b\u00e1o c\u00e1o to\u00e0n di\u1ec7n. B\u00e1o c\u00e1o ghi l\u1ea1i t\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc \u2013 t\u1eeb ph\u00e2n t\u00edch r\u1ee7i ro qua DQ, IQ v\u00e0 OQ \u0111\u1ebfn PQ.<\/p><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><a href=\"https:\/\/www.s-vt.net\/vi\/operational-qualification\/\">OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/a><\/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>PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (trang n\u00e0y)<\/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><p>C\u00f4ng ty <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 hi\u1ec7u n\u0103ng \u2013 v\u00e0 theo y\u00eau c\u1ea7u, \u1edf t\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc th\u1ea9m \u0111\u1ecbnh kh\u00e1c.<\/p><h2>C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ)<\/h2>\n<h3>Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ) l\u00e0 g\u00ec?<\/h3>\n<p>PQ (Performance Qualification) 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 \u0111\u01b0\u1ee3c k\u1ebft n\u1ed1i v\u1edbi nhau v\u1eadn h\u00e0nh hi\u1ec7u qu\u1ea3 v\u00e0 c\u00f3 t\u00ednh l\u1eb7p l\u1ea1i d\u1ef1a tr\u00ean ph\u01b0\u01a1ng ph\u00e1p quy tr\u00ecnh v\u00e0 ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t (H\u01b0\u1edbng d\u1eabn EU-GMP, Ph\u1ee5 l\u1ee5c 15).<\/p>\n<h3>Khi n\u00e0o th\u1ef1c hi\u1ec7n PQ?<\/h3>\n<p>Sau khi OQ ho\u00e0n t\u1ea5t th\u00e0nh c\u00f4ng v\u00e0 lu\u00f4n tr\u01b0\u1edbc th\u1ea9m \u0111\u1ecbnh quy tr\u00ecnh ho\u1eb7c th\u1ea9m \u0111\u1ecbnh v\u1ec7 sinh.<\/p>\n<h3>Nh\u1eefng h\u1ec7 th\u1ed1ng n\u00e0o c\u1ea7n PQ?<\/h3>\n<p>Th\u00f4ng th\u01b0\u1eddng l\u00e0 c\u00e1c h\u1ec7 th\u1ed1ng ph\u1ee9c t\u1ea1p, li\u00ean k\u1ebft v\u1edbi nhau nh\u01b0 d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, m\u00e1y chi\u1ebft r\u00f3t ho\u1eb7c h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft.<\/p>\n<h3>PQ ki\u1ec3m tra nh\u1eefng ti\u00eau ch\u00ed n\u00e0o?<\/h3>\n<p>C\u00e1c th\u00f4ng s\u1ed1 hi\u1ec7u n\u0103ng v\u1edbi gi\u1edbi h\u1ea1n tr\u00ean v\u00e0 d\u01b0\u1edbi, v\u00ed d\u1ee5 nhi\u1ec7t \u0111\u1ed9, t\u1ed1c \u0111\u1ed9 quay, \u00e1p su\u1ea5t, l\u01b0u l\u01b0\u1ee3ng, s\u1ea3n l\u01b0\u1ee3ng \u0111\u00e3 th\u1ecfa thu\u1eadn c\u0169ng nh\u01b0 \u0111\u1ed9 ch\u00ednh x\u00e1c v\u00e0 dung sai \u2013 th\u01b0\u1eddng trong khu\u00f4n kh\u1ed5 m\u1ed9t th\u1eed nghi\u1ec7m placebo.<\/p>\n<h3>Ho\u00e0n t\u1ea5t th\u1ea9m \u0111\u1ecbnh bao g\u1ed3m nh\u1eefng g\u00ec?<\/h3>\n<p>M\u1ed9t b\u00e1o c\u00e1o to\u00e0n di\u1ec7n v\u1ec1 t\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc \u2013 t\u1eeb ph\u00e2n t\u00edch r\u1ee7i ro qua DQ, IQ v\u00e0 OQ \u0111\u1ebfn PQ.<\/p>\n<p><\/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 hi\u1ec7u n\u0103ng \u2013 qua \u0111i\u1ec7n tho\u1ea1i theo s\u1ed1 <a href=\"tel:+494203789492\">+49 4203 789492<\/a> ho\u1eb7c qua email <a href=\"mailto:i&#110;fo&#64;s&#45;vt.&#110;et\">i&#110;fo&#64;s-v&#116;&#46;&#110;et<\/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\/operational-qualification\/\"><span>OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/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\":\"PQ \u2013 Th\u1ea9m \u0111\u1ecbnh 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khi\u1ebft.\"}},{\"@type\":\"Question\",\"name\":\"PQ ki\u1ec3m tra nh\u1eefng ti\u00eau ch\u00ed n\u00e0o?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"C\u00e1c th\u00f4ng s\u1ed1 hi\u1ec7u n\u0103ng v\u1edbi gi\u1edbi h\u1ea1n tr\u00ean v\u00e0 d\u01b0\u1edbi, v\u00ed d\u1ee5 nhi\u1ec7t \u0111\u1ed9, t\u1ed1c \u0111\u1ed9 quay, \u00e1p su\u1ea5t, l\u01b0u l\u01b0\u1ee3ng, s\u1ea3n l\u01b0\u1ee3ng \u0111\u00e3 th\u1ecfa thu\u1eadn c\u0169ng nh\u01b0 \u0111\u1ed9 ch\u00ednh x\u00e1c v\u00e0 dung sai \u2013 th\u01b0\u1eddng trong khu\u00f4n kh\u1ed5 m\u1ed9t th\u1eed nghi\u1ec7m placebo.\"}},{\"@type\":\"Question\",\"name\":\"Ho\u00e0n t\u1ea5t th\u1ea9m \u0111\u1ecbnh bao g\u1ed3m nh\u1eefng g\u00ec?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"M\u1ed9t b\u00e1o c\u00e1o to\u00e0n di\u1ec7n v\u1ec1 t\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc \u2013 t\u1eeb ph\u00e2n t\u00edch r\u1ee7i ro qua DQ, IQ v\u00e0 OQ \u0111\u1ebfn 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