{"id":18998,"date":"2026-11-11T22:50:51","date_gmt":"2026-11-11T21:50:51","guid":{"rendered":"https:\/\/www.s-vt.net\/dq-tham-dinh-thiet-ke-design-qualification\/"},"modified":"2026-11-11T23:20:26","modified_gmt":"2026-11-11T22:20:26","slug":"design-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/vi\/design-qualification\/","title":{"rendered":"DQ \u2013 Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (Design Qualification)"},"content":{"rendered":"

Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ) l\u00e0 b\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng thi\u1ebft k\u1ebf d\u1ef1 ki\u1ebfn c\u1ee7a nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng \u0111\u00e3 \u0111\u1ecbnh.<\/p>

<\/i>B\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n<\/strong>Thi\u1ebft k\u1ebf v\u00e0 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c \u0111\u1ed1i chi\u1ebfu m\u1ed9t c\u00e1ch c\u00f3 th\u1ec3 truy xu\u1ea5t.<\/span><\/div>
<\/i>Ph\u00e2n t\u00edch r\u1ee7i ro tr\u01b0\u1edbc<\/strong>Nh\u1eadn di\u1ec7n r\u1ee7i ro tr\u01b0\u1edbc khi ch\u1ed1t thi\u1ebft k\u1ebf.<\/span><\/div>
<\/i>B\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt v\u00e0 b\u1ea3n \u0111\u1eb7c t\u1ea3 ch\u1ee9c n\u0103ng<\/strong>\u0110\u1ed1i chi\u1ebfu c\u00f3 h\u1ec7 th\u1ed1ng v\u1edbi t\u00e0i li\u1ec7u c\u1ee7a nh\u00e0 cung c\u1ea5p.<\/span><\/div><\/div>

\u0110\u1ecbnh ngh\u0129a th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/h2>
<\/i>

Aide Memoire GMP<\/h3>

\u201cB\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng thi\u1ebft k\u1ebf d\u1ef1 ki\u1ebfn c\u1ee7a nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng \u0111\u00e3 \u0111\u1ecbnh.\u201d (Thanh tra ho\u1ea1t \u0111\u1ed9ng th\u1ea9m \u0111\u1ecbnh thi\u1ebft b\u1ecb v\u00e0 th\u1ea9m \u0111\u1ecbnh quy tr\u00ecnh trong s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m nghi\u1ec7m d\u01b0\u1ee3c ph\u1ea9m)<\/p><\/div>

<\/i>

H\u01b0\u1edbng d\u1eabn EU-GMP, Ph\u1ee5 l\u1ee5c 15<\/h3>

\u201cVi\u1ec7c x\u00e1c nh\u1eadn b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng thi\u1ebft k\u1ebf \u0111\u01b0\u1ee3c \u0111\u1ec1 xu\u1ea5t cho nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch d\u1ef1 ki\u1ebfn.\u201d<\/p><\/div><\/div>

Ph\u00e2n t\u00edch r\u1ee7i ro tr\u01b0\u1edbc DQ<\/h2>

Tr\u01b0\u1edbc khi th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf, th\u00f4ng th\u01b0\u1eddng s\u1ebd ti\u1ebfn h\u00e0nh ph\u00e2n t\u00edch r\u1ee7i ro to\u00e0n di\u1ec7n cho d\u1ef1 \u00e1n. Ph\u00e2n t\u00edch n\u00e0y ph\u00e1t hi\u1ec7n r\u1ee7i ro tr\u01b0\u1edbc khi thi\u1ebft k\u1ebf, \u0111\u1ec3 c\u00f3 th\u1ec3 \u0111\u00e1nh gi\u00e1 m\u1ee9c \u0111\u1ed9 v\u00e0 t\u00ednh \u0111\u1ebfn ch\u00fang ngay t\u1eeb giai \u0111o\u1ea1n thi\u1ebft k\u1ebf. Nh\u1edd \u0111\u00f3, quy tr\u00ecnh \u0111\u1ea1t \u0111\u1ed9 an to\u00e0n cao v\u00e0 c\u00e1c ngu\u1ed3n l\u1ed7i ti\u1ec1m \u1ea9n ph\u1ea7n l\u1edbn \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb t\u1eeb tr\u01b0\u1edbc.<\/p>

C\u00e1c b\u01b0\u1edbc th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/h2>
  1. 1<\/span>K\u1ebf ho\u1ea1ch DQ<\/strong>L\u1eadp k\u1ebf ho\u1ea1ch DQ.<\/span><\/li>
  2. 2<\/span>Ph\u01b0\u01a1ng ph\u00e1p th\u1ef1c hi\u1ec7n<\/strong>M\u00f4 t\u1ea3 c\u00e1ch th\u1ee9c th\u1ef1c hi\u1ec7n.<\/span><\/li>
  3. 3<\/span>H\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c<\/strong>X\u00e1c \u0111\u1ecbnh c\u00e1c h\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c.<\/span><\/li>
  4. 4<\/span>B\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt<\/strong>L\u1eadp b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt ho\u1eb7c h\u1ed3 s\u01a1 m\u1eddi th\u1ea7u.<\/span><\/li>
  5. 5<\/span>Ph\u00e2n t\u00edch r\u1ee7i ro<\/strong>T\u00edch h\u1ee3p k\u1ebft qu\u1ea3 ph\u00e2n t\u00edch r\u1ee7i ro.<\/span><\/li>
  6. 6<\/span>Ph\u00ea duy\u1ec7t<\/strong>L\u1ea5y ph\u00ea duy\u1ec7t t\u1eeb ch\u1ee7 \u0111\u1ea7u t\u01b0.<\/span><\/li>
  7. 7<\/span>Ki\u1ec3m tra b\u1ea3n \u0111\u1eb7c t\u1ea3 ch\u1ee9c n\u0103ng<\/strong>So s\u00e1nh b\u1ea3n \u0111\u1eb7c t\u1ea3 ch\u1ee9c n\u0103ng c\u1ee7a nh\u00e0 cung c\u1ea5p v\u1edbi b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/span><\/li>
  8. 8<\/span>Ki\u1ec3m tra thi\u1ebft k\u1ebf k\u1ebft c\u1ea5u<\/strong>So s\u00e1nh c\u00e1c t\u00e0i li\u1ec7u thi\u1ebft k\u1ebf \u0111\u01b0\u1ee3c \u0111\u1ec7 tr\u00ecnh.<\/span><\/li>
  9. 9<\/span>Ki\u1ec3m tra ch\u1ee9c n\u0103ng<\/strong>\u0110\u1ed1i chi\u1ebfu c\u00e1c m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng, bao g\u1ed3m c\u1ea3 h\u1ec7 th\u1ed1ng \u0111i\u1ec1u khi\u1ec3n<\/a> v\u1edbi b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt.<\/span><\/li>
  10. 10<\/span>L\u1eadp h\u1ed3 s\u01a1<\/strong>L\u1eadp h\u1ed3 s\u01a1 v\u00e0 ph\u00ea duy\u1ec7t vi\u1ec7c th\u1ef1c hi\u1ec7n.<\/span><\/li><\/ol>

    T\u1ed5ng quan quy tr\u00ecnh th\u1ea9m \u0111\u1ecbnh<\/h2>
    1. 1<\/span>RA \u2013 Ph\u00e2n t\u00edch r\u1ee7i ro<\/strong>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>
    2. 2<\/span>DQ \u2013 Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (trang n\u00e0y)<\/strong>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>
    3. 3<\/span>IQ \u2013 Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t<\/a><\/strong>Ki\u1ec3m tra vi\u1ec7c l\u1eafp \u0111\u1eb7t so v\u1edbi h\u1ed3 s\u01a1 \u0111\u1eb7t h\u00e0ng.<\/span><\/li>
    4. 4<\/span>OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/a><\/strong>Ki\u1ec3m tra ch\u1ee9c n\u0103ng ho\u1ea1t \u0111\u1ed9ng theo d\u1ef1 ki\u1ebfn.<\/span><\/li>
    5. 5<\/span>PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng<\/a><\/strong>B\u1eb1ng ch\u1ee9ng v\u1ec1 hi\u1ec7u n\u0103ng y\u00eau c\u1ea7u khi v\u1eadn h\u00e0nh.<\/span><\/li><\/ol>
      Ti\u1ebfp theo: IQ \u2013 Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t <\/i><\/a><\/div>

      C\u00f4ng ty SEEFRIED Verfahrenstechnik GmbH<\/strong> c\u00f9ng Qu\u00fd kh\u00e1ch l\u1eadp h\u1ed3 s\u01a1 th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf \u2013 bao g\u1ed3m b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt v\u00e0 h\u1ed3 s\u01a1 m\u1eddi th\u1ea7u.<\/p>

      C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ)<\/h2>

      Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ) l\u00e0 g\u00ec?<\/h3>

      DQ l\u00e0 b\u1eb1ng ch\u1ee9ng b\u1eb1ng v\u0103n b\u1ea3n r\u1eb1ng thi\u1ebft k\u1ebf d\u1ef1 ki\u1ebfn c\u1ee7a nh\u00e0 x\u01b0\u1edfng, h\u1ec7 th\u1ed1ng v\u00e0 thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng \u0111\u00e3 \u0111\u1ecbnh (H\u01b0\u1edbng d\u1eabn EU-GMP, Ph\u1ee5 l\u1ee5c 15).<\/p>

      DQ g\u1ed3m nh\u1eefng b\u01b0\u1edbc n\u00e0o?<\/h3>

      Bao g\u1ed3m k\u1ebf ho\u1ea1ch DQ, m\u00f4 t\u1ea3 c\u00e1ch th\u1ee9c th\u1ef1c hi\u1ec7n, b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt ho\u1eb7c h\u1ed3 s\u01a1 m\u1eddi th\u1ea7u, t\u00edch h\u1ee3p ph\u00e2n t\u00edch r\u1ee7i ro, \u0111\u1ed1i chi\u1ebfu b\u1ea3n \u0111\u1eb7c t\u1ea3 ch\u1ee9c n\u0103ng, t\u00e0i li\u1ec7u thi\u1ebft k\u1ebf v\u00e0 m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng v\u1edbi b\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt, c\u0169ng nh\u01b0 l\u1eadp h\u1ed3 s\u01a1 v\u00e0 ph\u00ea duy\u1ec7t.<\/p>

      V\u00ec sao ph\u00e2n t\u00edch r\u1ee7i ro \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u01b0\u1edbc DQ?<\/h3>

      Ph\u00e2n t\u00edch r\u1ee7i ro nh\u1eadn di\u1ec7n r\u1ee7i ro tr\u01b0\u1edbc khi thi\u1ebft k\u1ebf \u0111\u1ec3 c\u00f3 th\u1ec3 t\u00ednh \u0111\u1ebfn ch\u00fang trong thi\u1ebft k\u1ebf. \u0110i\u1ec1u n\u00e0y n\u00e2ng cao \u0111\u1ed9 an to\u00e0n c\u1ee7a quy tr\u00ecnh v\u00e0 ph\u1ea7n l\u1edbn lo\u1ea1i tr\u1eeb c\u00e1c ngu\u1ed3n l\u1ed7i t\u1eeb tr\u01b0\u1edbc.<\/p>

      Sau DQ l\u00e0 b\u01b0\u1edbc n\u00e0o?<\/h3>

      Sau DQ l\u00e0 th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t (IQ), th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ) v\u00e0 th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ).<\/p>

      H\u00e3y li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i<\/h2>
      Ch\u00fang t\u00f4i s\u1eb5n l\u00f2ng t\u01b0 v\u1ea5n cho Qu\u00fd kh\u00e1ch v\u1ec1 th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf \u2013 qua \u0111i\u1ec7n tho\u1ea1i theo s\u1ed1 +49 4203 789492<\/a> ho\u1eb7c qua email info@s-vt.net<\/a>.<\/div>
      G\u1eedi y\u00eau c\u1ea7u<\/a>T\u1ea5t c\u1ea3 d\u1ecbch v\u1ee5<\/a><\/div><\/div>

      C\u00e1c d\u1ecbch v\u1ee5 kh\u00e1c<\/h2>
      Thi\u1ebft k\u1ebf<\/span><\/i><\/a>Basic engineering (thi\u1ebft k\u1ebf c\u01a1 s\u1edf)<\/span><\/i><\/a>H\u1ed7 tr\u1ee3 thi\u1ebft k\u1ebf chi ti\u1ebft<\/span><\/i><\/a>H\u1ed7 tr\u1ee3 mua s\u1eafm<\/span><\/i><\/a>B\u1ea3ng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt cho h\u1ec7 th\u1ed1ng c\u00f4ng ngh\u1ec7<\/span><\/i><\/a>L\u1eadp v\u00e0 ki\u1ec3m so\u00e1t ti\u1ebfn \u0111\u1ed9<\/span><\/i><\/a>Gi\u00e1m s\u00e1t thi c\u00f4ng<\/span><\/i><\/a>IQ \u2013 Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t<\/span><\/i><\/a>OQ \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/span><\/i><\/a>PQ \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng<\/span><\/i><\/a>T\u1ed1i \u01b0u h\u00f3a qu\u00e1 tr\u00ecnh<\/span><\/i><\/a><\/div>