\nTóm t\u1eaft n\u1ed9i dung<\/label>\n

Chia s\u1ebb t\u1eeb chuy\u00ean gia Tony Harrison<\/a>
- Gi\u1edbi thi\u1ec7u<\/a><\/li>
- H\u01b0\u1edbng d\u1eabn gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch<\/a><\/li>
- C\u1ea7n s\u1eeda \u0111\u1ed5i ISO14644\u20131 v\u00e0 \u20132 \u0111\u1ec3 ph\u00e2n lo\u1ea1i ph\u00f2ng s\u1ea1ch<\/a><\/li>
- Nh\u1eefng thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi ISO 14644\u20131<\/a><\/li><\/ul><\/li>
- H\u01b0\u1edbng d\u1eabn n\u0103m 2018 c\u1ee7a FDA v\u1ec1 21 CFR ph\u1ea7n 11 H\u01b0\u1edbng d\u1eabn v\u1ec1 t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u cho ng\u00e0nh<\/a>
  - H\u01b0\u1edbng d\u1eabn ALCOA c\u1ee7a FDA \u0111\u1ec1 c\u1eadp \u0111\u1ebfn:<\/a><\/li>
  - Qua h\u01b0\u1edbng d\u1eabn n\u00e0y, ng\u01b0\u1eddi qu\u1ea3n l\u00fd \u0110\u1ea3m b\u1ea3o Ch\u1ea5t l\u01b0\u1ee3ng n\u00ean \u0111\u1eb7t nh\u1eefng c\u00e2u h\u1ecfi sau:<\/a><\/li><\/ul><\/li>
  - MET ONE 3400+ \u2013 M\u00e1y \u0111\u1ebfm ti\u1ec3u ph\u00e2n kh\u00f4ng kh\u00ed gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch c\u1ee7a Beckman Coulter Life Sciences\u00a0<\/a>
    - Thi\u1ebft b\u1ecb tu\u00e2n th\u1ee7 21 CFR Ph\u1ea7n 11 nh\u01b0 b\u1ea3n t\u00f3m t\u1eaft d\u01b0\u1edbi \u0111\u00e2y:<\/a><\/li><\/ul><\/li>
    - \u0110\u1eb7t c\u00e2u h\u1ecfi cho Tony Harrison<\/a>
      - 1. V\u1edbi t\u01b0 c\u00e1ch l\u00e0 th\u00e0nh vi\u00ean ch\u1ee7 ch\u1ed1t c\u1ee7a nh\u00f3m ISO \u0111\u00e3 s\u1eeda \u0111\u1ed5i ISO 14644\u20131 v\u00e0 \u20132 \u0111\u1ec3 ph\u00e2n lo\u1ea1i \u00f4 nhi\u1ec5m kh\u00f4ng kh\u00ed trong ph\u00f2ng s\u1ea1ch \u2013 b\u1ea1n \u0111\u00e3 \u0111\u1eb7t ra nh\u1eefng thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ph\u00f2ng s\u1ea1ch GMP b\u1eb1ng c\u00e1ch nh\u1ea5n m\u1ea1nh v\u00e0o c\u00e1c y\u00eau c\u1ea7u l\u1ea5y m\u1eabu nghi\u00eam ng\u1eb7t h\u01a1n nhi\u1ec1u trong phi\u00ean b\u1ea3n 2015. T\u1ea1i sao \u0111i\u1ec1u n\u00e0y l\u1ea1i quan tr\u1ecdng \u0111\u1ebfn v\u1eady?<\/a><\/li>
      - 2. FDA \u0111\u00e3 khuy\u1ebfn ngh\u1ecb c\u00e1c chi\u1ebfn l\u01b0\u1ee3c hi\u1ec7u qu\u1ea3 \u0111\u1ec3 qu\u1ea3n l\u00fd r\u1ee7i ro v\u1ec1 t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u trong h\u01a1n 20 n\u0103m. B\u1ea1n c\u00f3 th\u1ec3 m\u00f4 t\u1ea3 m\u1ed9t s\u1ed1 l\u1ed7i\/l\u1ed7i x\u1ea3y ra h\u00e0ng ng\u00e0y v\u00e0 t\u1ea1i sao kh\u00f4ng? MET ONE 3400+ c\u00f3 th\u1ec3 gi\u1ea3i quy\u1ebft \u0111\u01b0\u1ee3c nh\u1eefng l\u1ed7i n\u00e0y kh\u00f4ng?<\/a><\/li>
      - 3. L\u1eddi khuy\u00ean c\u1ee7a FDA ALCOA n\u00eau r\u00f5 nh\u1eefng g\u00ec \u0111ang x\u1ea3y ra v\u00e0 nh\u1eefng g\u00ec c\u1ea7n ph\u1ea3i l\u00e0m.\u00a0MET ONE 3400+ s\u1ebd gi\u00fap c\u00e1c nh\u00e0 qu\u1ea3n l\u00fd gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch gi\u1ea3i quy\u1ebft c\u00e1c khuy\u1ebfn ngh\u1ecb ALCOA c\u1ee7a FDA nh\u01b0 th\u1ebf n\u00e0o?<\/a><\/li>
      - 4. MET ONE 3400+ c\u00f3 g\u00ec \u0111\u1ed9c \u0111\u00e1o?<\/a><\/li>
      - 5. MET ONE 3400+ c\u1ea3i thi\u1ec7n quy tr\u00ecnh l\u00e0m vi\u1ec7c nh\u01b0 th\u1ebf n\u00e0o?<\/a><\/li>
      - 6. MET ONE 3400+ t\u1ef1 \u0111\u1ed9ng thu th\u1eadp d\u1eef li\u1ec7u. T\u1ea1i sao \u0111i\u1ec1u \u0111\u00f3 l\u1ea1i quan tr\u1ecdng?<\/a><\/li>
      - 7. L\u00e0m sao \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o kh\u00f4ng b\u1ecf so\u00e1t h\u1ea1t, c\u00f3 c\u1ea7n ph\u1ea3i theo d\u00f5i tr\u1ef1c ti\u1ebfp?<\/a><\/li>
      - 8. Thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng nh\u01b0 th\u1ebf n\u00e0o \u0111\u1ec3 n\u00f3 ho\u1ea1t \u0111\u1ed9ng t\u1ef1 \u0111\u1ed9ng sau \u0111\u00f3?<\/a><\/li>
      - 9. Vi\u1ec7c c\u1ea5u h\u00ecnh SOP d\u1ec5 d\u00e0ng \u0111\u1ebfn m\u1ee9c n\u00e0o?<\/a><\/li>
      - 10. Hi\u1ec7n nay nhu c\u1ea7u nghi\u00ean c\u1ee9u v\u1eafc xin ng\u1eeba COVID\u201319 l\u00e0 r\u1ea5t l\u1edbn. MET ONE 3400+ c\u00f3 th\u1ec3 t\u1ea1o ra s\u1ef1 kh\u00e1c bi\u1ec7t g\u00ec?<\/a><\/li>
      - 11. MET ONE 3400+ ti\u1ebft ki\u1ec7m th\u1eddi gian h\u01a1n so v\u1edbi c\u00e1c ph\u01b0\u01a1ng ph\u00e1p truy\u1ec1n th\u1ed1ng nh\u01b0 th\u1ebf n\u00e0o?<\/a><\/li>
      - 12. Ph\u1ea3n h\u1ed3i c\u1ee7a kh\u00e1ch h\u00e0ng v\u1ec1 MET ONE 3400+?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n
        \n
        <\/span>Chia s\u1ebb t\u1eeb chuy\u00ean gia Tony Harrison<\/strong><\/span><\/h2>\n<\/span>Gi\u1edbi thi\u1ec7u<\/strong><\/span><\/h3>\nTony l\u00e0 chuy\u00ean gia qu\u1ed1c t\u1ebf v\u1ec1 th\u1eed nghi\u1ec7m b\u1ed5 sung GMP QC, v\u1edbi kinh nghi\u1ec7m s\u00e2u r\u1ed9ng v\u1ec1 gi\u00e1m s\u00e1t h\u1ec7 th\u1ed1ng n\u01b0\u1edbc t\u1ed5ng l\u01b0\u1ee3ng carbon h\u1eefu c\u01a1 (TOC) , \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n v\u00e0 ozon, c\u00e1c ph\u01b0\u01a1ng ph\u00e1p hay nh\u1ea5t v\u1ec1 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> th\u01b0\u1eddng xuy\u00ean trong ph\u00f2ng s\u1ea1ch, c\u0169ng nh\u01b0 thi\u1ebft b\u1ecb \u0111o \u0111\u1eb7c t\u00ednh h\u1ea1t.<\/p>\n
        \u00d4ng l\u00e0 chuy\u00ean gia to\u00e0n c\u1ea7u c\u1ee7a Beckman Coulter Life Sciences, chuy\u00ean v\u1ec1 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> th\u01b0\u1eddng quy trong ph\u00f2ng s\u1ea1ch tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n GMP v\u00e0 ISO.Tony\u00a0di\u1ec5n thuy\u1ebft v\u1ec1 TOC, \u0111\u1ebfm h\u1ea1t ch\u1ea5t l\u1ecfng, kh\u1eed tr\u00f9ng b\u1eb1ng ozone cho h\u1ec7 th\u1ed1ng n\u01b0\u1edbc v\u00e0 gi\u00e1m s\u00e1t ph\u00f2ng s\u1ea1ch, \u0111\u1ed3ng th\u1eddi l\u00e0 c\u1ef1u bi\u00ean t\u1eadp vi\u00ean v\u1ec1 H\u01b0\u1edbng d\u1eabn ISPE v\u1ec1 V\u1ec7 sinh b\u1eb1ng Ozone cho H\u1ec7 th\u1ed1ng N\u01b0\u1edbc D\u01b0\u1ee3c ph\u1ea9m v\u00e0 l\u00e0 t\u1ed5ng bi\u00ean t\u1eadp c\u1ee7a PHSS Best Practice.<\/p>\n
        <\/span>H\u01b0\u1edbng d\u1eabn gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> ph\u00f2ng s\u1ea1ch<\/strong><\/span><\/h3>\n
        $\"\u0111\u00e3$ Tony \u0111\u01b0\u1ee3c giao nhi\u1ec7m v\u1ee5 s\u1eeda \u0111\u1ed5i ISO 14644\u20131 v\u00e0 \u20132 \u0111\u1ec3 ph\u00e2n lo\u1ea1i ph\u00f2ng s\u1ea1ch.\u00a0Ng\u01b0\u1eddi ta \u0111\u00e3 quy\u1ebft \u0111\u1ecbnh r\u1eb1ng c\u00e1c l\u0129nh v\u1ef1c c\u1ee7a qu\u00e1 tr\u00ecnh ph\u00e2n lo\u1ea1i c\u1ea7n ph\u1ea3i s\u1eeda \u0111\u1ed5i \u0111\u1ec3 c\u1ea3i thi\u1ec7n \u0111\u1ed9 ch\u00ednh x\u00e1c th\u1ed1ng k\u00ea.\u00a0Tr\u01b0\u1edbc \u0111\u00e2y \u00f4ng \u0111\u00e3 gi\u1eef ch\u1ee9c Ch\u1ee7 t\u1ecbch Nh\u00f3m l\u00e0m vi\u1ec7c ISO \u0111\u00e3 s\u1eeda \u0111\u1ed5i ISO 14698\u20131 v\u00e0 \u20132 \u0111\u1ec3 ki\u1ec3m so\u00e1t vi khu\u1ea9n trong ph\u00f2ng s\u1ea1ch.<\/p>\n
        *C\u00e1c th\u1eed nghi\u1ec7m chuy\u00ean kh\u1ea3o t\u00f3m t\u1eaft (d\u01b0\u1ee3c ph\u1ea9m) l\u00e0 c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ti\u00eau chu\u1ea9n h\u00f3a v\u00e0 th\u1eed nghi\u1ec7m \u0111\u1eb7c \u0111i\u1ec3m k\u1ef9 thu\u1eadt \u0111\u1ed1i v\u1edbi c\u00e1c nguy\u00ean li\u1ec7u th\u00f4 v\u00e0 th\u00e0nh ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m th\u00f4ng th\u01b0\u1eddng.\u00a0Ch\u00fang \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u01b0 m\u1ed9t y\u00eau c\u1ea7u c\u01a1 b\u1ea3n c\u1ea7n thi\u1ebft cho h\u1ea7u h\u1ebft c\u00e1c l\u1ea7n \u0111\u1ec7 tr\u00ecnh quy \u0111\u1ecbnh tr\u00ean to\u00e0n th\u1ebf gi\u1edbi.<\/em><\/p>\n
        <\/span>C\u1ea7n s\u1eeda \u0111\u1ed5i ISO14644\u20131 v\u00e0 \u20132 \u0111\u1ec3 ph\u00e2n lo\u1ea1i ph\u00f2ng s\u1ea1ch<\/strong><\/span><\/h3>\n
        FDA CGMP tuy\u00ean b\u1ed1: \u201cM\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t c\u01a1 s\u1edf x\u1eed l\u00fd v\u00f4 tr\u00f9ng \u0111\u1ea7y \u0111\u1ee7 c\u0169ng s\u1ebd \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c ph\u00e2n lo\u1ea1i khu v\u1ef1c ph\u00f2ng s\u1ea1ch th\u01b0\u1eddng xuy\u00ean.\u201dNhu c\u1ea7u s\u1eeda \u0111\u1ed5i ISO 14644\u20131 v\u00e0 \u20132 l\u00e0 do ng\u00e0nh c\u00f4ng nghi\u1ec7p lo ng\u1ea1i v\u1ec1 \u0111\u1ed9 ch\u00ednh x\u00e1c c\u1ee7a m\u1ed9t s\u1ed1 m\u00e1y \u0111\u1ebfm h\u1ea1t kh\u00f4ng kh\u00ed hi\u1ec7n c\u00f3 tr\u00ean th\u1ecb tr\u01b0\u1eddng, \u0111\u1eb7c bi\u1ec7t l\u00e0 c\u00e1c m\u1eabu chi ph\u00ed r\u1ebb v\u1edbi c\u1ea3m bi\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng th\u1ea5p \u0111\u1ebfn m\u1ee9c h\u1ecd kh\u00f4ng th\u1ec3 \u0111\u1ecbnh c\u1ee1 h\u1ea1t b\u1eb1ng b\u1ea5t k\u1ef3 \u0111\u1ed9 ch\u00ednh x\u00e1c n\u00e0o.C\u0169ng c\u00f3 nh\u1eefng lo ng\u1ea1i v\u1ec1 vi\u1ec7c c\u00e1c ph\u00e1t hi\u1ec7n ch\u1ec9 d\u1ef1a tr\u00ean m\u1ed9t s\u1ed1 \u0111\u1ecba \u0111i\u1ec3m l\u1ea5y m\u1eabu h\u1ea1n ch\u1ebf, c\u0169ng nh\u01b0 c\u00e1c ph\u01b0\u01a1ng ph\u00e1p l\u1ea5y m\u1eabu th\u1ef1c t\u1ebf mang t\u00ednh th\u1ee7 c\u00f4ng.Do nh\u1eefng vi ph\u1ea1m n\u00e0y v\u00e0 nh\u1eefng h\u1ea1n ch\u1ebf c\u1ee7a th\u1ef1c ti\u1ec5n hi\u1ec7n t\u1ea1i, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 phi\u00ean b\u1ea3n 2015 (\u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i) c\u1ee7a 14644\u20131 c\u00f3 y\u00eau c\u1ea7u r\u1eb1ng m\u00e1y \u0111\u1ebfm h\u1ea1t ph\u1ea3i tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n hi\u1ec7u su\u1ea5t v\u00e0 hi\u1ec7u chu\u1ea9n c\u1ee7a m\u00e1y \u0111\u1ebfm h\u1ea1t, ISO 21501\u20134.<\/p>\n
        <\/span>Nh\u1eefng thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi ISO 14644\u20131<\/strong><\/span><\/h3>\n
        Nh\u1eefng thay \u0111\u1ed5i c\u01a1 b\u1ea3n trong t\u00e0i li\u1ec7u ISO 14644\u20131:2015 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn c\u1ed9ng \u0111\u1ed3ng GMP l\u00e0:<\/p>\n
        \n
        Thay \u0111\u1ed5i ph\u01b0\u01a1ng ph\u00e1p t\u00ednh s\u1ed1 l\u01b0\u1ee3ng v\u1ecb tr\u00ed m\u1eabu \u0111\u1ec3 ph\u00e2n lo\u1ea1i\/t\u00e1i \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng.<\/li>\n
        Lo\u1ea1i b\u1ecf t\u00ednh to\u00e1n Gi\u1edbi h\u1ea1n tin c\u1eady tr\u00ean (UCL) 95%.<\/li>\n
        Tham kh\u1ea3o ISO 21501\u20134 trong quy \u0111\u1ecbnh* Ph\u1ee5 l\u1ee5c A trong \u0111\u00f3 x\u00e1c \u0111\u1ecbnh c\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi m\u00e1y \u0111\u1ebfm h\u1ea1t kh\u00f4ng kh\u00ed<\/li>\n
        Lo\u1ea1i b\u1ecf n\u1ed3ng \u0111\u1ed9 t\u1ed1i \u0111a cho ph\u00e9p c\u1ee7a h\u1ea1t trong kh\u00f4ng kh\u00ed\/m3<\/li>\n
        \u22655 micron cho ISO Lo\u1ea1i 5 t\u1eeb b\u1ea3ng C\u1ea5p \u0110\u1ed9 S\u1ea1ch (ISO Lo\u1ea1i 5 \u1edf m\u1ee9c \u2265 5 micron t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi Lo\u1ea1i B theo ti\u00eau chu\u1ea9n GMP \u1edf tr\u1ea1ng th\u00e1i t\u0129nh).<\/li>\n<\/ul>\n
        C\u00e1c y\u00eau c\u1ea7u tu\u00e2n th\u1ee7 m\u1edbi, ch\u1eb7t ch\u1ebd h\u01a1n s\u1ebd d\u1eabn \u0111\u1ebfn nh\u1eefng c\u1ea3i ti\u1ebfn c\u01a1 b\u1ea3n \u0111\u1ed1i v\u1edbi th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t kh\u00f4ng nhi\u1ec5m b\u1ea9n nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a t\u00e0i li\u1ec7u CGMP c\u1ee7a Hoa K\u1ef3 v\u00e0 GMP c\u1ee7a Ch\u00e2u \u00c2u.<\/p>\n
        \u0110\u1ec3 bi\u1ebft th\u00eam chi ti\u1ebft, h\u00e3y xem S\u00e1ch tr\u1eafng ‘Nh\u1eefng thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi vi\u1ec7c ph\u00e2n lo\u1ea1i l\u1ea1i ph\u00f2ng s\u1ea1ch theo ti\u00eau chu\u1ea9n GMP’ c\u1ee7a Tony Harrison.<\/p>\n
        <\/span>H\u01b0\u1edbng d\u1eabn n\u0103m 2018 c\u1ee7a FDA v\u1ec1 21 CFR ph\u1ea7n 11 H\u01b0\u1edbng d\u1eabn v\u1ec1 t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u cho ng\u00e0nh<\/strong><\/span><\/h2>\n
        \u0110i\u1ec1u n\u00e0y n\u00eau r\u00f5: \u201cTrong nh\u1eefng n\u0103m g\u1ea7n \u0111\u00e2y, FDA ng\u00e0y c\u00e0ng quan s\u00e1t th\u1ea5y c\u00e1c vi ph\u1ea1m CGMP li\u00ean quan \u0111\u1ebfn t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra CGMP.\u00a0Nh\u1eefng vi ph\u1ea1m CGMP li\u00ean quan \u0111\u1ebfn t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u n\u00e0y \u0111\u00e3 d\u1eabn \u0111\u1ebfn nhi\u1ec1u h\u00e0nh \u0111\u1ed9ng qu\u1ea3n l\u00fd, bao g\u1ed3m th\u01b0 c\u1ea3nh b\u00e1o, c\u1ea3nh b\u00e1o nh\u1eadp kh\u1ea9u v\u00e0 ngh\u1ecb \u0111\u1ecbnh \u0111\u1ed3ng \u00fd.\u201cC\u00e1c c\u00f4ng ty n\u00ean th\u1ef1c hi\u1ec7n c\u00e1c chi\u1ebfn l\u01b0\u1ee3c c\u00f3 \u00fd ngh\u0129a v\u00e0 hi\u1ec7u qu\u1ea3 \u0111\u1ec3 qu\u1ea3n l\u00fd r\u1ee7i ro v\u1ec1 t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u c\u1ee7a m\u00ecnh d\u1ef1a tr\u00ean s\u1ef1 hi\u1ec3u bi\u1ebft v\u1ec1 quy tr\u00ecnh v\u00e0 qu\u1ea3n l\u00fd ki\u1ebfn \u200b\u200bth\u1ee9c v\u1ec1 c\u00f4ng ngh\u1ec7\u201d.\u00a0N\u00f3 cho bi\u1ebft th\u00eam r\u1eb1ng c\u00e1c h\u1ed3 s\u01a1 ph\u1ea3i \u0111\u01b0\u1ee3c “ki\u1ec3m tra”, “x\u00e1c minh” ho\u1eb7c “xem x\u00e9t”.<\/p>\n
        <\/span>H\u01b0\u1edbng d\u1eabn ALCOA c\u1ee7a FDA \u0111\u1ec1 c\u1eadp \u0111\u1ebfn:<\/strong><\/span><\/h3>\n
        \n
        A<\/strong> Attributable C\u00f3 th\u1ec3 li\u00ean k\u1ebft<\/em><\/li>\n
        L<\/strong> Legible R\u00f5 r\u00e0ng<\/em><\/li>\n
        C<\/strong> Contemporaneously recorded Ghi l\u1ea1i \u0111\u1ed3ng th\u1eddi<\/em><\/li>\n
        O<\/strong> Original Nguy\u00ean b\u1ea3n<\/em><\/li>\n
        A<\/strong> Accurate Ch\u00ednh x\u00e1c<\/em><\/li>\n<\/ul>\n
        <\/span>Qua h\u01b0\u1edbng d\u1eabn n\u00e0y, ng\u01b0\u1eddi qu\u1ea3n l\u00fd \u0110\u1ea3m b\u1ea3o Ch\u1ea5t l\u01b0\u1ee3ng n\u00ean \u0111\u1eb7t nh\u1eefng c\u00e2u h\u1ecfi sau:<\/strong><\/span><\/h3>\n
        \n
        C\u00f3 c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng d\u1eef li\u1ec7u \u0111\u01b0\u1ee3c ho\u00e0n thi\u1ec7n kh\u00f4ng?<\/li>\n
        C\u00e1c ho\u1ea1t \u0111\u1ed9ng c\u00f3 \u0111\u01b0\u1ee3c ghi l\u1ea1i v\u00e0o th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n kh\u00f4ng?<\/li>\n
        C\u00e1c ho\u1ea1t \u0111\u1ed9ng c\u00f3 thu\u1ed9c v\u1ec1 m\u1ed9t c\u00e1 nh\u00e2n c\u1ee5 th\u1ec3 kh\u00f4ng?<\/li>\n
        Ch\u1ec9 nh\u1eefng c\u00e1 nh\u00e2n \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n m\u1edbi c\u00f3 th\u1ec3 thay \u0111\u1ed5i h\u1ed3 s\u01a1?<\/li>\n
        C\u00f3 h\u1ed3 s\u01a1 thay \u0111\u1ed5i d\u1eef li\u1ec7u kh\u00f4ng?<\/li>\n
        H\u1ed3 s\u01a1 c\u00f3 \u0111\u01b0\u1ee3c xem x\u00e9t v\u1ec1 t\u00ednh ch\u00ednh x\u00e1c, \u0111\u1ea7y \u0111\u1ee7 v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp kh\u00f4ng?<\/li>\n<\/ul>\n
        <\/span>MET ONE 3400+<\/a> \u2013 M\u00e1y \u0111\u1ebfm ti\u1ec3u ph\u00e2n kh\u00f4ng kh\u00ed gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> ph\u00f2ng s\u1ea1ch c\u1ee7a Beckman Coulter Life Sciences\u00a0<\/strong><\/span><\/h2>\n
        $\"\u0111\u00e3$ <\/p>\n
        <\/span>Thi\u1ebft b\u1ecb tu\u00e2n th\u1ee7 21 CFR Ph\u1ea7n 11 nh\u01b0 b\u1ea3n t\u00f3m t\u1eaft d\u01b0\u1edbi \u0111\u00e2y:<\/strong><\/span><\/h3>\n
        C\u00f3 c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng d\u1eef li\u1ec7u \u0111\u01b0\u1ee3c ho\u00e0n thi\u1ec7n kh\u00f4ng?<\/em><\/p>\n
        SOP \u0111i\u1ec7n t\u1eed v\u00e0 b\u1ea3n \u0111\u1ed3 l\u1ea5y m\u1eabu \u0111\u01b0\u1ee3c t\u1ea3i l\u00ean v\u00e0 \u0111\u1ecbnh c\u1ea5u h\u00ecnh trong M\u00e1y \u0111\u1ebfm ti\u1ec3u ph\u00e2n kh\u00f4ng kh\u00ed MET ONE 3400+<\/a>\u00a0, v\u1edbi vi\u1ec7c ki\u1ec3m so\u00e1t phi\u00ean b\u1ea3n SOP c\u0169ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong m\u00e1y \u0111\u1ebfm.\u00a0C\u00e1c v\u1ecb tr\u00ed m\u1eabu \u0111\u00e3 ho\u00e0n th\u00e0nh s\u1ebd chuy\u1ec3n sang m\u00e0u xanh l\u1ee5c, cho ph\u00e9p ng\u01b0\u1eddi d\u00f9ng bi\u1ebft nhanh r\u1eb1ng ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> \u0111\u1ecbnh k\u1ef3 h\u00e0ng ng\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c ho\u00e0n th\u00e0nh v\u00e0 kh\u00f4ng c\u00f3 m\u1eabu n\u00e0o b\u1ecb b\u1ecf s\u00f3t.<\/p>\n
        C\u00e1c ho\u1ea1t \u0111\u1ed9ng c\u00f3 \u0111\u01b0\u1ee3c ghi l\u1ea1i v\u00e0o th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n kh\u00f4ng?<\/em><\/p>\n
        H\u1ed3 s\u01a1 \u0111i\u1ec7n t\u1eed v\u1ec1 c\u00e1c ho\u1ea1t \u0111\u1ed9ng l\u1ea5y m\u1eabu trong ng\u00e0y \u0111\u01b0\u1ee3c t\u1ea1o \u0111\u1ed3ng th\u1eddi tr\u00ean b\u1ed9 \u0111\u1ebfm MET ONE 3400+<\/a> v\u00e0 xu\u1ea5t qua Ethernet m\u00e0 kh\u00f4ng c\u1ea7n b\u1ea5t k\u1ef3 ph\u1ea7n m\u1ec1m b\u00ean ngo\u00e0i n\u00e0o, \u0111\u1ea3m b\u1ea3o c\u00e1c ho\u1ea1t \u0111\u1ed9ng \u0111\u01b0\u1ee3c ghi l\u1ea1i ch\u00ednh x\u00e1c t\u1ea1i th\u1eddi \u0111i\u1ec3m th\u1ef1c hi\u1ec7n.<\/p>\n
        C\u00e1c ho\u1ea1t \u0111\u1ed9ng c\u00f3 thu\u1ed9c v\u1ec1 m\u1ed9t c\u00e1 nh\u00e2n c\u1ee5 th\u1ec3 kh\u00f4ng?<\/em><\/p>\n
        MET ONE 3400+<\/a> s\u1eed d\u1ee5ng Microsoft Active Directory \u0111\u1ec3 ki\u1ec3m so\u00e1t th\u00f4ng tin x\u00e1c th\u1ef1c T\u00ean ng\u01b0\u1eddi d\u00f9ng v\u00e0 M\u1eadt kh\u1ea9u, \u0111\u1ed3ng th\u1eddi ch\u1eef k\u00fd \u0111i\u1ec7n t\u1eed \u0111\u01b0\u1ee3c \u0111\u00ednh k\u00e8m v\u00e0o h\u1ed3 s\u01a1 \u0111i\u1ec7n t\u1eed m\u00e0 b\u1ed9 \u0111\u1ebfm t\u1ea1o ra, \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c ho\u1ea1t \u0111\u1ed9ng v\u00e0 h\u1ed3 s\u01a1 c\u00f3 th\u1ec3 quy cho m\u1ed9t c\u00e1 nh\u00e2n c\u1ee5 th\u1ec3.<\/p>\n
        Ch\u1ec9 nh\u1eefng c\u00e1 nh\u00e2n \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n m\u1edbi c\u00f3 th\u1ec3 thay \u0111\u1ed5i h\u1ed3 s\u01a1?<\/em><\/p>\n
        MET ONE 3400+<\/a> s\u1eed d\u1ee5ng c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t T\u00ean ng\u01b0\u1eddi d\u00f9ng v\u00e0 M\u1eadt kh\u1ea9u \u0111a c\u1ea5p v\u1edbi quy\u1ec1n truy c\u1eadp c\u00f3 th\u1ec3 \u0111\u1ecbnh c\u1ea5u h\u00ecnh \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ec9 nh\u1eefng nh\u00e2n vi\u00ean \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n m\u1edbi c\u00f3 th\u1ec3 th\u1ef1c hi\u1ec7n c\u00e1c thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 v\u00e0 m\u1ecdi thay \u0111\u1ed5i \u0111\u1ec1u \u0111\u01b0\u1ee3c ghi l\u1ea1i trong H\u1ed3 s\u01a1 Ki\u1ec3m tra tr\u00ean m\u00e1y.<\/p>\n
        C\u00f3 h\u1ed3 s\u01a1 thay \u0111\u1ed5i d\u1eef li\u1ec7u kh\u00f4ng?<\/em><\/p>\n
        M\u1ecdi thay \u0111\u1ed5i \u0111\u1ec1u \u0111\u01b0\u1ee3c ghi l\u1ea1i trong Qu\u00e1 tr\u00ecnh ki\u1ec3m tra tr\u00ean m\u00e1y, c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c l\u1ecdc v\u00e0 s\u1eafp x\u1ebfp nhanh ch\u00f3ng \u0111\u1ec3 cung c\u1ea5p b\u00e1o c\u00e1o trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra.<\/p>\n
        H\u1ed3 s\u01a1 c\u00f3 \u0111\u01b0\u1ee3c xem x\u00e9t v\u1ec1 t\u00ednh ch\u00ednh x\u00e1c, \u0111\u1ea7y \u0111\u1ee7 v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp kh\u00f4ng?<\/strong><\/em><\/p>\n
        Vi\u1ec7c xem x\u00e9t v\u00e0 ph\u00ea duy\u1ec7t t\u1eeb xa d\u1eef li\u1ec7u l\u1ea5y m\u1eabu qua tr\u00ecnh duy\u1ec7t web b\u1edfi nh\u00e2n vi\u00ean c\u00f3 th\u1ea9m quy\u1ec1n \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n ngay t\u1ea1i ch\u1ed7\u2013\u2013 v\u00e0 c\u00e1c h\u1ed3 s\u01a1 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t c\u00f3 ch\u1eef k\u00fd \u0111i\u1ec7n t\u1eed \u0111\u01b0\u1ee3c t\u1ea1o v\u00e0 xu\u1ea5t tr\u1ef1c ti\u1ebfp qua Ethernet.<\/p>\n
        <\/span>\u0110\u1eb7t c\u00e2u h\u1ecfi cho Tony Harrison<\/strong><\/span><\/h2>\n<\/span>1. V\u1edbi t\u01b0 c\u00e1ch l\u00e0 th\u00e0nh vi\u00ean ch\u1ee7 ch\u1ed1t c\u1ee7a nh\u00f3m ISO \u0111\u00e3 s\u1eeda \u0111\u1ed5i ISO 14644\u20131 v\u00e0 \u20132 \u0111\u1ec3 ph\u00e2n lo\u1ea1i \u00f4 nhi\u1ec5m kh\u00f4ng kh\u00ed trong ph\u00f2ng s\u1ea1ch \u2013 b\u1ea1n \u0111\u00e3 \u0111\u1eb7t ra nh\u1eefng thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ph\u00f2ng s\u1ea1ch GMP b\u1eb1ng c\u00e1ch nh\u1ea5n m\u1ea1nh v\u00e0o c\u00e1c y\u00eau c\u1ea7u l\u1ea5y m\u1eabu nghi\u00eam ng\u1eb7t h\u01a1n nhi\u1ec1u trong phi\u00ean b\u1ea3n 2015. T\u1ea1i sao \u0111i\u1ec1u n\u00e0y l\u1ea1i quan tr\u1ecdng \u0111\u1ebfn v\u1eady?<\/strong><\/span><\/h3>\n
        Th\u00e1ch th\u1ee9c khi thi\u1ebft k\u1ebf ph\u00f2ng s\u1ea1ch l\u00e0 \u0111\u1ea3m b\u1ea3o ph\u00f2ng c\u00f3 m\u1ee9c \u0111\u1ed9 \u00f4 nhi\u1ec5m kh\u00f4ng kh\u00ed \u0111\u1ed3ng \u0111\u1ec1u \u1edf t\u1ea5t c\u1ea3 c\u00e1c v\u1ecb tr\u00ed \u2013 v\u00e0 t\u00ecm c\u00e1ch ch\u1ee9ng minh \u0111i\u1ec1u n\u00e0y. Ch\u00fang t\u00f4i th\u1ea5y r\u00f5 r\u1eb1ng phi\u00ean b\u1ea3n n\u0103m 1999 c\u1ee7a ti\u00eau chu\u1ea9n ISO y\u00eau c\u1ea7u kh\u00f4ng \u0111\u1ee7 v\u1ecb tr\u00ed l\u1ea5y m\u1eabu \u0111\u1ec3 ph\u00e1t hi\u1ec7n c\u00e1c t\u00fai kh\u00f4ng kh\u00ed b\u1ecb \u00f4 nhi\u1ec5m ri\u00eang bi\u1ec7t. Do \u0111\u00f3, c\u1ea7n ph\u1ea3i y\u00eau c\u1ea7u c\u00e1c c\u00f4ng ty t\u0103ng s\u1ed1 l\u01b0\u1ee3ng \u0111\u1ecba \u0111i\u1ec3m l\u1ea5y m\u1eabu. \u0110i\u1ec1u n\u00e0y s\u1ebd cho ph\u00e9p c\u00f4ng ty c\u00f3 \u0111\u01b0\u1ee3c th\u1ed1ng k\u00ea r\u00f5 r\u00e0ng h\u01a1n v\u1ec1 m\u1ee9c \u0111\u1ed9 \u00f4 nhi\u1ec5m trong to\u00e0n b\u1ed9 ph\u00f2ng s\u1ea1ch<\/p>\n
        <\/span>2. FDA \u0111\u00e3 khuy\u1ebfn ngh\u1ecb c\u00e1c chi\u1ebfn l\u01b0\u1ee3c hi\u1ec7u qu\u1ea3 \u0111\u1ec3 qu\u1ea3n l\u00fd r\u1ee7i ro v\u1ec1 t\u00ednh to\u00e0n v\u1eb9n d\u1eef li\u1ec7u trong h\u01a1n 20 n\u0103m. B\u1ea1n c\u00f3 th\u1ec3 m\u00f4 t\u1ea3 m\u1ed9t s\u1ed1 l\u1ed7i\/l\u1ed7i x\u1ea3y ra h\u00e0ng ng\u00e0y v\u00e0 t\u1ea1i sao kh\u00f4ng? MET ONE 3400+<\/a> c\u00f3 th\u1ec3 gi\u1ea3i quy\u1ebft \u0111\u01b0\u1ee3c nh\u1eefng l\u1ed7i n\u00e0y kh\u00f4ng?<\/strong><\/span><\/h3>\n
        Nh\u00f3m gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddn<\/a>g ph\u00f2ng s\u1ea1ch t\u1ea1i m\u1ed9t c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m sinh h\u1ecdc, ch\u1eb3ng h\u1ea1n nh\u01b0 nh\u00e0 s\u1ea3n xu\u1ea5t v\u1eafc xin, th\u01b0\u1eddng thu th\u1eadp h\u00e0ng ngh\u00ecn m\u1eabu kh\u00f4ng kh\u00ed ph\u00f2ng s\u1ea1ch m\u1ed7i th\u00e1ng l\u00e0 \u0111i\u1ec1u r\u1ea5t b\u00ecnh th\u01b0\u1eddng.<\/p>\n
        \u0110i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i nh\u1eadn ra r\u1eb1ng vi\u1ec7c l\u1ea5y m\u1eabu l\u00e0 m\u1ed9t qu\u00e1 tr\u00ecnh th\u1ee7 c\u00f4ng, k\u1ef9 thu\u1eadt vi\u00ean ph\u1ea3i th\u1ef1c hi\u1ec7n nhi\u1ec1u b\u01b0\u1edbc t\u1ed1n th\u1eddi gian tr\u01b0\u1edbc khi h\u1ecd \u0111\u1ea1t \u0111\u01b0\u1ee3c k\u1ebft qu\u1ea3.\u00a0H\u1ea7u nh\u01b0 kh\u00f4ng th\u1ec3 tr\u00e1nh \u0111\u01b0\u1ee3c l\u1ed7i \u0111\u01a1n gi\u1ea3n c\u1ee7a con ng\u01b0\u1eddi khi s\u1eed d\u1ee5ng quy tr\u00ecnh th\u1ee7 c\u00f4ng nh\u01b0 v\u1eady.<\/p>\n
        \u0110\u1ea7u ti\u00ean, h\u1ecd ph\u1ea3i tu\u00e2n theo b\u1ea3n \u0111\u1ed3 c\u00e1c v\u1ecb tr\u00ed l\u1ea5y m\u1eabu cho t\u1eebng ph\u00f2ng s\u1ea1ch. Sau \u0111\u00f3, t\u1ea1i m\u1ed7i v\u1ecb tr\u00ed, h\u1ecd nh\u1eadp th\u1ee7 c\u00f4ng t\u00ean m\u1eabu v\u00e0o b\u1ed9 \u0111\u1ebfm, t\u1ef1 c\u1ea5u h\u00ecnh c\u1ee1 m\u1eabu v\u00e0 s\u1ed1 l\u01b0\u1ee3ng m\u1eabu c\u1ea7n l\u1ea5y v\u00e0 in k\u1ebft qu\u1ea3, t\u1ef1 \u0111\u00e1nh gi\u00e1 v\u00e0 \u0111i\u1ec1n v\u00e0o form m\u1eabu c\u00f3 s\u1eb5n. Cu\u1ed1i c\u00f9ng, h\u1ecd k\u00fd t\u00ean, c\u00e1c b\u1ea3n in tr\u00ean gi\u1ea5y \u0111\u01b0\u1ee3c \u0111\u1ed1i chi\u1ebfu v\u00e0 th\u00f4ng tin t\u1eeb m\u1ed7i b\u1ea3n in \u0111\u01b0\u1ee3c chuy\u1ec3n th\u1ee7 c\u00f4ng sang \u0111\u1ecbnh d\u1ea1ng \u0111i\u1ec7n t\u1eed.<\/p>\n
        Tuy nhi\u00ean, FDA ph\u00e1t hi\u1ec7n ra nh\u1eefng sai s\u00f3t trong h\u1ed3 s\u01a1 cu\u1ed1i c\u00f9ng v\u00e0 trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra c\u00f2n ph\u00e1t hi\u1ec7n ra r\u1eb1ng c\u00e1c m\u1eabu \u0111\u00e3 b\u1ecb b\u1ecf s\u00f3t do l\u1ed7i con ng\u01b0\u1eddi.<\/p>\n
        <\/span>3. L\u1eddi khuy\u00ean c\u1ee7a FDA ALCOA n\u00eau r\u00f5 nh\u1eefng g\u00ec \u0111ang x\u1ea3y ra v\u00e0 nh\u1eefng g\u00ec c\u1ea7n ph\u1ea3i l\u00e0m.\u00a0MET ONE 3400+<\/a> s\u1ebd gi\u00fap c\u00e1c nh\u00e0 qu\u1ea3n l\u00fd gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> ph\u00f2ng s\u1ea1ch gi\u1ea3i quy\u1ebft c\u00e1c khuy\u1ebfn ngh\u1ecb ALCOA c\u1ee7a FDA nh\u01b0 th\u1ebf n\u00e0o?<\/strong><\/span><\/h3>\n
        \n
        A<\/strong> Attributable C\u00f3 th\u1ec3 li\u00ean k\u1ebft<\/em><\/li>\n
        L<\/strong> Legible R\u00f5 r\u00e0ng<\/em><\/li>\n
        C<\/strong> Contemporaneously recorded Ghi l\u1ea1i \u0111\u1ed3ng th\u1eddi<\/em><\/li>\n
        O<\/strong> Original Nguy\u00ean b\u1ea3n<\/em><\/li>\n
        A<\/strong> Accurate Ch\u00ednh x\u00e1c<\/em><\/li>\n<\/ul>\nMET ONE 3400+<\/a> m\u1edbi \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 t\u1ef1 \u0111\u1ed9ng h\u00f3a quy tr\u00ecnh th\u1ee7 c\u00f4ng n\u00e0y v\u00e0 gi\u00fap c\u1ea3i thi\u1ec7n vi\u1ec7c tu\u00e2n th\u1ee7 21 CFR ph\u1ea7n 11<\/strong> ALCOA c\u1ee7a FDA.<\/p>\n
        H\u1ed3 s\u01a1 \u0111i\u1ec7n t\u1eed \u0111\u01b0\u1ee3c t\u1ea1o \u0111\u1ed3ng th\u1eddi v\u00e0 \u0111\u01b0\u1ee3c quy cho k\u1ef9 thu\u1eadt vi\u00ean, v\u00ec h\u1ecd ph\u1ea3i \u0111\u0103ng nh\u1eadp v\u00e0o qu\u1ea7y b\u1eb1ng th\u00f4ng tin x\u00e1c th\u1ef1c t\u00ean ng\u01b0\u1eddi d\u00f9ng v\u00e0 m\u1eadt kh\u1ea9u do Microsoft Active Directory ki\u1ec3m so\u00e1t.<\/p>\n
        Nh\u1eadp c\u00e1c \u0111\u00e1nh gi\u00e1 v\u00e0o h\u1ed3 s\u01a1 \u0111i\u1ec7n t\u1eed th\u00f4ng qua b\u00e0n ph\u00edm qwerty tr\u00ean m\u00e0n h\u00ecnh<\/p>\n
        Sau \u0111\u00f3, h\u1ed3 s\u01a1 \u0111i\u1ec7n t\u1eed g\u1ed1c s\u1ebd \u0111\u01b0\u1ee3c ng\u01b0\u1eddi gi\u00e1m s\u00e1t xem x\u00e9t\/ph\u00ea duy\u1ec7t t\u1eeb xa l\u00e0 ch\u00ednh x\u00e1c b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng tr\u00ecnh duy\u1ec7t web, sau \u0111\u00f3 xu\u1ea5t t\u1eeb \u200b\u200bqu\u1ea7y qua Ethernet ho\u1eb7c Wi-Fi. \u0110\u1ed9 ch\u00ednh x\u00e1c \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn th\u00eam b\u1eb1ng quy tr\u00ecnh ki\u1ec3m tra to\u00e0n di\u1ec7n \u0111\u01b0\u1ee3c t\u00edch h\u1ee3p s\u1eb5n.<\/p>\n
        <\/span>4. MET ONE 3400+<\/a> c\u00f3 g\u00ec \u0111\u1ed9c \u0111\u00e1o?<\/strong><\/span><\/h3>\n
        \u0110i\u1ec1u n\u1ed5i b\u1eadt \u1edf MET ONE 3400+<\/a> <\/strong> l\u00e0 c\u00e1ch n\u00f3 t\u1ef1 \u0111\u1ed9ng h\u00f3a quy tr\u00ecnh l\u1ea5y m\u1eabu, lo\u1ea1i b\u1ecf nguy c\u01a1 x\u1ea3y ra l\u1ed7i th\u1ee7 c\u00f4ng v\u00e0 c\u1ea3i thi\u1ec7n quy tr\u00ecnh l\u00e0m vi\u1ec7c b\u1eb1ng c\u00e1ch ti\u1ebft ki\u1ec7m th\u1eddi gian v\u00e0 gi\u1ea3m thi\u1ec3u l\u1ed7i.<\/p>\n
        $\"\u0111\u00e3$ <\/p>\n
        Sau khi x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c c\u00e1c v\u1ecb tr\u00ed l\u1ea5y m\u1eabu, t\u1ea5t c\u1ea3 nh\u1eefng g\u00ec ng\u01b0\u1eddi d\u00f9ng ph\u1ea3i l\u00e0m l\u00e0 t\u1ea3i b\u1ea3n \u0111\u1ed3 hi\u1ec3n th\u1ecb c\u00e1c v\u1ecb tr\u00ed m\u1eabu l\u00ean b\u1ed9 \u0111\u1ebfm \u0111\u1ec3 t\u1ea1o b\u1ea3n \u0111\u1ed3 l\u1ea5y m\u1eabu t\u01b0\u01a1ng t\u00e1c tr\u00ean m\u00e0n h\u00ecnh.\u00a0B\u1ea1n ch\u1ec9 c\u1ea7n thi\u1ebft l\u1eadp t\u00ednh n\u0103ng n\u00e0y m\u1ed9t l\u1ea7n v\u00e0 sau \u0111\u00f3 n\u00f3 s\u1ebd tr\u1edf th\u00e0nh h\u01b0\u1edbng d\u1eabn t\u01b0\u01a1ng t\u00e1c \u0111i\u1ec7n t\u1eed, tr\u00ean m\u00e0n h\u00ecnh m\u1ed7i khi qu\u00e1 tr\u00ecnh gi\u00e1m s\u00e1t m\u1eabu di\u1ec5n ra.<\/p>\n
        <\/span>5. MET ONE 3400+<\/a> c\u1ea3i thi\u1ec7n quy tr\u00ecnh l\u00e0m vi\u1ec7c nh\u01b0 th\u1ebf n\u00e0o?<\/strong><\/span><\/h3>\n
        B\u1ea3n \u0111\u1ed3 l\u1ea5y m\u1eabu t\u01b0\u01a1ng t\u00e1c tr\u00ean m\u00e0n h\u00ecnh c\u00f3 ngh\u0129a l\u00e0 gi\u1edd \u0111\u00e2y k\u1ef9 thu\u1eadt vi\u00ean ch\u1ec9 ph\u1ea3i \u0111i \u0111\u1ebfn t\u1eebng v\u1ecb tr\u00ed l\u1ea5y m\u1eabu nh\u01b0 hi\u1ec3n th\u1ecb tr\u00ean m\u00e0n h\u00ecnh;\u00a0h\u1ecd ch\u1ea1m v\u00e0o v\u1ecb tr\u00ed tr\u00ean b\u1ea3n \u0111\u1ed3 t\u01b0\u01a1ng t\u00e1c v\u00e0 b\u1ed9 \u0111\u1ebfm s\u1ebd th\u1ef1c hi\u1ec7n ph\u1ea7n c\u00f2n l\u1ea1i.<\/p>\n
        Kh\u00f4ng c\u00f2n ph\u1ea3i nh\u1eadp t\u00ean v\u1ecb tr\u00ed theo c\u00e1ch th\u1ee7 c\u00f4ng ho\u1eb7c \u0111\u1ecbnh c\u1ea5u h\u00ecnh b\u1ed9 \u0111\u1ebfm theo c\u00e1ch th\u1ee7 c\u00f4ng cho t\u1eebng v\u1ecb tr\u00ed. \u0110i\u1ec1u n\u00e0y gi\u00fap c\u1ea3i thi\u1ec7n t\u00ednh to\u00e0n v\u1eb9n c\u1ee7a d\u1eef li\u1ec7u v\u00e0 gi\u00fap \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 ALCOA.<\/p>\n
        Ti\u1ebft ki\u1ec7m th\u1eddi gian h\u01a1n n\u1eefa trong qu\u00e1 tr\u00ecnh xem x\u00e9t d\u1eef li\u1ec7u. Ng\u01b0\u1eddi gi\u00e1m s\u00e1t c\u00f3 th\u1ec3 \u0111\u0103ng nh\u1eadp t\u1eeb xa th\u00f4ng qua tr\u00ecnh duy\u1ec7t web \u0111\u1ec3 xem x\u00e9t\/ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 l\u1ea5y m\u1eabu trong ng\u00e0y v\u1ec1 t\u00ednh \u0111\u1ea7y \u0111\u1ee7 v\u00e0 ch\u00ednh x\u00e1c. Sau \u0111\u00f3, h\u1ecd k\u00fd t\u00ean b\u1eb1ng ch\u1eef k\u00fd \u0111i\u1ec7n t\u1eed v\u00e0 k\u00edch ho\u1ea1t tr\u1ef1c ti\u1ebfp.<\/p>\n
        <\/span>6. MET ONE 3400+<\/a> t\u1ef1 \u0111\u1ed9ng thu th\u1eadp d\u1eef li\u1ec7u. T\u1ea1i sao \u0111i\u1ec1u \u0111\u00f3 l\u1ea1i quan tr\u1ecdng?<\/strong><\/span><\/h3>\n
        V\u1edbi h\u00e0ng ngh\u00ecn m\u1eabu \u0111\u01b0\u1ee3c l\u1ea5y m\u1ed7i th\u00e1ng t\u1ea1i m\u1ed7i nh\u00e0 m\u00e1y, r\u1ea5t d\u1ec5 x\u1ea3y ra l\u1ed7i c\u1ee7a con ng\u01b0\u1eddi. Vi\u1ec7c t\u1ef1 \u0111\u1ed9ng h\u00f3a quy tr\u00ecnh gi\u00fap gi\u1ea3m kh\u1ea3 n\u0103ng x\u1ea3y ra l\u1ed7i c\u1ee7a con ng\u01b0\u1eddi c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn nguy c\u01a1 m\u1ea5t m\u1ed9t l\u00f4 do d\u1eef li\u1ec7u m\u1eabu kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7\/kh\u00f4ng ch\u00ednh x\u00e1c.<\/p>\n
        <\/span>7. L\u00e0m sao \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o kh\u00f4ng b\u1ecf so\u00e1t h\u1ea1t, c\u00f3 c\u1ea7n ph\u1ea3i theo d\u00f5i tr\u1ef1c ti\u1ebfp?<\/strong><\/span><\/h3>\n
        Vi\u1ec7c theo d\u00f5i c\u00e1c h\u1ea1t kh\u00f4ng th\u1ec3 t\u1ef1 \u0111\u1ed9ng h\u00f3a, nh\u01b0ng ch\u00fang t\u00f4i c\u00f3 th\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c m\u1eabu \u0111\u1ec1u \u0111\u01b0\u1ee3c l\u1ea5y. Khi m\u1ed7i m\u1eabu ho\u00e0n t\u1ea5t, v\u1ecb tr\u00ed m\u1eabu s\u1ebd chuy\u1ec3n sang m\u00e0u xanh l\u1ee5c tr\u00ean m\u00e0n h\u00ecnh v\u00e0 k\u1ef9 thu\u1eadt vi\u00ean c\u00f3 th\u1ec3 xem nhanh xem h\u1ecd \u0111\u00e3 l\u1ea5y t\u1ea5t c\u1ea3 c\u00e1c m\u1eabu c\u1ea7n thi\u1ebft v\u00e0 s\u1ebd kh\u00f4ng c\u00f3 m\u1eabu b\u1ecb b\u1ecf so\u00e1t<\/p>\n
        <\/span>8. Thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng nh\u01b0 th\u1ebf n\u00e0o \u0111\u1ec3 n\u00f3 ho\u1ea1t \u0111\u1ed9ng t\u1ef1 \u0111\u1ed9ng sau \u0111\u00f3?<\/strong><\/span><\/h3>\n
        Vi\u1ec7c thi\u1ebft l\u1eadp ch\u1ec9 l\u00e0 vi\u1ec7c m\u1ed9t l\u1ea7n. Ch\u1ec9 c\u1ea7n t\u1ea3i l\u00ean b\u1ea3n \u0111\u1ed3 l\u1ea5y m\u1eabu Quy tr\u00ecnh thao t\u00e1c ti\u00eau chu\u1ea9n (SOP), ch\u1ec9 \u0111\u1ecbnh c\u00e1c v\u1ecb tr\u00ed l\u1ea5y m\u1eabu v\u00e0 l\u1eadp tr\u00ecnh b\u1ed9 \u0111\u1ebfm v\u1edbi c\u00e1c y\u00eau c\u1ea7u SOP l\u1ea5y m\u1eabu cho t\u1eebng v\u1ecb tr\u00ed. Sau khi \u0111\u01b0\u1ee3c l\u1eadp tr\u00ecnh, b\u1ed9 \u0111\u1ebfm s\u1ebd t\u1ef1 \u0111\u1ed9ng h\u00f3a ch\u01b0\u01a1ng tr\u00ecnh l\u1ea5y m\u1eabu m\u00e0 kh\u00f4ng c\u1ea7n b\u1ea5t k\u1ef3 s\u1ef1 can thi\u1ec7p n\u00e0o c\u1ee7a ng\u01b0\u1eddi d\u00f9ng.<\/p>\n
        <\/span>9. Vi\u1ec7c c\u1ea5u h\u00ecnh SOP d\u1ec5 d\u00e0ng \u0111\u1ebfn m\u1ee9c n\u00e0o?<\/strong><\/span><\/h3>\n
        M\u1ed9t t\u00ednh n\u0103ng kh\u00e1c l\u00e0 vi\u1ec7c ki\u1ec3m so\u00e1t phi\u00ean b\u1ea3n quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n (SOP) hi\u1ec7n \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u00ean trong b\u1ed9 \u0111\u1ebfm. Qu\u1ea3n tr\u1ecb vi\u00ean c\u00f3 th\u1ec3 \u0111\u0103ng nh\u1eadp v\u00e0o b\u1ed9 \u0111\u1ebfm t\u1eeb xa ch\u1ec9 b\u1eb1ng tr\u00ecnh duy\u1ec7t web, \u0111\u1eb7t c\u1ea5u h\u00ecnh phi\u00ean b\u1ea3n SOP hi\u1ec7n t\u1ea1i v\u00e0o b\u1ed9 \u0111\u1ebfm, ch\u1ec9 \u0111\u1ecbnh s\u1ed1 phi\u00ean b\u1ea3n r\u1ed3i ph\u00e1t h\u00e0nh phi\u00ean b\u1ea3n \u0111\u1ec3 s\u1eed d\u1ee5ng b\u1eb1ng Th\u00f4ng tin x\u00e1c th\u1ef1c Microsoft Active Directory c\u1ee7a h\u1ecd. T\u1ea5t c\u1ea3 h\u1ed3 s\u01a1 l\u1ea5y m\u1eabu \u0111\u1ecbnh k\u1ef3 \u0111\u1ec1u c\u00f3 t\u00ean SOP v\u00e0 s\u1ed1 phi\u00ean b\u1ea3n \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 l\u1ea5y m\u1eabu.<\/p>\n
        <\/span>10. Hi\u1ec7n nay nhu c\u1ea7u nghi\u00ean c\u1ee9u v\u1eafc xin ng\u1eeba COVID\u201319 l\u00e0 r\u1ea5t l\u1edbn. MET ONE 3400+<\/a> c\u00f3 th\u1ec3 t\u1ea1o ra s\u1ef1 kh\u00e1c bi\u1ec7t g\u00ec?<\/strong><\/span><\/h3>\n
        B\u1ed9 ph\u1eadn nghi\u00ean c\u1ee9u s\u1ea3n xu\u1ea5t v\u1eafc xin kh\u00f4ng ch\u1ecbu s\u1ef1 gi\u00e1m s\u00e1t ch\u1eb7t ch\u1ebd c\u1ee7a GMP nh\u01b0 c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t.<\/p>\n
        Sau khi t\u00ecm ra v\u1eafc xin hi\u1ec7u qu\u1ea3 cho COVID\u201319, MET ONE 3400+ s\u1ebd gi\u00fap c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ea3m b\u1ea3o c\u01a1 s\u1edf tu\u00e2n th\u1ee7 \u0111\u1ec3 kh\u00f4ng b\u1ecb th\u1ea5t l\u1ea1c l\u00f4 do kh\u00f4ng tu\u00e2n th\u1ee7 v\u00e0 ngu\u1ed3n cung v\u1eafc xin c\u00f3 gi\u00e1 tr\u1ecb c\u00f3 th\u1ec3 \u0111\u1ebfn tay ng\u01b0\u1eddi s\u1eed d\u1ee5ng, c\u00e1c b\u00e1c s\u0129 v\u00e0 y t\u00e1 c\u1ea7n qu\u1ea3n l\u00fd n\u00f3.<\/p>\n
        <\/span> $\"\u0110\u1ea7u$ 11. MET ONE 3400+<\/a> ti\u1ebft ki\u1ec7m th\u1eddi gian h\u01a1n so v\u1edbi c\u00e1c ph\u01b0\u01a1ng ph\u00e1p truy\u1ec1n th\u1ed1ng nh\u01b0 th\u1ebf n\u00e0o?<\/strong><\/span><\/h3>\n
        Theo m\u1ed9t cu\u1ed9c kh\u1ea3o s\u00e1t do Beckman Coulter Life Sciences th\u1ef1c hi\u1ec7n, kho\u1ea3n ti\u1ebft ki\u1ec7m th\u1eddi gian l\u1edbn nh\u1ea5t \u0111\u1ebfn t\u1eeb vi\u1ec7c t\u1ef1 \u0111\u1ed9ng h\u00f3a quy tr\u00ecnh xem x\u00e9t v\u00e0 ph\u00ea duy\u1ec7t c\u0169ng nh\u01b0 lo\u1ea1i b\u1ecf vi\u1ec7c sao ch\u00e9p d\u1eef li\u1ec7u th\u1ee7 c\u00f4ng kh\u1ecfi t\u1ea5t c\u1ea3 c\u00e1c t\u1edd gi\u1ea5y \u0111\u00f3.\u00a0Vi\u1ec7c n\u00e0y ch\u1ec9 m\u1ea5t v\u00e0i ph\u00fat.<\/p>\n
        Kh\u00e1ch h\u00e0ng cho bi\u1ebft qu\u00e1 tr\u00ecnh xem x\u00e9t, ph\u00ea duy\u1ec7t th\u1ee7 c\u00f4ng v\u00e0 sao ch\u00e9p d\u1eef li\u1ec7u th\u1ee7 c\u00f4ng c\u00f3 th\u1ec3 m\u1ea5t t\u1edbi 90 ph\u00fat m\u1ed7i ng\u00e0y, v\u00ec v\u1eady \u0111\u00f3 l\u00e0 m\u1ed9t kho\u1ea3n ti\u1ebft ki\u1ec7m th\u1eddi gian l\u1edbn.<\/p>\n
        <\/span>12. Ph\u1ea3n h\u1ed3i c\u1ee7a kh\u00e1ch h\u00e0ng v\u1ec1 MET ONE 3400+<\/a>?<\/strong><\/span><\/h3>\n
        Thi\u1ebft k\u1ebf t\u1ef1 \u0111\u1ed9ng 3400+<\/a> d\u1ef1a tr\u00ean ph\u1ea3n h\u1ed3i c\u1ee7a kh\u00e1ch h\u00e0ng, khi kh\u1ea3o s\u00e1t v\u1ec1 nh\u1eefng g\u00ec kh\u00e1ch h\u00e0ng g\u1eb7p ph\u1ea3i v\u1edbi c\u00e1c ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a> \u0111\u1ecbnh k\u1ef3 th\u1ee7 c\u00f4ng.<\/p>\n
        Kh\u00e1ch h\u00e0ng \u0111\u00e3 r\u1ea5t \u1ea5n t\u01b0\u1ee3ng v\u1ec1 ch\u1ee9c n\u0103ng c\u1ee7a 3400+<\/a>. M\u1ed9t c\u00e2u h\u1ecfi t\u00f4i th\u01b0\u1eddng nh\u1eadn \u0111\u01b0\u1ee3c l\u00e0 \u201cTh\u1eadt sao? B\u1ea3n \u0111\u1ed3 SOP th\u1ef1c s\u1ef1 xu\u1ea5t hi\u1ec7n tr\u00ean m\u00e0n h\u00ecnh v\u00e0 \u0111\u01b0\u1ee3c t\u1ef1 \u0111\u1ed9ng h\u00f3a? Th\u1eadt \u1ea5n t\u01b0\u1ee3ng!” B\u1ea3n \u0111\u1ed3 tr\u00ean m\u00e0n h\u00ecnh d\u01b0\u1eddng nh\u01b0 l\u00e0 \u0111i\u1ec1u \u1ea5n t\u01b0\u1ee3ng nh\u1ea5t m\u00e0 kh\u00e1ch h\u00e0ng t\u1eadp trung v\u00e0o trong qu\u00e1 tr\u00ecnh th\u1ef1c hi\u1ec7n th\u00ed nghi\u1ec7m tr\u00ean thi\u1ebft b\u1ecb.<\/p>\n
        Ngu\u1ed3n: https:\/\/www.beckman.com\/resources\/reading-material\/interviews\/tony-harrison-met-one-3400-plus<\/a><\/p>\n
        M\u1ecbnh Khang l\u00e0 nh\u00e0 ph\u00e2n ph\u1ed1i v\u00e0 nh\u1eadp kh\u1ea9u tr\u1ef1c ti\u1ebfp c\u00e1c thi\u1ebft b\u1ecb gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/a>\u00a0h\u00e3ng\u00a0 Beckman Coulter<\/a>.<\/strong><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
        Chia s\u1ebb t\u1eeb chuy\u00ean gia Tony Harrison Gi\u1edbi thi\u1ec7u Tony l\u00e0 chuy\u00ean gia qu\u1ed1c t\u1ebf v\u1ec1 th\u1eed nghi\u1ec7m b\u1ed5 sung GMP QC, v\u1edbi kinh nghi\u1ec7m s\u00e2u r\u1ed9ng v\u1ec1 gi\u00e1m s\u00e1t h\u1ec7 th\u1ed1ng n\u01b0\u1edbc t\u1ed5ng l\u01b0\u1ee3ng carbon h\u1eefu c\u01a1 (TOC) , \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n v\u00e0 ozon, c\u00e1c ph\u01b0\u01a1ng ph\u00e1p hay nh\u1ea5t v\u1ec1 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng…<\/p>\n","protected":false},"author":3,"featured_media":10332,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[40],"tags":[],"_links":{"self":[{"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/posts\/10325"}],"collection":[{"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/comments?post=10325"}],"version-history":[{"count":8,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/posts\/10325\/revisions"}],"predecessor-version":[{"id":10481,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/posts\/10325\/revisions\/10481"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/media\/10332"}],"wp:attachment":[{"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/media?parent=10325"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/categories?post=10325"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gd-1.com\/wp-json\/wp\/v2\/tags?post=10325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}