{"id":10881,"date":"2026-04-28T07:34:40","date_gmt":"2026-04-28T07:34:40","guid":{"rendered":"https:\/\/sepro.vn\/?p=10881"},"modified":"2026-04-28T07:34:40","modified_gmt":"2026-04-28T07:34:40","slug":"sop-la-gi-trong-nganh-duoc-dinh-nghia","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/sop-la-gi-trong-nganh-duoc-dinh-nghia\/","title":{"rendered":"SOP L\u00e0 G\u00ec Trong Ng\u00e0nh D\u01b0\u1ee3c \u2014 \u0110\u1ecbnh Ngh\u0129a, C\u1ea5u Tr\u00fac V\u00e0 C\u00e1ch Tri\u1ec3n Khai Theo GMP"},"content":{"rendered":"

Trong ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m, SOP (Standard Operating Procedure \u2014 Quy Tr\u00ecnh Thao T\u00e1c Chu\u1ea9n) l\u00e0 n\u1ec1n t\u1ea3ng c\u1ee7a m\u1ecdi ho\u1ea1t \u0111\u1ed9ng, t\u1eeb s\u1ea3n xu\u1ea5t thu\u1ed1c, kh\u1eed khu\u1ea9n ph\u00f2ng s\u1ea1ch, cho \u0111\u1ebfn qu\u1ea3n l\u00fd nh\u00e2n s\u1ef1. Tuy nhi\u00ean, nhi\u1ec1u nh\u00e0 m\u00e1y d\u01b0\u1ee3c \u1edf Vi\u1ec7t Nam v\u1eabn hi\u1ec3u SOP l\u00e0 t\u00e0i li\u1ec7u h\u00ecnh th\u1ee9c \u0111\u1ec3 v\u1ec7 sinh h\u1ed3 s\u01a1, ch\u1ee9 kh\u00f4ng ph\u1ea3i c\u00f4ng c\u1ee5 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng th\u1ef1c t\u1ebf.<\/span><\/p>\n

B\u00e0i vi\u1ebft n\u00e0y gi\u1ea3i th\u00edch chi ti\u1ebft SOP l\u00e0 g\u00ec, t\u1ea1i sao SOP c\u1ea7n thi\u1ebft, c\u1ea5u tr\u00fac SOP theo GMP-WHO\/EU, c\u00e1ch vi\u1ebft SOP cho c\u00e1c quy tr\u00ecnh kh\u00e1c nhau (v\u1ec7 sinh, gowning, environmental monitoring), c\u0169ng nh\u01b0 nh\u1eefng tranh c\u00e3i l\u1edbn v\u1ec1 SOP c\u1ee9ng nh\u1eafc vs linh ho\u1ea1t, gi\u1ea5y vs \u0111i\u1ec7n t\u1eed, v\u00e0 m\u1ee9c \u0111\u1ed9 tu\u00e2n th\u1ee7 c\u1ea7n thi\u1ebft \u0111\u1ec3 tr\u00e1nh vi ph\u1ea1m GMP.<\/span><\/p>\n

SOP L\u00e0 G\u00ec Trong Ng\u00e0nh D\u01b0\u1ee3c?<\/b><\/h2>\n

SOP (Standard Operating Procedure)<\/b> l\u00e0 t\u00e0i li\u1ec7u m\u00f4 t\u1ea3 chi ti\u1ebft c\u00e1c b\u01b0\u1edbc th\u1ef1c hi\u1ec7n m\u1ed9t quy tr\u00ecnh, \u0111\u1ea3m b\u1ea3o m\u1ecdi nh\u00e2n vi\u00ean (k\u1ec3 c\u1ea3 nh\u00e2n vi\u00ean m\u1edbi) \u0111\u1ec1u th\u1ef1c hi\u1ec7n c\u00f4ng vi\u1ec7c theo c\u00e1ch gi\u1ed1ng nhau, c\u00f3 quy tr\u00ecnh ch\u1eb7t ch\u1ebd, v\u00e0 c\u00f3 th\u1ec3 ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c.<\/span><\/p>\n

Trong ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m, SOP kh\u00f4ng ch\u1ec9 l\u00e0 h\u01b0\u1edbng d\u1eabn, m\u00e0 l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c theo GMP (Good Manufacturing Practice)<\/b>. M\u1ed7i ho\u1ea1t \u0111\u1ed9ng quan tr\u1ecdng t\u1eeb chu\u1ea9n b\u1ecb nguy\u00ean li\u1ec7u, s\u1ea3n xu\u1ea5t, kh\u1eed khu\u1ea9n ph\u00f2ng s\u1ea1ch, l\u1ea5y m\u1eabu vi sinh, \u0111\u1ebfn gowning (m\u1eb7c qu\u1ea7n \u00e1o ph\u00f2ng s\u1ea1ch) <\/span>\u0111\u1ec1u ph\u1ea3i c\u00f3 SOP ri\u00eang.<\/b><\/p>\n

C\u1ea5u tr\u00fac c\u01a1 b\u1ea3n c\u1ee7a SOP:<\/b><\/h2>\n
\"SOP
SOP l\u00e0 g\u00ec trong ng\u00e0nh d\u01b0\u1ee3c<\/figcaption><\/figure>\n

SOP kh\u00f4ng ph\u1ea3i ch\u1ec9 l\u00e0 h\u00ecnh th\u1ee9c m\u00e0 l\u00e0 c\u00f4ng c\u1ee5 th\u1ef1c t\u1ebf \u0111\u1ec3 ki\u1ec3m so\u00e1t qu\u00e1 tr\u00ecnh v\u00e0 <\/span>\u0111\u1ea3m b\u1ea3o h\u1ea7u h\u1ebft c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u1ec1u \u0111\u1ea1t chu\u1ea9n v\u1edbi ch\u1ea5t l\u01b0\u1ee3ng cao nh\u1ea5t.<\/b><\/p>\n

    \n
  1. Ti\u00eau \u0111\u1ec1 v\u00e0 m\u00e3 s\u1ed1 SOP<\/span><\/li>\n
  2. Ph\u1ea1m vi \u00e1p d\u1ee5ng<\/span><\/li>\n
  3. M\u1ee5c \u0111\u00edch<\/span><\/li>\n
  4. \u0110\u1ecbnh ngh\u0129a<\/span><\/li>\n
  5. Tr\u00e1ch nhi\u1ec7m<\/span><\/li>\n
  6. Quy tr\u00ecnh (b\u01b0\u1edbc chi ti\u1ebft)<\/span><\/li>\n
  7. Ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn<\/span><\/li>\n
  8. Ghi ch\u00e9p\/bi\u1ec3u m\u1eabu<\/span><\/li>\n
  9. Ph\u1ee5 l\u1ee5c (n\u1ebfu c\u00f3)<\/a><\/span><\/li>\n<\/ol>\n

    T\u1ea1i Sao SOP L\u1ea1i Quan Tr\u1ecdng?<\/b><\/h2>\n
    \"SOP
    SOP trong ng\u00e0nh d\u01b0\u1ee3c l\u00e0 g\u00ec<\/figcaption><\/figure>\n

    L\u00fd Do 1: \u0110\u1ea3m B\u1ea3o Nh\u1ea5t Qu\u00e1n<\/b><\/h3>\n

    N\u1ebfu kh\u00f4ng c\u00f3 SOP, m\u1ed7i nh\u00e2n vi\u00ean s\u1ebd l\u00e0m c\u00f4ng vi\u1ec7c theo nhi\u1ec1u c\u00e1ch kh\u00e1c nhau. <\/span>Ng\u01b0\u1eddi n\u00e0y kh\u1eed khu\u1ea9n ph\u00f2ng s\u1ea1ch v\u1edbi contact time 10 ph\u00fat, ng\u01b0\u1eddi kh\u00e1c 5 ph\u00fat.<\/b>\u00a0<\/span><\/p>\n

    K\u1ebft qu\u1ea3 l\u00e0 ch\u1ea5t l\u01b0\u1ee3ng kh\u00f4ng \u1ed5n \u0111\u1ecbnh, r\u1ee7i ro vi sinh cao.<\/span><\/p>\n

    SOP \u0111\u1ea3m b\u1ea3o t\u1ea5t c\u1ea3 nh\u00e2n vi\u00ean \u0111\u1ec1u th\u1ef1c hi\u1ec7n \u0111\u00fang m\u1ed9t quy tr\u00ecnh, m\u1ed7i l\u1ea7n, m\u1ed7i ng\u00e0y. \u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng khi ph\u1ea3i thay ca, ho\u1eb7c khi nh\u00e2n vi\u00ean c\u00f3 k\u1ef3 ngh\u1ec9.<\/span><\/p>\n

    L\u00fd Do 2: Ki\u1ec3m So\u00e1t Ch\u1ea5t L\u01b0\u1ee3ng<\/b><\/h3>\n

    SOP quy \u0111\u1ecbnh ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn (acceptance criteria). V\u00ed d\u1ee5, ATP test ph\u1ea3i d\u01b0\u1edbi 100 RLU, n\u01b0\u1edbc WFI ph\u1ea3i c\u00f3 TOC d\u01b0\u1edbi 0.5 ppm, vi sinh kh\u00f4ng kh\u00ed ph\u1ea3i d\u01b0\u1edbi 1 CFU\/m\u00b3 \u1edf Grade A. N\u1ebfu v\u01b0\u1ee3t qu\u00e1, ph\u1ea3i c\u00f3 bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c t\u1ee9c th\u00ec.<\/span><\/p>\n

    Kh\u00f4ng c\u00f3 SOP, nh\u00e2n vi\u00ean kh\u00f4ng bi\u1ebft ph\u1ea3i ki\u1ec3m tra g\u00ec, khi n\u00e0o ph\u1ea3i d\u1eebng l\u1ea1i, ho\u1eb7c ph\u1ea3i l\u00e0m g\u00ec khi ph\u00e1t sinh v\u1ea5n \u0111\u1ec1.<\/span><\/p>\n

    L\u00fd Do 3: Tu\u00e2n Th\u1ee7 GMP<\/b><\/h3>\n

    GMP y\u00eau c\u1ea7u m\u1ecdi ho\u1ea1t \u0111\u1ed9ng ph\u1ea3i \u0111\u01b0\u1ee3c ghi ch\u00e9p, c\u00f3 th\u1ec3 theo d\u00f5i \u0111\u01b0\u1ee3c (traceable) t\u1ea5t c\u1ea3 m\u1ecdi th\u1ee9 \u0111\u1ec1u t\u1ed3n t\u1ea1i \u1edf SOP. N\u1ebfu nh\u00e0 m\u00e1y kh\u00f4ng c\u00f3 SOP ho\u1eb7c kh\u00f4ng tu\u00e2n th\u1ee7, s\u1ebd b\u1ecb vi ph\u1ea1m GMP, c\u1ea5m s\u1ea3n xu\u1ea5t, v\u00e0 ph\u1ea3i thu h\u1ed3i s\u1ea3n ph\u1ea9m.<\/span><\/p>\n

    L\u00fd Do 4: \u0110\u00e0o T\u1ea1o Nh\u00e2n Vi\u00ean M\u1edbi<\/b><\/h3>\n

    Nh\u00e2n vi\u00ean m\u1edbi c\u00f3 th\u1ec3 h\u1ecdc t\u1eeb SOP, kh\u00f4ng c\u1ea7n ph\u1ea3i d\u1ea1y t\u1eebng ng\u01b0\u1eddi m\u1ed9t, \u0111i\u1ec1u n\u00e0y ti\u1ebft ki\u1ec7m th\u1eddi gian, chi ph\u00ed v\u00e0 gi\u1ea3m sai s\u00f3t. SOP l\u00e0 t\u00e0i li\u1ec7u tham chi\u1ebfu khi nh\u00e2n vi\u00ean qu\u00ean ho\u1eb7c g\u1eb7p t\u00ecnh hu\u1ed1ng m\u1edbi.<\/span><\/p>\n

    C\u00e1c Lo\u1ea1i SOP Ch\u00ednh Trong Ng\u00e0nh D\u01b0\u1ee3c<\/b><\/h2>\n

    SOP V\u1ec7 Sinh V\u00e0 Kh\u1eed Khu\u1ea9n Ph\u00f2ng S\u1ea1ch<\/b><\/h3>\n

    M\u00f4 t\u1ea3 <\/span>c\u00e1c b\u01b0\u1edbc v\u1ec7 sinh tr\u1ea7n, t\u01b0\u1eddng, s\u00e0n thi\u1ebft b\u1ecb<\/b>. T\u1eeb vi\u1ec7c l\u00ean k\u1ebf ho\u1ea1ch, chu\u1ea9n b\u1ecb h\u00f3a ch\u1ea5t, lau r\u1eeda, kh\u1eed khu\u1ea9n (contact time, n\u1ed3ng \u0111\u1ed9), ki\u1ec3m tra ATP, cho \u0111\u1ebfn ghi ch\u00e9p k\u1ebft qu\u1ea3.<\/span><\/p>\n

    SOP v\u1ec7 sinh th\u01b0\u1eddng bao g\u1ed3m:<\/b><\/h4>\n