{"id":13074,"date":"2020-05-26T08:19:47","date_gmt":"2020-05-26T08:19:47","guid":{"rendered":"http:\/\/kiav.net\/?p=13074"},"modified":"2020-07-06T16:23:04","modified_gmt":"2020-07-06T16:23:04","slug":"tu-vi-khi-hau-binder-ung-dung-trong-nghanh-cong-nghiep-duoc-pham","status":"publish","type":"post","link":"https:\/\/kiav.net\/news\/tu-vi-khi-hau-binder-ung-dung-trong-nghanh-cong-nghiep-duoc-pham\/","title":{"rendered":"T\u1ee7 vi kh\u00ed h\u1eadu Binder: \u1ee8ng d\u1ee5ng trong ng\u00e0nh c\u00f4ng nghi\u1ec7p D\u01b0\u1ee3c ph\u1ea9m"},"content":{"rendered":"<p>Ki\u1ec3m tra \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a th\u00e0nh ph\u1ea9m v\u00e0 s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m ph\u1ea3i tu\u00e2n theo ti\u00eau chu\u1ea9n ICH Q1A (R2) &#8211; Ki\u1ec3m tra \u0111\u1ed9 quang h\u00f3a theo ti\u00eau chu\u1ea9n Q1B(R2), nh\u1eefng d\u1eef li\u1ec7u t\u1eeb c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra n\u00e0y l\u00e0 c\u00e1c d\u1eef li\u1ec7u quan tr\u1ecdng \u0111\u1ec3 g\u1eedi cho c\u00e1c c\u01a1 quan y t\u1ebf ki\u1ec3m duy\u1ec7t. Trong b\u00e0i vi\u1ebft n\u00e0y, ch\u00fang t\u00f4i s\u1ebd m\u00f4 t\u1ea3 c\u00e1c \u0111\u1eb7c t\u00ednh k\u1ef9 thu\u1eadt c\u00f3 \u00fd ngh\u0129a \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng trong c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh tu\u00e2n theo ICH ho\u1eb7c c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf kh\u00e1c v\u1edbi t\u1ee7 vi kh\u00ed h\u1eadu BINDER.<\/p>\n<h2><strong>1. Ki\u1ec3m tra \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh v\u00e0 \u0111\u1ed9 quang h\u00f3a, d\u01b0\u1ee3c t\u00ednh c\u1ee7a th\u00e0nh ph\u1ea7n d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u00e0nh ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m <\/strong><\/h2>\n<p>Ki\u1ec3m tra \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh v\u00e0 kh\u1ea3 n\u0103ng quang h\u00f3a \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u1eb1m ki\u1ec3m tra d\u01b0\u1ee3c t\u00ednh c\u1ee7a c\u00e1c th\u00e0nh ph\u1ea7n d\u01b0\u1ee3c ph\u1ea9m (API) ho\u1eb7c th\u00e0nh ph\u1ea9m (FPP) b\u1eb1ng c\u00e1ch thay \u0111\u1ed5i th\u1eddi gian, nhi\u1ec7t \u0111\u1ed9, kh\u00ed h\u1eadu, \u00e1nh s\u00e1ng. Th\u1ef1c hi\u1ec7n c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra n\u00e0y b\u1eb1ng t\u1ee7 vi kh\u00ed h\u1eadu nh\u1eb1m x\u00e1c \u0111\u1ecbnh th\u1eddi gian h\u1ebft h\u1ea1n c\u1ee7a s\u1ea3n ph\u1ea9m, th\u1eddi gian ti\u1ebfp theo \u0111\u1ec3 ki\u1ec3m tra d\u01b0\u1ee3c t\u00ednh v\u00e0 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o qu\u1ea3n. Nh\u1eefng thi\u1ebft b\u1ecb T\u1ee7 vi kh\u00ed h\u1eadu hay c\u00f2n g\u1ecdi l\u00e0 t\u1ee7 l\u00e3o h\u00f3a c\u1ea5p t\u1ed1c (T\u1ee7 gi\u1ea3 l\u1eadp m\u00f4i tr\u01b0\u1eddng) \u0111\u1ec3 th\u1ef1c hi\u1ec7n c\u00e1c nghi\u00ean c\u1ee9u n\u00e0y m\u00e0 H\u00f3a Vi\u1ec7t hi\u1ec7n \u0111ang l\u00e0 nh\u00e0 ph\u00e2n ph\u1ed1i ch\u00ednh th\u1ee9c.<\/p>\n<ul>\n<li><a href=\"http:\/\/kiav.net\/product-category\/binder-duc\/tu-vi-khi-hau\/\"><strong>T\u1ee7 vi kh\u00ed h\u1eadu KBF 115, KBF 240, KBF 720, KBF 1020<\/strong><\/a><\/li>\n<li><a href=\"http:\/\/kiav.net\/product-category\/binder-duc\/tu-vi-khi-hau\/\"><strong>T\u1ee7 vi kh\u00ed h\u1eadu c\u00f3 \u00e1nh s\u00e1ng KBF P 240, KBF P 720 <\/strong><\/a><\/li>\n<li><a href=\"http:\/\/kiav.net\/product-category\/binder-duc\/tu-vi-khi-hau\/\"><strong>T\u1ee7 vi kh\u00ed h\u1eadu c\u00f3 \u00e1nh s\u00e1ng KBF LQC 240, KBF LQC 720<\/strong><\/a><\/li>\n<li><a href=\"http:\/\/kiav.net\/product-category\/binder-duc\/tu-vi-khi-hau\/\"><strong>T\u1ee7 vi kh\u00ed h\u1eadu gi\u00e1 r\u1ebb Solid.Line KBF S115, KBF S240, KBF S720, KBF S1020<\/strong><\/a><\/li>\n<\/ul>\n<p>Ti\u00eau chu\u1ea9n Q1A (R2) \u0111\u00e3 c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb n\u0103m 2003 v\u00e0 Q1B t\u1eeb n\u0103m 1996. Nh\u1edd \u0111\u00f3, c\u00e1c th\u1eed nghi\u1ec7m \u0111\u1ed9 \u1ea9m \u0111\u00e3 tr\u1ea3i qua nh\u1eefng b\u01b0\u1edbc ph\u00e1t tri\u1ec3n l\u1edbn.<\/p>\n<h2><strong>2. Y\u00eau c\u1ea7u thi\u1ebft b\u1ecb<\/strong><\/h2>\n<p>\u0110\u1ed9 ch\u00ednh x\u00e1c v\u00e0 \u0111\u1ed9 l\u1eb7p l\u1ea1i c\u1ee7a c\u00e1c th\u00f4ng s\u1ed1, \u0111\u1ed9 tin c\u1eady v\u00e0 \u0111\u1ed9 b\u1ec1n khi t\u1ee7 ho\u1ea1t \u0111\u1ed9ng li\u00ean t\u1ee5c l\u00e0 nh\u1eefng y\u1ebfu t\u1ed1 \u01b0u ti\u00ean quan tr\u1ecdng h\u00e0ng \u0111\u1ea7u c\u1ee7a m\u1ed9t t\u1ee7 vi kh\u00ed h\u1eadu (T\u1ee7 l\u00e3o h\u00f3a c\u1ea5p t\u1ed1c). Ch\u01b0\u01a1ng tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng tr\u1ef1c quan v\u00e0 c\u00e1c d\u1eef li\u1ec7u, t\u00e0i li\u1ec7u ph\u1ea3i \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n CFR 21 part 11 c\u1ee7a FDA 21. Ngo\u00e0i ra, c\u00f2n c\u00f3 c\u00e1c ch\u1ee9ng ch\u1ec9 hi\u1ec7u chu\u1ea9n, b\u1ed9 ghi d\u1eef li\u1ec7u, v\u00e0 b\u1ed9 t\u00e0i li\u1ec7u th\u1ea9m \u0111\u1ecbnh c\u0169ng r\u1ea5t quan tr\u1ecdng.<\/p>\n<h2><strong>3. C\u00e1c y\u00eau c\u1ea7u c\u1ea7n thi\u1ebft khi s\u1eed d\u1ee5ng t\u1ee7 vi kh\u00ed h\u1eadu trong D\u01b0\u1ee3c ph\u1ea9m<\/strong><\/h2>\n<ul>\n<li><strong>Bi\u1ec3u \u0111\u1ed3 nhi\u1ec7t \u0111\u1ed9 &#8211; \u0111\u1ed9 \u1ea9m<\/strong><\/li>\n<\/ul>\n<p>Bi\u1ec3u \u0111\u1ed3 nhi\u1ec7t \u0111\u1ed9 &#8211; \u0111\u1ed9 \u1ea9m gi\u00fap ch\u00fang ta nh\u00ecn \u0111\u01b0\u1ee3c t\u1ed5ng quan c\u00e1c gi\u00e1 tr\u1ecb nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m c\u0169ng nh\u01b0 c\u00e1c \u0111i\u1ec1u ki\u1ec7n kh\u00ed h\u1eadu m\u00f4i tr\u01b0\u1eddng. Hi\u1ec7u su\u1ea5t l\u00e0m vi\u1ec7c c\u1ee7a T\u1ee7 Binder b\u1ec1n b\u1ec9, sai s\u1ed1 nhi\u1ec7t r\u1ea5t nh\u1ecf, kh\u00f4ng \u0111\u00e1ng k\u1ec3, lu\u00f4n \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c \u0111i\u1ec1u ki\u1ec7n kh\u00ed h\u1eadu theo ti\u00eau chu\u1ea9n ICH, \u0111\u00e1p \u1ee9ng \u0111\u1ec3 m\u00f4 ph\u1ecfng t\u1ea5t c\u1ea3 5 v\u00f9ng kh\u00ed h\u1eadu t\u1eeb v\u00f9ng kh\u00ed h\u1eadu I \u0111\u1ebfn IVb. C\u00e1c d\u00f2ng t\u1ee7 kh\u00e1c ch\u1ec9 m\u00f4 ph\u1ecfng m\u1ed9t s\u1ed1 \u0111i\u1ec1u ki\u1ec7n kh\u00ed h\u1eadu nh\u1ea5t \u0111\u1ecbnh n\u00ean ph\u1ea1m vi \u1ee9ng d\u1ee5ng h\u1ea1n ch\u1ebf h\u01a1n so v\u1edbi t\u1ee7 vi kh\u00ed h\u1eadu Binder.<\/p>\n<ul>\n<li><strong>C\u00e1c lu\u1ed3ng kh\u00ed \u0111i ngang &#8211; d\u1ecdc<\/strong><\/li>\n<\/ul>\n<p>Tr\u01b0\u1eddng h\u1ee3p lu\u1ed3ng kh\u00ed ngang, kh\u00f4ng kh\u00ed khu\u1ebfch t\u00e1n \u0111\u1ec1u \u1edf b\u1ea5t k\u00ec v\u1ecb tr\u00ed n\u00e0o tr\u00ean m\u1ed7i khay. Ph\u00e2n ph\u1ed1i nhi\u1ec7t theo chi\u1ec1u n\u00e0y s\u1ebd gi\u00fap ph\u00e2n ph\u1ed1i nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m \u0111\u1ed3ng \u0111\u1ec1u trong t\u1ee7. \u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t \u0111\u00fang trong tr\u01b0\u1eddng h\u1ee3p lu\u1ed3ng kh\u00f4ng kh\u00ed hai m\u1eb7t, n\u1eb1m ngang. Trong tr\u01b0\u1eddng h\u1ee3p lu\u1ed3ng kh\u00f4ng kh\u00ed th\u1eb3ng \u0111\u1ee9ng, t\u1ee9c l\u00e0 t\u1eeb d\u01b0\u1edbi l\u00ean tr\u00ean, kh\u00f4ng kh\u00ed khu\u1ebfch t\u00e1n qua c\u00e1c khay. \u0110\u1ed9 \u0111\u1ed3ng \u0111\u1ec1u nhi\u1ec7t v\u1eabn ch\u00ednh x\u00e1c ngay c\u1ea3 khi c\u00f3 s\u1ef1 c\u1ea3n tr\u1edf c\u1ee7a c\u00e1c khay.<\/p>\n<ul>\n<li><strong>\u00c1nh s\u00e1ng<\/strong><\/li>\n<\/ul>\n<p>Khi ki\u1ec3m tra m\u1eabu theo ti\u00eau chu\u1ea9n ICH Q1B, ngo\u00e0i nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m c\u00f2n c\u00f3 th\u00f4ng s\u1ed1 \u00e1nh s\u00e1ng. Ngu\u1ed3n s\u00e1ng v\u00e0 m\u1ee9c chi\u1ebfu s\u00e1ng t\u00f9y theo nhu c\u1ea7u ng\u01b0\u1eddi s\u1eed d\u1ee5ng. \u00c1nh s\u00e1ng VIS ph\u1ea3i \u0111\u1ea1t t\u1ed1i thi\u1ec3u 1.2 tri\u1ec7u lux\/gi\u1edd v\u00e0 \u00e1nh s\u00e1ng UV ph\u1ea3i \u0111\u1ea1t t\u1ed1i thi\u1ec3u 200Wh\/m2 trong qu\u00e1 tr\u00ecnh test m\u1eabu.<\/p>\n<p>Y\u1ebfu t\u1ed1 nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m v\u00e0 \u00e1nh s\u00e1ng \u0111\u01b0\u1ee3c ph\u00e2n b\u1ed1 \u0111\u1ed3ng \u0111\u1ec1u tr\u00ean m\u1ed7i khay l\u00e0 \u0111i\u1ec1u t\u1ed1i quan tr\u1ecdng. C\u0169ng nh\u01b0 nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m, \u00e1nh s\u00e1ng ph\u1ea3i \u0111\u01b0\u1ee3c l\u1eadp tr\u00ecnh \u0111\u1ec3 \u0111\u00e1p \u1ee9ng quy \u0111\u1ecbnh 21 CFR part 11 c\u1ee7a FDA.<\/p>\n<ul>\n<li><strong>N\u01b0\u1edbc cho b\u1ed9 t\u1ea1o \u1ea9m<\/strong><\/li>\n<\/ul>\n<p>N\u01b0\u1edbc l\u00e0 th\u00e0nh ph\u1ea7n quan tr\u1ecdng trong b\u1ed9 t\u1ea1o \u1ea9m &#8211; ngu\u1ed3n n\u01b0\u1edbc s\u1eed d\u1ee5ng ph\u1ea3i c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng t\u1ed1t. C\u00f3 nhi\u1ec1u c\u00e1ch \u0111\u1ec3 cung c\u1ea5p ngu\u1ed3n n\u01b0\u1edbc, c\u00f3 th\u1ec3 k\u1ebft n\u1ed1i tr\u1ef1c ti\u1ebfp v\u1edbi ngu\u1ed3n n\u01b0\u1edbc t\u1ea1i ch\u1ed7 ho\u1eb7c c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng b\u1ed3n ch\u1ee9a n\u01b0\u1edbc v\u1edbi th\u1ec3 t\u00edch l\u1edbn c\u1ee7a Binder \u0111\u01b0\u1ee3c cung c\u1ea5p nh\u01b0 ph\u1ee5 ki\u1ec7n \u0111i li\u1ec1n \u0111\u1ec3 c\u1ea5p v\u00e0 x\u1ea3 n\u01b0\u1edbc. Ho\u1eb7c c\u00f3 th\u1ec3 l\u1eafp \u0111\u1eb7t n\u1ed1i v\u1edbi ngu\u1ed3n n\u01b0\u1edbc \u1edf xa t\u1ee7. K\u1ec3 c\u1ea3 ngu\u1ed3n n\u01b0\u1edbc \u0111\u1eb7t xa hay g\u1ea7n c\u0169ng c\u1ea7n c\u00f3 b\u1ed9 trao \u0111\u1ed5i ion \u0111\u1ec3 n\u01b0\u1edbc \u0111\u1ea1t ch\u1ea5t l\u01b0\u1ee3ng t\u1ed1t tr\u01b0\u1edbc khi cung c\u1ea5p \u0111\u1ebfn t\u1ee7.<\/p>\n<ul>\n<li><strong>Ho\u1ea1t \u0111\u1ed9ng li\u00ean t\u1ee5c<\/strong><\/li>\n<\/ul>\n<p>C\u00e1c t\u1ee7 vi kh\u00ed h\u1eadu BINDER (T\u1ee7 ki\u1ec3m tra th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m) c\u00f3 th\u1ec3 ho\u1ea1t \u0111\u1ed9ng li\u00ean t\u1ee5c 8000h\/n\u0103m. Ho\u1ea1t \u0111\u1ed9ng m\u1ea1nh m\u1ebd, s\u1eed d\u1ee5ng v\u1eadt li\u1ec7u b\u1ec1n b\u1ec9 v\u00e0 c\u00e1c th\u00e0nh ph\u1ea7n trong t\u1ee7 lu\u00f4n mang l\u1ea1i \u0111\u1ed9 tin c\u1eady t\u1ed1i \u0111a v\u00e0 s\u1eed d\u1ee5ng l\u00e2u d\u00e0i qua nhi\u1ec1u n\u0103m. \u0110\u1ec3 gi\u1ea3m nguy c\u01a1 l\u00e2y nhi\u1ec5m ch\u00e9o v\u00e0 l\u00e2y nhi\u1ec5m sinh h\u1ecdc b\u00ean trong t\u1ee7, H\u00e3ng \u0111\u00e3 thi\u1ebft k\u1ec3 t\u1ee7 \u0111\u1ec3 d\u1ec5 d\u00e0ng v\u1ec7 sinh v\u00e0 lau ch\u00f9i. H\u1ee3p kim, th\u00e9p kh\u00f4ng g\u1ec9 v\u1edbi c\u00e1c g\u00f3c \u0111\u01b0\u1ee3c bo tr\u00f2n, khay ch\u1ee9a c\u00f3 th\u1ec3 h\u1ea5p ti\u1ec7t tr\u00f9ng v\u00e0 kh\u00f4ng c\u00f3 v\u1eadt li\u1ec7u t\u1ed5ng h\u1ee3p trong t\u1ee7. M\u1ed9t s\u1ed1 d\u00f2ng t\u1ee7 c\u0169ng c\u00f3 d\u1ea3i nhi\u1ec7t \u0111\u1ed9 m\u1edf r\u1ed9ng l\u00ean t\u1edbi 100\u00b0C, ngh\u0129a l\u00e0 c\u00f3 th\u1ec3 kh\u1eed tr\u00f9ng.<\/p>\n<ul>\n<li><strong>L\u1eadp tr\u00ecnh v\u00e0 t\u00e0i li\u1ec7u<\/strong><\/li>\n<\/ul>\n<p>M\u1ed9t y\u1ebfu t\u1ed1 quan tr\u1ecdng \u0111\u1ec3 \u1ee9ng d\u1ee5ng \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn l\u00e0 b\u1ed9 t\u00e0i li\u1ec7u ho\u00e0n ch\u1ec9nh t\u1ea5t c\u1ea3 c\u00e1c tham s\u1ed1 cho m\u1ecdi tr\u1ea1ng th\u00e1i v\u1eadn h\u00e0nh. T\u00e0i li\u1ec7u ph\u1ea3i \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c ti\u00eau chu\u1ea9n CFR 21 part 11 \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 v\u00e0 ch\u1eef k\u00ed \u0111i\u1ec7n t\u1eed. C\u00e1c ch\u1ee9ng nh\u1eadn quan tr\u1ecdng v\u1ec1 hi\u1ec7u chu\u1ea9n nhi\u1ec7t \u0111\u1ed9, kh\u00ed h\u1eadu v\u00e0 \u00e1nh s\u00e1ng, b\u1ed9 ghi d\u1eef li\u1ec7u (t\u00e0i li\u1ec7u quy tr\u00ecnh ghi d\u1eef li\u1ec7u \u0111\u1ed9c l\u1eadp) v\u00e0 t\u00e0i li\u1ec7u th\u1ea9m \u0111\u1ecbnh v\u1edbi IQ (t\u00e0i li\u1ec7u c\u00e0i \u0111\u1eb7t), OQ (t\u00e0i li\u1ec7u v\u1eadn h\u00e0nh) v\u00e0 PQ (t\u00e0i li\u1ec7u hi\u1ec7u su\u1ea5t)<\/p>\n<h2><strong>4. C\u00e1c h\u01b0\u1edbng d\u1eabn quan tr\u1ecdng kh\u00e1c: WHO, FDA, MHW v\u00e0 VICH<\/strong><\/h2>\n<p>C\u00e1c h\u01b0\u1edbng d\u1eabn quan tr\u1ecdng kh\u00e1c \u0111\u00e3 \u0111\u01b0\u1ee3c T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi (WHO) c\u00f4ng b\u1ed1: Th\u1eed nghi\u1ec7m \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a c\u00e1c th\u00e0nh ph\u1ea7n d\u01b0\u1ee3c t\u00ednh d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m th\u00e0nh ph\u1ea9m. H\u01b0\u1edbng d\u1eabn c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 b\u1edfi c\u00e1c t\u1ed5 ch\u1ee9c sau: C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) t\u1ea1i Hoa K\u1ef3, C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m Ch\u00e2u \u00c2u (EMEA) v\u00e0 B\u1ed9 Y t\u1ebf v\u00e0 Ph\u00fac l\u1ee3i (MHW) t\u1ea1i Nh\u1eadt B\u1ea3n.<\/p>\n<p>\u0110\u1ed1i v\u1edbi c\u00e1c th\u00e0nh ph\u1ea7n d\u01b0\u1ee3c t\u00ednh d\u01b0\u1ee3c ph\u1ea9m trong thu\u1ed1c th\u00fa y VICH GL3 (R) \u201cTh\u1eed nghi\u1ec7m \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a thu\u1ed1c Th\u00fa y\u201d v\u00e0 VICH GL5 \u201cTh\u1eed nghi\u1ec7m kh\u1ea3 n\u0103ng quang h\u00f3a c\u1ee7a c\u00e1c thu\u1ed1c th\u00fa y m\u1edbi v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c\u201d \u0111\u1ec3 m\u00f4 t\u1ea3 th\u1eed nghi\u1ec7m \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh t\u01b0\u01a1ng \u1ee9ng.<\/p>\n<p><strong>Ngu\u1ed3n Binder<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ki\u1ec3m tra \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a th\u00e0nh ph\u1ea9m v\u00e0 s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m ph\u1ea3i tu\u00e2n theo ti\u00eau chu\u1ea9n ICH Q1A (R2) &#8211; Ki\u1ec3m tra \u0111\u1ed9 quang h\u00f3a theo ti\u00eau chu\u1ea9n Q1B(R2), nh\u1eefng d\u1eef li\u1ec7u t\u1eeb c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra n\u00e0y l\u00e0 c\u00e1c d\u1eef li\u1ec7u quan tr\u1ecdng \u0111\u1ec3 g\u1eedi cho c\u00e1c c\u01a1 quan y t\u1ebf [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":13131,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[2353,2346],"yoast_head":"\n<title>T\u1ee7 vi kh\u00ed h\u1eadu Binder: \u1ee8ng d\u1ee5ng trong ng\u00e0nh c\u00f4ng nghi\u1ec7p D\u01b0\u1ee3c ph\u1ea9m<\/title>\n<meta name=\"description\" content=\"Hi\u1ec7u su\u1ea5t l\u00e0m 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