{"id":2327,"date":"2026-09-18T13:22:00","date_gmt":"2026-09-18T06:22:00","guid":{"rendered":"https:\/\/tfipharma.com\/?p=2327"},"modified":"2026-09-18T14:28:24","modified_gmt":"2026-09-18T07:28:24","slug":"who-gmp-la-gi-tieu-chuan-san-xuat-thuoc-tai-tfi","status":"publish","type":"post","link":"https:\/\/tfipharma.com\/en\/who-gmp-la-gi-tieu-chuan-san-xuat-thuoc-tai-tfi\/","title":{"rendered":"WHO-GMP L\u00e0 G\u00ec? Ti\u00eau Chu\u1ea9n S\u1ea3n Xu\u1ea5t Thu\u1ed1c T\u1ea1i Nh\u00e0 M\u00e1y TFI N\u0103m 2026"},"content":{"rendered":"

Trong ng\u00e0nh s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, <\/span>WHO-GMP<\/b> \u0111\u01b0\u1ee3c coi l\u00e0 “kim ch\u1ec9 nam” b\u1eaft bu\u1ed9c \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o m\u1ed7i vi\u00ean thu\u1ed1c khi ra th\u1ecb tr\u01b0\u1eddng \u0111\u1ec1u \u0111\u1ea1t ch\u1ea5t l\u01b0\u1ee3ng, \u0111\u1ed9 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb t\u1ed1i \u01b0u theo \u0111\u00fang c\u00e1c quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh c\u1ee7a B\u1ed9 Y t\u1ebf. V\u1eady ti\u00eau chu\u1ea9n WHO-GMP l\u00e0 g\u00ec v\u00e0 <\/span>C\u00f4ng ty C\u1ed5 ph\u1ea7n Trust Farma Qu\u1ed1c t\u1ebf (TFI)<\/b> \u0111ang \u00e1p d\u1ee5ng chu\u1ea9n m\u1ef1c n\u00e0y nh\u01b0 th\u1ebf n\u00e0o trong v\u1eadn h\u00e0nh nh\u00e0 m\u00e1y n\u0103m 2026?<\/span><\/p>\n

\"\"<\/a><\/p>\n

 <\/p>\n

1. WHO-GMP L\u00e0 G\u00ec?<\/b><\/h2>\n

WHO-GMP<\/b> (<\/span>World Health Organization – Good Manufacturing Practices<\/span><\/i>) l\u00e0 <\/span>Th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t thu\u1ed1c<\/b> do T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi ban h\u00e0nh. T\u1ea1i Vi\u1ec7t Nam, c\u00e1c nguy\u00ean t\u1eafc WHO-GMP \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf ch\u00ednh th\u1ee9c c\u1ee5 th\u1ec3 h\u00f3a v\u00e0 quy \u0111\u1ecbnh chi ti\u1ebft t\u1ea1i <\/span>Th\u00f4ng t\u01b0 35\/2018\/TT-BYT<\/b> v\u1ec1 Th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t thu\u1ed1c, nguy\u00ean li\u1ec7u l\u00e0m thu\u1ed1c.<\/span><\/p>\n

Kh\u00e1c v\u1edbi vi\u1ec7c ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01a1n thu\u1ea7n tr\u00ean th\u00e0nh ph\u1ea9m cu\u1ed1i c\u00f9ng, WHO-GMP can thi\u1ec7p v\u00e0 ki\u1ec3m so\u00e1t <\/span>to\u00e0n b\u1ed9 qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t<\/b> \u2014 t\u1eeb nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o, nh\u00e0 x\u01b0\u1edfng, trang thi\u1ebft b\u1ecb, quy tr\u00ecnh thao t\u00e1c chu\u1ea9n (SOP) \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng m\u00f4i tr\u01b0\u1eddng v\u00e0 tr\u00ecnh \u0111\u1ed9 c\u1ee7a nh\u00e2n s\u1ef1.<\/span><\/p>\n

2. C\u00e1c Tr\u1ee5 C\u1ed9t Ch\u00ednh Trong Ti\u00eau Chu\u1ea9n WHO-GMP<\/b><\/h2>\n

Theo t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn c\u1ee7a T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi (TRS 986, Annex 2) v\u00e0 quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 Y t\u1ebf, m\u1ed9t nh\u00e0 m\u00e1y \u0111\u1ea1t chu\u1ea9n WHO-GMP ph\u1ea3i \u0111\u00e1p \u1ee9ng nghi\u00eam ng\u1eb7t 5 y\u1ebfu t\u1ed1 c\u1ed1t l\u00f5i:<\/span><\/p>\n