{"id":391514,"date":"2024-10-03T21:09:43","date_gmt":"2024-10-03T14:09:43","guid":{"rendered":"https:\/\/hoanghamobile.com\/tin-tuc\/?p=391514"},"modified":"2024-10-03T21:11:08","modified_gmt":"2024-10-03T14:11:08","slug":"gmp-la-gi","status":"publish","type":"post","link":"https:\/\/hoanghamobile.com\/tin-tuc\/gmp-la-gi\/","title":{"rendered":"GMP l\u00e0 g\u00ec? C\u00e1c y\u00eau c\u1ea7u c\u1ee7a GMP v\u00e0 quy tr\u00ecnh tri\u1ec3n khai"},"content":{"rendered":"

GMP l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng trong s\u1ea3n xu\u1ea5t, \u0111\u1eb7c bi\u1ec7t l\u00e0 trong ng\u00e0nh c\u00f4ng nghi\u1ec7p d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m. B\u00e0i vi\u1ebft n\u00e0y s\u1ebd gi\u1edbi thi\u1ec7u v\u1ec1 kh\u00e1i ni\u1ec7m GMP l\u00e0 g\u00ec, c\u00e1c ti\u00eau chu\u1ea9n quan tr\u1ecdng nh\u01b0 GMP EU, WHO, cGMP v\u00e0 Pics GMP, c\u0169ng nh\u01b0 c\u00e1c y\u00eau c\u1ea7u c\u1ea7n thi\u1ebft trong qu\u00e1 tr\u00ecnh tri\u1ec3n khai GMP.<\/span><\/p>\n

GMP l\u00e0 g\u00ec?<\/b><\/h2>\n

GMP (Good Manufacturing Practices) l\u00e0 h\u1ec7 th\u1ed1ng c\u00e1c quy \u0111\u1ecbnh, nguy\u00ean t\u1eafc v\u00e0 h\u01b0\u1edbng d\u1eabn b\u1eaft bu\u1ed9c trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, \u0111\u1eb7c bi\u1ec7t trong c\u00e1c ng\u00e0nh c\u00f4ng nghi\u1ec7p c\u00f3 y\u00eau c\u1ea7u cao v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, th\u1ef1c ph\u1ea9m, m\u1ef9 ph\u1ea9m, v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf. GMP l\u00e0 m\u1ed9t ph\u1ea7n quan tr\u1ecdng trong h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng, gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng kh\u00f4ng ch\u1ec9 \u0111\u1ea1t ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng cao m\u00e0 c\u00f2n an to\u00e0n cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng.<\/span><\/p>\n

\"GMP<\/p>\n

GMP c\u00f2n \u0111\u01b0\u1ee3c hi\u1ec3u l\u00e0 m\u1ed9t c\u00f4ng c\u1ee5 qu\u1ea3n l\u00fd gi\u00fap nh\u00e0 s\u1ea3n xu\u1ea5t ki\u1ec3m so\u00e1t m\u1ecdi kh\u00eda c\u1ea1nh trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t nh\u1eb1m ng\u0103n ng\u1eeba c\u00e1c sai s\u00f3t, gi\u1ea3m thi\u1ec3u r\u1ee7i ro v\u00e0 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed3ng nh\u1ea5t c\u1ee7a s\u1ea3n ph\u1ea9m. \u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng trong c\u00e1c ng\u00e0nh nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, n\u01a1i m\u00e0 m\u1ed9t l\u1ed7i nh\u1ecf trong s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn nh\u1eefng h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng cho s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi ti\u00eau d\u00f9ng.<\/span><\/p>\n

C\u00e1c ti\u00eau chu\u1ea9n GMP l\u00e0 g\u00ec?<\/b><\/h2>\n

C\u00e1c ti\u00eau chu\u1ea9n GMP l\u00e0 t\u1eadp h\u1ee3p c\u00e1c nguy\u00ean t\u1eafc v\u00e0 h\u01b0\u1edbng d\u1eabn nh\u1eb1m \u0111\u1ea3m b\u1ea3o qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t di\u1ec5n ra trong \u0111i\u1ec1u ki\u1ec7n t\u1ed1t nh\u1ea5t \u0111\u1ec3 t\u1ea1o ra s\u1ea3n ph\u1ea9m an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng cao.\u00a0<\/span><\/p>\n

Ti\u00eau chu\u1ea9n EU <\/b>GMP <\/b>l\u00e0 g\u00ec?<\/b><\/h3>\n

Ti\u00eau chu\u1ea9n EU GMP l\u00e0 m\u1ed9t trong nh\u1eefng ti\u00eau chu\u1ea9n nghi\u00eam ng\u1eb7t nh\u1ea5t tr\u00ean th\u1ebf gi\u1edbi, \u00e1p d\u1ee5ng cho c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ho\u1eb7c nh\u1eadp kh\u1ea9u v\u00e0o Li\u00ean minh ch\u00e2u \u00c2u (EU). EU GMP \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t theo quy tr\u00ecnh nghi\u00eam ng\u1eb7t, \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u v\u1ec1 an to\u00e0n, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

\"Ti\u00eau<\/p>\n

Ti\u00eau chu\u1ea9n EU GMP c\u0169ng y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i c\u00f3 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd r\u1ee7i ro, \u0111\u1ea3m b\u1ea3o s\u1ef1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. V\u1edbi vi\u1ec7c tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n EU GMP, c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m s\u1ebd \u0111\u1ea1t \u0111\u01b0\u1ee3c s\u1ef1 tin c\u1eady t\u1eeb ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 t\u1ea1o \u0111i\u1ec1u ki\u1ec7n thu\u1eadn l\u1ee3i cho vi\u1ec7c xu\u1ea5t kh\u1ea9u v\u00e0o th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf.<\/span><\/p>\n

Ti\u00eau chu\u1ea9n <\/b>WHO <\/b>GMP l\u00e0 g\u00ec?<\/b><\/h3>\n

Ti\u00eau chu\u1ea9n WHO GMP l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng c\u00e1c h\u01b0\u1edbng d\u1eabn do T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi (WHO) \u0111\u01b0a ra, nh\u1eb1m \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m tr\u00ean to\u00e0n c\u1ea7u. WHO GMP \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 h\u1ed7 tr\u1ee3 c\u00e1c qu\u1ed1c gia ph\u00e1t tri\u1ec3n v\u00e0 duy tr\u00ec c\u00e1c ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m.<\/span><\/p>\n

\"Ti\u00eau<\/p>\n

Tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n WHO GMP kh\u00f4ng ch\u1ec9 gi\u00fap c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t duy tr\u00ec ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m m\u00e0 c\u00f2n t\u1ea1o \u0111i\u1ec1u ki\u1ec7n thu\u1eadn l\u1ee3i cho vi\u1ec7c l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m tr\u00ean th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf. V\u1edbi ti\u00eau chu\u1ea9n n\u00e0y, c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m s\u1ebd c\u00f3 kh\u1ea3 n\u0103ng c\u1ea1nh tranh cao v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u kh\u1eaft khe t\u1eeb c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m tr\u00ean to\u00e0n c\u1ea7u.<\/span><\/p>\n

Ti\u00eau chu\u1ea9n cGMP l\u00e0 g\u00ec?<\/b><\/h3>\n

Ti\u00eau chu\u1ea9n cGMP (Current Good Manufacturing Practices) l\u00e0 phi\u00ean b\u1ea3n c\u1eadp nh\u1eadt c\u1ee7a GMP, \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng ph\u1ed5 bi\u1ebfn trong ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m t\u1ea1i Hoa K\u1ef3. Ti\u00eau chu\u1ea9n cGMP \u0111\u01b0\u1ee3c C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) thi\u1ebft l\u1eadp, nh\u1eb1m \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t theo c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng cao nh\u1ea5t, \u0111\u00e1p \u1ee9ng nhu c\u1ea7u hi\u1ec7n t\u1ea1i c\u1ee7a th\u1ecb tr\u01b0\u1eddng v\u00e0 ng\u01b0\u1eddi ti\u00eau d\u00f9ng.<\/span><\/p>\n

\"Ti\u00eau<\/p>\n

Ti\u00eau chu\u1ea9n cGMP kh\u00e1c bi\u1ec7t \u1edf ch\u1ed7 n\u00f3 kh\u00f4ng ch\u1ec9 \u00e1p d\u1ee5ng c\u00e1c nguy\u00ean t\u1eafc c\u01a1 b\u1ea3n c\u1ee7a GMP m\u00e0 c\u00f2n y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t li\u00ean t\u1ee5c c\u1eadp nh\u1eadt v\u00e0 c\u1ea3i ti\u1ebfn quy tr\u00ecnh s\u1ea3n xu\u1ea5t c\u1ee7a m\u00ecnh \u0111\u1ec3 ph\u00f9 h\u1ee3p v\u1edbi nh\u1eefng ti\u1ebfn b\u1ed9 khoa h\u1ecdc v\u00e0 c\u00f4ng ngh\u1ec7 m\u1edbi nh\u1ea5t.\u00a0<\/span>Vi\u1ec7c tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n cGMP kh\u00f4ng ch\u1ec9 gi\u00fap c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m \u0111\u1ea1t ch\u1ea5t l\u01b0\u1ee3ng cao m\u00e0 c\u00f2n b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi ti\u00eau d\u00f9ng, \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m.\u00a0<\/span><\/p>\n

Ti\u00eau chu\u1ea9n PIC\/S GMP l\u00e0 g\u00ec?<\/b><\/h3>\n

Ti\u00eau chu\u1ea9n PIC\/S GMP l\u00e0 m\u1ed9t trong nh\u1eefng ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t (GMP) \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n b\u1edfi H\u1ec7 th\u1ed1ng h\u1ee3p t\u00e1c thanh tra d\u01b0\u1ee3c ph\u1ea9m (Pharmaceutical Inspection Co-operation Scheme – PIC\/S). Ti\u00eau chu\u1ea9n n\u00e0y \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf nh\u1eb1m h\u00e0i h\u00f2a c\u00e1c y\u00eau c\u1ea7u GMP tr\u00ean to\u00e0n c\u1ea7u, gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m v\u00e0 y t\u1ebf \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n cao nh\u1ea5t.<\/span><\/p>\n

\"Ti\u00eau<\/p>\n

PIC\/S GMP l\u00e0 ti\u00eau chu\u1ea9n \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn v\u00e0 \u00e1p d\u1ee5ng b\u1edfi h\u01a1n 50 c\u01a1 quan qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m tr\u00ean to\u00e0n th\u1ebf gi\u1edbi, bao g\u1ed3m nhi\u1ec1u qu\u1ed1c gia ph\u00e1t tri\u1ec3n nh\u01b0 Hoa K\u1ef3, Canada, \u00dac v\u00e0 c\u00e1c n\u01b0\u1edbc thu\u1ed9c Li\u00ean minh ch\u00e2u \u00c2u.\u00a0<\/span>PIC\/S GMP \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng trong vi\u1ec7c t\u1ea1o ra m\u1ed9t h\u1ec7 th\u1ed1ng gi\u00e1m s\u00e1t ch\u1eb7t ch\u1ebd, \u0111\u1ea3m b\u1ea3o r\u1eb1ng m\u1ecdi s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t theo m\u1ed9t ti\u00eau chu\u1ea9n th\u1ed1ng nh\u1ea5t tr\u00ean to\u00e0n c\u1ea7u.<\/span><\/p>\n

Vi\u1ec7c tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n n\u00e0y gi\u00fap c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t d\u1ec5 d\u00e0ng h\u01a1n trong vi\u1ec7c xu\u1ea5t kh\u1ea9u s\u1ea3n ph\u1ea9m sang c\u00e1c th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf, \u0111\u1ed3ng th\u1eddi \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m lu\u00f4n \u0111\u1ea1t \u0111\u01b0\u1ee3c ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng.<\/span><\/p>\n

C\u00e1c y\u00eau c\u1ea7u c\u1ee7a GMP l\u00e0 g\u00ec?<\/b><\/h2>\n

C\u00e1c y\u00eau c\u1ea7u c\u1ee7a GMP bao g\u1ed3m m\u1ed9t lo\u1ea1t c\u00e1c quy \u0111\u1ecbnh nghi\u00eam ng\u1eb7t nh\u1eb1m \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t.\u00a0<\/span><\/p>\n

Y\u00eau c\u1ea7u s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi lao \u0111\u1ed9ng<\/b><\/h3>\n

Trong h\u1ec7 th\u1ed1ng GMP, s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi lao \u0111\u1ed9ng \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng trong vi\u1ec7c \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m. <\/span>Tr\u01b0\u1edbc h\u1ebft, nh\u00e2n vi\u00ean tham gia v\u00e0o qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra s\u1ee9c kh\u1ecfe \u0111\u1ecbnh k\u1ef3, \u0111\u1ea3m b\u1ea3o kh\u00f4ng m\u1eafc c\u00e1c b\u1ec7nh truy\u1ec1n nhi\u1ec5m c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ea3n ph\u1ea9m.<\/span><\/p>\n

Ngo\u00e0i ra, h\u1ecd c\u1ea7n \u0111\u01b0\u1ee3c trang b\u1ecb \u0111\u1ea7y \u0111\u1ee7 trang ph\u1ee5c b\u1ea3o h\u1ed9, nh\u01b0 g\u0103ng tay, m\u0169 v\u00e0 kh\u1ea9u trang, \u0111\u1ec3 h\u1ea1n ch\u1ebf s\u1ef1 ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp v\u1edbi s\u1ea3n ph\u1ea9m. \u0110\u1eb7c bi\u1ec7t, trong c\u00e1c ng\u00e0nh s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m, vi\u1ec7c tu\u00e2n th\u1ee7 quy tr\u00ecnh v\u1ec7 sinh c\u00e1 nh\u00e2n l\u00e0 b\u1eaft bu\u1ed9c, bao g\u1ed3m r\u1eeda tay \u0111\u00fang c\u00e1ch v\u00e0 s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb b\u1ea3o h\u1ed9 c\u00e1 nh\u00e2n \u0111\u00fang quy \u0111\u1ecbnh.<\/span><\/p>\n

\"Y\u00eau<\/p>\n

C\u00e1c nh\u00e0 m\u00e1y c\u1ea7n ph\u1ea3i c\u00f3 quy tr\u00ecnh v\u1ec7 sinh nh\u00e0 x\u01b0\u1edfng r\u00f5 r\u00e0ng, \u0111\u1ed3ng th\u1eddi cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ti\u1ec7n nghi nh\u01b0 khu v\u1ef1c ngh\u1ec9 ng\u01a1i, ph\u00f2ng thay \u0111\u1ed3 v\u00e0 nh\u00e0 v\u1ec7 sinh \u0111\u1ea1t chu\u1ea9n. Nh\u1eefng bi\u1ec7n ph\u00e1p n\u00e0y gi\u00fap ng\u0103n ng\u1eeba \u00f4 nhi\u1ec5m ch\u00e9o, b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, v\u00e0 g\u00f3p ph\u1ea7n duy tr\u00ec m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t an to\u00e0n, hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

Y\u00eau c\u1ea7u v\u1ec1 nh\u00e0 x\u01b0\u1edfng v\u00e0 m\u00e1y m\u00f3c, thi\u1ebft b\u1ecb ch\u1ebf bi\u1ebfn<\/b><\/h3>\n

Khi t\u00ecm hi\u1ec3u GMP l\u00e0 g\u00ec v\u00e0 nh\u1eefng y\u00eau c\u1ea7u c\u1ee7a GMP th\u00ec y\u00eau c\u1ea7u v\u1ec1 nh\u00e0 x\u01b0\u1edfng v\u00e0 m\u00e1y m\u00f3c, thi\u1ebft b\u1ecb ch\u1ebf bi\u1ebfn l\u00e0 y\u1ebfu t\u1ed1 then ch\u1ed1t, \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng. Y\u1ebfu t\u1ed1 n\u00e0y s\u1ebd \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. <\/span>Nh\u00e0 x\u01b0\u1edfng ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf sao cho ph\u00f9 h\u1ee3p v\u1edbi quy m\u00f4 s\u1ea3n xu\u1ea5t, \u0111\u1ea3m b\u1ea3o s\u1ea1ch s\u1ebd, tho\u00e1ng m\u00e1t v\u00e0 d\u1ec5 d\u00e0ng v\u1ec7 sinh. C\u1ea5u tr\u00fac nh\u00e0 x\u01b0\u1edfng c\u1ea7n ng\u0103n ch\u1eb7n s\u1ef1 x\u00e2m nh\u1eadp c\u1ee7a c\u00f4n tr\u00f9ng, b\u1ee5i b\u1ea9n, v\u00e0 c\u00e1c y\u1ebfu t\u1ed1 g\u00e2y nhi\u1ec5m khu\u1ea9n. H\u1ec7 th\u1ed1ng tho\u00e1t n\u01b0\u1edbc, th\u00f4ng gi\u00f3 v\u00e0 \u00e1nh s\u00e1ng c\u0169ng c\u1ea7n \u0111\u01b0\u1ee3c t\u1ed1i \u01b0u h\u00f3a \u0111\u1ec3 t\u1ea1o ra m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t an to\u00e0n.<\/span><\/p>\n

\"Y\u00eau<\/p>\n

M\u00e1y m\u00f3c v\u00e0 thi\u1ebft b\u1ecb ch\u1ebf bi\u1ebfn ph\u1ea3i \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t \u0111\u00fang c\u00e1ch, v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n v\u1ec7 sinh. T\u1ea5t c\u1ea3 thi\u1ebft b\u1ecb ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra, b\u1ea3o d\u01b0\u1ee1ng \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ho\u1ea1t \u0111\u1ed9ng hi\u1ec7u qu\u1ea3 v\u00e0 kh\u00f4ng g\u00e2y \u00f4 nhi\u1ec5m s\u1ea3n ph\u1ea9m. Ngo\u00e0i ra, c\u00e1c thi\u1ebft b\u1ecb c\u1ea7n d\u1ec5 d\u00e0ng v\u1ec7 sinh v\u00e0 l\u00e0m s\u1ea1ch \u0111\u1ec3 ng\u0103n ng\u1eeba \u00f4 nhi\u1ec5m ch\u00e9o, \u0111\u1ed3ng th\u1eddi ph\u1ea3i \u0111\u01b0\u1ee3c hi\u1ec7u chu\u1ea9n th\u01b0\u1eddng xuy\u00ean \u0111\u1ec3 duy tr\u00ec \u0111\u1ed9 ch\u00ednh x\u00e1c v\u00e0 hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

Y\u00eau c\u1ea7u \u0111i\u1ec1u ki\u1ec7n v\u1ec7 sinh nh\u00e0 x\u01b0\u1edfng, m\u00f4i tr\u01b0\u1eddng<\/b><\/h3>\n

Y\u00eau c\u1ea7u \u0111i\u1ec1u ki\u1ec7n v\u1ec7 sinh nh\u00e0 x\u01b0\u1edfng v\u00e0 m\u00f4i tr\u01b0\u1eddng l\u00e0 m\u1ed9t ph\u1ea7n quan tr\u1ecdng trong h\u1ec7 th\u1ed1ng GMP, \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong m\u00f4i tr\u01b0\u1eddng s\u1ea1ch s\u1ebd, an to\u00e0n v\u00e0 kh\u00f4ng b\u1ecb nhi\u1ec5m b\u1ea9n. N<\/span>h\u00e0 x\u01b0\u1edfng ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng v\u00e0 thi\u1ebft k\u1ebf sao cho d\u1ec5 d\u00e0ng v\u1ec7 sinh, v\u1edbi c\u00e1c b\u1ec1 m\u1eb7t, t\u01b0\u1eddng v\u00e0 s\u00e0n nh\u00e0 l\u00e0m t\u1eeb v\u1eadt li\u1ec7u kh\u00f4ng th\u1ea5m n\u01b0\u1edbc, kh\u00f4ng th\u1ea5m d\u1ea7u, v\u00e0 d\u1ec5 d\u00e0ng lau ch\u00f9i. H\u1ec7 th\u1ed1ng tho\u00e1t n\u01b0\u1edbc ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 ng\u0103n ch\u1eb7n s\u1ef1 t\u00edch t\u1ee5 c\u1ee7a n\u01b0\u1edbc th\u1ea3i, b\u1ee5i b\u1ea9n, v\u00e0 c\u1eb7n b\u00e3, \u0111\u1ed3ng th\u1eddi \u0111\u1ea3m b\u1ea3o kh\u00f4ng g\u00e2y \u00f4 nhi\u1ec5m ng\u01b0\u1ee3c l\u1ea1i cho m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t.<\/span><\/p>\n

\"Y\u00eau<\/p>\n

M\u00f4i tr\u01b0\u1eddng xung quanh nh\u00e0 x\u01b0\u1edfng c\u0169ng c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd, v\u1edbi c\u00e1c bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba nh\u01b0 ch\u1ed1ng c\u00f4n tr\u00f9ng, \u0111\u1ed9ng v\u1eadt g\u00e2y h\u1ea1i x\u00e2m nh\u1eadp, v\u00e0 ki\u1ec3m so\u00e1t ngu\u1ed3n n\u01b0\u1edbc s\u1ea1ch. H\u1ec7 th\u1ed1ng th\u00f4ng gi\u00f3, \u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed ph\u1ea3i ho\u1ea1t \u0111\u1ed9ng hi\u1ec7u qu\u1ea3, duy tr\u00ec nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m \u1ed5n \u0111\u1ecbnh, ph\u00f9 h\u1ee3p v\u1edbi y\u00eau c\u1ea7u s\u1ea3n xu\u1ea5t t\u1eebng lo\u1ea1i s\u1ea3n ph\u1ea9m. <\/span>Vi\u1ec7c n\u00e0y kh\u00f4ng ch\u1ec9 gi\u00fap \u0111\u1ea3m b\u1ea3o s\u1ea3n ph\u1ea9m \u0111\u1ea1t ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng m\u00e0 c\u00f2n gi\u1ea3m thi\u1ec3u nguy c\u01a1 nhi\u1ec5m b\u1ea9n.<\/span><\/p>\n

Y\u00eau c\u1ea7u v\u1ec1 ki\u1ec3m so\u00e1t quy tr\u00ecnh ch\u1ebf bi\u1ebfn<\/b><\/h3>\n

Y\u00eau c\u1ea7u v\u1ec1 ki\u1ec3m so\u00e1t quy tr\u00ecnh ch\u1ebf bi\u1ebfn l\u00e0 y\u1ebfu t\u1ed1 then ch\u1ed1t, c\u1ea7n \u0111\u01b0\u1ee3c ch\u00fa tr\u1ecdng khi t\u00ecm hi\u1ec3u GMP l\u00e0 g\u00ec. Y\u1ebfu t\u1ed1 n\u00e0y<\/span>\u00a0\u0111\u1ea3m b\u1ea3o r\u1eb1ng m\u1ecdi s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t \u0111\u1ec1u an to\u00e0n cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng. <\/span>Tr\u01b0\u1edbc h\u1ebft, quy tr\u00ecnh ch\u1ebf bi\u1ebfn ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng d\u1ef1a tr\u00ean c\u00e1c ti\u00eau chu\u1ea9n r\u00f5 r\u00e0ng, v\u1edbi c\u00e1c b\u01b0\u1edbc th\u1ef1c hi\u1ec7n \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a chi ti\u1ebft \u0111\u1ec3 tr\u00e1nh sai s\u00f3t.<\/span><\/p>\n

M\u1ecdi nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra k\u1ef9 l\u01b0\u1ee1ng v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 ngu\u1ed3n g\u1ed1c, \u0111\u1ea3m b\u1ea3o kh\u00f4ng c\u00f3 b\u1ea5t k\u1ef3 y\u1ebfu t\u1ed1 n\u00e0o c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng x\u1ea5u \u0111\u1ebfn s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng. Trong su\u1ed1t qu\u00e1 tr\u00ecnh ch\u1ebf bi\u1ebfn, vi\u1ec7c ki\u1ec3m so\u00e1t c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt nh\u01b0 nhi\u1ec7t \u0111\u1ed9, \u00e1p su\u1ea5t, th\u1eddi gian, v\u00e0 \u0111\u1ed9 \u1ea9m l\u00e0 c\u1ef1c k\u1ef3 quan tr\u1ecdng, gi\u00fap duy tr\u00ec ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a s\u1ea3n ph\u1ea9m.<\/span><\/p>\n

\"Y\u00eau<\/p>\n

Ngo\u00e0i ra, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i \u00e1p d\u1ee5ng c\u00e1c bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba r\u1ee7i ro v\u00e0 \u0111\u1ea3m b\u1ea3o r\u1eb1ng m\u1ecdi quy tr\u00ecnh \u0111\u1ec1u \u0111\u01b0\u1ee3c theo d\u00f5i, ghi ch\u00e9p chi ti\u1ebft. C\u00e1c thi\u1ebft b\u1ecb v\u00e0 m\u00e1y m\u00f3c s\u1eed d\u1ee5ng trong quy tr\u00ecnh ch\u1ebf bi\u1ebfn ph\u1ea3i \u0111\u01b0\u1ee3c b\u1ea3o d\u01b0\u1ee1ng v\u00e0 hi\u1ec7u chu\u1ea9n \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ho\u1ea1t \u0111\u1ed9ng ch\u00ednh x\u00e1c v\u00e0 hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

Y\u00eau c\u1ea7u v\u1ec1 ki\u1ec3m so\u00e1t qu\u00e1 tr\u00ecnh b\u1ea3o qu\u1ea3n v\u00e0 ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m<\/b><\/h3>\n

Trong h\u1ec7 th\u1ed1ng GMP, y\u00eau c\u1ea7u v\u1ec1 ki\u1ec3m so\u00e1t qu\u00e1 tr\u00ecnh b\u1ea3o qu\u1ea3n v\u00e0 ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m l\u00e0 m\u1ed9t kh\u00eda c\u1ea1nh quan tr\u1ecdng nh\u1eb1m \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m duy tr\u00ec ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n t\u1eeb nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t \u0111\u1ebfn tay ng\u01b0\u1eddi ti\u00eau d\u00f9ng. <\/span>C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i thi\u1ebft l\u1eadp quy tr\u00ecnh b\u1ea3o qu\u1ea3n ch\u1eb7t ch\u1ebd, \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c l\u01b0u tr\u1eef trong \u0111i\u1ec1u ki\u1ec7n th\u00edch h\u1ee3p v\u1ec1 nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m v\u00e0 \u00e1nh s\u00e1ng. <\/span><\/p>\n

Kho l\u01b0u tr\u1eef ph\u1ea3i s\u1ea1ch s\u1ebd, tho\u00e1ng m\u00e1t v\u00e0 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u0111\u1ec3 ng\u0103n ch\u1eb7n s\u1ef1 x\u00e2m nh\u1eadp c\u1ee7a c\u00f4n tr\u00f9ng, b\u1ee5i b\u1ea9n v\u00e0 c\u00e1c y\u1ebfu t\u1ed1 g\u00e2y h\u1ea1i kh\u00e1c. C\u00e1c s\u1ea3n ph\u1ea9m nh\u1ea1y c\u1ea3m v\u1edbi m\u00f4i tr\u01b0\u1eddng nh\u01b0 thu\u1ed1c ho\u1eb7c th\u1ef1c ph\u1ea9m c\u1ea7n \u0111\u01b0\u1ee3c b\u1ea3o qu\u1ea3n trong c\u00e1c \u0111i\u1ec1u ki\u1ec7n \u0111\u1eb7c bi\u1ec7t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh \u1ed5n \u0111\u1ecbnh v\u00e0 hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

\"Y\u00eau<\/p>\n

Trong qu\u00e1 tr\u00ecnh ph\u00e2n ph\u1ed1i, c\u00e1c y\u00eau c\u1ea7u v\u1ec1 ki\u1ec3m so\u00e1t ph\u1ea3i \u0111\u01b0\u1ee3c duy tr\u00ec, \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m kh\u00f4ng b\u1ecb t\u1ed5n h\u1ea1i trong qu\u00e1 tr\u00ecnh v\u1eadn chuy\u1ec3n. C\u00e1c ph\u01b0\u01a1ng ti\u1ec7n v\u1eadn chuy\u1ec3n ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n v\u1ec7 sinh v\u00e0 \u0111\u01b0\u1ee3c trang b\u1ecb \u0111\u1ea7y \u0111\u1ee7 \u0111\u1ec3 b\u1ea3o v\u1ec7 s\u1ea3n ph\u1ea9m kh\u1ecfi t\u00e1c \u0111\u1ed9ng c\u1ee7a m\u00f4i tr\u01b0\u1eddng. \u0110\u1ed3ng th\u1eddi, quy tr\u00ecnh v\u1eadn chuy\u1ec3n ph\u1ea3i \u0111\u01b0\u1ee3c theo d\u00f5i v\u00e0 ghi nh\u1eadn, t\u1eeb kh\u00e2u xu\u1ea5t kho \u0111\u1ebfn khi s\u1ea3n ph\u1ea9m \u0111\u1ebfn tay ng\u01b0\u1eddi ti\u00eau d\u00f9ng.<\/span><\/p>\n

Quy tr\u00ecnh tri\u1ec3n khai GMP l\u00e0 g\u00ec?<\/b><\/h2>\n

Vi\u1ec7c tri\u1ec3n khai h\u1ec7 th\u1ed1ng GMP l\u00e0 m\u1ed9t qu\u00e1 tr\u00ecnh ph\u1ee9c t\u1ea1p, \u0111\u00f2i h\u1ecfi doanh nghi\u1ec7p ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh v\u00e0 h\u01b0\u1edbng d\u1eabn nghi\u00eam ng\u1eb7t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 quy tr\u00ecnh chi ti\u1ebft \u0111\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn GMP t\u1ea1i Vi\u1ec7t Nam:<\/span><\/p>\n

B\u01b0\u1edbc 1: Chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 v\u00e0 g\u1eedi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd ki\u1ec3m tra GMP<\/b><\/h3>\n

B\u01b0\u1edbc \u0111\u1ea7u ti\u00ean trong quy tr\u00ecnh tri\u1ec3n khai GMP l\u00e0 chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1. V\u1eady h\u1ed3 s\u01a1 h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd ki\u1ec3m tra GMP l\u00e0 g\u00ec? H\u1ed3 s\u01a1 n\u00e0y c\u1ea7n bao g\u1ed3m c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn quy tr\u00ecnh s\u1ea3n xu\u1ea5t, \u0111i\u1ec1u ki\u1ec7n nh\u00e0 x\u01b0\u1edfng, thi\u1ebft b\u1ecb m\u00e1y m\u00f3c, quy tr\u00ecnh ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng, v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p an to\u00e0n v\u1ec7 sinh. Ngo\u00e0i ra, doanh nghi\u1ec7p c\u1ea7n cung c\u1ea5p th\u00f4ng tin chi ti\u1ebft v\u1ec1 nguy\u00ean li\u1ec7u s\u1eed d\u1ee5ng, quy tr\u00ecnh b\u1ea3o qu\u1ea3n v\u00e0 ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m.<\/span><\/p>\n

H\u1ed3 s\u01a1 ho\u00e0n ch\u1ec9nh sau \u0111\u00f3 s\u1ebd \u0111\u01b0\u1ee3c g\u1eedi v\u1ec1 C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c B\u1ed9 Y t\u1ebf \u0111\u1ec3 \u0111\u0103ng k\u00fd ki\u1ec3m tra. Vi\u1ec7c chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 \u0111\u00fang v\u00e0 \u0111\u1ea7y \u0111\u1ee7 l\u00e0 r\u1ea5t quan tr\u1ecdng, v\u00ec \u0111\u00e2y l\u00e0 b\u01b0\u1edbc \u0111\u1ea7u ti\u00ean \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 xem doanh nghi\u1ec7p c\u00f3 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a GMP hay kh\u00f4ng. M\u1ed9t h\u1ed3 s\u01a1 kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 ho\u1eb7c kh\u00f4ng ch\u00ednh x\u00e1c c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn vi\u1ec7c b\u1ecb t\u1eeb ch\u1ed1i ho\u1eb7c y\u00eau c\u1ea7u b\u1ed5 sung, l\u00e0m ch\u1eadm ti\u1ebfn \u0111\u1ed9 tri\u1ec3n khai GMP.<\/span><\/p>\n

\"Chu\u1ea9n<\/p>\n

B\u01b0\u1edbc 2: Xem x\u00e9t h\u1ed3 s\u01a1<\/b><\/h3>\n

Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd, C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c s\u1ebd ti\u1ebfn h\u00e0nh ti\u1ebfp nh\u1eadn, ki\u1ec3m tra v\u00e0 th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1. Quy tr\u00ecnh xem x\u00e9t h\u1ed3 s\u01a1 n\u00e0y nh\u1eb1m \u0111\u1ea3m b\u1ea3o r\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c th\u00f4ng tin cung c\u1ea5p \u0111\u1ec1u ch\u00ednh x\u00e1c v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a ti\u00eau chu\u1ea9n GMP. C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c s\u1ebd ki\u1ec3m tra k\u1ef9 l\u01b0\u1ee1ng c\u00e1c chi ti\u1ebft li\u00ean quan \u0111\u1ebfn quy tr\u00ecnh s\u1ea3n xu\u1ea5t, \u0111i\u1ec1u ki\u1ec7n nh\u00e0 x\u01b0\u1edfng, v\u00e0 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng.<\/span><\/p>\n

\"Xem<\/p>\n

N\u1ebfu h\u1ed3 s\u01a1 \u0111\u1ea1t y\u00eau c\u1ea7u, C\u1ee5c s\u1ebd th\u00f4ng b\u00e1o cho doanh nghi\u1ec7p v\u00e0 ti\u1ebfn h\u00e0nh b\u01b0\u1edbc ti\u1ebfp theo trong quy tr\u00ecnh ki\u1ec3m tra. Ng\u01b0\u1ee3c l\u1ea1i, n\u1ebfu h\u1ed3 s\u01a1 kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u, doanh nghi\u1ec7p s\u1ebd nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o y\u00eau c\u1ea7u b\u1ed5 sung ho\u1eb7c ch\u1ec9nh s\u1eeda h\u1ed3 s\u01a1.<\/span><\/p>\n

B\u01b0\u1edbc 3: Ki\u1ec3m tra c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t<\/b><\/h3>\n

Trong v\u00f2ng 60 ng\u00e0y k\u1ec3 t\u1eeb khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7, C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c s\u1ebd quy\u1ebft \u0111\u1ecbnh th\u00e0nh l\u1eadp \u0111o\u00e0n ki\u1ec3m tra \u0111\u1ec3 ti\u1ebfn h\u00e0nh ki\u1ec3m tra th\u1ef1c t\u1ebf t\u1ea1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t. \u0110o\u00e0n ki\u1ec3m tra s\u1ebd \u0111\u00e1nh gi\u00e1 c\u00e1c ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t c\u1ee7a doanh nghi\u1ec7p d\u1ef1a tr\u00ean c\u00e1c nguy\u00ean t\u1eafc v\u00e0 ti\u00eau chu\u1ea9n WHO GMP, c\u0169ng nh\u01b0 c\u00e1c quy \u0111\u1ecbnh chuy\u00ean m\u00f4n hi\u1ec7n h\u00e0nh.<\/span><\/p>\n

\"Ki\u1ec3m<\/p>\n

Qu\u00e1 tr\u00ecnh ki\u1ec3m tra n\u00e0y bao g\u1ed3m vi\u1ec7c \u0111\u00e1nh gi\u00e1 to\u00e0n b\u1ed9 quy tr\u00ecnh s\u1ea3n xu\u1ea5t, t\u1eeb ti\u1ebfp nh\u1eadn nguy\u00ean li\u1ec7u, quy tr\u00ecnh ch\u1ebf bi\u1ebfn, \u0111\u1ebfn b\u1ea3o qu\u1ea3n v\u00e0 ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m. Ngo\u00e0i ra, \u0111i\u1ec1u ki\u1ec7n v\u1ec7 sinh nh\u00e0 x\u01b0\u1edfng, m\u00f4i tr\u01b0\u1eddng l\u00e0m vi\u1ec7c, v\u00e0 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi lao \u0111\u1ed9ng c\u0169ng s\u1ebd \u0111\u01b0\u1ee3c ki\u1ec3m tra ch\u1eb7t ch\u1ebd.<\/span><\/p>\n

B\u01b0\u1edbc 4: \u0110\u00e1nh gi\u00e1 v\u00e0 kh\u1eafc ph\u1ee5c c\u00e1c t\u1ed3n t\u1ea1i<\/b><\/h3>\n

Sau khi ho\u00e0n t\u1ea5t ki\u1ec3m tra c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, \u0111o\u00e0n ki\u1ec3m tra s\u1ebd \u0111\u01b0a ra \u0111\u00e1nh gi\u00e1 v\u1ec1 m\u1ee9c \u0111\u1ed9 tu\u00e2n th\u1ee7 GMP c\u1ee7a doanh nghi\u1ec7p. N\u1ebfu c\u01a1 s\u1edf \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c y\u00eau c\u1ea7u, doanh nghi\u1ec7p s\u1ebd \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn GMP. Tuy nhi\u00ean, n\u1ebfu c\u00f3 nh\u1eefng t\u1ed3n t\u1ea1i c\u1ea7n kh\u1eafc ph\u1ee5c, doanh nghi\u1ec7p s\u1ebd c\u00f3 th\u1eddi gian 2 th\u00e1ng \u0111\u1ec3 s\u1eeda ch\u1eefa v\u00e0 b\u00e1o c\u00e1o k\u1ebft qu\u1ea3 kh\u1eafc ph\u1ee5c v\u1ec1 C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c.<\/span><\/p>\n

\"\u0110\u00e1nh<\/p>\n

Trong tr\u01b0\u1eddng h\u1ee3p doanh nghi\u1ec7p ch\u01b0a \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c c\u00e1c nguy\u00ean t\u1eafc v\u00e0 ti\u00eau chu\u1ea9n WHO GMP, c\u1ea7n ti\u1ebfn h\u00e0nh kh\u1eafc ph\u1ee5c, s\u1eeda ch\u1eefa c\u00e1c t\u1ed3n t\u1ea1i v\u00e0 n\u1ed9p l\u1ea1i h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd ki\u1ec3m tra nh\u01b0 l\u1ea7n \u0111\u1ea7u.<\/span><\/p>\n

B\u01b0\u1edbc 5: C\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn<\/b><\/h3>\n

Khi doanh nghi\u1ec7p \u0111\u00e3 kh\u1eafc ph\u1ee5c \u0111\u01b0\u1ee3c c\u00e1c t\u1ed3n t\u1ea1i (n\u1ebfu c\u00f3) v\u00e0 \u0111\u1ea1t y\u00eau c\u1ea7u, C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c s\u1ebd c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn GMP. V\u1eady gi\u1ea5y ch\u1ee9ng nh\u1eadn GMP l\u00e0 g\u00ec? Gi\u1ea5y ch\u1ee9ng nh\u1eadn n\u00e0y l\u00e0 minh ch\u1ee9ng cho vi\u1ec7c doanh nghi\u1ec7p tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n trong s\u1ea3n xu\u1ea5t, v\u00e0 l\u00e0 \u0111i\u1ec1u ki\u1ec7n b\u1eaft bu\u1ed9c \u0111\u1ec3 s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng.<\/span><\/p>\n

\"C\u1ea5p<\/p>\n

B\u01b0\u1edbc 6: Ki\u1ec3m tra gi\u00e1m s\u00e1t<\/b><\/h3>\n

Sau khi \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn GMP, doanh nghi\u1ec7p c\u1ea7n ti\u1ebfp t\u1ee5c duy tr\u00ec c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 y\u00eau c\u1ea7u \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m tra. C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c s\u1ebd th\u1ef1c hi\u1ec7n c\u00e1c cu\u1ed9c ki\u1ec3m tra gi\u00e1m s\u00e1t \u0111\u1ecbnh k\u1ef3 ho\u1eb7c \u0111\u1ed9t xu\u1ea5t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng doanh nghi\u1ec7p lu\u00f4n tu\u00e2n th\u1ee7 \u0111\u00fang c\u00e1c quy \u0111\u1ecbnh GMP. C\u00e1c vi ph\u1ea1m ho\u1eb7c kh\u00f4ng tu\u00e2n th\u1ee7 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn vi\u1ec7c thu h\u1ed3i gi\u1ea5y ch\u1ee9ng nh\u1eadn v\u00e0 ng\u1eebng s\u1ea3n xu\u1ea5t.<\/span><\/p>\n

K\u1ebft lu\u1eadn<\/b><\/h2>\n

B\u00ean c\u1ea1nh kh\u00e1i ni\u1ec7m GMP l\u00e0 g\u00ec, b\u1ea1n c\u0169ng \u0111\u00e3 bi\u1ebft c\u00e1c y\u00eau c\u1ea7u c\u0169ng nh\u01b0 quy tr\u00ecnh tri\u1ec3n khai GMP. Vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t c\u1ee7a GMP kh\u00f4ng ch\u1ec9 gi\u00fap doanh nghi\u1ec7p duy tr\u00ec ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t cao m\u00e0 c\u00f2n b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 n\u00e2ng cao uy t\u00edn tr\u00ean th\u1ecb tr\u01b0\u1eddng.\u00a0<\/span><\/p>\n

\u0110\u1ecdc th\u00eam:<\/p>\n