{"id":958,"date":"2024-04-18T09:20:49","date_gmt":"2024-04-18T01:20:49","guid":{"rendered":"http:\/\/www.csw-vn.cn\/?p=958"},"modified":"2024-09-30T16:28:16","modified_gmt":"2024-09-30T08:28:16","slug":"gmp%e8%ae%a4%e8%af%81%e5%92%a8%e8%af%a2","status":"publish","type":"post","link":"http:\/\/www.csw-vn.cn\/vi\/958.html","title":{"rendered":"T\u01b0 v\u1ea5n ch\u1ee9ng nh\u1eadn GMP"},"content":{"rendered":"<pre class=\"wp-block-code\"><code>      <strong>  B\u1ed1i c\u1ea3nh d\u1ef1 \u00e1n<\/strong>\n        N\u1ec1n t\u1ea3ng c\u1ee7a ch\u1ee9ng nh\u1eadn GMP ch\u1ee7 y\u1ebfu l\u00e0 do c\u00e1c y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf. FDA y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb y t\u1ebf theo \u0110\u1eb7c \u0111i\u1ec3m k\u1ef9 thu\u1eadt s\u1ea3n xu\u1ea5t t\u1ed1t QSR820 (ti\u00eau chu\u1ea9n 21CFR820), b\u1ea5t k\u1ec3 thi\u1ebft b\u1ecb y t\u1ebf lo\u1ea1i I, lo\u1ea1i II hay lo\u1ea1i III do doanh nghi\u1ec7p s\u1ea3n xu\u1ea5t. \n        Ch\u1ee9ng nh\u1eadn GMP, c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 ch\u1ee9ng nh\u1eadn QSR820, l\u00e0 m\u1ed9t trong nh\u1eefng y\u00eau c\u1ea7u c\u01a1 b\u1ea3n c\u1ee7a FDA \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf. FDA y\u00eau c\u1ea7u t\u1ea5t c\u1ea3 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n n\u00e0y trong qu\u00e1 tr\u00ecnh thi\u1ebft k\u1ebf v\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf. M\u1eb7c d\u00f9 FDA kh\u00f4ng ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 h\u1ec7 th\u1ed1ng GMP ho\u1eb7c \u1ee7y th\u00e1c cho c\u00e1c t\u1ed5 ch\u1ee9c b\u00ean th\u1ee9 ba ti\u1ebfn h\u00e0nh ch\u1ee9ng nh\u1eadn GMP trong qu\u00e1 tr\u00ecnh xin gi\u1ea5y ph\u00e9p ni\u00eam y\u1ebft cho doanh nghi\u1ec7p v\u00e0 s\u1ea3n ph\u1ea9m, nh\u01b0ng trong c\u00e1c cu\u1ed9c ki\u1ec3m tra ho\u1eb7c \u0111i\u1ec1u tra th\u1ecb tr\u01b0\u1eddng ti\u1ebfp theo, n\u1ebfu doanh nghi\u1ec7p kh\u00f4ng tu\u00e2n th\u1ee7 c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt s\u1ea3n xu\u1ea5t t\u1ed1t QSR820, h\u1ecd s\u1ebd ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi\n      <strong>  Gi\u1edbi thi\u1ec7u d\u1ef1 \u00e1n<\/strong>\n        Ch\u1ee9ng nh\u1eadn GMP l\u00e0 ch\u1ee9ng nh\u1eadn GMP thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a M\u1ef9 QSR820, c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 ch\u1ee9ng nh\u1eadn QSR820. FDA y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf theo Ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t t\u1ed1t QSR820 (Ti\u00eau chu\u1ea9n 21CFR820), b\u1ea5t k\u1ec3 c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf lo\u1ea1i I, II ho\u1eb7c III do doanh nghi\u1ec7p s\u1ea3n xu\u1ea5t. \n        Ch\u1ee9ng nh\u1eadn GMP kh\u00f4ng ch\u1ec9 ch\u00fa \u00fd \u0111\u1ebfn c\u00e1c \u0111i\u1ec1u ki\u1ec7n v\u1ec7 sinh trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t m\u00e0 c\u00f2n l\u00e0m t\u0103ng c\u00e1c y\u00eau c\u1ea7u v\u1ec1 thi\u1ebft k\u1ebf, b\u1ea3o tr\u00ec v\u00e0 l\u1eafp r\u00e1p s\u1ea3n ph\u1ea9m. Do \u0111\u00f3, GMP c\u00f3 c\u00e1c y\u00eau c\u1ea7u cao \u0111\u1ed1i v\u1edbi quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 quy tr\u00ecnh thi\u1ebft k\u1ebf s\u1ea3n ph\u1ea9m, v\u00e0 tr\u1ecdng t\u00e2m c\u1ee7a vi\u1ec7c ki\u1ec3m to\u00e1n s\u1ebd l\u00e0 li\u1ec7u SOP quy tr\u00ecnh c\u00f3 \u0111\u01b0\u1ee3c l\u1eafp r\u00e1p hay kh\u00f4ng, li\u1ec7u thi\u1ebft k\u1ebf quy tr\u00ecnh s\u1ea3n ph\u1ea9m v\u00e0 ki\u1ec3m tra d\u1eef li\u1ec7u c\u00f3 ho\u00e0n h\u1ea3o hay kh\u00f4ng, v.v.\n     <strong>   Quy tr\u00ecnh ch\u1ee9ng nh\u1eadn GMP<\/strong>\n        Quy tr\u00ecnh ch\u1ee9ng nh\u1eadn GMP ch\u1ee7 y\u1ebfu bao g\u1ed3m c\u00e1c b\u01b0\u1edbc sau: \n        Chu\u1ea9n b\u1ecb cho c\u00e1c \u0111\u01a1n xin ch\u1ee9ng nh\u1eadn GMP: L\u1ef1a ch\u1ecdn c\u00e1c t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n v\u00e0 uy t\u00edn, n\u1ed9p h\u1ed3 s\u01a1 v\u00e0 s\u1eafp x\u1ebfp th\u1eddi gian xem x\u00e9t. Thanh to\u00e1n ph\u00ed ch\u1ee9ng nh\u1eadn 1. \n        Ki\u1ec3m to\u00e1n t\u1ea1i ch\u1ed7: Chu\u1ea9n b\u1ecb c\u00e1c t\u00e0i li\u1ec7u v\u00e0 h\u1ed3 s\u01a1 li\u00ean quan, bao g\u1ed3m s\u00e1ch h\u01b0\u1edbng d\u1eabn GMP, s\u01a1 \u0111\u1ed3 quy tr\u00ecnh, danh s\u00e1ch thi\u1ebft b\u1ecb, h\u1ed3 s\u01a1 \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1, h\u1ed3 s\u01a1 ki\u1ec3m tra s\u1ea3n ph\u1ea9m, v.v. C\u00e1c t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn s\u1ebd c\u1eed ki\u1ec3m to\u00e1n vi\u00ean ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 t\u1ea1i ch\u1ed7, bao g\u1ed3m thi\u1ebft b\u1ecb, x\u01b0\u1edfng s\u1ea3n xu\u1ea5t, quy tr\u00ecnh, \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1 v\u00e0 c\u00e1c kh\u00eda c\u1ea1nh kh\u00e1c 1. \n        Ch\u1ec9nh s\u1eeda v\u00e0 xem x\u00e9t: Th\u1ef1c hi\u1ec7n c\u00e1c ch\u1ec9nh s\u1eeda v\u00e0 c\u1ea3i ti\u1ebfn c\u1ea7n thi\u1ebft d\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 ki\u1ec3m to\u00e1n v\u00e0 c\u00e1c khuy\u1ebfn ngh\u1ecb c\u1ea3i ti\u1ebfn. C\u01a1 quan ch\u1ee9ng nh\u1eadn c\u1eed ki\u1ec3m to\u00e1n vi\u00ean xem x\u00e9t t\u00ecnh h\u00ecnh kh\u1eafc ph\u1ee5c v\u00e0 x\u00e1c \u0111\u1ecbnh xem vi\u1ec7c kh\u1eafc ph\u1ee5c c\u00f3 di\u1ec5n ra hay kh\u00f4ng 1. \n        Gi\u1ea5y ch\u1ee9ng nh\u1eadn c\u1ea5p: Sau khi c\u01a1 quan ch\u1ee9ng nh\u1eadn x\u00e1c nh\u1eadn r\u1eb1ng vi\u1ec7c ch\u1ec9nh s\u1eeda \u0111\u00e3 \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng, c\u01a1 quan s\u1ebd c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ee9ng nh\u1eadn GMP.\n      <strong>  L\u1ee3i \u00edch c\u1ee7a ch\u1ee9ng nh\u1eadn GMP<\/strong>\n        \u01afu \u0111i\u1ec3m c\u1ed1t l\u00f5i c\u1ee7a ch\u1ee9ng nh\u1eadn GMP l\u00e0 cung c\u1ea5p c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 h\u01b0\u1edbng d\u1eabn r\u00f5 r\u00e0ng cho h\u1ec7 th\u1ed1ng s\u1ea3n xu\u1ea5t v\u00e0 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m. B\u1eb1ng c\u00e1ch tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u c\u1ee7a ch\u1ee9ng nh\u1eadn GMP, doanh nghi\u1ec7p c\u00f3 th\u1ec3 thi\u1ebft l\u1eadp m\u1ed9t m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n, \u0111\u1ec3 n\u00e2ng cao kh\u1ea3 n\u0103ng c\u1ea1nh tranh th\u1ecb tr\u01b0\u1eddng c\u1ee7a s\u1ea3n ph\u1ea9m v\u00e0 chi\u1ebfm \u0111\u01b0\u1ee3c l\u00f2ng tin c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng. \n        C\u1ee5 th\u1ec3, nh\u1eefng l\u1ee3i \u00edch c\u1ee7a ch\u1ee9ng nh\u1eadn GMP bao g\u1ed3m: \n        \u0110\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n s\u1ea3n ph\u1ea9m: Ch\u1ee9ng nh\u1eadn GMP y\u00eau c\u1ea7u doanh nghi\u1ec7p ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n nghi\u00eam ng\u1eb7t v\u1ec1 l\u1ef1a ch\u1ecdn \u0111\u1ecba \u0111i\u1ec3m nh\u00e0 m\u00e1y, thi\u1ebft k\u1ebf nh\u00e0 m\u00e1y, mua s\u1eafm thi\u1ebft b\u1ecb, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1, v.v., \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng. \n        C\u1ea3i thi\u1ec7n ni\u1ec1m tin c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng: Th\u00f4ng qua ch\u1ee9ng nh\u1eadn GMP, ng\u01b0\u1eddi ti\u00eau d\u00f9ng c\u00f3 th\u1ec3 t\u1ef1 tin r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u00e3 tr\u1ea3i qua qu\u00e1 tr\u00ecnh ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n nghi\u00eam ng\u1eb7t, do \u0111\u00f3 n\u00e2ng cao ni\u1ec1m tin c\u1ee7a h\u1ecd v\u00e0o s\u1ea3n ph\u1ea9m. \n        \u0110\u1ea9y m\u1ea1nh th\u01b0\u01a1ng m\u1ea1i qu\u1ed1c t\u1ebf: \u0110\u1ed1i v\u1edbi c\u00e1c doanh nghi\u1ec7p c\u00f3 nhu c\u1ea7u gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf, ch\u1ee9ng nh\u1eadn GMP l\u00e0 \u0111i\u1ec1u ki\u1ec7n c\u1ea7n thi\u1ebft \u0111\u1ec3 th\u00e2m nh\u1eadp th\u1ecb tr\u01b0\u1eddng c\u1ee7a nhi\u1ec1u qu\u1ed1c gia, v\u00f9ng l\u00e3nh th\u1ed5, gi\u00fap doanh nghi\u1ec7p m\u1edf r\u1ed9ng kinh doanh qu\u1ed1c t\u1ebf. \n        Chu\u1ea9n h\u00f3a qu\u1ea3n l\u00fd doanh nghi\u1ec7p: Ch\u1ee9ng nh\u1eadn GMP \u0111\u00f2i h\u1ecfi doanh nghi\u1ec7p ph\u1ea3i thi\u1ebft l\u1eadp m\u1ed9t h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ho\u00e0n ch\u1ec9nh, chu\u1ea9n h\u00f3a quy tr\u00ecnh qu\u1ea3n l\u00fd c\u1ee7a doanh nghi\u1ec7p, n\u00e2ng cao hi\u1ec7u qu\u1ea3 ho\u1ea1t \u0111\u1ed9ng t\u1ed5ng th\u1ec3. \n        Chuangshi Supply Chain Quality Management Technology Service (Vietnam) Co., Ltd. l\u00e0 m\u1ed9t t\u1ed5 ch\u1ee9c d\u1ecbch v\u1ee5 c\u00f4ng ngh\u1ec7 qu\u1ea3n l\u00fd to\u00e0n c\u1ea7u li\u00ean k\u1ebft v\u1edbi Chuangda Enterprise (Hong Kong) Co., Ltd. \u0110\u00e2y l\u00e0 m\u1ed9t th\u01b0\u01a1ng hi\u1ec7u n\u1ed5i ti\u1ebfng c\u1ee7a M\u1ea1ng l\u01b0\u1edbi Ki\u1ec3m tra Nh\u00e0 m\u00e1y Trung Qu\u1ed1c. N\u00f3 c\u00f3 tr\u1ee5 s\u1edf ch\u00ednh t\u1ea1i H\u1ed3ng K\u00f4ng, Th\u00e2m Quy\u1ebfn, Yiwu, \u0110\u00f4ng Quan,<\/code><\/pre>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":1459,"comment_status":"open","ping_status":"open","sticky":true,"template":"","format":"standard","meta":{"themepark_post_bcolor":"#f5f5f5","themepark_post_width":"1022px","themepark_post_img":"","themepark_post_img_po":"left","themepark_post_img_re":false,"themepark_post_img_cover":false,"themepark_post_img_fixed":false,"themepark_post_hide_title":false,"themepark_post_main_b":"","themepark_post_main_p":100,"themepark_paddingblock":false,"footnotes":""},"categories":[11],"tags":[],"class_list":["post-958","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-renzheng"],"metadata":{"_edit_lock":["1727684896:1"],"_edit_last":["1"],"catce":["sidebar-widgets4"],"_thumbnail_id":["1459"],"views":["490"],"themepark_seo_title":["GMP\u8ba4\u8bc1\u54a8\u8be2_\u8ba4\u8bc1\u6807\u51c6_\u8ba4\u8bc1\u8f85\u5bfc\u673a\u6784_\u521b\u601d\u7ef4\u4f9b\u5e94\u94fe\u8d28\u91cf\u7ba1\u7406\u6280\u672f\u670d\u52a1\uff08\u8d8a\u5357\uff09\u6709\u9650\u516c\u53f8"],"themepark_seo_description":["\u4ec0\u4e48\u662fGMP\u8ba4\u8bc1\u54a8\u8be2\uff1f\u521b\u601d\u7ef4\u4f9b\u5e94\u94fe\u8d28\u91cf\u7ba1\u7406\u6280\u672f\u670d\u52a1\uff08\u8d8a\u5357\uff09\u6709\u9650\u516c\u53f8-\u6b63\u89c4\u8ba4\u8bc1\u8f85\u5bfc\u673a\u6784,\u63d0\u4f9b\u8ba4\u8bc1\u6807\u51c6\u3001\u8ba4\u8bc1\u54a8\u8be2\u8f85\u5bfc\u670d\u52a1,\u6210\u529f\u5408\u4f5c\u8d85\u8fc7\u4e0a\u4e07\u5bb6\u77e5\u540d\u4f01\u4e1a,\u5ba1\u6838\u5468\u671f\u77ed,\u901a\u8fc7\u540e\u4ed8\u6b3e\uff01"],"themepark_seo_keyword":["GMP\u8ba4\u8bc1\u54a8\u8be2,\u8ba4\u8bc1\u6807\u51c6,\u8ba4\u8bc1\u8f85\u5bfc,\u8ba4\u8bc1\u8f85\u5bfc\u673a\u6784,\u521b\u601d\u7ef4\u4f9b\u5e94\u94fe\u8d28\u91cf\u7ba1\u7406\u6280\u672f\u670d\u52a1\uff08\u8d8a\u5357\uff09\u6709\u9650\u516c\u53f8"]},"medium_url":"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/\u672a\u6807\u9898-1-14.jpg","thumbnail_url":"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/\u672a\u6807\u9898-1-14.jpg","full_url":"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/\u672a\u6807\u9898-1-14.jpg","_links":{"self":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/958","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/comments?post=958"}],"version-history":[{"count":2,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/958\/revisions"}],"predecessor-version":[{"id":2539,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/958\/revisions\/2539"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/media\/1459"}],"wp:attachment":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/media?parent=958"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/categories?post=958"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/tags?post=958"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}