{"id":3199,"date":"2025-05-15T11:36:49","date_gmt":"2025-05-15T03:36:49","guid":{"rendered":"http:\/\/www.csw-vn.cn\/?p=3199"},"modified":"2025-05-15T11:38:46","modified_gmt":"2025-05-15T03:38:46","slug":"gmp110%e8%ae%a4%e8%af%81%e5%92%a8%e8%af%a2","status":"publish","type":"post","link":"http:\/\/www.csw-vn.cn\/vi\/3199.html","title":{"rendered":"T\u01b0 v\u1ea5n ch\u1ee9ng nh\u1eadn GMP110"},"content":{"rendered":"<pre class=\"wp-block-code\"><code>     <strong>   B\u1ed1i c\u1ea3nh d\u1ef1 \u00e1n<\/strong>\n        N\u0103m 1969, FDA Hoa K\u1ef3 \u0111\u00e3 x\u00e2y d\u1ef1ng Quy \u0111\u1ecbnh Ho\u1ea1t \u0111\u1ed9ng Th\u1ef1c ph\u1ea9m T\u1ed1t, ban \u0111\u1ea7u \u0111\u01b0\u1ee3c xu\u1ea5t b\u1ea3n d\u01b0\u1edbi d\u1ea1ng Ph\u1ea7n 21 Ph\u1ea7n 128 c\u1ee7a B\u1ed9 lu\u1eadt Li\u00ean bang (CFR). N\u0103m 1977, 21CFRPart128 \u0111\u00e3 \u0111\u01b0\u1ee3c bi\u00ean so\u1ea1n l\u1ea1i v\u00e0 xu\u1ea5t b\u1ea3n v\u1edbi t\u00ean 21CFRPart110, b\u1eaft bu\u1ed9c v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd l\u00e0 c\u01a1 s\u1edf k\u1ef9 thu\u1eadt cho h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd v\u1ec7 sinh v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i v\u00e0 l\u01b0u tr\u1eef th\u1ef1c ph\u1ea9m. Sau \u0111\u00f3, nhi\u1ec1u qu\u1ed1c gia v\u00e0 khu v\u1ef1c \u0111\u00e3 r\u00fat ra kinh nghi\u1ec7m c\u1ee7a Hoa K\u1ef3 v\u00e0 x\u00e2y d\u1ef1ng c\u00e1c ti\u00eau chu\u1ea9n GMP th\u1ef1c ph\u1ea9m c\u1ee7a ri\u00eang h\u1ecd \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o v\u1ec7 sinh v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng th\u1ef1c ph\u1ea9m v\u00e0 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe v\u00e0 s\u1ef1 an to\u00e0n c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng.\n       <strong> Gi\u1edbi thi\u1ec7u d\u1ef1 \u00e1n<\/strong>\n        Ch\u1ee9ng nh\u1eadn GMP110, t\u1ee9c l\u00e0 Th\u1ef1c h\u00e0nh S\u1ea3n xu\u1ea5t T\u1ed1t (GMP) c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA), \u0111\u1eb7c bi\u1ec7t \u0111\u1ec1 c\u1eadp \u0111\u1ebfn c\u00e1c quy \u0111\u1ecbnh 21CFRPart110. \u0110\u00e2y l\u00e0 b\u1ed9 th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt ho\u1ea1t \u0111\u1ed9ng cho c\u00e1c doanh nghi\u1ec7p s\u1ea3n xu\u1ea5t, ch\u1ebf bi\u1ebfn th\u1ef1c ph\u1ea9m, nh\u1eb1m \u0111\u1ea3m b\u1ea3o s\u1ee9c kh\u1ecfe v\u00e0 an to\u00e0n th\u1ef1c ph\u1ea9m trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i, b\u1ea3o qu\u1ea3n v\u00e0 ph\u00e2n ph\u1ed1i.\n      <strong>  Quy tr\u00ecnh ki\u1ec3m to\u00e1n ch\u1ee9ng nh\u1eadn GMP110<\/strong>\n        1. Chu\u1ea9n b\u1ecb tr\u01b0\u1edbc v\u00e0 \u0111\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9 \n        Th\u00e0nh l\u1eadp \u0111\u1ed9i ng\u0169 qu\u1ea3n l\u00fd an to\u00e0n th\u1ef1c ph\u1ea9m, b\u1ed5 nhi\u1ec7m \u0111\u1ea1i di\u1ec7n qu\u1ea3n l\u00fd, l\u00e0m r\u00f5 vi\u1ec7c ph\u00e2n chia tr\u00e1ch nhi\u1ec7m. \n        \u0110\u00e1nh gi\u00e1 s\u01a1 b\u1ed9 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd hi\u1ec7n c\u00f3 c\u1ee7a doanh nghi\u1ec7p, x\u00e1c \u0111\u1ecbnh c\u00e1c l\u1ed7 h\u1ed5ng v\u1edbi c\u00e1c ti\u00eau chu\u1ea9n ch\u1ee9ng nh\u1eadn v\u00e0 x\u00e2y d\u1ef1ng k\u1ebf ho\u1ea1ch c\u1ea3i ti\u1ebfn. \n        T\u1ed5 ch\u1ee9c \u0111\u00e0o t\u1ea1o nh\u00e2n vi\u00ean \u0111\u1ec3 n\u00e2ng cao hi\u1ec3u bi\u1ebft v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c ti\u00eau chu\u1ea9n ch\u1ee9ng nh\u1eadn. \n        2. L\u1eadp t\u00e0i li\u1ec7u v\u00e0 thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng \n        Chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u theo ti\u00eau chu\u1ea9n ch\u1ee9ng nh\u1eadn, bao g\u1ed3m ch\u00ednh s\u00e1ch an to\u00e0n th\u1ef1c ph\u1ea9m, s\u00e1ch h\u01b0\u1edbng d\u1eabn, t\u00e0i li\u1ec7u th\u1ee7 t\u1ee5c v\u00e0 bi\u1ec3u m\u1eabu h\u1ed3 s\u01a1. \n        \u0110\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c t\u00e0i li\u1ec7u ph\u00f9 h\u1ee3p v\u1edbi kh\u1ea3 n\u0103ng ho\u1ea1t \u0111\u1ed9ng, kh\u1ea3 n\u0103ng x\u00e1c minh v\u00e0 kh\u1ea3 n\u0103ng b\u1ea3o tr\u00ec, \u0111\u1ed3ng th\u1eddi ph\u1ea3n \u00e1nh ho\u1ea1t \u0111\u1ed9ng th\u1ef1c t\u1ebf c\u1ee7a doanh nghi\u1ec7p. \n        3. Ch\u1ecdn m\u1ed9t c\u01a1 quan ch\u1ee9ng nh\u1eadn \n        Ch\u1ecdn m\u1ed9t t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn c\u00f3 b\u1eb1ng c\u1ea5p c\u1ee7a \u1ee6y ban Ki\u1ec3m \u0111\u1ecbnh v\u00e0 Gi\u00e1m s\u00e1t Qu\u1ed1c gia v\u00e0 danh ti\u1ebfng t\u1ed1t \u0111\u1ec3 x\u00e1c nh\u1eadn ph\u1ea1m vi ch\u1ee9ng nh\u1eadn v\u00e0 n\u1ed9i dung d\u1ecbch v\u1ee5 c\u1ee7a m\u00ecnh. \n        4. G\u1eedi \u0111\u01a1n \u0111\u0103ng k\u00fd v\u00e0 t\u00e0i li\u1ec7u \u0111\u1ec3 xem x\u00e9t \n        N\u1ed9p t\u00e0i li\u1ec7u \u0111\u0103ng k\u00fd cho c\u01a1 quan ch\u1ee9ng nh\u1eadn, bao g\u1ed3m gi\u1ea5y ph\u00e9p kinh doanh, gi\u1ea5y ph\u00e9p s\u1ea3n xu\u1ea5t, t\u00e0i li\u1ec7u h\u1ec7 th\u1ed1ng, v.v. \n        C\u01a1 quan ch\u1ee9ng nh\u1eadn ti\u1ebfn h\u00e0nh ki\u1ec3m tra s\u01a1 b\u1ed9 c\u00e1c t\u00e0i li\u1ec7u v\u00e0 s\u1eafp x\u1ebfp \u0111\u00e1nh gi\u00e1 on-site sau khi x\u00e1c nh\u1eadn s\u1ef1 ph\u00f9 h\u1ee3p. \n        5. Ki\u1ec3m to\u00e1n v\u00e0 kh\u1eafc ph\u1ee5c t\u1ea1i ch\u1ed7 \n        Ki\u1ec3m to\u00e1n vi\u00ean ti\u1ebfn h\u00e0nh ki\u1ec3m tra t\u1ea1i ch\u1ed7, bao g\u1ed3m xem x\u00e9t t\u00e0i li\u1ec7u, \u0111\u00e1nh gi\u00e1 \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t, ph\u1ecfng v\u1ea5n nh\u00e2n vi\u00ean, v.v. \n        \u0110\u1ed1i v\u1edbi nh\u1eefng s\u1ef1 kh\u00f4ng ph\u00f9 h\u1ee3p \u0111\u01b0\u1ee3c t\u00ecm th\u1ea5y, c\u00e1c doanh nghi\u1ec7p c\u1ea7n kh\u1eafc ph\u1ee5c trong th\u1eddi h\u1ea1n v\u00e0 n\u1ed9p b\u1eb1ng ch\u1ee9ng kh\u1eafc ph\u1ee5c. \n        6. Quy\u1ebft \u0111\u1ecbnh v\u00e0 c\u1ea5p ch\u1ee9ng nh\u1eadn \n        Sau khi ki\u1ec3m to\u00e1n \u0111\u01b0\u1ee3c th\u00f4ng qua, c\u01a1 quan ch\u1ee9ng nh\u1eadn s\u1ebd c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ee9ng nh\u1eadn (th\u01b0\u1eddng c\u00f3 gi\u00e1 tr\u1ecb trong 3 n\u0103m). \n        Th\u00f4ng tin ch\u1ee9ng nh\u1eadn c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 tr\u00ean trang web ch\u00ednh th\u1ee9c ho\u1eb7c n\u1ec1n t\u1ea3ng ng\u00e0nh. \n        7. Gi\u00e1m s\u00e1t, ki\u1ec3m to\u00e1n v\u00e0 c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c \n        N\u00f3 c\u1ea7n \u0111\u01b0\u1ee3c gi\u00e1m s\u00e1t v\u00e0 ki\u1ec3m to\u00e1n h\u00e0ng n\u0103m \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ho\u1ea1t \u0111\u1ed9ng li\u00ean t\u1ee5c v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a h\u1ec7 th\u1ed1ng. \n        B\u1ea1n c\u1ea7n \u0111\u0103ng k\u00fd l\u1ea1i ch\u1ee9ng nh\u1eadn tr\u01b0\u1edbc khi ch\u1ee9ng ch\u1ec9 h\u1ebft h\u1ea1n. Qu\u00e1 tr\u00ecnh n\u00e0y t\u01b0\u01a1ng t\u1ef1 nh\u01b0 ch\u1ee9ng nh\u1eadn ban \u0111\u1ea7u.\n       <strong> L\u1ee3i \u00edch c\u1ee7a ch\u1ee9ng nh\u1eadn GMP110<\/strong>\n        C\u1ea3i thi\u1ec7n ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m: \u0111\u1ea3m b\u1ea3o r\u1eb1ng th\u1ef1c ph\u1ea9m \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 v\u1ec7 sinh th\u00f4ng qua ki\u1ec3m so\u00e1t quy tr\u00ecnh s\u1ea3n xu\u1ea5t nghi\u00eam ng\u1eb7t. \n        B\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng: gi\u1ea3m \u00f4 nhi\u1ec5m th\u1ef1c ph\u1ea9m v\u00e0 r\u1ee7i ro an to\u00e0n, v\u00e0 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng. \n        N\u00e2ng cao kh\u1ea3 n\u0103ng c\u1ea1nh tranh th\u1ecb tr\u01b0\u1eddng: C\u00e1c doanh nghi\u1ec7p \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn c\u1ea1nh tranh h\u01a1n tr\u00ean th\u1ecb tr\u01b0\u1eddng v\u00e0 c\u00f3 th\u1ec3 \u0111\u00e1p \u1ee9ng t\u1ed1t h\u01a1n c\u00e1c y\u00eau c\u1ea7u c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u1ec1 an to\u00e0n th\u1ef1c ph\u1ea9m. \n        \u0110\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh: \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh c\u1ee7a FDA v\u00e0 tr\u00e1nh c\u00e1c r\u1ee7i ro ph\u00e1p l\u00fd do vi ph\u1ea1m. \n        C\u1ea3i thi\u1ec7n h\u00ecnh \u1ea3nh c\u00f4ng ty: C\u00e1c doanh nghi\u1ec7p \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn c\u00f3 uy t\u00edn cao h\u01a1n trong m\u1eaft ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 \u0111\u1ed1i t\u00e1c, \u0111i\u1ec1u n\u00e0y gi\u00fap thi\u1ebft l\u1eadp m\u1ed9t h\u00ecnh \u1ea3nh c\u00f4ng ty t\u1ed1t. \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,\n<\/code><\/pre>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":3201,"comment_status":"open","ping_status":"open","sticky":false,"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-3199","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-renzheng"],"metadata":{"_edit_lock":["1747280326:1"],"_edit_last":["1"],"catce":["sidebar-widgets4"],"_thumbnail_id":["3201"],"themepark_seo_title":[""],"themepark_seo_description":[""],"themepark_seo_keyword":[""],"views":["351"]},"medium_url":"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2025\/05\/GMP110.jpg","thumbnail_url":"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2025\/05\/GMP110.jpg","full_url":"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2025\/05\/GMP110.jpg","_links":{"self":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/3199","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=3199"}],"version-history":[{"count":2,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/3199\/revisions"}],"predecessor-version":[{"id":3205,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/3199\/revisions\/3205"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/media\/3201"}],"wp:attachment":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/media?parent=3199"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/categories?post=3199"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/tags?post=3199"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}