{"id":4366,"date":"2024-02-25T08:22:48","date_gmt":"2024-02-25T08:22:48","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/service\/key-considerations-and-general-procedures-for-cell-therapy-facilities\/"},"modified":"2025-09-29T13:01:50","modified_gmt":"2025-09-29T06:01:50","slug":"nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao","status":"publish","type":"service","link":"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/","title":{"rendered":"Nh\u1eefng C\u00e2n Nh\u1eafc &#038; Quy Tr\u00ecnh C\u01a1 B\u1ea3n Khi X\u00e2y D\u1ef1ng Trung T\u00e2m Li\u1ec7u Ph\u00e1p T\u1ebf B\u00e0o"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Cac_thong_so_ky_thuat_duoc_trinh_bay_rat_quan_trong_trong_viec_thiet_ke_va_van_hanh_cac_trung_tam_lieu_phap_te_bao_dac_biet_la_cac_trung_tam_san_xuat_lieu_te_bao_tri_lieu_tuan_theo_tieu_chuan_cGMP\" >C\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y r\u1ea5t quan tr\u1ecdng trong vi\u1ec7c thi\u1ebft k\u1ebf v\u00e0 v\u1eadn h\u00e0nh c\u00e1c trung t\u00e2m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, \u0111\u1eb7c bi\u1ec7t l\u00e0 c\u00e1c trung t\u00e2m s\u1ea3n xu\u1ea5t li\u1ec7u t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;tu\u00e2n theo ti\u00eau chu\u1ea9n cGMP.<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Cac_yeu_cau_o_khu_vuc_san_xuat_te_bao_tri_lieu\" >C\u00e1c y\u00eau c\u1ea7u \u1edf khu v\u1ef1c s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Cac_yeu_cau_doi_voi_khu_vuc_ho_tro_san_xuat_te_bao_tri_lieu\" >C\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi khu v\u1ef1c h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t&nbsp;t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Cac_yeu_cau_doi_voi_phong_thi_nghiem_QC_va_phong_thi_nghiem_vi_sinh\" >C\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi&nbsp;ph\u00f2ng th\u00ed nghi\u1ec7m QC v\u00e0 ph\u00f2ng th\u00ed nghi\u1ec7m vi sinh<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Co_so_ha_tang_cong_nghe_thong_tin\" >C\u01a1 s\u1edf h\u1ea1 t\u1ea7ng c\u00f4ng ngh\u1ec7 th\u00f4ng tin<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Cac_yeu_cau_ve_may_moc_va_su_dung\" >C\u00e1c y\u00eau c\u1ea7u v\u1ec1 m\u00e1y m\u00f3c v\u00e0 s\u1eed d\u1ee5ng<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Yeu_cau_ve_nha_kho\" >Y\u00eau c\u1ea7u v\u1ec1 nh\u00e0 kho<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/nhung-can-nhac-quy-trinh-co-ban-khi-xay-dung-trung-tam-lieu-phap-te-bao\/#Tai_lieu_tham_khao\" >T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Cac_thong_so_ky_thuat_duoc_trinh_bay_rat_quan_trong_trong_viec_thiet_ke_va_van_hanh_cac_trung_tam_lieu_phap_te_bao_dac_biet_la_cac_trung_tam_san_xuat_lieu_te_bao_tri_lieu_tuan_theo_tieu_chuan_cGMP\"><\/span>C\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y r\u1ea5t quan tr\u1ecdng trong vi\u1ec7c thi\u1ebft k\u1ebf v\u00e0 v\u1eadn h\u00e0nh c\u00e1c trung t\u00e2m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, \u0111\u1eb7c bi\u1ec7t l\u00e0 c\u00e1c trung t\u00e2m s\u1ea3n xu\u1ea5t li\u1ec7u t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;tu\u00e2n theo ti\u00eau chu\u1ea9n cGMP.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/7MkrUDdiAzfOO6sLEZshsdCVHsQktMvZNrvLtM4k.png\" alt=\"\" width=\"400\" height=\"350\"><\/p>\n<p>C\u00e1c trung t\u00e2m t\u1ebf b\u00e0o g\u1ed1c\/ c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t&nbsp;t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;ph\u1ea3i \u0111\u1ee7 n\u0103ng l\u1ef1c c\u1ea7n thi\u1ebft cho s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m d\u1ef1 ki\u1ebfn, th\u1eed nghi\u1ec7m v\u00e0 l\u01b0u tr\u1eef. C\u00e1c \u0111i\u1ec1u ki\u1ec7n c\u01a1 s\u1edf v\u1eadt ch\u1ea5t, trang thi\u1ebft b\u1ecb, quy tr\u00ecnh k\u1ef9 thu\u1eadt, n\u0103ng l\u1ef1c chuy\u00ean m\u00f4n ph\u1ea3i \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ti\u00eau ch\u00ed \u0111\u1ec3 tri\u1ec3n khai nghi\u00ean c\u1ee9u v\u00e0 \u1ee9ng d\u1ee5ng \u0111i\u1ec1u tr\u1ecb l\u00e2m s\u00e0ng theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 y t\u1ebf&nbsp;v\u00e0 \u0111\u01b0\u1ee3c kh\u1ea3o s\u00e1t, th\u1ea9m \u0111\u1ecbnh tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p ho\u1ea1t \u0111\u1ed9ng\/ v\u1eadn h\u00e0nh.<\/p>\n<ul>\n<li><strong>C\u01a1 s\u1edf ph\u1ea3i tu\u00e2n th\u1ee7 t\u1ea5t c\u1ea3 c\u00e1c quy t\u1eafc v\u00e0 quy \u0111\u1ecbnh c\u1ee7a qu\u1ed1c gia<\/strong> (<strong>theo quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh c\u1ee7a B\u1ed9 y t\u1ebf)<\/strong> \u0111\u1ec3 s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m sinh h\u1ecdc v\u00e0 s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng. Nh\u00f3m n\u00e0y bao g\u1ed3m y\u00eau c\u1ea7u ph\u1ea3i c\u00f3 v\u00e0 duy tr\u00ec t\u1ea5t c\u1ea3 c\u00e1c gi\u1ea5y ph\u00e9p c\u1ea7n thi\u1ebft \u0111\u1ec3 kinh doanh v\u1edbi t\u01b0 c\u00e1ch l\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c d\u01b0\u1ee3c ph\u1ea9m sinh h\u1ecdc t\u1ea1i n\u01a1i c\u00f4ng ty s\u1ebd ho\u1ea1t \u0111\u1ed9ng.<\/li>\n<li><strong>C\u01a1 s\u1edf s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o ph\u1ea3i bao g\u1ed3m c\u00e1c khu v\u1ef1c:<\/strong> Ph\u00f2ng h\u00e0nh ch\u00ednh v\u00e0 v\u0103n ph\u00f2ng; khu v\u1ef1c \u0111\u1ec3 h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh, internet v\u00e0 \u0111i\u1ec7n tho\u1ea1i; khu v\u1ef1c kho b\u00e3i v\u00e0 v\u1eadn chuy\u1ec3n, nh\u1eadn h\u00e0ng; khu v\u1ef1c s\u1ea3n xu\u1ea5t; ph\u00f2ng ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng (QC) v\u00e0 ph\u00f2ng lab vi sinh; khu v\u1ef1c h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t; khu v\u1ef1c b\u1ea3o qu\u1ea3n s\u1ea3n ph\u1ea9m.<\/li>\n<li>C\u00e1c c\u00f4ng vi\u1ec7c h\u00e0nh ch\u00ednh v\u00e0 h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t kh\u00e1c (n\u01a1i kh\u00f4ng c\u00f3 hi\u1ec7n di\u1ec7n s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o) c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u1edf c\u00e1c ph\u00f2ng t\u00e1ch bi\u1ec7t v\u1edbi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t. C\u1ea7n c\u00f3 c\u00e1c ph\u00f2ng ngh\u1ec9 gi\u1ea3i lao d\u00e0nh cho nh\u00e2n vi\u00ean v\u00e0 ph\u00f2ng \u0111\u00e0o t\u1ea1o c\u1ea3 trong nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t v\u00e0 t\u1ea1i c\u00e1c khu v\u1ef1c h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t.<\/li>\n<li><strong>Thi\u1ebft k\u1ebf c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o n\u00ean b\u1ed1 tr\u00ed h\u01b0\u1edbng di chuy\u1ec3n m\u1ed9t chi\u1ec1u <\/strong>c\u1ee7a nguy\u00ean li\u1ec7u th\u00f4 ho\u1eb7c s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o, c\u1ee7a nh\u00e2n vi\u00ean v\u1eadn h\u00e0nh v\u00e0 c\u1ee7a ch\u1ea5t th\u1ea3i \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o s\u1ef1 ph\u00e2n ly t\u1ed1i \u0111a v\u00e0 s\u1ef1 giao nhau t\u1ed1i thi\u1ec3u.<\/li>\n<li>Thi\u1ebft k\u1ebf c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o c\u1ea7n xem x\u00e9t c\u00e1c y\u1ebfu t\u1ed1 \u0111\u1ea3m b\u1ea3o an ninh xung quanh v\u00e0 h\u1ea1n ch\u1ebf ti\u1ebfp c\u1eadn \u0111\u1ed1i v\u1edbi c\u00e1c khu v\u1ef1c \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t trong c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, \u0111\u1ea3m b\u1ea3o s\u1ef1 an to\u00e0n (\u0111\u1ed9ng \u0111\u1ea5t, ng\u1eadp l\u1ee5t\u2026) l\u00e2u d\u00e0i cho l\u01b0u tr\u1eef c\u00e1c \u0111\u01a1n v\u1ecb t\u1ebf b\u00e0o g\u1ed1c.<\/li>\n<li>Thi\u1ebft k\u1ebf c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o c\u1ea7n xem x\u00e9t ngu\u1ed3n \u0111i\u1ec7n d\u1ef1 ph\u00f2ng (m\u00e1y ph\u00e1t \u0111i\u1ec7n, UPS), \u0111\u1eb7c bi\u1ec7t l\u00e0 \u1edf nh\u1eefng khu v\u1ef1c th\u01b0\u1eddng b\u1ecb m\u1ea5t \u0111i\u1ec7n.<\/li>\n<li>C\u1ea7n c\u00f3 \u0111\u1ee7 ch\u1ed7 \u0111\u1eadu xe cho nh\u00e2n vi\u00ean v\u00e0 ng\u01b0\u1eddi v\u1eadn chuy\u1ec3n, \u0111\u1ed3ng th\u1eddi c\u00f3 \u0111\u1ee7 \u00e1nh s\u00e1ng v\u00e0 c\u00e1c t\u00ednh n\u0103ng an to\u00e0n trong khu v\u1ef1c \u0111\u1eadu xe.<\/li>\n<li>C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o ph\u1ea3i \u0111\u00e1p \u1ee9ng v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n c\u1ee7a C\u01a1 quan Qu\u1ea3n l\u00fd an to\u00e0n lao \u0111\u1ed9ng v\u00e0 c\u00e1c quy \u0111\u1ecbnh b\u1ea3o \u0111\u1ea3m an to\u00e0n trong ph\u00f2ng th\u00ed nghi\u1ec7m.<\/li>\n<li>C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o ph\u1ea3i xem x\u00e9t c\u00e1c \u0111\u01b0\u1eddng d\u1eabn kh\u00ed quan tr\u1ecdng, \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u s\u1eed d\u1ee5ng c\u1ee7a c\u00e1c h\u1ec7 th\u1ed1ng thi\u1ebft b\u1ecb, ch\u1eb3ng h\u1ea1n nh\u01b0 \u0111\u01b0\u1eddng d\u1eabn nit\u01a1 l\u1ecfng v\u00e0 CO2.<\/li>\n<li>Thi\u1ebft k\u1ebf c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o c\u1ea7n xem x\u00e9t c\u01a1 s\u1edf h\u1ea1 t\u1ea7ng c\u00e1p d\u1eef li\u1ec7u c\u1ea7n thi\u1ebft cho c\u00e1c thi\u1ebft b\u1ecb v\u00e0 m\u00e1y t\u00ednh n\u1ed1i m\u1ea1ng, \u0111\u1eb7c bi\u1ec7t l\u00e0 c\u00f3 s\u1eed d\u1ee5ng ph\u1ea7n m\u1ec1m v\u1eadn h\u00e0nh.<\/li>\n<li>C\u00e1c b\u1ea3ng thi\u1ebft k\u1ebf x\u00e2y d\u1ef1ng chi ti\u1ebft c\u1ea7n \u0111\u01b0\u1ee3c chia s\u1ebd \u0111\u1ebfn c\u00e1c nh\u00e0 th\u1ea7u thi c\u00f4ng. T\u00e0i li\u1ec7u n\u00e0y \u0111\u1eb7t ra c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi quy tr\u00ecnh, c\u00e1ch b\u1ed1 tr\u00ed t\u1ea7ng, ph\u00e2n lo\u1ea1i ph\u00f2ng, vi\u1ec7c s\u1eed d\u1ee5ng v\u00e0 b\u1ed5 sung, h\u01b0\u1edbng di chuy\u1ec3n c\u1ee7a nh\u00e2n vi\u00ean, ti\u1ebfn tr\u00ecnh s\u1ea3n xu\u1ea5t, nguy\u00ean li\u1ec7u th\u00f4, s\u1ea3n ph\u1ea9m v\u00e0 ch\u1ea5t th\u1ea3i. T\u1eeb c\u01a1 s\u1edf thi\u1ebft k\u1ebf n\u00e0y, s\u01a1 \u0111\u1ed3 m\u1eb7t b\u1eb1ng chi ti\u1ebft c\u0169ng nh\u01b0 m\u00f4 t\u1ea3 thi\u1ebft b\u1ecb, h\u1ec7 th\u1ed1ng \u1ed1ng n\u01b0\u1edbc v\u00e0 \u0111i\u1ec7n c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ho\u00e0n th\u00e0nh.<\/li>\n<li>Thi\u1ebft k\u1ebf h\u1ec7 th\u1ed1ng \u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed (HVAC) c\u1ee7a c\u01a1 s\u1edf n\u00ean bao g\u1ed3m m\u1ed9t ho\u1eb7c nhi\u1ec1u b\u1ed9 x\u1eed l\u00fd kh\u00f4ng kh\u00ed ri\u00eang bi\u1ec7t cho c\u00e1c khu v\u1ef1c x\u1eed l\u00fd v\u00f4 tr\u00f9ng.<\/li>\n<li>Trong c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o \u0111\u00e1p \u1ee9ng chu\u1ea9n GMP n\u00ean s\u1eed d\u1ee5ng lo\u1ea1i n\u01b0\u1edbc pha ti\u00eam (WFI) ho\u1eb7c n\u01b0\u1edbc tinh khi\u1ebft (PW) \u0111\u1ea1t chu\u1ea9n USP (d\u01b0\u1ee3c \u0111i\u1ec3n M\u1ef9) \u0111\u1ec3 pha ch\u1ebf c\u00e1c dung d\u1ecbch d\u00f9ng ho\u1eb7c \u0111\u1ec3 l\u00e0m s\u1ea1ch v\u00e0 kh\u1eed tr\u00f9ng c\u00e1c khu v\u1ef1c x\u1eed l\u00fd v\u00f4 tr\u00f9ng.<\/li>\n<li>C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o c\u1ea7n duy tr\u00ec m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t c\u00f4n tr\u00f9ng, vi sinh v\u00e0 v\u1ec7 sinh ph\u00f9 h\u1ee3p theo c\u00e1c quy tr\u00ecnh \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Cac_yeu_cau_o_khu_vuc_san_xuat_te_bao_tri_lieu\"><\/span><strong>C\u00e1c y\u00eau c\u1ea7u \u1edf khu v\u1ef1c s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>B\u1ea3n ch\u1ea5t c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 s\u1ea3n xu\u1ea5t trong trung t\u00e2m&nbsp;li\u1ec7u ph\u00e1p&nbsp;t\u1ebf b\u00e0o ph\u1ea3i quy \u0111\u1ecbnh vi\u1ec7c ph\u00e2n lo\u1ea1i kh\u00f4ng kh\u00ed c\u1ee7a c\u00e1c d\u00e3y nh\u00e0 s\u1ea3n xu\u1ea5t (b\u1ea3ng 1). N\u00f3i chung, <strong>t\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m s\u1ea3n xu\u1ea5t b\u1eb1ng h\u1ec7 th\u1ed1ng thi\u1ebft b\u1ecb m\u1edf ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong t\u1ee7 an to\u00e0n sinh h\u1ecdc (BSC) theo ti\u00eau chu\u1ea9n ISO 5 (tr\u01b0\u1edbc \u0111\u00e2y l\u00e0 Class 100)<\/strong>, \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf c\u00f3 ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng \u1edf m\u1ed9t m\u1ee9c \u0111\u1ed9 t\u01b0\u01a1ng x\u1ee9ng v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c x\u1eed l\u00fd v\u00f4 tr\u00f9ng. Nh\u00e0 s\u1ea3n xu\u1ea5t n\u00ean tham kh\u1ea3o \u00fd ki\u1ebfn c\u1ee7a m\u1ed9t nh\u00e0 t\u01b0 v\u1ea5n c\u00f3 n\u0103ng l\u1ef1c v\u00e0 quy \u0111\u1ecbnh c\u1ee7a FDA tr\u01b0\u1edbc khi ho\u00e0n thi\u1ec7n ph\u00e2n lo\u1ea1i c\u01a1 s\u1edf. \u0110\u1ed1i v\u1edbi h\u1ea7u h\u1ebft c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a cGMP, c\u1ea7n tu\u00e2n theo h\u01b0\u1edbng d\u1eabn x\u1eed l\u00fd v\u00f4 tr\u00f9ng. <strong>Vi\u1ec7c s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo c\u00e1c b\u1ed9 ti\u00eau chu\u1ea9n ISO 7, v\u00e0 t\u1ea5t c\u1ea3 c\u00e1c thao t\u00e1c m\u1edf ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong c\u00e1c t\u1ee7 BSC \u0111\u1ea1t ti\u00eau chu\u1ea9n ISO 5 n\u1eb1m khu v\u1ef1c \u0111\u1ea1t ti\u00eau chu\u1ea9n ISO 7<\/strong>.<\/p>\n<p>B\u1ea3ng 1. Ti\u00eau chu\u1ea9n ph\u00e2n lo\u1ea1i kh\u00f4ng kh\u00ed: Li\u00ean bang Hoa K\u1ef3 v\u00e0 ISO so s\u00e1nh v\u00e0 m\u1ee9c \u0111\u1ed9 h\u00e0nh \u0111\u1ed9ng c\u00f3 th\u1ec3 \u0111\u1ebfm \u0111\u01b0\u1ee3c<\/p>\n<figure class=\"table\">\n<table>\n<tbody>\n<tr>\n<td>\n<p style=\"text-align:center;\">Ph\u00e2n lo\u1ea1i v\u00f9ng s\u1ea1ch (h\u1ea1t 0,5 um \/ ft3)<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">Ch\u1ec9 \u0111\u1ecbnh ISO<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">&gt; 0,5 um H\u1ea1t \/ m3<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">M\u1ee9c \u0111\u1ed9 ho\u1ea1t \u0111\u1ed9ng kh\u00f4ng kh\u00ed ch\u1ee7 \u0111\u1ed9ng (CFU kh\u1ea3 thi \/ m3)<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">C\u00e1c c\u1ea5p \u0111\u1ed9 h\u00e0nh \u0111\u1ed9ng l\u1ea5y m\u1eabu kh\u00f4ng kh\u00ed th\u1ee5 \u0111\u1ed9ng *<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p style=\"text-align:center;\">100<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">5<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">3.520<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">1<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">1<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p style=\"text-align:center;\">1.000<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">6<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">35.200<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">7<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">3<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p style=\"text-align:center;\">10.000<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">7<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">352.000<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">10<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">5<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p style=\"text-align:center;\">100.000<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">8<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">3.520.000<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">100<\/p>\n<\/td>\n<td>\n<p style=\"text-align:center;\">50<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<p><i>*\u0110\u0129a c\u00e0i \u0111\u1eb7t vi sinh \u0111\u01b0\u1eddng k\u00ednh 90 mm; CFU\/ 4 gi\u1edd.<\/i><\/p>\n<p><strong>\u0110\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m&nbsp;t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;\u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong h\u1ec7 th\u1ed1ng k\u00edn \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh th\u00f4ng qua x\u00e1c nh\u1eadn quy tr\u00ecnh v\u00f4 tr\u00f9ng, khu v\u1ef1c c\u1ea5p \u0111\u1ed9 s\u1ea1ch kh\u00f4ng ph\u00e2n lo\u1ea1i (CNC) th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng<\/strong>. \u0110\u1ed1i v\u1edbi m\u1ee5c \u0111\u00edch thi\u1ebft k\u1ebf, c\u00e1c khu v\u1ef1c n\u00e0y \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng b\u1eb1ng c\u00e1c v\u1eadt li\u1ec7u v\u00e0 h\u1ec7 th\u1ed1ng t\u01b0\u01a1ng t\u1ef1 nh\u01b0 ti\u00eau chu\u1ea9n ISO 8, bao g\u1ed3m kh\u00f4ng kh\u00ed \u0111\u01b0\u1ee3c l\u1ecdc \u0111\u1ea1t ti\u00eau chu\u1ea9n HEPA, nh\u01b0ng ch\u00fang kh\u00f4ng \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ho\u1eb7c gi\u00e1m s\u00e1t nh\u01b0 h\u1ec7 th\u1ed1ng ISO 8. \u1ede Ch\u00e2u \u00c2u, c\u00e1c khu v\u1ef1c n\u00e0y c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c x\u1ebfp lo\u1ea1i sang lo\u1ea1i D ho\u1eb7c E, trong khi \u1edf Hoa K\u1ef3, thu\u1eadt ng\u1eef th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u1ea5t l\u00e0 CNC.<\/p>\n<p>C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 v\u1eadn h\u00e0nh tu\u00e2n theo <strong>h\u01b0\u1edbng d\u1eabn nghi\u00ean c\u1ee9u \u1ee9ng d\u1ee5ng t\u1ebf b\u00e0o v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u1eeb t\u1ebf b\u00e0o t\u1ea1i Vi\u1ec7t Nam theo Quy\u1ebft \u0111\u1ecbnh s\u1ed1 4259\/Q\u0110-BYT ng\u00e0y 12\/10\/2020 c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf<\/strong> ho\u1eb7c FDA (M\u1ef9), bao g\u1ed3m 21 CFR 210, 211.600.610 v\u00e0 1271 (t\u1ea1i M\u1ef9).<\/p>\n<p>C\u00e1c y\u00eau c\u1ea7u v\u1ec1 vi\u1ec7c cung c\u1ea5p c\u00e1c khu v\u1ef1c d\u00e0nh ri\u00eang (ph\u00f2ng s\u1ea1ch) \u0111\u01b0\u1ee3c c\u00e1ch ly th\u00edch h\u1ee3p v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c \u0111ang \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong c\u01a1 s\u1edf c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t tr\u00ean c\u01a1 s\u1edf t\u00ednh ch\u1ea5t c\u1ee7a s\u1ea3n ph\u1ea9m v\u00e0 kh\u1ed1i l\u01b0\u1ee3ng x\u1eed l\u00fd.<\/p>\n<p>K\u1ebf ho\u1ea1ch x\u00e2y d\u1ef1ng n\u00ean xem x\u00e9t c\u00e1c y\u00eau c\u1ea7u nh\u01b0 kh\u00f4ng gian s\u1ea1ch v\u1edbi v\u1eadt li\u1ec7u b\u1ec1n, c\u00e1c \u0111\u01b0\u1eddng n\u1ed1i k\u00edn, c\u00e1c \u0111i\u1ec3m giao nhau gi\u1eefa g\u00f3c t\u01b0\u1eddng v\u00e0 s\u00e0n, c\u00e1c c\u1ed9t t\u01b0\u1eddng nguy\u00ean kh\u1ed1i s\u1ebd l\u00e0m cho c\u00e1c khu v\u1ef1c x\u1eed l\u00fd v\u00f4 tr\u00f9ng v\u00e0 ph\u00f2ng x\u1eed l\u00fd m\u1eabu (tr\u1ea7n nh\u00e0, s\u00e0n, t\u01b0\u1eddng) nh\u1eb5n v\u00e0 d\u1ec5 lau ch\u00f9i. Ph\u00f2ng s\u1ea1ch ho\u00e0n thi\u1ec7n th\u00ec c\u00e1c b\u1ec1 m\u1eb7t, v\u1eadt li\u1ec7u v\u00e0 \u0111\u1ed3 \u0111\u1ea1c trong ph\u00f2ng s\u1ea1ch n\u00ean \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho t\u1ea5t c\u1ea3 c\u00e1c khu v\u1ef1c \u0111\u00e3 ph\u00e2n lo\u1ea1i. Ch\u00fang bao g\u1ed3m c\u00e1c h\u1ea1ng m\u1ee5c nh\u01b0 c\u1eeda s\u1ed5, c\u1eeda ra v\u00e0o, t\u1ea5m m\u00f4-\u0111un, s\u00e0n epoxy, \u0111\u00e8n, v\u1ecf\/ t\u1ea5m l\u1ecdc HEPA, m\u1eb7t b\u00e0n b\u1eb1ng th\u00e9p kh\u00f4ng g\u1ec9 ho\u1eb7c ch\u1ed1ng h\u00f3a ch\u1ea5t, v\u00e0 nh\u1eefng th\u1ee9 t\u01b0\u01a1ng t\u1ef1 d\u00e0nh ri\u00eang cho ph\u00f2ng s\u1ea1ch. T\u1ea5t c\u1ea3 c\u00e1c b\u1ec1 m\u1eb7t ph\u00f2ng s\u1ea1ch ph\u1ea3i nh\u1eb5n, c\u00f3 th\u1ec3 d\u1ec5 d\u00e0ng l\u00e0m s\u1ea1ch,&nbsp; kh\u00f4ng c\u00f3 c\u00e1c khe h\u1edf v\u00e0 c\u00e1c b\u1ec1 m\u1eb7t kh\u00f3 l\u00e0m s\u1ea1ch.<\/p>\n<p>C\u01a1 s\u1edf ph\u1ea3i \u0111\u01b0\u1ee3c trang b\u1ecb \u0111\u1ea7y \u0111\u1ee7 \u0111\u1ec3 c\u00f3 h\u1ec7 th\u1ed1ng th\u00f4ng gi\u00f3 th\u00edch h\u1ee3p, h\u1ec7 th\u1ed1ng l\u1ecdc HEPA, trao \u0111\u1ed5i kh\u00f4ng kh\u00ed v\u00e0 ch\u00eanh l\u1ec7ch \u00e1p su\u1ea5t kh\u00f4ng kh\u00ed. \u00c1p su\u1ea5t d\u01b0\u01a1ng \u0111\u1ed1i v\u1edbi m\u00f4i tr\u01b0\u1eddng k\u00e9m s\u1ea1ch c\u1ea7n \u0111\u01b0\u1ee3c duy tr\u00ec v\u00e0 gi\u00e1m s\u00e1t b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p th\u1ee7 c\u00f4ng ho\u1eb7c b\u1eb1ng m\u00e1y t\u00ednh. Vi\u1ec7c n\u00e0y n\u00ean \u0111\u01b0\u1ee3c gi\u1edbi h\u1ea1n \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e2n vi\u00ean \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o th\u00edch h\u1ee3p v\u00e0 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u0111\u1ec3 duy tr\u00ec ch\u00eanh l\u1ec7ch \u00e1p su\u1ea5t, t\u1ed1t nh\u1ea5t l\u00e0 s\u1eed d\u1ee5ng c\u00e1c kh\u00f3a c\u1eeda li\u00ean \u0111\u1ed9ng trong c\u00e1c khu v\u1ef1c chuy\u1ec3n ti\u1ebfp, ch\u1eb3ng h\u1ea1n nh\u01b0 ph\u00f2ng thay \u0111\u1ed3 v\u00e0 ph\u00f2ng x\u1eed l\u00fd.<\/p>\n<p>C\u1ea7n xem x\u00e9t m\u1ee9c \u0111\u1ed9 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n thi\u1ebft k\u1ebf (DQ), tr\u00ecnh \u0111\u1ed9 l\u1eafp \u0111\u1eb7t (IQ), tr\u00ecnh \u0111\u1ed9 v\u1eadn h\u00e0nh (OQ) v\u00e0 tr\u00ecnh \u0111\u1ed9 n\u0103ng l\u1ef1c (PQ) c\u1ee7a c\u01a1 s\u1edf v\u00e0 h\u1ec7 th\u1ed1ng. C\u00e1c y\u00eau c\u1ea7u v\u1ec1 t\u1ea7n su\u1ea5t v\u00e0 c\u01b0\u1eddng \u0111\u1ed9 quan tr\u1eafc m\u00f4i tr\u01b0\u1eddng c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t.<\/p>\n<p>K\u1ebf ho\u1ea1ch b\u1ed1 tr\u00ed c\u01a1 s\u1edf ph\u1ea3i d\u1ef1 ki\u1ebfn chi\u1ec1u l\u01b0u th\u00f4ng ph\u00f9 h\u1ee3p c\u1ee7a s\u1ea3n ph\u1ea9m, nguy\u00ean li\u1ec7u, nh\u00e2n s\u1ef1 v\u00e0 ch\u1ea5t th\u1ea3i. N\u00ean k\u1ebft h\u1ee3p c\u00e1c nguy\u00ean t\u1eafc l\u01b0u th\u00f4ng m\u1ed9t chi\u1ec1u \u0111\u1ec3 gi\u1ea3m thi\u1ec3u s\u1ef1 giao nhau, n\u1ebfu kh\u1ea3 thi, v\u00e0 ph\u1ea3i cho ph\u00e9p c\u00e1c m\u1ee9c \u0111\u1ed9 ph\u00e2n t\u00e1ch v\u00e0 c\u00f4 l\u1eadp th\u00edch h\u1ee3p. K\u1ebf ho\u1ea1ch n\u00e0y c\u0169ng n\u00ean bao g\u1ed3m c\u1ea3 s\u1ef1 l\u01b0u th\u00f4ng trong qu\u00e1 tr\u00ecnh x\u1eed l\u00fd v\u00e0 l\u01b0u th\u00f4ng m\u1eabu v\u1edbi c\u00e1c khu v\u1ef1c l\u00e2n c\u1eadn, c\u00f3 th\u1ec3 b\u1ed1 tr\u00ed l\u01b0u th\u00f4ng qua l\u1ea1i n\u1ebfu mu\u1ed1n. T\u1ea5t c\u1ea3 c\u00e1c khu v\u1ef1c s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng, c\u00e1c h\u00e0nh lang li\u1ec1n k\u1ec1 v\u00e0 c\u00e1c ph\u00f2ng Gowing v\u00e0 Degowing li\u00ean quan ph\u1ea3i \u1edf m\u1ee9c ph\u00e2n lo\u1ea1i t\u1ed1i thi\u1ec3u c\u1ee7a ISO 8. \u0110i\u1ec1u \u00e1p ho\u1eb7c lu\u1ed3ng kh\u00f4ng kh\u00ed (t\u1eeb khu v\u1ef1c s\u1ea1ch h\u01a1n \u0111\u1ebfn khu v\u1ef1c k\u00e9m s\u1ea1ch h\u01a1n), s\u01a1 \u0111\u1ed3 ph\u00e2n lo\u1ea1i ho\u1eb7c x\u1eed l\u00fd kh\u00f4ng kh\u00ed ph\u1ea3i l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a k\u1ebf ho\u1ea1ch b\u1ed1 tr\u00ed.<\/p>\n<p>Thi\u1ebft k\u1ebf c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o cho c\u00e1c khu v\u1ef1c v\u00f4 tr\u00f9ng\/ h\u1ec7 th\u1ed1ng m\u1edf ph\u1ea3i cho ph\u00e9p s\u1eed d\u1ee5ng \u0111\u1ed3 b\u1ea3o h\u1ed9 (gowing) v\u1edbi c\u00e1c c\u1ea5p \u0111\u1ed9 b\u1ea3o v\u1ec7 kh\u00e1c nhau theo ph\u00e2n lo\u1ea1i ph\u00f2ng s\u1ea1ch ISO, t\u1ed1t nh\u1ea5t l\u00e0 \u1edf c\u00e1c khu v\u1ef1c \u0111\u1ec7m (Gowing- ph\u00f2ng thay \u0111\u1ed3 tr\u01b0\u1edbc khi v\u00f4 ph\u00f2ng s\u1ea1ch v\u00e0 Degowing &#8211; ph\u00f2ng c\u1edfi b\u1ecf \u0111\u1ed3 tr\u01b0\u1edbc khi ra kh\u1ecfi ph\u00f2ng s\u1ea1ch). Tuy nhi\u00ean, khi s\u1eed d\u1ee5ng c\u00e1c h\u1ec7 th\u1ed1ng k\u00edn, \u0111\u1ed3 b\u1ea3o h\u1ed9 c\u1ea5p \u0111\u1ed9 1 l\u00e0 ph\u00f9 h\u1ee3p. C\u1ea7n m\u00f4 t\u1ea3 v\u00e0 ni\u00eam y\u1ebft c\u1ea5p \u0111\u1ed9 b\u1ea3o v\u1ec7 c\u1ee7a \u0111\u1ed3 b\u1ea3o h\u1ed9 \u0111\u1ec3 ph\u00f9 h\u1ee3p v\u1edbi ch\u1ee9c n\u0103ng c\u1ee7a t\u1eebng khu v\u1ef1c trong c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t. C\u00e1c ph\u00f2ng \u0111\u1ec7m n\u00ean \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng cho nh\u00e2n vi\u00ean di chuy\u1ec3n m\u1ed9t chi\u1ec1u, \u0111\u1eb7c bi\u1ec7t khi nh\u00e2n vi\u00ean \u0111ang th\u1ef1c hi\u1ec7n x\u1eed l\u00fd v\u00f4 tr\u00f9ng.&nbsp; Ph\u00f2ng gowing ph\u1ea3i c\u00f3 c\u00f9ng ph\u00e2n lo\u1ea1i c\u1ea5p s\u1ea1ch v\u1edbi khu v\u1ef1c m\u00e0 n\u00f3 b\u1ea3o v\u1ec7.<\/p>\n<p>Thi\u1ebft k\u1ebf c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o ph\u1ea3i t\u00ednh \u0111\u1ebfn s\u1ef1 t\u00e1ch bi\u1ec7t th\u00f4ng qua c\u00e1c \u0111\u01a1n v\u1ecb x\u1eed l\u00fd kh\u00f4ng kh\u00ed ri\u00eang l\u1ebb v\u00e0 c\u00e1c h\u1ea1n ch\u1ebf v\u1ec1 <strong>s\u1ef1 di chuy\u1ec3n c\u1ee7a nh\u00e2n vi\u00ean gi\u1eefa c\u00e1c \u201cm\u00f4-\u0111un\u201d \u0111\u1ec3 tr\u00e1nh l\u1eabn l\u1ed9n ho\u1eb7c nhi\u1ec5m ch\u00e9o trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t<\/strong>.<\/p>\n<p>T\u1ed1t nh\u1ea5t, <strong>m\u1ed7i ph\u00f2ng s\u1ea1ch n\u00ean c\u00f3 m\u1ed9t \u0111\u01a1n v\u1ecb HVAC \u0111\u1ed9c l\u1eadp v\u1edbi HEPA \u0111\u1ea7u cu\u1ed1i tr\u1ea7n<\/strong> v\u00e0 c\u00e1c \u0111\u01b0\u1eddng \u1ed1ng d\u1eabn tr\u1edf l\u1ea1i t\u01b0\u1eddng ho\u1eb7c t\u01b0\u1eddng th\u1ea5p \u0111\u1ec3 t\u00e1i ch\u1ebf v\u00e0 x\u1ea3. C\u00e1c b\u1ed9 ph\u1eadn x\u1eed l\u00fd kh\u00f4ng kh\u00ed ph\u1ea3i&nbsp; ti\u1ebfp c\u1eadn \u0111\u01b0\u1ee3c \u0111\u1ec3 c\u00f3 th\u1ec3 ti\u1ebfn h\u00e0nh b\u1ea3o d\u01b0\u1ee1ng t\u1eeb b\u00ean ngo\u00e0i m\u00e0 kh\u00f4ng l\u00e0m vi ph\u1ea1m ph\u1ea7n \u0111\u00e3 ph\u00e2n lo\u1ea1i b\u00ean trong c\u00e1c m\u00f4-\u0111un. B\u1ed9 x\u1eed l\u00fd kh\u00f4ng kh\u00ed cho khu v\u1ef1c x\u1eed l\u00fd ph\u1ea3i t\u00e1ch bi\u1ec7t v\u1edbi khu v\u1ef1c v\u0103n ph\u00f2ng v\u00e0 khu v\u1ef1c ch\u01b0a \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i.<\/p>\n<p><strong>Thi\u1ebft k\u1ebf v\u00e0 x\u00e2y d\u1ef1ng ph\u1ea3i cho ph\u00e9p s\u1ef1 ph\u00e1t tri\u1ec3n v\u00e0 m\u1edf r\u1ed9ng kh\u00f4ng gian c\u1ee7a c\u01a1 s\u1edf, t\u0103ng nhu c\u1ea7u v\u1ec1 th\u1ec3 t\u00edch m\u1eabu m\u00e0 kh\u00f4ng c\u1ea7n c\u00e1c quy tr\u00ecnh s\u1ea3n xu\u1ea5t li\u00ean t\u1ee5c.<\/strong> Vi\u1ec7c s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn m\u00f4-\u0111un ph\u1ea3i \u0111\u01b0\u1ee3c xem x\u00e9t \u0111\u1ec3 cho ph\u00e9p m\u1edf r\u1ed9ng c\u00e1c khu v\u1ef1c s\u1ea3n xu\u1ea5t theo nhi\u1ec1u h\u01b0\u1edbng, n\u1ebfu c\u1ea7n thi\u1ebft. K\u1ebf ho\u1ea1ch ph\u1ea3i d\u1ef1 ki\u1ebfn nhu c\u1ea7u m\u1edf r\u1ed9ng m\u1ed9t ho\u1eb7c nhi\u1ec1u m\u00f4-\u0111un t\u1ea1i m\u1ed9t th\u1eddi \u0111i\u1ec3m v\u00e0 k\u1ebft n\u1ed1i v\u1edbi c\u00e1c khu v\u1ef1c ho\u1ea1t \u0111\u1ed9ng hi\u1ec7n c\u00f3, sau khi ho\u00e0n th\u00e0nh vi\u1ec7c x\u00e1c nh\u1eadn v\u00e0 sau khi \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c b\u1ea5t k\u1ef3 ph\u00ea duy\u1ec7t quy \u0111\u1ecbnh b\u1eaft bu\u1ed9c n\u00e0o.<\/p>\n<p>C\u1ea7n xem x\u00e9t vi\u1ec7c \u00e1p d\u1ee5ng c\u00e1c h\u1ec7 th\u1ed1ng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n v\u00e0 c\u00e1c \u0111\u01a1n v\u1ecb ph\u00e2n t\u00e1ch, v\u00ec nh\u1eefng h\u1ec7 th\u1ed1ng n\u00e0y kh\u00f4ng y\u00eau c\u1ea7u th\u1ea9m \u0111\u1ecbnh v\u1ec7 sinh. C\u00e1c h\u1ec7 th\u1ed1ng s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n c\u00f3 th\u1ec3 \u00edt t\u1ed1n k\u00e9m h\u01a1n, chi ph\u00ed th\u1ea9m \u0111\u1ecbnh th\u1ea5p h\u01a1n v\u00e0 do \u0111\u00f3 hi\u1ec7u qu\u1ea3 h\u01a1n, \u0111\u1eb7c bi\u1ec7t l\u00e0 \u0111\u1ed1i v\u1edbi s\u1ea3n xu\u1ea5t giai \u0111o\u1ea1n th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng. <strong>C\u00e1c h\u1ec7 th\u1ed1ng s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n th\u01b0\u1eddng l\u00e0 c\u00e1c h\u1ec7 th\u1ed1ng kh\u00e9p k\u00edn v\u00e0 do \u0111\u00f3 c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong m\u00f4i tr\u01b0\u1eddng CNC so v\u1edbi h\u1ec7 th\u1ed1ng \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i \u0111\u1ea7y \u0111\u1ee7, \u0111i\u1ec1u n\u00e0y s\u1ebd gi\u1ea3m \u0111\u00e1ng k\u1ec3 g\u00e1nh n\u1eb7ng c\u1ee7a vi\u1ec7c th\u1ef1c hi\u1ec7n gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng tr\u00ean di\u1ec7n r\u1ed9ng. <\/strong>Ng\u01b0\u1eddi \u0111\u1ecdc c\u1ea7n l\u01b0u \u00fd r\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c h\u1ec7 th\u1ed1ng kh\u00e9p k\u00edn ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn v\u1edbi c\u00e1c quy tr\u00ecnh x\u00e1c nh\u1eadn v\u00f4 tr\u00f9ng.<\/p>\n<p><strong>Nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m<\/strong><\/p>\n<p>Khu v\u1ef1c x\u1eed l\u00fd v\u00f4 tr\u00f9ng trong ph\u00f2ng s\u1ea1ch c\u00f3 th\u1ec3 ho\u1ea1t \u0111\u1ed9ng \u1edf m\u1ed9t lo\u1ea1t c\u00e1c m\u1ee9c nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1edfi s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ng\u01b0\u1eddi v\u1eadn h\u00e0nh. Nhi\u1ec7t \u0111\u1ed9 ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t trong t\u1ea5t c\u1ea3 c\u00e1c khu v\u1ef1c \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i v\u00e0 CNC. \u0110\u1ed9 \u1ea9m ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t trong c\u00e1c khu v\u1ef1c \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i, n\u01a1i qu\u00e1 tr\u00ecnh x\u1eed l\u00fd v\u00f4 tr\u00f9ng di\u1ec5n ra trong m\u1ed9t h\u1ec7 th\u1ed1ng m\u1edf. <strong>Gi\u1edbi h\u1ea1n ki\u1ec3m so\u00e1t \u0111\u1ed9 \u1ea9m t\u01b0\u01a1ng \u0111\u1ed1i (RH) \u0111i\u1ec3n h\u00ecnh l\u00e0 20% \u0111\u1ebfn 80% RH ho\u1eb7c 30% \u0111\u1ebfn 70% RH<\/strong>. T\u1ed1t nh\u1ea5t, <strong>trong c\u00e1c ph\u00f2ng ch\u1ee9a c\u00e1c b\u00ecnh nit\u01a1 l\u1ecfng l\u01b0u tr\u1eef m\u1eabu, \u0111\u1ed9 \u1ea9m s\u1ebd \u0111\u01b0\u1ee3c gi\u1eef \u1edf m\u1ee9c th\u1ea5p \u0111\u1ec3 tr\u00e1nh t\u00edch t\u1ee5 \u0111\u00f4ng \u0111\u00e1 qu\u00e1 m\u1ee9c, d\u00f9 c\u00e1c khu v\u1ef1c n\u00e0y c\u00f3 \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i hay kh\u00f4ng. T\u1ea5t c\u1ea3 c\u00e1c khu v\u1ef1c \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ph\u1ea3i \u0111\u01b0\u1ee3c gi\u00e1m s\u00e1t v\u00e0 ki\u1ec3m so\u00e1t b\u1edfi m\u1ed9t h\u1ec7 th\u1ed1ng HVAC (\u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed) \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn.<\/strong><\/p>\n<p><strong>Y\u00eau c\u1ea7u v\u1ec1 kh\u00f4ng gian<\/strong><\/p>\n<p>Khu v\u1ef1c s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;ph\u1ea3i c\u00f3 \u0111\u1ee7 kh\u00f4ng gian \u0111\u1ec3 duy tr\u00ec m\u00f4i tr\u01b0\u1eddng v\u00f4 tr\u00f9ng v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m c\u1ea7n thi\u1ebft cho ho\u1ea1t \u0111\u1ed9ng c\u1ee5 th\u1ec3, c\u00f3 xem x\u00e9t \u0111\u1ebfn thi\u1ebft b\u1ecb v\u00e0 s\u1ed1 l\u01b0\u1ee3ng nh\u00e2n vi\u00ean. C\u01a1 s\u1edf ph\u1ea3i cung c\u1ea5p vi\u1ec7c b\u1ea3o qu\u1ea3n an to\u00e0n nguy\u00ean li\u1ec7u, th\u00e0nh ph\u1ea7n v\u00e0 t\u00e0i li\u1ec7u \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t. C\u00e1c khu v\u1ef1c trong kh\u00f4ng gian s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c cung c\u1ea5p \u0111\u1ec3 ti\u1ebfp c\u1eadn c\u00e1c th\u00e0nh ph\u1ea7n t\u1ebf b\u00e0o nh\u1eadp v\u00e0o v\u00e0 \u0111\u1ec3 ki\u1ec3m \u0111\u1ecbnh v\u00e0 l\u01b0u gi\u1eef c\u00e1c th\u00e0nh ph\u1ea9m cho \u0111\u1ebfn khi ch\u00fang \u0111\u01b0\u1ee3c xu\u1ea5t x\u01b0\u1edfng.<\/p>\n<p>V\u00ec c\u00e1c y\u00eau c\u1ea7u v\u1ec1 \u0111\u1ed9 s\u1ea1ch \u0111\u1ed1i v\u1edbi ph\u00f2ng th\u00ed nghi\u1ec7m QC v\u00e0 th\u1eed nghi\u1ec7m \u00edt nghi\u00eam ng\u1eb7t h\u01a1n \u0111\u1ed1i v\u1edbi c\u00e1c khu v\u1ef1c s\u1ea3n xu\u1ea5t, n\u00ean th\u1ef1c t\u1ebf c\u00f3 th\u1ec3 t\u00e1ch ri\u00eang c\u00e1c ph\u00f2ng n\u00e0y b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng passbox ho\u1eb7c c\u1eeda s\u1ed5 th\u00f4ng nhau \u0111\u1ec3 v\u1eadn chuy\u1ec3n c\u00e1c m\u1eabu th\u1eed nghi\u1ec7m. C\u00e1c khu v\u1ef1c ti\u1ebfp c\u1eadn v\u00e0 l\u1ea5y m\u1eabu c\u0169ng c\u00f3 th\u1ec3 t\u00e1ch bi\u1ec7t v\u1edbi c\u00e1c khu v\u1ef1c x\u1eed l\u00fd b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng c\u00f9ng m\u1ed9t thi\u1ebft k\u1ebf passbox.<\/p>\n<p>C\u00f3 th\u1ec3 c\u1ea7n m\u1ed9t khu v\u1ef1c s\u1ea3n xu\u1ea5t b\u1ed5 sung ho\u1eb7c ri\u00eang bi\u1ec7t \u0111\u1ec3 x\u1eed l\u00fd m\u1eabu t\u1eeb nh\u1eefng b\u1ec7nh nh\u00e2n ho\u1eb7c ng\u01b0\u1eddi hi\u1ebfn t\u1eb7ng c\u00f3 nguy c\u01a1 cao ho\u1eb7c c\u00f3 k\u1ebft qu\u1ea3 x\u00e9t nghi\u1ec7m huy\u1ebft thanh d\u01b0\u01a1ng t\u00ednh. C\u00e1c khu v\u1ef1c nh\u01b0 v\u1eady n\u00ean \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf nh\u01b0 khu v\u1ef1c nguy c\u01a1 v\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c t\u00e1ch ri\u00eang bi\u1ec7t, bao g\u1ed3m c\u1ea3 vi\u1ec7c l\u1eafp \u0111\u1eb7t h\u1ec7 th\u1ed1ng HVAC \u0111\u1ed9c l\u1eadp v\u1edbi 100% kh\u00ed th\u1ea3i. T\u1ed1t nh\u1ea5t, nh\u00e2n vi\u00ean \u0111i v\u00e0o c\u00e1c khu v\u1ef1c n\u00e0y c\u1ee7a c\u01a1 s\u1edf kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p v\u00e0o c\u00e1c khu v\u1ef1c s\u1ea3n xu\u1ea5t kh\u00e1c trong c\u00f9ng m\u1ed9t ng\u00e0y, v\u00e0 y\u00eau c\u1ea7u trang b\u1ecb l\u1ea1i qu\u1ea7n \u00e1o b\u1ea3o h\u1ed9 c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Cac_yeu_cau_doi_voi_khu_vuc_ho_tro_san_xuat_te_bao_tri_lieu\"><\/span><strong>C\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi khu v\u1ef1c h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t&nbsp;t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>C\u1ea7n xem x\u00e9t c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m trung t\u00e2m ho\u1ea1t \u0111\u1ed9ng ho\u1eb7c khu v\u1ef1c h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t l\u00e0 kh\u00f4ng gian s\u1ea1ch \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t. M\u1ed9t c\u00e1ch \u0111\u1ec3 th\u1ef1c hi\u1ec7n \u0111i\u1ec1u n\u00e0y l\u00e0 b\u1ed1 tr\u00ed c\u00e1c khu v\u1ef1c ph\u00f2ng s\u1ea1ch ISO 8 th\u00edch h\u1ee3p (h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t ho\u1eb7c ph\u00f2ng th\u00ed nghi\u1ec7m) bao quanh ho\u1eb7c li\u1ec1n k\u1ec1 v\u1edbi c\u00e1c khu v\u1ef1c s\u1ea3n xu\u1ea5t ISO 7 c\u00f3 BSCs ISO 5 (\u0111\u1ed1i v\u1edbi c\u00e1c quy tr\u00ecnh m\u1edf) trong khu v\u1ef1c ISO 7. Vi\u1ec7c ra v\u00e0o khu v\u1ef1c h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t n\u00ean h\u1ea1n ch\u1ebf \u0111\u1ed1i v\u1edbi nh\u00e2n vi\u00ean \u0111\u01b0\u1ee3c ph\u00e9p ti\u1ebfp c\u1eadn kh\u00f4ng gian s\u1ea3n xu\u1ea5t.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Cac_yeu_cau_doi_voi_phong_thi_nghiem_QC_va_phong_thi_nghiem_vi_sinh\"><\/span><strong>C\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi&nbsp;ph\u00f2ng th\u00ed nghi\u1ec7m QC v\u00e0 ph\u00f2ng th\u00ed nghi\u1ec7m vi sinh<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>T\u00f9y thu\u1ed9c v\u00e0o m\u1ee9c \u0111\u1ed9 nguy hi\u1ec3m c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c th\u1eed nghi\u1ec7m, kh\u00f4ng gian ph\u00f2ng th\u00ed nghi\u1ec7m QC v\u00e0 vi sinh c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c v\u1eadn h\u00e0nh nh\u01b0 kh\u00f4ng gian s\u1ea1ch \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t v\u00e0 duy tr\u00ec \u1edf m\u1ee9c ch\u00eanh l\u1ec7ch \u00e1p su\u1ea5t d\u01b0\u01a1ng ho\u1eb7c \u00e2m th\u00edch h\u1ee3p v\u1edbi ph\u00f2ng th\u00ed nghi\u1ec7m v\u00e0 kh\u00f4ng gian v\u0103n ph\u00f2ng xung quanh. C\u00e1c y\u1ebfu t\u1ed1 sau \u0111\u00e2y c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t khi thi\u1ebft k\u1ebf ph\u00f2ng lab QC v\u00e0 vi sinh l\u00e0 th\u00e0nh ph\u1ea7n c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u:<\/p>\n<ul>\n<li>Ph\u00f2ng th\u00ed nghi\u1ec7m QC v\u00e0 vi sinh ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 h\u1ed7 tr\u1ee3 c\u00e1c y\u00eau c\u1ea7u th\u1eed nghi\u1ec7m trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 xu\u1ea5t x\u01b0\u1edfng s\u1ea3n ph\u1ea9m hi\u1ec7n t\u1ea1i v\u00e0 t\u01b0\u01a1ng lai trong kh\u1ea3 n\u0103ng l\u00e0m vi\u1ec7c d\u1ef1 ki\u1ebfn.<\/li>\n<li><strong>N\u1ebfu x\u00e9t nghi\u1ec7m mycoplasma \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n, c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m QC ph\u1ea3i c\u00f3 m\u1ed9t kh\u00f4ng gian ri\u00eang bi\u1ec7t th\u00edch h\u1ee3p<\/strong> \u0111\u1ec3 th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m mycoplasma b\u1eb1ng ph\u1ea3n \u1ee9ng chu\u1ed7i polymerase (PCR).<\/li>\n<li>C\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m vi sinh ph\u1ea3i cung c\u1ea5p s\u1ef1 ph\u00e2n bi\u1ec7t th\u00edch h\u1ee3p cho c\u00e1c m\u1eabu ph\u00e2n t\u00edch \u0111\u1ed9 v\u00f4 tr\u00f9ng t\u1eeb c\u00e1c kh\u00f4ng gian l\u00e0m vi\u1ec7c ph\u00e2n t\u00edch ho\u1eb7c vi sinh kh\u00e1c. Quy \u0111\u1ecbnh n\u00e0y th\u01b0\u1eddng bao g\u1ed3m vi\u1ec7c c\u00f3 c\u00e1c khu v\u1ef1c \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i \u0111\u1ec3 ki\u1ec3m tra \u0111\u1ed9 v\u00f4 tr\u00f9ng.<\/li>\n<li>Ph\u00f2ng th\u00ed nghi\u1ec7m QC ph\u1ea3i c\u00f3 kh\u00f4ng gian d\u00e0nh ri\u00eang cho vi\u1ec7c ti\u1ebfp c\u1eadn nguy\u00ean li\u1ec7u th\u00f4 nh\u1eadp v\u00e0o v\u00e0 xu\u1ea5t x\u01b0\u1edfng (l\u01b0u gi\u1eef v\u00e0 v\u1eadn chuy\u1ec3n) c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t cu\u1ed1i c\u00f9ng.<\/li>\n<li>Ph\u00f2ng lab QC n\u00ean bao g\u1ed3m vi\u1ec7c ki\u1ec3m so\u00e1t v\u00e0 \u0111i\u1ec1u ch\u1ec9nh nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m.<\/li>\n<li>C\u1ea7n c\u00f3 c\u00e1c quy \u0111\u1ecbnh th\u00edch h\u1ee3p cho QC v\u00e0 c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m vi sinh \u0111\u1ec3 ti\u1ebfn h\u00e0nh c\u00e1c ho\u1ea1t \u0111\u1ed9ng gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng.<\/li>\n<li>C\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m QC v\u00e0 vi sinh ph\u1ea3i c\u00f3 quy m\u00f4 ph\u00f9 h\u1ee3p v\u1edbi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng theo c\u00e1c y\u00eau c\u1ea7u c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ho\u1eb7c th\u1eed nghi\u1ec7m trong c\u01a1 s\u1edf.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Co_so_ha_tang_cong_nghe_thong_tin\"><\/span><strong>C\u01a1 s\u1edf h\u1ea1 t\u1ea7ng c\u00f4ng ngh\u1ec7 th\u00f4ng tin<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>C\u1ea7n xem x\u00e9t vi\u1ec7c tin h\u1ecdc h\u00f3a c\u00e1c ho\u1ea1t \u0111\u1ed9ng trong l\u0129nh v\u1ef1c QC, v\u1eadt li\u1ec7u, s\u1ea3n xu\u1ea5t v\u00e0 vi sinh hi\u1ec7n t\u1ea1i ho\u1eb7c trong t\u01b0\u01a1ng lai. Thi\u1ebft b\u1ecb \u0111o \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c li\u00ean k\u1ebft v\u1edbi t\u1eebng m\u00e1y ch\u1ee7 v\u00e0 \u0111\u01b0\u1ee3c t\u00edch h\u1ee3p v\u1edbi t\u1eebng ph\u1ea7n c\u1ee7a thi\u1ebft b\u1ecb tr\u00ean giao di\u1ec7n \u0111i\u1ec7n t\u1eed c\u00f3 s\u1eb5n. Ngo\u00e0i ra, m\u1ed7i thi\u1ebft b\u1ecb n\u00e0y c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c trang b\u1ecb kh\u1ea3 n\u0103ng \u0111\u1ecdc m\u00e3 v\u1ea1ch \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh c\u00e1c m\u1eabu v\u00e0 kh\u1edbp v\u1edbi ngu\u1ed3n g\u1ed1c c\u1ee7a ch\u00fang. <strong>M\u00e3 v\u1ea1ch r\u1ea5t h\u1eefu \u00edch trong vi\u1ec7c gi\u1ea3m l\u1ed7i v\u00e0 t\u1ea1o ra hi\u1ec7u qu\u1ea3 trong c\u00e1c ho\u1ea1t \u0111\u1ed9ng v\u1edbi th\u00f4ng l\u01b0\u1ee3ng cao<\/strong>. T\u00f9y thu\u1ed9c v\u00e0o m\u1ee9c \u0111\u1ed9 ph\u00e1t tri\u1ec3n c\u1ee7a h\u1ed3 s\u01a1 \u0111i\u1ec7n t\u1eed, d\u1eef li\u1ec7u ph\u00e2n t\u00edch m\u1eabu c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c t\u1ea3i l\u00ean c\u01a1 s\u1edf d\u1eef li\u1ec7u, \u0111i\u1ec1u n\u00e0y s\u1ebd gi\u1ea3m nhu c\u1ea7u t\u00ednh to\u00e1n v\u00e0 th\u1ee7 t\u1ee5c gi\u1ea5y t\u1edd. <strong>Ph\u1ea7n m\u1ec1m<\/strong> \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho b\u1ea5t k\u1ef3 ph\u1ea7n n\u00e0o c\u1ee7a qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c th\u1ef1c ho\u1eb7c x\u00e1c nh\u1eadn. X\u00e1c th\u1ef1c ph\u1ea7n m\u1ec1m v\u00e0 m\u00e1y t\u00ednh s\u1ebd \u0111\u01b0\u1ee3c th\u1ea3o lu\u1eadn sau trong ph\u1ea7n n\u00e0y.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Cac_yeu_cau_ve_may_moc_va_su_dung\"><\/span><strong>C\u00e1c y\u00eau c\u1ea7u v\u1ec1 m\u00e1y m\u00f3c v\u00e0 s\u1eed d\u1ee5ng<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>C\u00e1c h\u1ec7 th\u1ed1ng b\u00e1o \u0111\u1ed9ng, b\u1ea3o tr\u00ec v\u00e0 gi\u00e1m s\u00e1t cho c\u01a1 s\u1edf v\u00e0 thi\u1ebft b\u1ecb<\/strong><\/p>\n<p>C\u1ea7n c\u00e2n nh\u1eafc l\u1ef1a ch\u1ecdn h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd t\u00f2a nh\u00e0 t\u1ef1 \u0111\u1ed9ng k\u1ebft h\u1ee3p c\u00e1c ch\u1ee9c n\u0103ng \u0111i\u1ec1u khi\u1ec3n, gi\u00e1m s\u00e1t v\u00e0 c\u1ea3nh b\u00e1o. T\u1ed1i thi\u1ec3u, m\u1ed9t h\u1ec7 th\u1ed1ng gi\u00e1m s\u00e1t c\u1ea3nh b\u00e1o th\u00edch h\u1ee3p v\u1edbi kh\u1ea3 n\u0103ng g\u1ecdi ra ph\u1ea3i \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t cho c\u00e1c thi\u1ebft b\u1ecb quan tr\u1ecdng. C\u01a1 s\u1edf, thi\u1ebft b\u1ecb v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng ph\u1ea3i \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong m\u1ed9t k\u1ebf ho\u1ea1ch t\u1ed5ng th\u1ec3 v\u1ec1 thi\u1ebft b\u1ecb. Thi\u1ebft b\u1ecb v\u00e0 h\u1ec7 th\u1ed1ng HVAC (h\u1ec7 th\u1ed1ng \u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed) ph\u1ea3i tu\u00e2n theo m\u1ee9c IQ, OQ ho\u1eb7c PQ th\u00edch h\u1ee3p \u0111\u1ec3 \u0111\u00e1p \u1ee9ng ho\u1eb7c v\u01b0\u1ee3t qu\u00e1 c\u00e1c ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t s\u1ea3n ph\u1ea9m. C\u1ea7n xem x\u00e9t y\u00eau c\u1ea7u IQ c\u1ee7a t\u1eebng ph\u1ea7n thi\u1ebft b\u1ecb \u0111\u1ed1i v\u1edbi kh\u00f4ng gian, ti\u1ec7n \u00edch v\u00e0 gi\u00e1m s\u00e1t. <strong>Trong tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u00f3 b\u1ed9 ph\u1eadn \u0111o l\u01b0\u1eddng chuy\u00ean d\u1ee5ng, c\u00f4ng ty ph\u1ea3i \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n v\u00e0 thu\u00ea m\u1ed9t nh\u00e0 th\u1ea7u ph\u1ee5 \u0111\u1ec3 qu\u1ea3n l\u00fd c\u00e1c nhu c\u1ea7u hi\u1ec7u chu\u1ea9n v\u00e0 b\u1ea3o tr\u00ec ph\u00f2ng ng\u1eeba \u0111\u1ecbnh k\u1ef3 c\u1ee7a c\u01a1 s\u1edf<\/strong>. N\u00ean d\u1ef1 ph\u00f2ng thi\u1ebft b\u1ecb v\u00e0 h\u1ed7 tr\u1ee3 b\u1edfi m\u00e1y ph\u00e1t \u0111i\u1ec7n d\u1ef1 ph\u00f2ng kh\u1ea9n c\u1ea5p \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o kh\u1ea3 n\u0103ng x\u1eed l\u00fd kh\u00f4ng b\u1ecb gi\u00e1n \u0111o\u1ea1n.<\/p>\n<p><strong>Kh\u00ed n\u00e9n<\/strong><\/p>\n<p>C\u01a1 s\u1edf c\u00f3 th\u1ec3 c\u1ea7n CO2, nit\u01a1 l\u1ecfng v\u00e0 kh\u00ed n\u00e9n c\u1ea5p y t\u1ebf, v\u1edbi c\u00e1c h\u1ec7 th\u1ed1ng d\u1ef1 ph\u00f2ng th\u00edch h\u1ee3p. C\u1ea7n c\u00f3 \u0111\u1ee7 kh\u00f4ng gian trong c\u00e1c khu v\u1ef1c m\u00e1y m\u00f3c c\u1ee7a t\u00f2a nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ec3 l\u01b0u tr\u1eef v\u00e0 v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng kh\u00ed y t\u1ebf, bao g\u1ed3m h\u1ec7 th\u1ed1ng chuy\u1ec3n \u0111\u1ed5i b\u00ecnh , gi\u00e1m s\u00e1t v\u00e0 c\u1ea3nh b\u00e1o t\u1ef1 \u0111\u1ed9ng, theo y\u00eau c\u1ea7u. \u01afu ti\u00ean thi\u1ebft k\u1ebf s\u1eed d\u1ee5ng b\u00ecnh c\u1ea5p kh\u00ed n\u00e9n trung t\u00e2m b\u00ean ngo\u00e0i khu v\u1ef1c s\u1ea3n xu\u1ea5t. Kh\u00f4ng n\u00ean \u0111\u1eb7t b\u00ecnh c\u1ea5p kh\u00ed n\u00e9n trong khu v\u1ef1c \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ho\u1eb7c \u0111\u01b0\u1ee3c ph\u00e2n c\u1ea5p \u0111\u1ed9 s\u1ea1ch.<\/p>\n<p><strong>Nit\u01a1 l\u1ecfng<\/strong><\/p>\n<p>C\u1ea7n xem x\u00e9t nhu c\u1ea7u l\u01b0u tr\u1eef nit\u01a1 l\u1ecfng v\u00e0 cung c\u1ea5p kho ch\u1ee9a ph\u00f9 h\u1ee3p v\u1edbi b\u1ed1 tr\u00ed v\u00e0 y\u00eau c\u1ea7u c\u1ee7a c\u01a1 s\u1edf. Nit\u01a1 l\u1ecfng th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 l\u01b0u tr\u1eef c\u00e1c s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u&nbsp;b\u1ea3o qu\u1ea3n l\u1ea1nh. Thi\u1ebft k\u1ebf c\u00e1c ph\u00f2ng c\u00f3 b\u00ecnh nit\u01a1 l\u1ecfng ch\u1ee9a m\u1eabu c\u1ea7n c\u00f3 m\u1ed9t \u0111i\u1ec1u kho\u1ea3n v\u1ec1 c\u1ea3nh b\u00e1o oxy th\u1ea5p. C\u00e1c b\u1ec3 ch\u1ee9a nit\u01a1 k\u00edn ph\u1ea3i c\u00f3 h\u1ec7 th\u1ed1ng ph\u00e2n ph\u1ed1i th\u00edch h\u1ee3p v\u1edbi s\u1ef1 gi\u00e1m s\u00e1t. C\u00e1c thi\u1ebft k\u1ebf s\u1eed d\u1ee5ng b\u00ecnh c\u1ea5p nit\u01a1 l\u1ecfng trung t\u00e2m b\u00ean ngo\u00e0i khu v\u1ef1c s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c \u01b0u ti\u00ean. Kh\u00f4ng n\u00ean \u0111\u1eb7t b\u00ecnh c\u1ea5p nit\u01a1 l\u1ecfng trong khu v\u1ef1c \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ho\u1eb7c \u0111\u01b0\u1ee3c ph\u00e2n c\u1ea5p \u0111\u1ed9 s\u1ea1ch.<\/p>\n<p><strong>H\u1ec7 th\u1ed1ng \u0111i\u1ec7n d\u1ef1 ph\u00f2ng kh\u1ea9n c\u1ea5p<\/strong><\/p>\n<p>H\u1ec7 th\u1ed1ng cung c\u1ea5p \u0111i\u1ec7n li\u00ean t\u1ee5c kh\u1ea9n c\u1ea5p (UPS) v\u00e0 h\u1ec7 th\u1ed1ng ph\u00e1t \u0111i\u1ec7n c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t \u0111\u1ec3 duy tr\u00ec ho\u1ea1t \u0111\u1ed9ng c\u1ee7a c\u00e1c h\u1ec7 th\u1ed1ng th\u00edch h\u1ee3p trong t\u1ea5t c\u1ea3 c\u00e1c l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00e0 h\u1ed7 tr\u1ee3. M\u00e1y ph\u00e1t \u0111i\u1ec7n kh\u1ea9n c\u1ea5p ph\u1ea3i t\u1ef1 \u0111\u1ed9ng cung c\u1ea5p \u0111i\u1ec7n trong tr\u01b0\u1eddng h\u1ee3p m\u1ea5t \u0111i\u1ec7n v\u00e0 ngu\u1ed3n \u0111i\u1ec7n ph\u1ea3i \u0111\u01b0\u1ee3c kh\u00f4i ph\u1ee5c trong kho\u1ea3ng th\u1eddi gian th\u00edch h\u1ee3p v\u1edbi dung sai s\u1ea3n xu\u1ea5t v\u00e0 m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c x\u1eed l\u00fd trong c\u01a1 s\u1edf.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Yeu_cau_ve_nha_kho\"><\/span><strong>Y\u00eau c\u1ea7u v\u1ec1 nh\u00e0 kho<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Nh\u00e0 kho ph\u1ea3i c\u00f3 c\u00e1c thu\u1ed9c t\u00ednh v\u00e0 ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng th\u00edch h\u1ee3p \u0111\u1ed1i v\u1edbi c\u00e1c lo\u1ea1i nguy\u00ean li\u1ec7u \u0111\u01b0\u1ee3c l\u01b0u tr\u1eef v\u00e0 <strong>ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u cGMP th\u00edch h\u1ee3p<\/strong> \u0111\u1ed1i v\u1edbi h\u00e0ng t\u1ed3n kho \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m d\u1ecbch v\u00e0 lo\u1ea1i b\u1ecf. N\u00f3 ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t v\u1ec1 m\u1eb7t m\u00f4i tr\u01b0\u1eddng \u0111\u1ec3 ng\u0103n ng\u1eeba h\u01b0 h\u1ecfng v\u00e0 xu\u1ed1ng c\u1ea5p \u0111\u1ed1i v\u1edbi c\u00e1c m\u1eb7t h\u00e0ng c\u1ea7n \u0111\u01b0\u1ee3c b\u1ea3o qu\u1ea3n \u1edf nhi\u1ec7t \u0111\u1ed9 ph\u00f2ng, v\u00e0 n\u00f3 ph\u1ea3i c\u00f3 c\u00e1c khu v\u1ef1c l\u01b0u tr\u1eef v\u1eadt li\u1ec7u an to\u00e0n ngo\u00e0i s\u00e0n nh\u00e0. C\u1ea7n h\u1ea1n ch\u1ebf ti\u1ebfp c\u1eadn t\u1ea5t c\u1ea3 c\u00e1c khu v\u1ef1c c\u00e1ch ly v\u00e0 b\u1ea3o qu\u1ea3n. Nh\u00e0 kho c\u1ea7n c\u00f3 bi\u1ec3n b\u00e1o GMP r\u00f5 r\u00e0ng cho t\u1ea5t c\u1ea3 c\u00e1c khu v\u1ef1c ch\u1ee9a nguy\u00ean li\u1ec7u.<\/p>\n<p>C\u1ea7n cung c\u1ea5p kho l\u01b0u tr\u1eef cho c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m xu\u1ea5t x\u01b0\u1edfng \u0111\u00e3 qua ki\u1ec3m d\u1ecbch c\u00f3 nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t v\u00e0 gi\u00e1m s\u00e1t th\u00edch h\u1ee3p. Khu v\u1ef1c \u1ed1ng ch\u00e2n v\u00e0 khu v\u1ef1c ti\u1ebfp nh\u1eadn (S\/R) ph\u1ea3i \u0111\u00e1nh s\u1ed1 th\u1ee9 t\u1ef1 v\u00e0 ph\u00e2n lo\u1ea1i kho ch\u1ee9a h\u00e0ng \u0111\u1ec3 nh\u1eadn nguy\u00ean li\u1ec7u th\u00f4 v\u00e0 b\u00ecnh kh\u00ed t\u1eeb c\u00e1c ph\u01b0\u01a1ng ti\u1ec7n th\u01b0\u01a1ng m\u1ea1i. C\u00e1c khu v\u1ef1c S\/R ph\u1ea3i cung c\u1ea5p \u0111\u1ee7 kh\u00f4ng gian \u0111\u1ec3 s\u1eafp x\u1ebfp, v\u1eadn chuy\u1ec3n v\u00e0 nh\u1eadn v\u1eadt li\u1ec7u, t\u1eeb c\u00e1c h\u1ed9p ri\u00eang l\u1ebb \u0111\u1ebfn c\u00e1c pallet \u0111\u1ea7y \u0111\u1ee7. C\u1ea7n xem x\u00e9t vi\u1ec7c ph\u00e2n t\u00e1ch v\u00e0 ki\u1ec3m so\u00e1t c\u00e1c v\u1eadt li\u1ec7u t\u1ebf b\u00e0o m\u1edbi thu th\u1eadp v\u00e0 l\u1ea5y s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng. <strong>C\u1ea7n xem x\u00e9t c\u00e1c khu v\u1ef1c b\u1ea3o qu\u1ea3n th\u00edch h\u1ee3p cho b\u00ecnh chuy\u1ec3n s\u1ea3n ph\u1ea9m kh\u00f4 b\u1eb1ng nit\u01a1 l\u1ecfng, n\u1ebfu s\u1eed d\u1ee5ng<\/strong>.<\/p>\n<p>T\u1ea5t c\u1ea3 c\u00e1c y\u1ebfu t\u1ed1 \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong ch\u01b0\u01a1ng n\u00e0y \u0111\u1ec1u r\u1ea5t quan tr\u1ecdng \u0111\u1ed1i v\u1edbi vi\u1ec7c thi\u1ebft k\u1ebf v\u00e0 v\u1eadn h\u00e0nh m\u1ed9t c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o theo chu\u1ea9n GMP, v\u00e0 nhi\u1ec1u y\u1ebfu t\u1ed1 trong s\u1ed1 n\u00e0y c\u0169ng \u00e1p d\u1ee5ng cho c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ebf t\u00e1c t\u1ed1i thi\u1ec3u (t\u1ee9c l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng c\u00e1ch tu\u00e2n theo c\u00e1c quy tr\u00ecnh th\u1ef1c h\u00e0nh t\u1ed1t). Ph\u1ea7n c\u00f2n l\u1ea1i c\u1ee7a ph\u1ea7n n\u00e0y m\u00f4 t\u1ea3 c\u00e1c h\u1ec7 th\u1ed1ng v\u00e0 quy tr\u00ecnh \u0111\u1ec3 ph\u00e1t tri\u1ec3n v\u00e0 v\u1eadn h\u00e0nh m\u1ed9t c\u01a1 s\u1edf CT ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Tai_lieu_tham_khao\"><\/span><strong>T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ol>\n<li><i>Cellular Therapy: Principles, Methods, and Regulations, 2nd edition.<\/i><\/li>\n<li><i>H\u01b0\u1edbng d\u1eabn nghi\u00ean c\u1ee9u \u1ee9ng d\u1ee5ng t\u1ebf b\u00e0o v\u00e0 s\u1ea3n ph\u1ea9m t\u1eeb t\u1ebf b\u00e0o t\u1ea1i Vi\u1ec7t Nam. Quy\u1ebft \u0111\u1ecbnh s\u1ed1 4259\/Q\u0110-BYT ng\u00e0y 12\/10\/2020 c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf<\/i><\/li>\n<\/ol>\n","protected":false},"featured_media":5853,"parent":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-4366","service","type-service","status-publish","has-post-thumbnail","hentry","service-category-huong-dan-quan-ly-thiet-bi"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nh\u1eefng C\u00e2n Nh\u1eafc &amp; Quy Tr\u00ecnh C\u01a1 B\u1ea3n Khi X\u00e2y D\u1ef1ng Trung T\u00e2m Li\u1ec7u Ph\u00e1p T\u1ebf B\u00e0o<\/title>\n<meta name=\"description\" content=\"C\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y r\u1ea5t quan tr\u1ecdng trong vi\u1ec7c thi\u1ebft k\u1ebf v\u00e0 v\u1eadn h\u00e0nh c\u00e1c trung t\u00e2m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, \u0111\u1eb7c bi\u1ec7t l\u00e0 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