{"id":9178,"date":"2026-02-10T07:25:02","date_gmt":"2026-02-10T07:25:02","guid":{"rendered":"https:\/\/sepro.vn\/?p=9178"},"modified":"2026-02-10T07:25:02","modified_gmt":"2026-02-10T07:25:02","slug":"dieu-kien-de-nha-may-dat-chung-nhan-gmp-eu","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/dieu-kien-de-nha-may-dat-chung-nhan-gmp-eu\/","title":{"rendered":"\u0110i\u1ec1u Ki\u1ec7n \u0110\u1ec3 Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Vi\u1ec7c \u0111\u1ea1t \u0111\u01b0\u1ee3c <strong><a href=\"https:\/\/sepro.vn\/dieu-kien-de-nha-may-dat-chung-nhan-gmp-eu\/\">ch\u1ee9ng nh\u1eadn GMP EU<\/a><\/strong> kh\u00f4ng d\u1eebng \u1edf vi\u1ec7c nh\u00e0 x\u01b0\u1edfng \u0111\u1ea1t chu\u1ea9n hay t\u00e0i li\u1ec7u \u0111\u1ea7y \u0111\u1ee7. \u0110i\u1ec1u quan tr\u1ecdng l\u00e0 b\u1ea1n ph\u1ea3i ch\u1ee9ng minh h\u1ec7 th\u1ed1ng nh\u00e0 m\u00e1y c\u00f3 s\u1ef1 ki\u1ec3m so\u00e1t, ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh theo th\u1eddi gian, c\u00e1c kh\u00e2u tr\u1ecdng y\u1ebfu \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh ph\u00f9 h\u1ee3p v\u00e0 m\u1ecdi d\u1eef li\u1ec7u li\u00ean quan \u0111\u1ec1u \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t t\u1ed1t v\u00e0 \u0111\u1ed9 tin c\u1eady cao.<\/span><\/p>\n<h2><b>GMP EU L\u00e0 G\u00ec V\u00e0 Ch\u1ee9ng Nh\u1eadn GMP EU C\u00f3 \u00dd Ngh\u0129a Th\u1ebf N\u00e0o<\/b><\/h2>\n<figure id=\"attachment_9181\" aria-describedby=\"caption-attachment-9181\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9181\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-3.png\" alt=\"eu-gmp\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-3.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-3-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-3-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-3-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9181\" class=\"wp-caption-text\"><em>GMP EU<\/em><\/figcaption><\/figure>\n<p><a href=\"https:\/\/sepro.vn\/gmp-eu-la-gi\/\"><b>GMP EU<\/b><\/a><span style=\"font-weight: 400;\"> l\u00e0 b\u1ed9 h\u01b0\u1edbng d\u1eabn Th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t do EU (Li\u00ean minh Ch\u00e2u \u00c2u) ban h\u00e0nh trong EudraLex Volume 4, d\u00f9ng \u0111\u1ec3 di\u1ec5n gi\u1ea3i c\u00e1c nguy\u00ean t\u1eafc d\u00f9ng thu\u1ed1c cho ng\u01b0\u1eddi v\u00e0 \u0111\u1ed9ng v\u1eadt, \u00e1p d\u1ee5ng cho c\u01a1 s\u1edf cung \u1ee9ng thu\u1ed1c v\u00e0o th\u1ecb tr\u01b0\u1eddng EU, k\u1ec3 c\u1ea3 nh\u00e0 m\u00e1y n\u1eb1m ngo\u00e0i EU.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ch\u1ee9ng nh\u1eadn GMP EU th\u01b0\u1eddng l\u00e0 k\u1ebft qu\u1ea3 thanh tra \u00e1p d\u1ee5ng cho m\u1ed9t c\u01a1 s\u1edf c\u1ee5 th\u1ec3 v\u00e0 m\u1ed9t ph\u1ea1m vi ho\u1ea1t \u0111\u1ed9ng x\u00e1c \u0111\u1ecbnh, ch\u1eb3ng h\u1ea1n s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i, ki\u1ec3m nghi\u1ec7m ho\u1eb7c m\u1ed9t nh\u00f3m d\u1ea1ng b\u00e0o ch\u1ebf nh\u1ea5t \u0111\u1ecbnh. V\u00ec v\u1eady, \u0111\u00e2y kh\u00f4ng ph\u1ea3i ch\u1ee9ng ch\u1ec9 chung cho to\u00e0n doanh nghi\u1ec7p, m\u00e0 g\u1eafn tr\u1ef1c ti\u1ebfp v\u1edbi \u0111\u1ecba \u0111i\u1ec3m v\u00e0 ph\u1ea1m vi \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn trong h\u1ed3 s\u01a1.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 tra c\u1ee9u th\u00f4ng tin ch\u1ee9ng nh\u1eadn, EU c\u00f3 c\u01a1 s\u1edf d\u1eef li\u1ec7u EudraGMDP do <\/span><b><a href=\"https:\/\/sepro.vn\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/\">EMA<\/a> <\/b><span style=\"font-weight: 400;\">duy tr\u00ec. C\u01a1 s\u1edf d\u1eef li\u1ec7u n\u00e0y ch\u1ee9a th\u00f4ng tin v\u1ec1 gi\u1ea5y ph\u00e9p s\u1ea3n xu\u1ea5t\/nh\u1eadp kh\u1ea9u v\u00e0 ch\u1ee9ng ch\u1ec9 GMP\/GDP; phi\u00ean b\u1ea3n c\u00f4ng khai \u0111\u00e3 c\u00f3 t\u1eeb n\u0103m 2011. (<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/eudragmdp-database?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">European Medicines Agency (EMA)<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/p>\n<h2><b>\u0110i\u1ec1u Ki\u1ec7n C\u1ed1t L\u00f5i \u0110\u1ec3 Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU<\/b><\/h2>\n<figure id=\"attachment_9134\" aria-describedby=\"caption-attachment-9134\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9134\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6.png\" alt=\"cach-dat-chung-chi-gmp-eu\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/6-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9134\" class=\"wp-caption-text\"><em>C\u00e1ch \u0111\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c ch\u1ee9ng ch\u1ec9 GMP EU<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Ph\u1ea7n n\u00e0y tr\u1ea3 l\u1eddi th\u1eb3ng c\u00e2u h\u1ecfi \u0111i\u1ec1u ki\u1ec7n \u0111\u1ec3 \u0111\u1ea1t GMP EU g\u1ed3m nh\u1eefng g\u00ec. C\u00f3 th\u1ec3 hi\u1ec3u ng\u1eafn g\u1ecdn l\u00e0 5 nh\u00f3m \u0111i\u1ec1u ki\u1ec7n ph\u1ea3i \u0111\u1ed3ng th\u1eddi m\u1ea1nh v\u00e0 c\u00f3 b\u1eb1ng ch\u1ee9ng.<\/span><\/p>\n<h3><b>H\u1ec7 Th\u1ed1ng Ch\u1ea5t L\u01b0\u1ee3ng D\u01b0\u1ee3c Ph\u1ea9m V\u00e0 Qu\u1ea3n L\u00fd R\u1ee7i Ro<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">PQS l\u00e0 tr\u1ee5c s\u1ed1ng c\u1ee7a GMP EU. Nh\u00e0 m\u00e1y c\u1ea7n v\u1eadn h\u00e0nh th\u1eadt c\u00e1c c\u01a1 ch\u1ebf sau:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Qu\u1ea3n l\u00fd sai l\u1ec7ch (deviation): ph\u00e1t hi\u1ec7n, \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng, \u0111i\u1ec1u tra \u0111\u1ebfn nguy\u00ean nh\u00e2n g\u1ed1c<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CAPA: h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba, c\u00f3 theo d\u00f5i hi\u1ec7u l\u1ef1c<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ki\u1ec3m so\u00e1t thay \u0111\u1ed5i (change control): thay \u0111\u1ed5i c\u00f3 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng v\u00e0 ph\u00ea duy\u1ec7t tr\u01b0\u1edbc khi tri\u1ec3n khai<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u1ef1 thanh tra (self-inspection): ph\u00e1t hi\u1ec7n r\u1ee7i ro, gi\u00e1m s\u00e1t tu\u00e2n th\u1ee7, \u0111\u00f3ng vi\u1ec7c<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Qu\u1ea3n l\u00fd r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng (QRM): \u01b0u ti\u00ean ngu\u1ed3n l\u1ef1c cho \u0111i\u1ec3m \u1ea3nh h\u01b0\u1edfng l\u1edbn<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m t\u1ea1o kh\u00e1c bi\u1ec7t khi thanh tra l\u00e0 b\u1eb1ng ch\u1ee9ng: b\u1ea1n c\u00f3 h\u1ed3 s\u01a1 \u0111i\u1ec1u tra r\u00f5 r\u00e0ng, CAPA \u0111\u00f3ng d\u1ee9t \u0111i\u1ec3m, thay \u0111\u1ed5i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t, v\u00e0 h\u1ec7 th\u1ed1ng ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh theo th\u1eddi gian.<\/span><\/p>\n<h3><b>H\u1ec7 Th\u1ed1ng Ch\u1ea5t L\u01b0\u1ee3ng D\u01b0\u1ee3c Ph\u1ea9m V\u00e0 Qu\u1ea3n L\u00fd R\u1ee7i Ro<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng d\u01b0\u1ee3c ph\u1ea9m (PQS: Pharmaceutical Quality System) l\u00e0 tr\u1ee5c s\u1ed1ng c\u1ee7a GMP EU. Nh\u00e0 m\u00e1y c\u1ea7n v\u1eadn h\u00e0nh ch\u1eb7t ch\u1ebd cho c\u00e1c c\u01a1 ch\u1ebf sau:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Qu\u1ea3n l\u00fd sai l\u1ec7ch (deviation)<\/b><span style=\"font-weight: 400;\">: ph\u00e1t hi\u1ec7n, \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng, \u0111i\u1ec1u tra \u0111\u1ebfn nguy\u00ean nh\u00e2n g\u1ed1c.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>H\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba (CAPA: Corrective And Preventive Action)<\/b><span style=\"font-weight: 400;\">: x\u1eed l\u00fd nguy\u00ean nh\u00e2n, ng\u0103n t\u00e1i di\u1ec5n v\u00e0 theo d\u00f5i hi\u1ec7u l\u1ef1c.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Ki\u1ec3m so\u00e1t thay \u0111\u1ed5i<\/b><span style=\"font-weight: 400;\">: m\u1ecdi thay \u0111\u1ed5i ph\u1ea3i c\u00f3 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng v\u00e0 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t tr\u01b0\u1edbc khi tri\u1ec3n khai<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>T\u1ef1 thanh tra<\/b><span style=\"font-weight: 400;\">: ph\u00e1t hi\u1ec7n r\u1ee7i ro, gi\u00e1m s\u00e1t tu\u00e2n th\u1ee7 v\u00e0 theo d\u00f5i \u0111\u00f3ng vi\u1ec7c<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Qu\u1ea3n l\u00fd r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng (QRM: Quality Risk Management)<\/b><span style=\"font-weight: 400;\">: \u01b0u ti\u00ean ngu\u1ed3n l\u1ef1c cho c\u00e1c \u0111i\u1ec3m \u1ea3nh h\u01b0\u1edfng l\u1edbn \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m t\u1ea1o kh\u00e1c bi\u1ec7t khi thanh tra kh\u00f4ng n\u1eb1m \u1edf vi\u1ec7c b\u1ea1n c\u00f3 t\u00e0i li\u1ec7u hay kh\u00f4ng, m\u00e0 n\u1eb1m \u1edf b\u1eb1ng ch\u1ee9ng v\u1eadn h\u00e0nh: \u0111i\u1ec1u tra r\u00f5 r\u00e0ng, CAPA \u0111\u00f3ng d\u1ee9t \u0111i\u1ec3m v\u00e0 c\u00f3 hi\u1ec7u l\u1ef1c, thay \u0111\u1ed5i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t, h\u1ec7 th\u1ed1ng \u1ed5n \u0111\u1ecbnh theo th\u1eddi gian.<\/span><\/p>\n<h3><b>Nh\u00e0 X\u01b0\u1edfng, Thi\u1ebft B\u1ecb V\u00e0 C\u00e1c H\u1ec7 Th\u1ed1ng H\u1ea1 T\u1ea7ng Ph\u1ee5c V\u1ee5 S\u1ea3n Xu\u1ea5t, V\u1ec7 Sinh<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Nh\u00e0 x\u01b0\u1edfng v\u00e0 thi\u1ebft b\u1ecb c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 gi\u1ea3m nhi\u1ec5m b\u1ea9n ch\u00e9o v\u00e0 d\u1ec5 ki\u1ec3m so\u00e1t:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>B\u1ed1 tr\u00ed lu\u1ed3ng di chuy\u1ec3n r\u00f5 r\u00e0ng:<\/b><span style=\"font-weight: 400;\"> ng\u01b0\u1eddi, nguy\u00ean li\u1ec7u, b\u00e1n th\u00e0nh ph\u1ea9m, th\u00e0nh ph\u1ea9m v\u00e0 r\u00e1c th\u1ea3i \u0111i theo l\u1ed1i ri\u00eang ho\u1eb7c theo th\u1ee9 t\u1ef1 h\u1ee3p l\u00fd \u0111\u1ec3 gi\u1ea3m nguy c\u01a1 nhi\u1ec5m b\u1ea9n ch\u00e9o.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Ki\u1ec3m so\u00e1t c\u00e1c h\u1ec7 th\u1ed1ng h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t:<\/b><span style=\"font-weight: 400;\"> \u0111i\u1ec1u h\u00f2a v\u00e0 \u00e1p su\u1ea5t ph\u00f2ng (HVAC), n\u01b0\u1edbc s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t, kh\u00ed n\u00e9n v\u00e0 c\u00e1c ngu\u1ed3n c\u1ea5p li\u00ean quan ph\u1ea3i theo d\u00f5i, b\u1ea3o tr\u00ec v\u00e0 hi\u1ec7u chu\u1ea9n theo \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 lu\u00f4n ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang y\u00eau c\u1ea7u.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>V\u1ec7 sinh v\u00e0 kh\u1eed khu\u1ea9n c\u00f3 ki\u1ec3m so\u00e1t:<\/b><span style=\"font-weight: 400;\"> c\u00f3 k\u1ebf ho\u1ea1ch, c\u00f3 h\u00f3a ch\u1ea5t v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ph\u00f9 h\u1ee3p, c\u00f3 ghi nh\u1eadn \u0111\u1ea7y \u0111\u1ee7 v\u00e0 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u1ec7 sinh khi c\u1ea7n.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">V\u1edbi s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng, Annex 1 th\u01b0\u1eddng \u1ea3nh h\u01b0\u1edfng m\u1ea1nh \u0111\u1ebfn thi\u1ebft k\u1ebf v\u00e0 v\u1eadn h\u00e0nh v\u00ec t\u1eadp trung v\u00e0o chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p gi\u1ea3m r\u1ee7i ro.\u00a0<\/span><\/p>\n<h3><b>Ki\u1ec3m So\u00e1t S\u1ea3n Xu\u1ea5t V\u00e0 Ki\u1ec3m Nghi\u1ec7m Ch\u1ea5t L\u01b0\u1ee3ng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Thanh tra GMP EU th\u01b0\u1eddng \u0111i theo logic: b\u1ea1n ki\u1ec3m so\u00e1t qu\u00e1 tr\u00ecnh th\u1ebf n\u00e0o v\u00e0 b\u1ea1n ch\u1ee9ng minh ch\u1ea5t l\u01b0\u1ee3ng ra sao.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1ea3n xu\u1ea5t: ki\u1ec3m so\u00e1t c\u00f4ng \u0111o\u1ea1n tr\u1ecdng y\u1ebfu, in-process control, v\u1ec7 sinh thi\u1ebft b\u1ecb, ghi ch\u00e9p, ki\u1ec3m so\u00e1t h\u1ed3 s\u01a1 s\u1ea3n xu\u1ea5t.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">QC: qu\u1ea3n l\u00fd OOS (k\u1ebft qu\u1ea3 ngo\u00e0i ti\u00eau chu\u1ea9n) v\u00e0 OOT (xu h\u01b0\u1edbng b\u1ea5t th\u01b0\u1eddng), qu\u1ea3n l\u00fd m\u1eabu, chu\u1ea9n, thi\u1ebft b\u1ecb, d\u1eef li\u1ec7u.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Truy xu\u1ea5t \u0111\u01b0\u1ee3c \u0111\u1ea7y \u0111\u1ee7 t\u1eeb nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o \u0111\u1ebfn t\u1eebng l\u00f4 th\u00e0nh ph\u1ea9m v\u00e0 c\u00e1c d\u1eef li\u1ec7u ki\u1ec3m nghi\u1ec7m li\u00ean quan ph\u1ea3i li\u00ean k\u1ebft ch\u1eb7t ch\u1ebd v\u1edbi h\u1ed3 s\u01a1 l\u00f4 \u0111\u1ec3 ki\u1ec3m tra l\u1ea1i nhanh, r\u00f5 v\u00e0 kh\u00f4ng \u0111\u1ee9t g\u00e3y.<\/span><\/li>\n<\/ul>\n<h3><b>Con Ng\u01b0\u1eddi V\u00e0 N\u0103ng L\u1ef1c<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">GMP EU kh\u00f4ng coi con ng\u01b0\u1eddi l\u00e0 y\u1ebfu t\u1ed1 ph\u1ee5. Nh\u00e0 m\u00e1y c\u1ea7n:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">QA \u0111\u1ed9c l\u1eadp, tr\u00e1ch nhi\u1ec7m r\u00f5 r\u00e0ng gi\u1eefa QA, QC, s\u1ea3n xu\u1ea5t, k\u1ef9 thu\u1eadt<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u00e0o t\u1ea1o theo vai tr\u00f2 v\u00e0 c\u00f3 \u0111\u00e1nh gi\u00e1 n\u0103ng l\u1ef1c, kh\u00f4ng ch\u1ec9 k\u00fd x\u00e1c nh\u1eadn<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">K\u1ef7 lu\u1eadt thao t\u00e1c theo SOP, \u0111\u1eb7c bi\u1ec7t v\u1edbi thao t\u00e1c \u1ea3nh h\u01b0\u1edfng ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 d\u1eef li\u1ec7u<\/span><\/li>\n<\/ul>\n<h3><b>B\u1ea3o Qu\u1ea3n, V\u1eadn Chuy\u1ec3n V\u00e0 Chu\u1ed7i Cung \u1ee8ng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Chu\u1ed7i cung \u1ee9ng th\u01b0\u1eddng ti\u1ec1m \u1ea9n r\u1ee7i ro kh\u00f3 th\u1ea5y, n\u00ean nh\u00e0 m\u00e1y c\u1ea7n ki\u1ec3m so\u00e1t ch\u1eb7t \u1edf hai m\u1ea3ng ch\u00ednh:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Kho b\u1ea3o qu\u1ea3n<\/b><span style=\"font-weight: 400;\">: theo d\u00f5i \u0111i\u1ec1u ki\u1ec7n nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m, \u00e1p d\u1ee5ng xu\u1ea5t kho theo h\u1ea1n d\u00f9ng tr\u01b0\u1edbc, x\u1eed l\u00fd sai l\u1ec7ch k\u1ecbp th\u1eddi v\u00e0 c\u00e1ch ly h\u00e0ng khi c\u00f3 nghi ng\u1edd.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Nh\u00e0 cung c\u1ea5p v\u00e0 \u0111\u01a1n v\u1ecb gia c\u00f4ng<\/b><span style=\"font-weight: 400;\">: c\u00f3 th\u1ecfa thu\u1eadn ch\u1ea5t l\u01b0\u1ee3ng r\u00f5 r\u00e0ng, \u0111\u00e1nh gi\u00e1 \u0111\u1ecbnh k\u1ef3, theo d\u00f5i ch\u1ea5t l\u01b0\u1ee3ng cung \u1ee9ng v\u00e0 ki\u1ec3m so\u00e1t m\u1ecdi thay \u0111\u1ed5i t\u1eeb ph\u00eda \u0111\u1ed1i t\u00e1c \u0111\u1ec3 tr\u00e1nh \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ea3n ph\u1ea9m.<\/span><\/li>\n<\/ul>\n<h2><b>Th\u1ea9m \u0110\u1ecbnh V\u00e0 D\u1eef Li\u1ec7u L\u00e0 Nh\u00f3m B\u1eb1ng Ch\u1ee9ng Hay B\u1ecb H\u1ecfi S\u00e2u<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Nhi\u1ec1u nh\u00e0 m\u00e1y c\u00f3 Quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n (SOP hay Standard Procedure) \u0111\u1ea7y \u0111\u1ee7 nh\u01b0ng v\u1eabn g\u1eb7p r\u1ee7i ro \u1edf ch\u1ed7 kh\u00f4ng ch\u1ee9ng minh \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t. Hai nh\u00f3m b\u1eb1ng ch\u1ee9ng hay b\u1ecb h\u1ecfi s\u00e2u l\u00e0 th\u1ea9m \u0111\u1ecbnh v\u00e0 d\u1eef li\u1ec7u.<\/span><\/p>\n<h2><b>Th\u1ea9m \u0110\u1ecbnh Theo V\u00f2ng \u0110\u1eddi V\u00e0 Ti\u00eau Ch\u00ed Ch\u1ea5p Nh\u1eadn R\u00f5 R\u00e0ng<\/b><\/h2>\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/2015-10_annex15_0.pdf\" target=\"_blank\" rel=\"noopener\"><b>Annex 15<\/b><\/a><span style=\"font-weight: 400;\"> n\u00f3i v\u1ec1 th\u1ea9m \u0111\u1ecbnh theo v\u00f2ng \u0111\u1eddi, ngh\u0129a l\u00e0 nh\u00e0 m\u00e1y ph\u1ea3i ch\u1ee9ng minh thi\u1ebft b\u1ecb, h\u1ec7 th\u1ed1ng v\u00e0 quy tr\u00ecnh \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m tra v\u00e0 x\u00e1c nh\u1eadn ph\u00f9 h\u1ee3p t\u1eeb l\u00fac thi\u1ebft k\u1ebf cho t\u1edbi khi v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh. C\u00f3 th\u1ec3 hi\u1ec3u r\u1eb1ng, khi thanh tra b\u1ea1n c\u1ea7n c\u00f3 b\u1eb1ng ch\u1ee9ng r\u00f5 r\u00e0ng r\u1eb1ng:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Thi\u1ebft b\u1ecb v\u00e0 h\u1ec7 th\u1ed1ng \u0111\u01b0\u1ee3c ki\u1ec3m tra theo t\u1eebng b\u01b0\u1edbc: x\u00e1c nh\u1eadn y\u00eau c\u1ea7u, ki\u1ec3m tra \u0111\u00fang thi\u1ebft k\u1ebf, l\u1eafp \u0111\u1eb7t \u0111\u00fang, ch\u1ea1y th\u1eed \u0111\u00fang, v\u00e0 ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh theo ti\u00eau ch\u00ed \u0111\u00e3 \u0111\u1eb7t ra.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 v\u1ec7 sinh \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh b\u00e0i b\u1ea3n: c\u00f3 k\u1ebf ho\u1ea1ch, c\u00f3 ti\u00eau ch\u00ed \u0111\u1ea1t ho\u1eb7c kh\u00f4ng \u0111\u1ea1t, c\u00f3 b\u00e1o c\u00e1o k\u1ebft qu\u1ea3, v\u00e0 n\u1ebfu c\u00f3 v\u1ea5n \u0111\u1ec1 th\u00ec ph\u1ea3i c\u00f3 h\u1ed3 s\u01a1 x\u1eed l\u00fd r\u00f5 r\u00e0ng.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u1ecdi thay \u0111\u1ed5i c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ec1u \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng v\u00e0 c\u1eadp nh\u1eadt l\u1ea1i h\u1ed3 s\u01a1 th\u1ea9m \u0111\u1ecbnh khi c\u1ea7n, kh\u00f4ng t\u1ef1 \u00fd thay \u0111\u1ed5i r\u1ed3i m\u1edbi b\u1ed5 sung sau.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">V\u1ec1 <\/span><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/annex11_01-2011_en_0.pdf\" target=\"_blank\" rel=\"noopener\"><b>Annex 11<\/b><\/a><span style=\"font-weight: 400;\">, \u0111\u00e2y l\u00e0 ph\u1ea7n n\u00f3i v\u1ec1 c\u00e1c h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh li\u00ean quan \u0111\u1ebfn GMP. \u00dd ch\u00ednh l\u00e0: d\u00f9ng ph\u1ea7n m\u1ec1m hay h\u1ec7 th\u1ed1ng \u0111i\u1ec7n t\u1eed th\u00ec ph\u1ea3i \u0111\u1ea3m b\u1ea3o d\u1eef li\u1ec7u v\u1eabn \u0111\u00e1ng tin nh\u01b0 ghi ch\u00e9p gi\u1ea5y. Khi \u0111o\u00e0n thanh tra h\u1ecfi s\u00e2u, nh\u00e0 m\u00e1y th\u01b0\u1eddng c\u1ea7n ch\u1ee9ng minh 3 \u0111i\u1ec3m:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">D\u1eef li\u1ec7u kh\u00f3 b\u1ecb can thi\u1ec7p: ai \u0111\u01b0\u1ee3c quy\u1ec1n l\u00e0m g\u00ec ph\u1ea3i r\u00f5, m\u1ecdi ch\u1ec9nh s\u1eeda ph\u1ea3i c\u00f3 d\u1ea5u v\u1ebft v\u00e0 c\u00f3 l\u00fd do h\u1ee3p l\u1ec7.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">D\u1eef li\u1ec7u kh\u00f4ng b\u1ecb m\u1ea5t: c\u00f3 sao l\u01b0u, c\u00f3 kh\u1ea3 n\u0103ng kh\u00f4i ph\u1ee5c v\u00e0 d\u1eef li\u1ec7u lu\u00f4n truy c\u1eadp \u0111\u01b0\u1ee3c khi c\u1ea7n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Truy xu\u1ea5t nhanh v\u00e0 gi\u1ea3i th\u00edch \u0111\u01b0\u1ee3c: khi b\u1ecb h\u1ecfi, b\u1ea1n l\u1ea5y \u0111\u01b0\u1ee3c d\u1eef li\u1ec7u g\u1ed1c, ch\u1ec9 ra l\u1ecbch s\u1eed thay \u0111\u1ed5i v\u00e0 gi\u1ea3i th\u00edch \u0111\u01b0\u1ee3c v\u00ec sao d\u1eef li\u1ec7u \u0111\u00f3 \u0111\u00e1ng tin.<\/span><\/li>\n<\/ul>\n<h2><b>C\u00e1ch \u0110\u0103ng K\u00fd V\u00e0 L\u1ed9 Tr\u00ecnh Th\u1ef1c T\u1ebf \u0110\u1ec3 Nh\u1eadn Ch\u1ee9ng Ch\u1ec9 GMP EU<\/b><\/h2>\n<figure id=\"attachment_9191\" aria-describedby=\"caption-attachment-9191\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9191\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-3.png\" alt=\"lo-trinh-nhan-gmp-eu-4-buoc\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-3.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-3-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-3-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-3-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9191\" class=\"wp-caption-text\"><em>L\u1ed9 tr\u00ecnh nh\u1eadn ch\u1ee9ng ch\u1ec9 GMP EU<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Kh\u00f4ng c\u00f3 m\u1ed9t m\u1eabu chung cho m\u1ecdi tr\u01b0\u1eddng h\u1ee3p, v\u00ec GMP EU g\u1eafn v\u1edbi th\u1ecb tr\u01b0\u1eddng m\u1ee5c ti\u00eau, d\u1ea1ng s\u1ea3n ph\u1ea9m v\u00e0 c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n s\u1ebd thanh tra. Tuy v\u1eady, l\u1ed9 tr\u00ecnh th\u1ef1c t\u1ebf th\u01b0\u1eddng c\u00f3 th\u1ec3 t\u00f3m g\u1ecdn trong 4 b\u01b0\u1edbc d\u01b0\u1edbi \u0111\u00e2y.<\/span><\/p>\n<h3><b>B\u01b0\u1edbc 1: X\u00e1c \u0110\u1ecbnh Ph\u1ea1m Vi V\u00e0 M\u1ee5c Ti\u00eau Th\u1ecb Tr\u01b0\u1eddng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Tr\u01b0\u1edbc khi n\u00f3i \u0111\u1ebfn xin ch\u1ee9ng ch\u1ec9, nh\u00e0 m\u00e1y c\u1ea7n ch\u1ed1t r\u00f5 ph\u1ea1m vi m\u00e0 m\u00ecnh mu\u1ed1n \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 theo GMP EU, v\u00ed d\u1ee5: s\u1ea3n xu\u1ea5t hay \u0111\u00f3ng g\u00f3i, ki\u1ec3m nghi\u1ec7m hay b\u1ea3o qu\u1ea3n, v\u00e0 d\u1ea1ng b\u00e0o ch\u1ebf n\u00e0o. \u0110\u00e2y l\u00e0 n\u1ec1n \u0111\u1ec3 b\u1ea1n thi\u1ebft k\u1ebf h\u1ec7 th\u1ed1ng, th\u1ea9m \u0111\u1ecbnh v\u00e0 chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 \u0111\u00fang tr\u1ecdng t\u00e2m.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">N\u1ebfu c\u00f3 s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng, Annex 1 th\u01b0\u1eddng t\u00e1c \u0111\u1ed9ng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn thi\u1ebft k\u1ebf, v\u1eadn h\u00e0nh v\u00e0 gi\u00e1m s\u00e1t, n\u00ean c\u1ea7n \u0111\u01b0a v\u00e0o \u01b0u ti\u00ean t\u1eeb \u0111\u1ea7u.\u00a0<\/span><\/p>\n<h3><b>B\u01b0\u1edbc 2: Gap Assessment V\u00e0 L\u1eadp Master Plan<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Gap assessment l\u00e0 b\u01b0\u1edbc so s\u00e1nh hi\u1ec7n tr\u1ea1ng v\u1edbi GMP EU Guide trong EudraLex Volume 4 v\u00e0 c\u00e1c ph\u1ee5 l\u1ee5c li\u00ean quan, \u0111\u1ec3 ch\u1ec9 ra ch\u1ed7 n\u00e0o \u0111ang thi\u1ebfu, thi\u1ebfu m\u1ee9c n\u00e0o, r\u1ee7i ro ra sao v\u00e0 c\u1ea7n bao l\u00e2u \u0111\u1ec3 kh\u1eafc ph\u1ee5c.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Master plan (k\u1ebf ho\u1ea1ch t\u1ed5ng th\u1ec3) n\u00ean gom c\u00e1c h\u1ea1ng m\u1ee5c l\u1edbn theo logic v\u1eadn h\u00e0nh, thay v\u00ec li\u1ec7t k\u00ea r\u1eddi r\u1ea1c. M\u1ed9t b\u1ea3n d\u1ec5 d\u00f9ng th\u01b0\u1eddng bao g\u1ed3m:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Thi\u1ebft k\u1ebf v\u00e0 ph\u00e2n lu\u1ed3ng khu v\u1ef1c \u0111\u1ec3 h\u1ea1n ch\u1ebf nhi\u1ec5m ch\u00e9o<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u00e1c h\u1ec7 th\u1ed1ng ph\u1ee5 tr\u1ee3 ph\u1ee5c v\u1ee5 s\u1ea3n xu\u1ea5t nh\u01b0 HVAC, n\u01b0\u1edbc, kh\u00ed n\u00e9n v\u00e0 c\u00e1c ngu\u1ed3n c\u1ea5p quan tr\u1ecdng kh\u00e1c<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V\u1ec7 sinh v\u00e0 kh\u1eed khu\u1ea9n, gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng ho\u1eb7c gi\u00e1m s\u00e1t ph\u00f9 h\u1ee3p theo r\u1ee7i ro<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u00e0o t\u1ea1o, nh\u00e0 cung c\u1ea5p, ki\u1ec3m so\u00e1t thay \u0111\u1ed5i, x\u1eed l\u00fd sai l\u1ec7ch v\u00e0 CAPA (h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Th\u1ea9m \u0111\u1ecbnh v\u00e0 to\u00e0n v\u1eb9n d\u1eef li\u1ec7u, v\u00ec \u0111\u00e2y l\u00e0 nh\u00f3m hay b\u1ecb h\u1ecfi s\u00e2u khi thanh tra<\/span><\/li>\n<\/ul>\n<h3><b>B\u01b0\u1edbc 3: Ch\u1ea1y B\u1eb1ng Ch\u1ee9ng V\u1eadn H\u00e0nh V\u00e0 Mock Audit<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Nhi\u1ec1u nh\u00e0 m\u00e1y ho\u00e0n thi\u1ec7n SOP r\u1ea5t nhanh, nh\u01b0ng l\u1ea1i thi\u1ebfu ph\u1ea7n quan tr\u1ecdng nh\u1ea5t l\u00e0 b\u1eb1ng ch\u1ee9ng v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh. \u1ede b\u01b0\u1edbc n\u00e0y, tr\u1ecdng t\u00e2m l\u00e0 t\u1ea1o ra d\u1eef li\u1ec7u v\u00e0 h\u1ed3 s\u01a1 \u0111\u1ee7 thuy\u1ebft ph\u1ee5c \u0111\u1ec3 ch\u1ee9ng minh h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t c\u00f3 hi\u1ec7u l\u1ef1c trong th\u1ef1c t\u1ebf, kh\u00f4ng ph\u1ea3i ch\u1ec9 \u0111\u00fang tr\u00ean gi\u1ea5y.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Mock audit gi\u00fap b\u1ea1n soi tr\u01b0\u1edbc c\u00e1c \u0111i\u1ec3m hay b\u1ecb h\u1ecfi s\u00e2u nh\u01b0: truy xu\u1ea5t h\u1ed3 s\u01a1 theo l\u00f4, \u0111\u1ed1i chi\u1ebfu d\u1eef li\u1ec7u g\u1ed1c, ph\u1ecfng v\u1ea5n theo vai tr\u00f2, v\u00e0 ki\u1ec3m so\u00e1t hi\u1ec7n tr\u01b0\u1eddng (\u0111\u00fang thao t\u00e1c, \u0111\u00fang lu\u1ed3ng, \u0111\u00fang ghi nh\u1eadn).<\/span><\/p>\n<h3><b>B\u01b0\u1edbc 4: Thanh Tra, Tr\u1ea3 L\u1eddi Quan S\u00e1t, Nh\u1eadn V\u00e0 Theo D\u00f5i T\u00ecnh Tr\u1ea1ng Ch\u1ee9ng Ch\u1ec9<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khi thanh tra di\u1ec5n ra, \u0111i\u1ec1u quan tr\u1ecdng kh\u00f4ng ch\u1ec9 l\u00e0 tr\u1ea3 l\u1eddi \u0111\u00fang, m\u00e0 l\u00e0 ch\u1ee9ng minh \u0111\u01b0\u1ee3c b\u1eb1ng h\u1ed3 s\u01a1 v\u00e0 d\u1eef li\u1ec7u. Sau thanh tra, nh\u00e0 m\u00e1y th\u01b0\u1eddng c\u1ea7n ph\u1ea3n h\u1ed3i quan s\u00e1t \u0111\u00fang h\u1ea1n, \u0111\u01b0a ra CAPA c\u00f3 nguy\u00ean nh\u00e2n g\u1ed1c v\u00e0 c\u00f3 b\u1eb1ng ch\u1ee9ng hi\u1ec7u l\u1ef1c.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">K\u1ebft qu\u1ea3 li\u00ean quan GMP (ch\u1ee9ng ch\u1ec9, t\u00ecnh tr\u1ea1ng tu\u00e2n th\u1ee7, v\u00e0 m\u1ed9t s\u1ed1 th\u00f4ng tin v\u1ec1 ph\u1ea1m vi) \u0111\u01b0\u1ee3c c\u00e1c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1eadp nh\u1eadt tr\u00ean EudraGMDP. EudraGMDP l\u00e0 c\u01a1 s\u1edf d\u1eef li\u1ec7u c\u1ee7a EU v\u1ec1 gi\u1ea5y ph\u00e9p li\u00ean quan s\u1ea3n xu\u1ea5t, nh\u1eadp kh\u1ea9u, ph\u00e2n ph\u1ed1i v\u00e0 c\u00e1c ch\u1ee9ng ch\u1ec9 GMP\/GDP; b\u1ea3n c\u00f4ng khai \u0111\u00e3 c\u00f3 t\u1eeb n\u0103m 2011. (<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/eudragmdp-database?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">European Medicines Agency (EMA)<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/p>\n<h2><b>Tr\u00ecnh T\u1ef1 Th\u01b0\u1eddng G\u1eb7p Khi \u0110\u0103ng K\u00fd Ki\u1ec3m Tra GMP WHO T\u1ea1i Vi\u1ec7t Nam<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Ph\u1ea7n n\u00e0y \u0111\u1ec3 tr\u00e1nh nh\u1ea7m l\u1eabn: quy tr\u00ecnh \u0111\u0103ng k\u00fd ki\u1ec3m tra GMP WHO t\u1ea1i Vi\u1ec7t Nam l\u00e0 th\u1ee7 t\u1ee5c c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd trong n\u01b0\u1edbc, kh\u00e1c b\u1ea3n ch\u1ea5t v\u1edbi GMP EU (GMP EU g\u1eafn v\u1edbi th\u1ecb tr\u01b0\u1eddng EU v\u00e0 c\u01a1 ch\u1ebf thanh tra c\u1ee7a EU\/EEA).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">M\u1ed9t tr\u00ecnh t\u1ef1 th\u01b0\u1eddng g\u1eb7p, di\u1ec5n gi\u1ea3i theo h\u01b0\u1edbng d\u1ec5 hi\u1ec3u, g\u1ed3m:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u01a1 s\u1edf t\u1ef1 r\u00e0 so\u00e1t m\u1ee9c \u0111\u00e1p \u1ee9ng GMP WHO v\u00e0 n\u1ed9p h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd ki\u1ec3m tra t\u1edbi c\u01a1 quan qu\u1ea3n l\u00fd c\u00f3 th\u1ea9m quy\u1ec1n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u01a1 quan qu\u1ea3n l\u00fd ti\u1ebfp nh\u1eadn v\u00e0 th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1; n\u1ebfu thi\u1ebfu ho\u1eb7c ch\u01b0a r\u00f5 s\u1ebd y\u00eau c\u1ea7u b\u1ed5 sung.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u1ed5 ch\u1ee9c \u0111o\u00e0n ki\u1ec3m tra v\u00e0 \u0111\u00e1nh gi\u00e1 th\u1ef1c t\u1ebf t\u1ea1i c\u01a1 s\u1edf khi nh\u00e0 m\u00e1y \u0111ang v\u1eadn h\u00e0nh; bi\u00ean b\u1ea3n ghi nh\u1eadn c\u00e1c \u0111i\u1ec3m ph\u00f9 h\u1ee3p v\u00e0 t\u1ed3n t\u1ea1i, c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a hai b\u00ean.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">X\u1eed l\u00fd sau ki\u1ec3m tra: n\u1ebfu c\u00f3 t\u1ed3n t\u1ea1i, c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n kh\u1eafc ph\u1ee5c v\u00e0 n\u1ed9p b\u00e1o c\u00e1o k\u00e8m b\u1eb1ng ch\u1ee9ng; c\u01a1 quan qu\u1ea3n l\u00fd xem x\u00e9t k\u1ebft lu\u1eadn ch\u00ednh th\u1ee9c v\u00e0 vi\u1ec7c c\u1ea5p ch\u1ee9ng nh\u1eadn theo quy \u0111\u1ecbnh.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u00e1nh gi\u00e1 \u0111\u1ecbnh k\u1ef3 duy tr\u00ec \u0111\u00e1p \u1ee9ng GMP th\u01b0\u1eddng theo chu k\u1ef3 3 n\u0103m (kh\u00f4ng t\u00ednh c\u00e1c \u0111\u1ee3t \u0111\u00e1nh gi\u00e1 \u0111\u1ed9t xu\u1ea5t). (<\/span><a href=\"https:\/\/thuvienphapluat.vn\/phap-luat\/ho-tro-phap-luat\/danh-gia-dinh-ky-viec-duy-tri-dap-ung-thuc-hanh-tot-san-xuat-thuoc-nguyen-lieu-lam-thuoc-theo-quy-d-52012.html?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">TH\u01af VI\u1ec6N PH\u00c1P LU\u1eacT<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">L\u01b0u \u00fd: c\u00e1c m\u1ed1c th\u1eddi h\u1ea1n x\u1eed l\u00fd h\u1ed3 s\u01a1, th\u1eddi h\u1ea1n g\u1eedi b\u00e1o c\u00e1o kh\u1eafc ph\u1ee5c, \u0111i\u1ec1u ki\u1ec7n t\u00e1i ki\u1ec3m tra\u2026 c\u1ea7n \u0111\u1ed1i chi\u1ebfu th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh v\u00e0 v\u0103n b\u1ea3n \u00e1p d\u1ee5ng t\u1ea1i th\u1eddi \u0111i\u1ec3m b\u1ea1n tri\u1ec3n khai v\u00ec c\u00f3 th\u1ec3 thay \u0111\u1ed5i theo c\u1eadp nh\u1eadt qu\u1ea3n l\u00fd.\u00a0<\/span><\/p>\n<h2><b>Th\u00e0nh Ph\u1ea7n H\u1ed3 S\u01a1 Th\u01b0\u1eddng G\u1eb7p<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 ng\u01b0\u1eddi \u0111\u1ecdc h\u00ecnh dung \u0111\u00fang b\u1ea3n ch\u1ea5t, c\u00f3 th\u1ec3 chia theo 2 nh\u00f3m:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">H\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd ki\u1ec3m tra l\u1ea7n \u0111\u1ea7u th\u01b0\u1eddng xoay quanh:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u01a1n \u0111\u0103ng k\u00fd ki\u1ec3m tra theo bi\u1ec3u m\u1eabu \u00e1p d\u1ee5ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ph\u00e1p l\u00fd c\u1ee7a c\u01a1 s\u1edf (gi\u1ea5y ph\u00e9p ho\u1eb7c \u0111\u0103ng k\u00fd li\u00ean quan)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u01a1 c\u1ea5u t\u1ed5 ch\u1ee9c, ph\u00e2n c\u00f4ng tr\u00e1ch nhi\u1ec7m v\u00e0 t\u1ed5ng quan \u0111\u00e0o t\u1ea1o GMP<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u01a1 \u0111\u1ed3 thi\u1ebft k\u1ebf nh\u00e0 m\u00e1y v\u00e0 c\u00e1c lu\u1ed3ng ch\u00ednh: ng\u01b0\u1eddi, nguy\u00ean li\u1ec7u, bao b\u00ec, b\u00e1n th\u00e0nh ph\u1ea9m, th\u00e0nh ph\u1ea9m, ch\u1ea5t th\u1ea3i<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Danh m\u1ee5c thi\u1ebft b\u1ecb ch\u00ednh v\u00e0 c\u00e1c h\u1ec7 th\u1ed1ng h\u1ea1 t\u1ea7ng li\u00ean quan \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">H\u1ed3 s\u01a1 t\u00e1i ki\u1ec3m tra th\u01b0\u1eddng t\u1eadp trung v\u00e0o:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u01a1n \u0111\u0103ng k\u00fd t\u00e1i ki\u1ec3m tra theo bi\u1ec3u m\u1eabu \u00e1p d\u1ee5ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">B\u00e1o c\u00e1o thay \u0111\u1ed5i trong giai \u0111o\u1ea1n v\u1eadn h\u00e0nh, v\u00e0 b\u00e1o c\u00e1o ho\u1ea1t \u0111\u1ed9ng theo k\u1ef3<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">B\u00e1o c\u00e1o kh\u1eafc ph\u1ee5c t\u1ed3n t\u1ea1i c\u1ee7a l\u1ea7n ki\u1ec3m tra tr\u01b0\u1edbc, k\u00e8m b\u1eb1ng ch\u1ee9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u00f3m t\u1eaft \u0111\u00e0o t\u1ea1o, t\u1ef1 thanh tra v\u00e0 c\u00e1c \u0111i\u1ec3m c\u1ea3i ti\u1ebfn ch\u00ednh<\/span><\/li>\n<\/ul>\n<h2><b>T\u00e0i Li\u1ec7u GMP EU N\u00ean \u0110\u1ecdc V\u00e0 GMP EU PDF N\u00ean T\u1ea3i \u1ede \u0110\u00e2u<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Ngu\u1ed3n n\u1ec1n t\u1ea3ng v\u00e0 ch\u00ednh th\u1ed1ng nh\u1ea5t \u0111\u1ec3 \u0111\u1ecdc GMP EU l\u00e0 EudraLex Volume 4 tr\u00ean website c\u1ee7a European Commission.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c t\u00e0i li\u1ec7u hay d\u00f9ng (n\u00ean t\u1ea3i t\u1eeb ngu\u1ed3n ch\u00ednh th\u1ed1ng):<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">EudraLex Volume 4 (trang t\u1ed5ng h\u1ee3p GMP EU Guide v\u00e0 ph\u1ee5 l\u1ee5c):<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Annex 1 Manufacture of Sterile Medicinal Products (b\u1ea3n 2022):<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/20220825_gmp-an1_en_0.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/20220825_gmp-an1_en_0.pdf<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Annex 11 Computerised Systems (h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh):<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/annex11_0.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/annex11_0.pdf<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Annex 15 Qualification and Validation (th\u1ea9m \u0111\u1ecbnh x\u00e1c nh\u1eadn, theo v\u00f2ng \u0111\u1eddi):<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/2015-10_annex15.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/2015-10_annex15.pdf<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n mu\u1ed1n ch\u00e8n link phi\u00ean b\u1ea3n m\u1edbi nh\u1ea5t tr\u1ef1c ti\u1ebfp v\u00e0o b\u00e0i khi xu\u1ea5t b\u1ea3n, h\u00e3y ki\u1ec3m tra l\u1ea1i ngay tr\u00ean trang EudraLex Volume 4 c\u1ee7a European Commission \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o \u0111\u00fang b\u1ea3n c\u1eadp nh\u1eadt t\u1ea1i th\u1eddi \u0111i\u1ec3m \u0111\u0103ng.\u00a0<\/span><\/p>\n<h2><b>So S\u00e1nh GMP WHO V\u00e0 GMP EU<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">WHO GMP th\u01b0\u1eddng \u0111\u00f3ng vai tr\u00f2 khung nguy\u00ean t\u1eafc GMP \u0111\u1ec3 c\u00e1c qu\u1ed1c gia tham chi\u1ebfu v\u00e0 n\u1ed9i lu\u1eadt h\u00f3a. (<\/span><a href=\"https:\/\/www.who.int\/publications\/m\/item\/trs986-annex2?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">T\u1ed5 Ch\u1ee9c Y T\u1ebf Th\u1ebf Gi\u1edbi<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">GMP EU nh\u00ecn chung chi ti\u1ebft h\u01a1n v\u00e0 g\u1eafn v\u1edbi h\u1ec7 th\u1ed1ng thanh tra, c\u01a1 ch\u1ebf ch\u1ee9ng nh\u1eadn v\u00e0 tra c\u1ee9u cho th\u1ecb tr\u01b0\u1eddng EU.<\/span><\/p>\n<h2><b>FAQ \u0110i\u1ec1u ki\u1ec7n \u0111\u1ec3 c\u00e1c nh\u00e0 m\u00e1y \u0111\u1ea1t GMP EU<\/b><\/h2>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ch\u1ee9ng nh\u1eadn GMP EU c\u00f3 ph\u1ea3i gi\u1ea5y chung cho to\u00e0n doanh nghi\u1ec7p kh\u00f4ng ?<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Kh\u00f4ng. Th\u00f4ng th\u01b0\u1eddng ch\u1ee9ng nh\u1eadn g\u1eafn v\u1edbi \u0111\u1ecba \u0111i\u1ec3m v\u00e0 ph\u1ea1m vi ho\u1ea1t \u0111\u1ed9ng sau thanh tra.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u00f3 th\u1ec3 tra c\u1ee9u ch\u1ee9ng nh\u1eadn GMP EU \u1edf \u0111\u00e2u<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">C\u00f3 th\u1ec3 tra c\u1ee9u tr\u00ean c\u01a1 s\u1edf d\u1eef li\u1ec7u EudraGMDP. (<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/eudragmdp-database?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">European Medicines Agency (EMA)<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Th\u1ea9m \u0111\u1ecbnh trong GMP EU th\u01b0\u1eddng bao g\u1ed3m nh\u1eefng g\u00ec<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Th\u01b0\u1eddng g\u1ed3m th\u1ea9m \u0111\u1ecbnh thi\u1ebft b\u1ecb, h\u1ec7 th\u1ed1ng, quy tr\u00ecnh v\u00e0 v\u1ec7 sinh theo v\u00f2ng \u0111\u1eddi.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V\u00ec sao \u0111o\u00e0n thanh tra hay h\u1ecfi s\u00e2u v\u1ec1 d\u1eef li\u1ec7u<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">V\u00ec d\u1eef li\u1ec7u l\u00e0 b\u1eb1ng ch\u1ee9ng tr\u1ef1c ti\u1ebfp cho vi\u1ec7c ki\u1ec3m so\u00e1t. H\u1ecd c\u1ea7n th\u1ea5y d\u1eef li\u1ec7u tin c\u1eady, truy v\u1ebft \u0111\u01b0\u1ee3c v\u00e0 kh\u00f4ng th\u1ec3 ch\u1ec9nh s\u1eeda l\u00e9n.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">N\u1ebfu nh\u00e0 m\u00e1y c\u00f3 v\u00f4 tr\u00f9ng th\u00ec n\u00ean \u01b0u ti\u00ean t\u00e0i li\u1ec7u n\u00e0o<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Annex 1 th\u01b0\u1eddng l\u00e0 ph\u1ea7n \u1ea3nh h\u01b0\u1edfng m\u1ea1nh \u0111\u1ebfn thi\u1ebft k\u1ebf, v\u1eadn h\u00e0nh v\u00e0 gi\u00e1m s\u00e1t v\u00f4 tr\u00f9ng.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u1eeb WHO GMP n\u00e2ng l\u00ean GMP EU n\u00ean b\u1eaft \u0111\u1ea7u \u1edf \u0111\u00e2u<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">B\u1eaft \u0111\u1ea7u t\u1eeb gap assessment theo EudraLex Volume 4, sau \u0111\u00f3 l\u1eadp master plan \u01b0u ti\u00ean theo r\u1ee7i ro.\u00a0<\/span><\/li>\n<\/ol>\n<h2><b>K\u1ebft Lu\u1eadn<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec1u ki\u1ec7n \u0111\u1ec3 nh\u00e0 m\u00e1y \u0111\u1ea1t ch\u1ee9ng nh\u1eadn GMP EU kh\u00f4ng g\u00f3i g\u1ecdn trong nh\u00e0 x\u01b0\u1edfng v\u00e0 gi\u1ea5y t\u1edd. B\u1ea1n c\u1ea7n m\u1ed9t h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng v\u1eadn h\u00e0nh th\u1eadt, c\u00e1c ph\u1ea7n quan tr\u1ecdng \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh ph\u00f9 h\u1ee3p, v\u00e0 d\u1eef li\u1ec7u tin c\u1eady, truy v\u1ebft \u0111\u01b0\u1ee3c \u0111\u1ec3 ch\u1ee9ng minh ki\u1ec3m so\u00e1t theo th\u1eddi gian.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n \u0111ang l\u00ean k\u1ebf ho\u1ea1ch \u0111\u1ea1t GMP EU, <strong><a href=\"https:\/\/sepro.vn\/\">Sepro<\/a><\/strong> cho r\u1eb1ng h\u01b0\u1edbng \u0111i hi\u1ec7u qu\u1ea3 l\u00e0 b\u1eaft \u0111\u1ea7u t\u1eeb EudraLex Volume 4, l\u00e0m gap assessment theo r\u1ee7i ro, x\u00e2y master plan c\u00f3 \u01b0u ti\u00ean r\u00f5, ch\u1ea1y mock audit v\u00e0 \u0111\u00f3ng CAPA d\u1ee9t \u0111i\u1ec3m tr\u01b0\u1edbc khi m\u1eddi thanh tra.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vi\u1ec7c \u0111\u1ea1t \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn GMP EU kh\u00f4ng d\u1eebng \u1edf vi\u1ec7c nh\u00e0 x\u01b0\u1edfng \u0111\u1ea1t chu\u1ea9n hay t\u00e0i li\u1ec7u \u0111\u1ea7y \u0111\u1ee7. \u0110i\u1ec1u quan tr\u1ecdng l\u00e0 b\u1ea1n ph\u1ea3i ch\u1ee9ng minh h\u1ec7 th\u1ed1ng nh\u00e0 m\u00e1y c\u00f3 s\u1ef1 ki\u1ec3m so\u00e1t, ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh theo th\u1eddi gian, c\u00e1c kh\u00e2u tr\u1ecdng y\u1ebfu \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh ph\u00f9 h\u1ee3p v\u00e0 m\u1ecdi &hellip; <a href=\"https:\/\/sepro.vn\/vi\/dieu-kien-de-nha-may-dat-chung-nhan-gmp-eu\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">\u0110i\u1ec1u Ki\u1ec7n \u0110\u1ec3 Nh\u00e0 M\u00e1y \u0110\u1ea1t Ch\u1ee9ng Nh\u1eadn GMP EU<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9193,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9178"}],"version-history":[{"count":5,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9178\/revisions"}],"predecessor-version":[{"id":9197,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9178\/revisions\/9197"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9193"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}