{"id":9292,"date":"2026-03-12T07:18:25","date_gmt":"2026-03-12T07:18:25","guid":{"rendered":"https:\/\/sepro.vn\/?p=9292"},"modified":"2026-03-12T07:18:25","modified_gmt":"2026-03-12T07:18:25","slug":"cgmp-la-gi-tu-dinh-nghia-den-van-hanh-thuc-te","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/cgmp-la-gi-tu-dinh-nghia-den-van-hanh-thuc-te\/","title":{"rendered":"cGMP L\u00e0 G\u00ec? T\u1eeb \u0110\u1ecbnh Ngh\u0129a \u0110\u1ebfn V\u1eadn H\u00e0nh Th\u1ef1c T\u1ebf"},"content":{"rendered":"

M\u1ed9t nh\u00e0 m\u00e1y d\u01b0\u1ee3c c\u00f3 \u0111\u1ea7y \u0111\u1ee7 SOP, h\u1ed3 s\u01a1 v\u1ec7 sinh \u0111\u01b0\u1ee3c k\u00fd duy\u1ec7t \u0111\u00fang quy tr\u00ecnh, nh\u00e2n vi\u00ean \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o \u0111\u1ecbnh k\u1ef3 m\u1ed7i n\u0103m. Nh\u01b0ng thanh tra vi\u00ean FDA v\u1eabn ph\u00e1t hi\u1ec7n c\u1eb7n s\u1ea3n ph\u1ea9m tr\u00ean thi\u1ebft b\u1ecb v\u00e0 ph\u00e1t h\u00e0nh th\u01b0 c\u1ea3nh b\u00e1o.<\/p>\n

\u0110i\u1ec1u \u0111\u00f3 kh\u00f4ng c\u00f3 ngh\u0129a l\u00e0 nh\u00e0 m\u00e1y thi\u1ebfu quy tr\u00ecnh m\u00e0 c\u00f3 ngh\u0129a l\u00e0 h\u1ecd ch\u01b0a th\u1ef1c s\u1ef1 hi\u1ec3u cGMP l\u00e0 g\u00ec. B\u00e0i vi\u1ebft n\u00e0y s\u1ebd gi\u1ea3i th\u00edch t\u1eeb \u0111\u1ecbnh ngh\u0129a ch\u00ednh x\u00e1c, y\u00eau c\u1ea7u ph\u00e1p l\u00fd c\u1ee7a FDA, \u0111\u1ebfn checklist t\u1ef1 ki\u1ec3m tra v\u00e0 3 case study vi ph\u1ea1m th\u1ef1c t\u1ebf \u0111\u1ec3 b\u1ea1n kh\u00f4ng r\u01a1i v\u00e0o t\u00ecnh hu\u1ed1ng t\u01b0\u01a1ng t\u1ef1.<\/p>\n

cGMP l\u00e0 g\u00ec v\u00e0 cGMP l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec<\/b><\/h2>\n
\"what-is-cGMP\"
cGMP l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n

cGMP l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a c\u1ee5m t\u1eeb ti\u1ebfng Anh <\/span>Current Good Manufacturing Practice<\/b><\/a> (Th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t hi\u1ec7n h\u00e0nh).<\/span><\/p>\n

Trong ng\u00e0nh d\u01b0\u1ee3c, cGMP ch\u00ednh l\u00e0 n\u1ec1n m\u00f3ng c\u1ee7a nh\u00e0 m\u00e1y \u2013 l\u00e0 c\u00e1ch ch\u00fang ta thi\u1ebft k\u1ebf, v\u1eadn h\u00e0nh v\u00e0 duy tr\u00ec m\u1ed9t h\u1ec7 th\u1ed1ng to\u00e0n di\u1ec7n \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u00ean thu\u1ed1c \u0111\u1ebfn tay ng\u01b0\u1eddi b\u1ec7nh lu\u00f4n \u0111\u1ea1t \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n v\u00e0 \u0111\u00fang chu\u1ea9n nh\u01b0 nh\u1eefng g\u00ec nh\u00e0 m\u00e1y \u0111\u00e3 c\u00f4ng b\u1ed1.<\/span><\/p>\n

\u0110i\u1ec3m quan tr\u1ecdng nh\u1ea5t m\u00e0 nh\u1eefng b\u1ea1n m\u1edbi v\u00e0o ngh\u1ec1 c\u1ea7n l\u01b0u \u00fd nh\u01b0: cGMP l\u00e0 y\u00eau c\u1ea7u v\u1ec1 t\u00ednh h\u1ec7 th\u1ed1ng. H\u1ec7 th\u1ed1ng \u0111\u00f3 \u0111\u01b0\u1ee3c c\u1ea5u th\u00e0nh t\u1eeb quy tr\u00ecnh chu\u1ea9n, h\u1ed3 s\u01a1 minh b\u1ea1ch, d\u1eef li\u1ec7u to\u00e0n v\u1eb9n v\u00e0 k\u1ef7 lu\u1eadt th\u1ef1c thi c\u1ee7a t\u1eebng nh\u00e2n s\u1ef1 tr\u00ean d\u00e2y chuy\u1ec1n.<\/span><\/p>\n

L\u01b0u \u00fd d\u1ec5 nh\u1ea7m v\u1ec1 ch\u1eef vi\u1ebft t\u1eaft<\/strong><\/h3>\n

Khi l\u00e0m vi\u1ec7c v\u1edbi c\u00e1c t\u00e0i li\u1ec7u trong khu v\u1ef1c ASEAN, b\u1ea1n s\u1ebd th\u1ec9nh tho\u1ea3ng b\u1eaft g\u1eb7p c\u1ee5m t\u1eeb <\/span>CGMP<\/b>. Trong b\u1ed1i c\u1ea3nh n\u00e0y, n\u00f3 th\u01b0\u1eddng \u0111\u01b0\u1ee3c d\u00f9ng \u0111\u1ec3 ch\u1ec9 Th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t m\u1ef9 ph\u1ea9m (Cosmetic Good Manufacturing Practice)<\/strong>.<\/span><\/p>\n

\u0110\u00e2y l\u00e0 b\u1ed9 nguy\u00ean t\u1eafc d\u00e0nh ri\u00eang cho \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t m\u1ef9 ph\u1ea9m theo h\u01b0\u1edbng d\u1eabn chung c\u1ee7a ASEAN. D\u00f9 c\u00f3 s\u1ef1 t\u01b0\u01a1ng \u0111\u1ed3ng v\u1ec1 t\u01b0 duy qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng, ph\u00e2n bi\u1ec7t r\u00f5 r\u00e0ng gi\u1eefa 2 b\u1ed9 nguy\u00ean t\u1eafc \u0111\u1ec3 tr\u00e1nh \u00e1p d\u1ee5ng sai ti\u00eau chu\u1ea9n cho nh\u00e0 m\u00e1y. Xuy\u00ean su\u1ed1t b\u00e0i chia s\u1ebb n\u00e0y, ch\u00fang ta s\u1ebd ch\u1ec9 b\u00e0n v\u1ec1 cGMP theo h\u1ec7 quy chi\u1ebfu c\u1ee7a ng\u00e0nh d\u01b0\u1ee3c.<\/span><\/p>\n

cGMP kh\u00e1c g\u00ec GMP v\u00e0 v\u00ec sao m\u1ecdi ng\u01b0\u1eddi hay hi\u1ec3u nh\u1ea7m<\/b><\/h2>\n
\"different-between-cgmp-gmp\"
Ph\u00e2n bi\u1ec7t cGMP v\u00e0 GMP<\/em><\/figcaption><\/figure>\n

GMP l\u00e0 n\u1ec1n t\u1ea3ng c\u01a1 b\u1ea3n c\u1ee7a cGMP<\/b>. Khi th\u00eam ch\u1eef “c” (Current – Hi\u1ec7n t\u1ea1i) v\u00e0o, cGMP \u0111\u00f2i h\u1ecfi t\u00ednh li\u00ean t\u1ee5c c\u1eadp nh\u1eadt v\u00e0 ph\u00f9 h\u1ee3p v\u1edbi b\u1ed1i c\u1ea3nh tri\u1ec3n khai th\u1ef1c t\u1ebf. Ngh\u0129a l\u00e0, c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t r\u1ee7i ro c\u1ee7a nh\u00e0 m\u00e1y ph\u1ea3i b\u1eaft k\u1ecbp v\u1edbi s\u1ef1 ti\u1ebfn b\u1ed9 c\u1ee7a c\u00f4ng ngh\u1ec7 v\u00e0 b\u1ed1i c\u1ea3nh khoa h\u1ecdc hi\u1ec7n t\u1ea1i, ch\u1ee9 kh\u00f4ng ph\u1ea3i m\u1ed9t b\u1ed9 quy tr\u00ecnh s\u1eed d\u1ee5ng cho 10 n\u0103m li\u00ean t\u1ee5c.<\/span><\/p>\n

M\u1ed9t sai l\u1ea7m r\u1ea5t ph\u1ed5 bi\u1ebfn \u1edf m\u1ecdi ng\u01b0\u1eddi l\u00e0 t\u01b0 duy v\u00e0 th\u1ef1c hi\u1ec7n \u0111\u1ed1i ph\u00f3. Khi b\u01b0\u1edbc v\u00e0o th\u1ef1c t\u1ebf, c\u00e1c b\u1ea1n th\u01b0\u1eddng \u01b0u ti\u00ean l\u00e0m cho h\u1ed3 s\u01a1 tr\u00f4ng c\u00f3 v\u1ebb ho\u00e0n h\u1ea3o thay v\u00ec th\u1ef1c s\u1ef1 t\u1eadp trung ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd c\u00e1c r\u1ee7i ro. B\u1ea1n c\u1ea7n nh\u1edb r\u1eb1ng, khi c\u00e1c thanh tra vi\u00ean \u0111\u00e1nh gi\u00e1, h\u1ecd kh\u00f4ng ch\u1ec9 h\u1ecfi “B\u1ea1n c\u00f3 SOP (Quy tr\u00ecnh chu\u1ea9n) kh\u00f4ng?”<\/strong>. H\u1ecd s\u1ebd \u0111\u00e0o s\u00e2u: SOP \u0111\u00f3 c\u00f3 \u0111\u01b0\u1ee3c th\u1ef1c thi nh\u1ea5t qu\u00e1n \u1edf nh\u00e0 m\u00e1y kh\u00f4ng? D\u1eef li\u1ec7u c\u00f3 truy xu\u1ea5t ng\u01b0\u1ee3c \u0111\u01b0\u1ee3c kh\u00f4ng? V\u00e0 khi c\u00f3 sai l\u1ec7ch, nh\u00e0 m\u00e1y c\u00f3 \u0111i\u1ec1u tra \u0111\u1ebfn t\u1eadn g\u1ed1c r\u1ec5 v\u1ea5n \u0111\u1ec1 hay kh\u00f4ng?<\/span><\/p>\n

cGMP c\u1ee7a FDA l\u00e0 g\u00ec v\u00e0 y\u00eau c\u1ea7u cGMP trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m<\/b><\/h2>\n
\"tieu-chuan-cGMP-cua-FDA\"
Ti\u00eau chu\u1ea9n cGMP c\u1ee7a FDA<\/em><\/figcaption><\/figure>\n

N\u1ebfu b\u1ea1n nh\u1eafm \u0111\u1ebfn th\u1ecb tr\u01b0\u1eddng M\u1ef9 ho\u1eb7c chu\u1ea9n b\u1ecb cho b\u01b0\u1edbc \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf, b\u1ea1n ph\u1ea3i l\u00e0m quen v\u1edbi <\/span>FDA<\/b><\/a>. Trong h\u1ec7 th\u1ed1ng ph\u00e1p lu\u1eadt c\u1ee7a Hoa K\u1ef3, y\u00eau c\u1ea7u cGMP \u0111\u1ed1i v\u1edbi thu\u1ed1c th\u00e0nh ph\u1ea9m \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh r\u00f5 t\u1ea1i <\/span>Title 21 c\u1ee7a B\u1ed9 Quy \u0111\u1ecbnh Li\u00ean bang (21 CFR)<\/b>. \u0110\u1ed1i v\u1edbi nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m, hai ph\u1ea7n thi\u1ebft y\u1ebfu m\u00e0 b\u1ea1n ph\u1ea3i n\u1eafm v\u1eefng l\u00e0 <\/span>Part 210<\/b> v\u00e0 <\/span>Part 211<\/b>.<\/span><\/p>\n

\u0110\u1ec3 \u0111\u01a1n gi\u1ea3n cho b\u1ea1n, h\u00e3y ti\u1ebfp c\u1eadn c\u00e1c y\u00eau c\u1ea7u n\u00e0y theo t\u01b0 duy logic sau:<\/span><\/p>\n