{"id":26965,"date":"2026-01-26T11:04:01","date_gmt":"2026-01-26T04:04:01","guid":{"rendered":"https:\/\/base.vn\/blog\/?p=26965"},"modified":"2026-01-27T16:09:04","modified_gmt":"2026-01-27T09:09:04","slug":"gmp-la-gi","status":"publish","type":"post","link":"https:\/\/base.vn\/blog\/gmp-la-gi\/","title":{"rendered":"GMP l\u00e0 g\u00ec? H\u01b0\u1edbng d\u1eabn v\u1ec1 th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t (Good Manufacturing Practices)"},"content":{"rendered":"\n

Good Manufacturing Practices (GMP) kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t thu\u1eadt ng\u1eef chuy\u00ean ng\u00e0nh m\u00e0 l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng c\u00e1c ti\u00eau chu\u1ea9n c\u1ef1c k\u1ef3 quan tr\u1ecdng, \u0111\u1ea3m b\u1ea3o m\u1ecdi s\u1ea3n ph\u1ea9m \u0111\u1ebfn tay ng\u01b0\u1eddi ti\u00eau d\u00f9ng \u0111\u1ec1u \u0111\u1ea1t ch\u1ea5t l\u01b0\u1ee3ng cao nh\u1ea5t v\u00e0 an to\u00e0n tuy\u1ec7t \u0111\u1ed1i. Trong b\u00e0i vi\u1ebft sau \u0111\u00e2y, h\u00e3y c\u00f9ng Base.vn<\/a> t\u00ecm hi\u1ec3u GMP l\u00e0 g\u00ec, v\u00e0 c\u00e1ch GMP gi\u00fap doanh nghi\u1ec7p ph\u00f2ng ng\u1eeba c\u00e1c r\u1ee7i ro li\u00ean quan \u0111\u1ebfn an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n

1. GMP l\u00e0 g\u00ec?<\/h2>\n\n\n\n

1.1 Kh\u00e1i ni\u1ec7m GMP (Good Manufacturing Practices)<\/h3>\n\n\n\n

GMP<\/strong> l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a c\u1ee5m t\u1eeb ti\u1ebfng Anh \u201cGood Manufacturing Practices\u201d<\/strong>, ngh\u0129a l\u00e0 \u201cTh\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t\u201d<\/strong>. \u0110\u00e2y l\u00e0 h\u1ec7 th\u1ed1ng ti\u00eau chu\u1ea9n \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng nh\u1eb1m ki\u1ec3m so\u00e1t to\u00e0n b\u1ed9 ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t, t\u1eeb con ng\u01b0\u1eddi, nh\u00e0 x\u01b0\u1edfng, thi\u1ebft b\u1ecb cho \u0111\u1ebfn nguy\u00ean v\u1eadt li\u1ec7u v\u00e0 quy tr\u00ecnh v\u1eadn h\u00e0nh. M\u1ee5c ti\u00eau c\u1ee7a GMP l\u00e0 \u0111\u1ea3m b\u1ea3o s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c t\u1ea1o ra m\u1ed9t c\u00e1ch\u00a0 an to\u00e0n v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e3 c\u00f4ng b\u1ed1.<\/p>\n\n\n\n

V\u1ec1 b\u1ea3n ch\u1ea5t, GMP kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t b\u1ed9 quy \u0111\u1ecbnh k\u1ef9 thu\u1eadt m\u00e0 c\u00f2n l\u00e0 c\u00e1ch ti\u1ebfp c\u1eadn qu\u1ea3n tr\u1ecb ch\u1ea5t l\u01b0\u1ee3ng mang t\u00ednh h\u1ec7 th\u1ed1ng. Khi \u00e1p d\u1ee5ng GMP, doanh nghi\u1ec7p kh\u00f4ng ch\u1ec9 \u201cl\u00e0m \u0111\u00fang\u201d \u1edf m\u1ed9t c\u00f4ng \u0111o\u1ea1n ri\u00eang l\u1ebb, m\u00e0 ph\u1ea3i ki\u1ec3m so\u00e1t \u0111\u1ed3ng b\u1ed9 to\u00e0n b\u1ed9 chu\u1ed7i s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n

Theo T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi (WHO), GMP l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a h\u1ec7 th\u1ed1ng \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng, gi\u00fap doanh nghi\u1ec7p thi\u1ebft k\u1ebf, gi\u00e1m s\u00e1t v\u00e0 ki\u1ec3m so\u00e1t quy tr\u00ecnh s\u1ea3n xu\u1ea5t<\/a> c\u0169ng nh\u01b0 \u0111i\u1ec1u ki\u1ec7n c\u01a1 s\u1edf v\u1eadt ch\u1ea5t. Trong khi \u0111\u00f3, C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) xem GMP l\u00e0 t\u1eadp h\u1ee3p c\u00e1c y\u00eau c\u1ea7u t\u1ed1i thi\u1ec3u m\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i tu\u00e2n th\u1ee7 \u0111\u1ec3 s\u1ea3n ph\u1ea9m \u0111\u1ea1t ch\u1ea5t l\u01b0\u1ee3ng ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 kh\u00f4ng g\u00e2y r\u1ee7i ro cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng.<\/p>\n\n\n

\n
\"GMP
GMP l\u00e0 g\u00ec?<\/em><\/figcaption><\/figure><\/div>\n\n\n

M\u1ed9t h\u1ec7 th\u1ed1ng GMP ho\u00e0n ch\u1ec9nh th\u01b0\u1eddng bao g\u1ed3m c\u00e1c nh\u00f3m y\u1ebfu t\u1ed1 ch\u00ednh sau:<\/p>\n\n\n\n

– Nh\u00e0 x\u01b0\u1edfng v\u00e0 c\u01a1 s\u1edf h\u1ea1 t\u1ea7ng:<\/strong> Nh\u00e0 x\u01b0\u1edfng c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 b\u1ed1 tr\u00ed ph\u00f9 h\u1ee3p v\u1edbi lu\u1ed3ng s\u1ea3n xu\u1ea5t, \u0111\u1ea3m b\u1ea3o d\u1ec5 v\u1ec7 sinh, ki\u1ec3m so\u00e1t t\u1ed1t nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m, th\u00f4ng gi\u00f3 v\u00e0 h\u1ea1n ch\u1ebf nguy c\u01a1 l\u00e2y nhi\u1ec5m ch\u00e9o.<\/p>\n\n\n\n

– Thi\u1ebft b\u1ecb s\u1ea3n xu\u1ea5t:<\/strong> Thi\u1ebft b\u1ecb ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t \u0111\u00fang c\u00e1ch, v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n \u0111\u1ecbnh k\u1ef3 v\u00e0 b\u1ea3o tr\u00ec theo k\u1ebf ho\u1ea1ch.<\/p>\n\n\n\n

– Nh\u00e2n s\u1ef1:<\/strong> Ng\u01b0\u1eddi lao \u0111\u1ed9ng c\u1ea7n c\u00f3 n\u0103ng l\u1ef1c chuy\u00ean m\u00f4n ph\u00f9 h\u1ee3p, \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o th\u01b0\u1eddng xuy\u00ean v\u1ec1 quy tr\u00ecnh, v\u1ec7 sinh c\u00e1 nh\u00e2n v\u00e0 \u00fd th\u1ee9c tu\u00e2n th\u1ee7 GMP.<\/p>\n\n\n\n

– Nguy\u00ean v\u1eadt li\u1ec7u:<\/strong> Nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o ph\u1ea3i c\u00f3 ngu\u1ed3n g\u1ed1c r\u00f5 r\u00e0ng, \u0111\u01b0\u1ee3c ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng v\u00e0 l\u01b0u tr\u1eef trong \u0111i\u1ec1u ki\u1ec7n ph\u00f9 h\u1ee3p.<\/p>\n\n\n\n

– Quy tr\u00ecnh s\u1ea3n xu\u1ea5t: <\/strong>M\u1ed7i c\u00f4ng \u0111o\u1ea1n c\u1ea7n \u0111\u01b0\u1ee3c chu\u1ea9n h\u00f3a b\u1eb1ng quy tr\u00ecnh thao t\u00e1c chu\u1ea9n, c\u00f3 h\u01b0\u1edbng d\u1eabn r\u00f5 r\u00e0ng, ghi ch\u00e9p \u0111\u1ea7y \u0111\u1ee7 v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c khi c\u1ea7n.<\/p>\n\n\n\n

– V\u1ec7 sinh v\u00e0 m\u00f4i tr\u01b0\u1eddng:<\/strong> Doanh nghi\u1ec7p ph\u1ea3i x\u00e2y d\u1ef1ng quy tr\u00ecnh v\u1ec7 sinh \u0111\u1ecbnh k\u1ef3, ki\u1ec3m so\u00e1t c\u00f4n tr\u00f9ng, vi sinh v\u1eadt v\u00e0 ph\u00f2ng ng\u1eeba \u00f4 nhi\u1ec5m ch\u00e9o gi\u1eefa c\u00e1c khu v\u1ef1c.<\/p>\n\n\n\n

– Ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng:<\/strong> Thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng ki\u1ec3m tra, th\u1eed nghi\u1ec7m v\u00e0 \u0111\u00e1nh gi\u00e1 s\u1ea3n ph\u1ea9m d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n kh\u00e1ch quan tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng.<\/p>\n\n\n\n

V\u00ed d\u1ee5, trong s\u1ea3n xu\u1ea5t thu\u1ed1c vi\u00ean n\u00e9n, GMP y\u00eau c\u1ea7u nguy\u00ean li\u1ec7u ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra h\u00e0m l\u01b0\u1ee3ng ho\u1ea1t ch\u1ea5t tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng, khu v\u1ef1c ph\u1ed1i tr\u1ed9n ph\u1ea3i \u0111\u1ea1t c\u1ea5p \u0111\u1ed9 s\u1ea1ch ph\u00f9 h\u1ee3p theo EU GMP (GMP c\u1ee7a Li\u00ean minh ch\u00e2u \u00c2u), m\u00e1y d\u1eadp vi\u00ean \u0111\u01b0\u1ee3c hi\u1ec7u chu\u1ea9n h\u00e0ng ng\u00e0y, nh\u00e2n vi\u00ean m\u1eb7c trang ph\u1ee5c b\u1ea3o h\u1ed9 \u0111\u00fang quy \u0111\u1ecbnh v\u00e0 th\u00e0nh ph\u1ea9m ph\u1ea3i tr\u1ea3i qua c\u00e1c th\u1eed nghi\u1ec7m v\u1ec1 \u0111\u1ed9 h\u00f2a tan, \u0111\u1ed9 \u0111\u1ed3ng \u0111\u1ec1u, vi sinh tr\u01b0\u1edbc khi xu\u1ea5t x\u01b0\u1edfng.<\/p>\n\n\n\n

Trong s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m, GMP t\u1eadp trung v\u00e0o vi\u1ec7c ki\u1ec3m so\u00e1t nhi\u1ec7t \u0111\u1ed9 n\u1ea5u ch\u00edn, ng\u0103n ng\u1eeba ti\u1ebfp x\u00fac gi\u1eefa th\u1ef1c ph\u1ea9m s\u1ed1ng v\u00e0 ch\u00edn, \u0111\u1ea3m b\u1ea3o v\u1ec7 sinh tay v\u00e0 d\u1ee5ng c\u1ee5. V\u1edbi m\u1ef9 ph\u1ea9m, GMP nh\u1ea5n m\u1ea1nh vi\u1ec7c ki\u1ec3m so\u00e1t vi sinh v\u1eadt, ph\u00f2ng ng\u1eeba nhi\u1ec5m b\u1ea9n h\u00f3a h\u1ecdc v\u00e0 \u0111\u1ea3m b\u1ea3o \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a c\u00f4ng th\u1ee9c trong su\u1ed1t v\u00f2ng \u0111\u1eddi s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n

\u0110\u1ecdc th\u00eam:<\/strong> S\u1ea3n xu\u1ea5t l\u00e0 g\u00ec? \u1ee8ng d\u1ee5ng c\u00f4ng ngh\u1ec7 v\u00e0o s\u1ea3n xu\u1ea5t th\u1eddi 4.0<\/a><\/p>\n\n\n\n

1.2 S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa GMP, cGMP, GMP-WHO v\u00e0 GMP-EU<\/h3>\n\n\n\n

GMP kh\u00f4ng ch\u1ec9 c\u00f3 m\u1ed9t phi\u00ean b\u1ea3n duy nh\u1ea5t m\u00e0 t\u1ed3n t\u1ea1i d\u01b0\u1edbi nhi\u1ec1u h\u00ecnh th\u1ee9c kh\u00e1c nhau, t\u00f9y theo c\u01a1 quan ban h\u00e0nh v\u00e0 th\u1ecb tr\u01b0\u1eddng \u00e1p d\u1ee5ng. Vi\u1ec7c hi\u1ec3u r\u00f5 s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa c\u00e1c chu\u1ea9n n\u00e0y s\u1ebd gi\u00fap doanh nghi\u1ec7p l\u1ef1a ch\u1ecdn \u0111\u00fang h\u01b0\u1edbng \u0111i ngay t\u1eeb \u0111\u1ea7u.<\/p>\n\n\n\n

– GMP ti\u00eau chu\u1ea9n (Basic GMP):<\/strong> L\u00e0 khung y\u00eau c\u1ea7u n\u1ec1n t\u1ea3ng, th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u01b0 m\u1ee9c t\u1ed1i thi\u1ec3u m\u00e0 c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u00e1p \u1ee9ng. Chu\u1ea9n n\u00e0y t\u1eadp trung v\u00e0o c\u00e1c nguy\u00ean t\u1eafc c\u1ed1t l\u00f5i nh\u01b0 v\u1ec7 sinh, ki\u1ec3m so\u00e1t quy tr\u00ecnh, qu\u1ea3n l\u00fd t\u00e0i li\u1ec7u v\u00e0 \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1.<\/p>\n\n\n\n

– cGMP (current Good Manufacturing Practices): <\/strong>L\u00e0 phi\u00ean b\u1ea3n do FDA Hoa K\u1ef3 ban h\u00e0nh v\u00e0 li\u00ean t\u1ee5c c\u1eadp nh\u1eadt. T\u1eeb \u201ccurrent\u201d (hi\u1ec7n h\u00e0nh) cho th\u1ea5y c\u00e1c y\u00eau c\u1ea7u kh\u00f4ng c\u1ed1 \u0111\u1ecbnh m\u00e0 lu\u00f4n \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh theo ti\u1ebfn b\u1ed9 khoa h\u1ecdc, c\u00f4ng ngh\u1ec7 v\u00e0 kinh nghi\u1ec7m qu\u1ea3n l\u00fd m\u1edbi. cGMP \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng trong l\u0129nh v\u1ef1c d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 m\u1ed9t s\u1ed1 nh\u00f3m th\u1ef1c ph\u1ea9m \u0111\u1eb7c th\u00f9 nh\u01b0 th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng. So v\u1edbi GMP c\u01a1 b\u1ea3n, cGMP \u0111\u00f2i h\u1ecfi h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng nghi\u00eam ng\u1eb7t h\u01a1n, bao g\u1ed3m ki\u1ec3m so\u00e1t thay \u0111\u1ed5i (change control), qu\u1ea3n l\u00fd sai l\u1ec7ch (deviation management) v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro \u0111\u1ecbnh k\u1ef3. T\u1ea1i Vi\u1ec7t Nam, cGMP \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf \u00e1p d\u1ee5ng ch\u00ednh th\u1ee9c trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n

– GMP-WHO: <\/strong>L\u00e0 b\u1ed9 h\u01b0\u1edbng d\u1eabn do T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi ban h\u00e0nh. Chu\u1ea9n n\u00e0y \u0111\u01b0\u1ee3c nhi\u1ec1u qu\u1ed1c gia \u0111ang ph\u00e1t tri\u1ec3n c\u00f4ng nh\u1eadn v\u00e0 s\u1eed d\u1ee5ng l\u00e0m c\u01a1 s\u1edf ph\u00e1p l\u00fd. GMP-WHO \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng theo d\u1ea1ng module, g\u1ed3m ph\u1ea7n h\u01b0\u1edbng d\u1eabn chung v\u00e0 c\u00e1c ph\u1ee5 l\u1ee5c ri\u00eang cho t\u1eebng nh\u00f3m s\u1ea3n ph\u1ea9m nh\u01b0 thu\u1ed1c d\u1ea1ng r\u1eafn, thu\u1ed1c v\u00f4 tr\u00f9ng, sinh ph\u1ea9m, v\u1eafc-xin hay thu\u1ed1c th\u1ea3o d\u01b0\u1ee3c. T\u1ea1i Vi\u1ec7t Nam, GMP-WHO \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn trong h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd thu\u1ed1c v\u00e0 l\u00e0 ti\u00eau chu\u1ea9n ph\u1ed5 bi\u1ebfn \u0111\u1ec3 doanh nghi\u1ec7p xu\u1ea5t kh\u1ea9u sang c\u00e1c th\u1ecb tr\u01b0\u1eddng nh\u01b0 \u0110\u00f4ng Nam \u00c1 v\u00e0 ch\u00e2u Phi.<\/p>\n\n\n\n

– GMP-EU:<\/strong> Do C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m ch\u00e2u \u00c2u (EMA \u2013 European Medicines Agency) x\u00e2y d\u1ef1ng, n\u1ed5i ti\u1ebfng v\u1edbi y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt r\u1ea5t kh\u1eaft khe. EU GMP g\u1ed3m 2 ph\u1ea7n ch\u00ednh: Ph\u1ea7n I \u00e1p d\u1ee5ng cho th\u00e0nh ph\u1ea9m d\u01b0\u1ee3c, Ph\u1ea7n II \u00e1p d\u1ee5ng cho ho\u1ea1t ch\u1ea5t d\u01b0\u1ee3c (API \u2013 Active Pharmaceutical Ingredient). \u0110i\u1ec3m n\u1ed5i b\u1eadt c\u1ee7a EU GMP l\u00e0 ph\u00e2n lo\u1ea1i khu v\u1ef1c s\u1ea3n xu\u1ea5t theo c\u1ea5p \u0111\u1ed9 s\u1ea1ch A, B, C, D v\u1edbi ti\u00eau chu\u1ea9n vi sinh v\u00e0 ti\u1ec3u ph\u00e2n r\u1ea5t cao. EU GMP c\u0169ng g\u1eafn ch\u1eb7t v\u1edbi h\u1ec7 th\u1ed1ng PIC\/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme \u2013 H\u1ec7 th\u1ed1ng h\u1ee3p t\u00e1c thanh tra d\u01b0\u1ee3c ph\u1ea9m qu\u1ed1c t\u1ebf).<\/p>\n\n\n\n

Ti\u00eau ch\u00ed so s\u00e1nh<\/strong><\/td>GMP c\u01a1 b\u1ea3n<\/strong><\/td>cGMP (FDA)<\/strong><\/td>GMP-WHO<\/strong><\/td>GMP-EU<\/strong><\/td><\/tr>
C\u01a1 quan ban h\u00e0nh<\/td>Qu\u1ed1c gia\/v\u00f9ng l\u00e3nh th\u1ed5<\/td>FDA (Hoa K\u1ef3)<\/td>WHO (Qu\u1ed1c t\u1ebf)<\/td>EMA (Li\u00ean minh Ch\u00e2u \u00c2u)<\/td><\/tr>
Ph\u1ea1m vi \u00e1p d\u1ee5ng<\/td>\u0110a ng\u00e0nh<\/td>D\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, th\u1ef1c ph\u1ea9m<\/td>D\u01b0\u1ee3c ph\u1ea9m, v\u1eafc-xin, sinh ph\u1ea9m<\/td>D\u01b0\u1ee3c ph\u1ea9m, API<\/td><\/tr>
M\u1ee9c \u0111\u1ed9 c\u1eadp nh\u1eadt<\/td>\u0110\u1ecbnh k\u1ef3<\/td>Li\u00ean t\u1ee5c, theo c\u00f4ng ngh\u1ec7<\/td>\u0110\u1ecbnh k\u1ef3, c\u1eadp nh\u1eadt theo chuy\u00ean \u0111\u1ec1<\/td>Th\u01b0\u1eddng xuy\u00ean<\/td><\/tr>
Y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt<\/td>Trung b\u00ecnh<\/td>Cao, chi ti\u1ebft<\/td>Trung b\u00ecnh-Cao<\/td>R\u1ea5t cao, ph\u00e2n lo\u1ea1i s\u1ea1ch<\/td><\/tr>
C\u00f4ng nh\u1eadn qu\u1ed1c t\u1ebf<\/td>H\u1ea1n ch\u1ebf<\/td>R\u1ed9ng r\u00e3i (xu\u1ea5t kh\u1ea9u M\u1ef9<\/td>R\u1ed9ng r\u00e3i (\u0111ang ph\u00e1t tri\u1ec3n)<\/td>R\u1ea5t r\u1ed9ng (xu\u1ea5t kh\u1ea9u EU)<\/td><\/tr>
Qu\u1ea3n l\u00fd thay \u0111\u1ed5i<\/td>C\u01a1 b\u1ea3n<\/td>B\u1eaft bu\u1ed9c, nghi\u00eam ng\u1eb7t<\/td>Khuy\u1ebfn ngh\u1ecb<\/td>B\u1eaft bu\u1ed9c, chi ti\u1ebft<\/td><\/tr>
Th\u1ecb tr\u01b0\u1eddng \u01b0u ti\u00ean \u00e1p d\u1ee5ng<\/td>N\u1ed9i \u0111\u1ecba<\/td>Hoa K\u1ef3, Canada<\/td>Ch\u00e2u \u00c1, Ch\u00e2u Phi, M\u1ef9 Latin<\/td>EU, \u00dac, Nh\u1eadt B\u1ea3n<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

S\u1ef1 chuy\u1ec3n d\u1ecbch t\u1eeb GMP truy\u1ec1n th\u1ed1ng sang cGMP th\u1ec3 hi\u1ec7n t\u01b0 duy qu\u1ea3n l\u00fd ti\u1ebfn b\u1ed9 h\u01a1n. Thay v\u00ec ch\u1ec9 tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ed1 \u0111\u1ecbnh, doanh nghi\u1ec7p ph\u1ea3i li\u00ean t\u1ee5c c\u1eadp nh\u1eadt ki\u1ebfn th\u1ee9c, c\u00f4ng ngh\u1ec7 v\u00e0 \u00e1p d\u1ee5ng qu\u1ea3n l\u00fd r\u1ee7i ro d\u1ef1a tr\u00ean c\u01a1 s\u1edf khoa h\u1ecdc. \u0110i\u1ec1u n\u00e0y kh\u00f4ng ch\u1ec9 gi\u00fap n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m m\u00e0 c\u00f2n h\u00ecnh th\u00e0nh v\u0103n h\u00f3a c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c trong to\u00e0n b\u1ed9 t\u1ed5 ch\u1ee9c.<\/p>\n\n\n\n

1.3 T\u1ea7m quan tr\u1ecdng c\u1ee7a GMP trong s\u1ea3n xu\u1ea5t hi\u1ec7n \u0111\u1ea1i<\/h3>\n\n\n\n

GMP kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd m\u00e0 c\u00f2n l\u00e0 n\u1ec1n t\u1ea3ng quan tr\u1ecdng gi\u00fap doanh nghi\u1ec7p ph\u00e1t tri\u1ec3n b\u1ec1n v\u1eefng trong b\u1ed1i c\u1ea3nh c\u1ea1nh tranh v\u00e0 h\u1ed9i nh\u1eadp to\u00e0n c\u1ea7u. Vai tr\u00f2 c\u1ee7a GMP th\u1ec3 hi\u1ec7n r\u00f5 \u1edf nhi\u1ec1u kh\u00eda c\u1ea1nh, t\u1eeb an to\u00e0n s\u1ea3n ph\u1ea9m \u0111\u1ebfn hi\u1ec7u qu\u1ea3 kinh doanh v\u00e0 n\u0103ng l\u1ef1c v\u1eadn h\u00e0nh n\u1ed9i b\u1ed9.<\/p>\n\n\n\n

Tr\u01b0\u1edbc h\u1ebft, GMP gi\u00fap b\u1ea3o v\u1ec7 ng\u01b0\u1eddi ti\u00eau d\u00f9ng kh\u1ecfi c\u00e1c r\u1ee7i ro li\u00ean quan \u0111\u1ebfn s\u1ea3n ph\u1ea9m k\u00e9m ch\u1ea5t l\u01b0\u1ee3ng, nhi\u1ec5m b\u1ea9n ho\u1eb7c kh\u00f4ng \u0111\u1ed3ng nh\u1ea5t gi\u1eefa c\u00e1c l\u00f4 s\u1ea3n xu\u1ea5t. Trong ng\u00e0nh d\u01b0\u1ee3c, ch\u1ec9 m\u1ed9t vi\u00ean thu\u1ed1c kh\u00f4ng \u0111\u1ea1t chu\u1ea9n c\u0169ng c\u00f3 th\u1ec3 g\u00e2y t\u00e1c d\u1ee5ng ph\u1ee5 nghi\u00eam tr\u1ecdng ho\u1eb7c l\u00e0m gi\u1ea3m hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb. V\u1edbi th\u1ef1c ph\u1ea9m, \u00f4 nhi\u1ec5m vi sinh c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn ng\u1ed9 \u0111\u1ed9c tr\u00ean di\u1ec7n r\u1ed9ng. GMP thi\u1ebft l\u1eadp nhi\u1ec1u l\u1edbp ki\u1ec3m so\u00e1t ph\u00f2ng ng\u1eeba, b\u1eaft \u0111\u1ea7u t\u1eeb nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o, \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t, \u0111\u1ebfn kh\u00e2u ki\u1ec3m tra th\u00e0nh ph\u1ea9m, nh\u1eb1m \u0111\u1ea3m b\u1ea3o m\u1ed7i l\u00f4 h\u00e0ng \u0111\u1ec1u \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e3 cam k\u1ebft.<\/p>\n\n\n\n

\u1ede g\u00f3c \u0111\u1ed9 kinh doanh, GMP g\u00f3p ph\u1ea7n n\u00e2ng cao uy t\u00edn v\u00e0 h\u00ecnh \u1ea3nh th\u01b0\u01a1ng hi\u1ec7u c\u1ee7a doanh nghi\u1ec7p. Vi\u1ec7c \u0111\u1ea1t ch\u1ee9ng nh\u1eadn GMP t\u1eeb c\u00e1c t\u1ed5 ch\u1ee9c uy t\u00edn l\u00e0 b\u1eb1ng ch\u1ee9ng r\u00f5 r\u00e0ng cho n\u0103ng l\u1ef1c qu\u1ea3n tr\u1ecb ch\u1ea5t l\u01b0\u1ee3ng. \u0110i\u1ec1u n\u00e0y gi\u00fap doanh nghi\u1ec7p t\u1ea1o \u0111\u01b0\u1ee3c ni\u1ec1m tin v\u1edbi kh\u00e1ch h\u00e0ng, \u0111\u1ed1i t\u00e1c v\u00e0 c\u01a1 quan qu\u1ea3n l\u00fd. Nhi\u1ec1u t\u1eadp \u0111o\u00e0n \u0111a qu\u1ed1c gia ch\u1ec9 l\u1ef1a ch\u1ecdn nh\u00e0 cung c\u1ea5p \u0111\u00e3 \u0111\u1ea1t GMP, v\u00e0 c\u00e1c h\u1ec7 th\u1ed1ng ph\u00e2n ph\u1ed1i l\u1edbn, si\u00eau th\u1ecb hi\u1ec7n \u0111\u1ea1i c\u0169ng \u01b0u ti\u00ean s\u1ea3n ph\u1ea9m \u0111\u1ebfn t\u1eeb nh\u1eefng c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t \u0111\u1ea1t chu\u1ea9n.<\/p>\n\n\n\n

M\u1ed9t l\u1ee3i \u00edch quan tr\u1ecdng kh\u00e1c c\u1ee7a GMP l\u00e0 kh\u1ea3 n\u0103ng m\u1edf r\u1ed9ng th\u1ecb tr\u01b0\u1eddng, \u0111\u1eb7c bi\u1ec7t l\u00e0 xu\u1ea5t kh\u1ea9u. Ph\u1ea7n l\u1edbn c\u00e1c qu\u1ed1c gia \u0111\u1ec1u y\u00eau c\u1ea7u s\u1ea3n ph\u1ea9m nh\u1eadp kh\u1ea9u ph\u1ea3i \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf \u0111\u1ea1t GMP \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn. V\u00ed d\u1ee5, doanh nghi\u1ec7p d\u01b0\u1ee3c t\u1ea1i Vi\u1ec7t Nam \u0111\u1ea1t GMP-WHO c\u00f3 th\u1ec3 ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng c\u1ee7a h\u01a1n 100 qu\u1ed1c gia th\u00e0nh vi\u00ean WHO. T\u01b0\u01a1ng t\u1ef1, doanh nghi\u1ec7p th\u1ef1c ph\u1ea9m \u0111\u1ea1t GMP theo chu\u1ea9n qu\u1ed1c t\u1ebf s\u1ebd thu\u1eadn l\u1ee3i h\u01a1n khi th\u00e2m nh\u1eadp c\u00e1c th\u1ecb tr\u01b0\u1eddng kh\u00f3 t\u00ednh nh\u01b0 Nh\u1eadt B\u1ea3n, H\u00e0n Qu\u1ed1c, Li\u00ean minh ch\u00e2u \u00c2u v\u00e0 Hoa K\u1ef3.<\/p>\n\n\n\n

Trong ho\u1ea1t \u0111\u1ed9ng n\u1ed9i b\u1ed9, GMP gi\u00fap doanh nghi\u1ec7p chu\u1ea9n h\u00f3a quy tr\u00ecnh, gi\u1ea3m l\u00e3ng ph\u00ed v\u00e0 n\u00e2ng cao hi\u1ec7u su\u1ea5t s\u1ea3n xu\u1ea5t. H\u1ec7 th\u1ed1ng t\u00e0i li\u1ec7u r\u00f5 r\u00e0ng v\u00e0 quy tr\u00ecnh th\u1ed1ng nh\u1ea5t gi\u00fap h\u1ea1n ch\u1ebf sai s\u00f3t do con ng\u01b0\u1eddi, r\u00fat ng\u1eafn th\u1eddi gian \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1 m\u1edbi v\u00e0 gi\u1ea3m s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng gi\u1eefa c\u00e1c ca s\u1ea3n xu\u1ea5t. Vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd nguy\u00ean v\u1eadt li\u1ec7u c\u0169ng gi\u00fap tr\u00e1nh t\u1ed3n kho qu\u00e1 h\u1ea1n ho\u1eb7c suy gi\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng. Nhi\u1ec1u doanh nghi\u1ec7p sau khi \u00e1p d\u1ee5ng GMP \u0111\u00e3 gi\u1ea3m t\u1ef7 l\u1ec7 s\u1ea3n ph\u1ea9m l\u1ed7i t\u1eeb m\u1ee9c 15\u201320% xu\u1ed1ng c\u00f2n d\u01b0\u1edbi 2\u20133%, qua \u0111\u00f3 ti\u1ebft ki\u1ec7m \u0111\u00e1ng k\u1ec3 chi ph\u00ed t\u00e1i ch\u1ebf v\u00e0 lo\u1ea1i b\u1ecf h\u00e0ng kh\u00f4ng \u0111\u1ea1t.<\/p>\n\n\n\n

Cu\u1ed1i c\u00f9ng, GMP g\u00f3p ph\u1ea7n x\u00e2y d\u1ef1ng v\u0103n h\u00f3a tr\u00e1ch nhi\u1ec7m v\u00e0 c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c trong doanh nghi\u1ec7p. Khi t\u1ea5t c\u1ea3 nh\u00e2n s\u1ef1, t\u1eeb l\u00e3nh \u0111\u1ea1o \u0111\u1ebfn c\u00f4ng nh\u00e2n tr\u1ef1c ti\u1ebfp s\u1ea3n xu\u1ea5t, \u0111\u1ec1u hi\u1ec3u v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c nguy\u00ean t\u1eafc GMP, doanh nghi\u1ec7p s\u1ebd h\u00ecnh th\u00e0nh \u0111\u01b0\u1ee3c n\u1ec1n t\u1ea3ng ch\u1ea5t l\u01b0\u1ee3ng v\u1eefng ch\u1eafc. \u0110\u00e2y ch\u00ednh l\u00e0 c\u01a1 s\u1edf \u0111\u1ec3 t\u1ed5 ch\u1ee9c linh ho\u1ea1t th\u00edch \u1ee9ng v\u1edbi thay \u0111\u1ed5i c\u1ee7a th\u1ecb tr\u01b0\u1eddng, c\u00f4ng ngh\u1ec7 v\u00e0 c\u00e1c y\u00eau c\u1ea7u qu\u1ea3n l\u00fd ng\u00e0y c\u00e0ng cao trong t\u01b0\u01a1ng lai.<\/p>\n\n\n

\n
\"T\u1ea7m
T\u1ea7m quan tr\u1ecdng c\u1ee7a GMP trong s\u1ea3n xu\u1ea5t hi\u1ec7n \u0111\u1ea1i<\/em><\/figcaption><\/figure><\/div>\n\n\n

2. GMP gi\u00fap doanh nghi\u1ec7p ph\u00f2ng ng\u1eeba r\u1ee7i ro th\u1ebf n\u00e0o?<\/h2>\n\n\n\n

Trong s\u1ea3n xu\u1ea5t, r\u1ee7i ro lu\u00f4n hi\u1ec7n h\u1eefu, t\u1eeb \u00f4 nhi\u1ec5m s\u1ea3n ph\u1ea9m, tr\u1ee5c tr\u1eb7c k\u1ef9 thu\u1eadt \u0111\u1ebfn sai s\u00f3t do con ng\u01b0\u1eddi. GMP \u0111\u00f3ng vai tr\u00f2 nh\u01b0 m\u1ed9t h\u1ec7 th\u1ed1ng ph\u00f2ng ng\u1eeba nhi\u1ec1u l\u1edbp, gi\u00fap doanh nghi\u1ec7p nh\u1eadn di\u1ec7n s\u1edbm, ki\u1ec3m so\u00e1t v\u00e0 gi\u1ea3m thi\u1ec3u r\u1ee7i ro ngay t\u1eeb \u0111\u1ea7u, thay v\u00ec x\u1eed l\u00fd h\u1eadu qu\u1ea3 khi s\u1ef1 c\u1ed1 \u0111\u00e3 x\u1ea3y ra.<\/p>\n\n\n\n

– Ph\u00f2ng ng\u1eeba r\u1ee7i ro \u00f4 nhi\u1ec5m:<\/strong> \u00d4 nhi\u1ec5m l\u00e0 r\u1ee7i ro nghi\u00eam tr\u1ecdng nh\u1ea5t trong s\u1ea3n xu\u1ea5t, bao g\u1ed3m \u00f4 nhi\u1ec5m vi sinh (vi khu\u1ea9n, n\u1ea5m m\u1ed1c), \u00f4 nhi\u1ec5m h\u00f3a h\u1ecdc (t\u1ea1p ch\u1ea5t, dung m\u00f4i d\u01b0, kim lo\u1ea1i n\u1eb7ng) v\u00e0 \u00f4 nhi\u1ec5m v\u1eadt l\u00fd (b\u1ee5i, m\u1ea3nh v\u1ee5n, s\u1ee3i v\u1ea3i). GMP ki\u1ec3m so\u00e1t r\u1ee7i ro n\u00e0y th\u00f4ng qua thi\u1ebft k\u1ebf nh\u00e0 x\u01b0\u1edfng theo nguy\u00ean t\u1eafc ph\u00e2n v\u00f9ng, t\u00e1ch bi\u1ec7t khu v\u1ef1c s\u1ea1ch v\u00e0 khu v\u1ef1c c\u00f3 nguy c\u01a1 cao. Kh\u00f4ng kh\u00ed trong khu s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u00e1p su\u1ea5t v\u00e0 l\u1ecdc qua HEPA (High-Efficiency Particulate Air \u2013 b\u1ed9 l\u1ecdc b\u1ee5i hi\u1ec7u su\u1ea5t cao, lo\u1ea1i b\u1ecf 99,97% h\u1ea1t b\u1ee5i 0,3 micromet). B\u00ean c\u1ea1nh \u0111\u00f3, quy tr\u00ecnh v\u1ec7 sinh \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh r\u00f5 r\u00e0ng v\u1ec1 c\u00e1ch l\u00e0m v\u00e0 t\u1ea7n su\u1ea5t, t\u1eeb v\u1ec7 sinh thi\u1ebft b\u1ecb sau m\u1ed7i l\u00f4 \u0111\u1ebfn kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3 khu v\u1ef1c s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n

– Gi\u1ea3m r\u1ee7i ro l\u1ed7i k\u1ef9 thu\u1eadt:<\/strong> L\u1ed7i k\u1ef9 thu\u1eadt x\u1ea3y ra khi thi\u1ebft b\u1ecb v\u1eadn h\u00e0nh sai th\u00f4ng s\u1ed1, c\u00e2n \u0111ong kh\u00f4ng ch\u00ednh x\u00e1c, nhi\u1ec7t \u0111\u1ed9 ho\u1eb7c th\u1eddi gian x\u1eed l\u00fd kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u. GMP y\u00eau c\u1ea7u c\u00e1c thi\u1ebft b\u1ecb quan tr\u1ecdng ph\u1ea3i \u0111\u01b0\u1ee3c hi\u1ec7u chu\u1ea9n \u0111\u1ecbnh k\u1ef3 v\u00e0 x\u00e1c nh\u1eadn thi\u1ebft b\u1ecb ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang khi l\u1eafp \u0111\u1eb7t m\u1edbi ho\u1eb7c sau s\u1eeda ch\u1eefa l\u1edbn. C\u00e1c th\u00f4ng s\u1ed1 quan tr\u1ecdng c\u1ee7a quy tr\u00ecnh (Critical Process Parameters) \u0111\u01b0\u1ee3c theo d\u00f5i li\u00ean t\u1ee5c v\u00e0 c\u00f3 c\u1ea3nh b\u00e1o khi x\u1ea3y ra sai l\u1ec7ch. Ngo\u00e0i ra, b\u1ea3o tr\u00ec ph\u00f2ng ng\u1eeba (preventive maintenance) s\u1ebd gi\u00fap h\u1ea1n ch\u1ebf h\u1ecfng h\u00f3c \u0111\u1ed9t xu\u1ea5t v\u00e0 gi\u00e1n \u0111o\u1ea1n s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n

– H\u1ea1n ch\u1ebf sai s\u00f3t do con ng\u01b0\u1eddi:<\/strong> Sai s\u00f3t c\u1ee7a nh\u00e2n vi\u00ean nh\u01b0 qu\u00ean b\u01b0\u1edbc thao t\u00e1c, nh\u1ea7m nguy\u00ean li\u1ec7u, ghi ch\u00e9p kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 l\u00e0 nguy\u00ean nh\u00e2n ph\u1ed5 bi\u1ebfn g\u00e2y s\u1ef1 c\u1ed1 ch\u1ea5t l\u01b0\u1ee3ng. GMP kh\u1eafc ph\u1ee5c v\u1ea5n \u0111\u1ec1 n\u00e0y b\u1eb1ng h\u1ec7 th\u1ed1ng SOP (Standard Operating Procedure \u2013 quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n)<\/a> \u0111\u01b0\u1ee3c vi\u1ebft r\u00e0nh m\u1ea1ch, d\u1ec5 hi\u1ec3u cho t\u1eebng c\u00f4ng vi\u1ec7c. Nh\u00e2n vi\u00ean ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o, \u0111\u00e1nh gi\u00e1 n\u0103ng l\u1ef1c tr\u01b0\u1edbc khi l\u00e0m vi\u1ec7c \u0111\u1ed9c l\u1eadp. V\u1edbi c\u00e1c thao t\u00e1c quan tr\u1ecdng, GMP \u00e1p d\u1ee5ng nguy\u00ean t\u1eafc b\u1ed1n m\u1eaft (four-eyes principle \u2013 hai ng\u01b0\u1eddi ki\u1ec3m tra ch\u00e9o) \u0111\u1ec3 gi\u1ea3m r\u1ee7i ro nh\u1ea7m l\u1eabn. B\u00ean c\u1ea1nh \u0111\u00f3, m\u00f4i tr\u01b0\u1eddng l\u00e0m vi\u1ec7c \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf theo nguy\u00ean t\u1eafc poka-yoke (ch\u1ed1ng sai l\u1ea7m), v\u00ed d\u1ee5 ph\u00e2n bi\u1ec7t m\u00e0u s\u1eafc, k\u00edch th\u01b0\u1edbc d\u1ee5ng c\u1ee5 ho\u1eb7c \u0111\u1ea7u n\u1ed1i \u0111\u1ec3 tr\u00e1nh l\u1eafp sai.<\/p>\n\n\n\n

– Ki\u1ec3m so\u00e1t r\u1ee7i ro nhi\u1ec5m ch\u00e9o:<\/strong> Nhi\u1ec5m ch\u00e9o x\u1ea3y ra khi s\u1ea3n ph\u1ea9m n\u00e0y l\u1eabn th\u00e0nh ph\u1ea7n c\u1ee7a s\u1ea3n ph\u1ea9m kh\u00e1c, \u0111\u1eb7c bi\u1ec7t nguy hi\u1ec3m v\u1edbi d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m g\u00e2y d\u1ecb \u1ee9ng. GMP ki\u1ec3m so\u00e1t b\u1eb1ng c\u00e1ch s\u1ea3n xu\u1ea5t theo chi\u1ebfn d\u1ecbch, sau \u0111\u00f3 th\u1ef1c hi\u1ec7n l\u00e0m s\u1ea1ch v\u00e0 x\u00e1c nh\u1eadn \u0111\u1ed9 s\u1ea1ch (cleaning validation). V\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m nguy c\u01a1 cao nh\u01b0 kh\u00e1ng sinh ho\u1eb7c hormone, GMP y\u00eau c\u1ea7u khu v\u1ef1c v\u00e0 thi\u1ebft b\u1ecb s\u1ea3n xu\u1ea5t ri\u00eang bi\u1ec7t.<\/p>\n\n\n\n

L\u01b0u \u00fd, GMP kh\u00f4ng gi\u00fap lo\u1ea1i b\u1ecf ho\u00e0n to\u00e0n r\u1ee7i ro, \u0111i\u1ec1u g\u1ea7n nh\u01b0 kh\u00f4ng th\u1ec3 trong s\u1ea3n xu\u1ea5t. Tuy nhi\u00ean, GMP gi\u00fap gi\u1ea3m r\u1ee7i ro xu\u1ed1ng m\u1ee9c ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c v\u00e0 thi\u1ebft l\u1eadp c\u01a1 ch\u1ebf ph\u00e1t hi\u1ec7n, x\u1eed l\u00fd nhanh khi c\u00f3 v\u1ea5n \u0111\u1ec1. Nh\u1edd \u0111\u00f3, doanh nghi\u1ec7p b\u1ea3o v\u1ec7 \u0111\u01b0\u1ee3c ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd.<\/p>\n\n\n

\n
\"GMP
GMP gi\u00fap doanh nghi\u1ec7p ph\u00f2ng ng\u1eeba r\u1ee7i ro th\u1ebf n\u00e0o?<\/em><\/figcaption><\/figure><\/div>\n\n\n

3. C\u00e1c nguy\u00ean t\u1eafc c\u1ed1t l\u00f5i c\u1ee7a GMP<\/h2>\n\n\n\n

3.1 10 nguy\u00ean t\u1eafc GMP theo WHO v\u00e0 FDA<\/h3>\n\n\n\n

C\u1ea3 WHO v\u00e0 FDA \u0111\u1ec1u th\u1ed1ng nh\u1ea5t r\u1eb1ng GMP ph\u1ea3i d\u1ef1a tr\u00ean nh\u1eefng nguy\u00ean t\u1eafc nh\u1ea5t \u0111\u1ecbnh, \u00e1p d\u1ee5ng cho m\u1ecdi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t. D\u00f9 c\u00e1ch tr\u00ecnh b\u00e0y c\u00f3 kh\u00e1c nhau, 10 nguy\u00ean t\u1eafc d\u01b0\u1edbi \u0111\u00e2y \u0111\u01b0\u1ee3c xem l\u00e0 \u201cx\u01b0\u01a1ng s\u1ed1ng\u201d c\u1ee7a h\u1ec7 th\u1ed1ng GMP hi\u1ec7n \u0111\u1ea1i.<\/p>\n\n\n\n

1. X\u00e2y d\u1ef1ng h\u1ec7 th\u1ed1ng \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng to\u00e0n di\u1ec7n:<\/strong><\/p>\n\n\n\n

Ch\u1ea5t l\u01b0\u1ee3ng kh\u00f4ng ph\u1ea3i ch\u1ec9 \u0111\u01b0\u1ee3c ki\u1ec3m tra \u1edf kh\u00e2u cu\u1ed1i, m\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t xuy\u00ean su\u1ed1t to\u00e0n b\u1ed9 qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. Doanh nghi\u1ec7p c\u1ea7n x\u00e2y d\u1ef1ng h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (Quality Management System) bao ph\u1ee7 t\u1eeb nghi\u00ean c\u1ee9u, thu mua nguy\u00ean li\u1ec7u, s\u1ea3n xu\u1ea5t, ki\u1ec3m nghi\u1ec7m, l\u01b0u kho, ph\u00e2n ph\u1ed1i \u0111\u1ebfn x\u1eed l\u00fd khi\u1ebfu n\u1ea1i. Tr\u00e1ch nhi\u1ec7m ph\u1ea3i \u0111\u01b0\u1ee3c ph\u00e2n c\u00f4ng r\u00f5 r\u00e0ng v\u00e0 b\u1ed9 ph\u1eadn ch\u1ea5t l\u01b0\u1ee3ng ph\u1ea3i \u0111\u1ed9c l\u1eadp v\u1edbi \u00e1p l\u1ef1c ti\u1ebfn \u0111\u1ed9. V\u00ed d\u1ee5, b\u1ed9 ph\u1eadn \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng (QA) c\u00f3 quy\u1ec1n kh\u00f4ng cho xu\u1ea5t x\u01b0\u1edfng m\u1ed9t l\u00f4 h\u00e0ng n\u1ebfu ph\u00e1t hi\u1ec7n kh\u00f4ng \u0111\u1ea1t, d\u00f9 \u0111i\u1ec1u n\u00e0y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn k\u1ebf ho\u1ea1ch giao h\u00e0ng.<\/p>\n\n\n\n

2. T\u00e0i li\u1ec7u h\u00f3a \u0111\u1ea7y \u0111\u1ee7 v\u00e0 ch\u00ednh x\u00e1c:<\/strong><\/p>\n\n\n\n

Nguy\u00ean t\u1eafc c\u1ed1t l\u00f5i c\u1ee7a GMP l\u00e0 \u201cl\u00e0m \u0111\u00fang nh\u1eefng g\u00ec \u0111\u00e3 vi\u1ebft v\u00e0 ghi l\u1ea1i \u0111\u00fang nh\u1eefng g\u00ec \u0111\u00e3 l\u00e0m\u201d. M\u1ecdi ho\u1ea1t \u0111\u1ed9ng quan tr\u1ecdng \u0111\u1ec1u ph\u1ea3i c\u00f3 t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn nh\u01b0 SOP, h\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c ho\u1eb7c c\u00f4ng th\u1ee9c g\u1ed1c, v\u00e0 c\u00f3 h\u1ed3 s\u01a1 ghi nh\u1eadn khi th\u1ef1c hi\u1ec7n nh\u01b0 h\u1ed3 s\u01a1 l\u00f4, s\u1ed5 theo d\u00f5i. T\u00e0i li\u1ec7u ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t phi\u00ean b\u1ea3n \u0111\u1ec3 tr\u00e1nh d\u00f9ng nh\u1ea7m b\u1ea3n c\u0169. Vi\u1ec7c ghi ch\u00e9p ph\u1ea3i th\u1ef1c hi\u1ec7n ngay t\u1ea1i th\u1eddi \u0111i\u1ec3m thao t\u00e1c, kh\u00f4ng ghi b\u1ed5 sung sau. N\u1ebfu c\u1ea7n s\u1eeda, ph\u1ea3i g\u1ea1ch ngang, ghi r\u00f5 l\u00fd do, k\u00fd t\u00ean v\u00e0 ghi ng\u00e0y. Nh\u1edd \u0111\u00f3, doanh nghi\u1ec7p c\u00f3 th\u1ec3 truy xu\u1ea5t nguy\u00ean nh\u00e2n khi x\u1ea3y ra s\u1ef1 c\u1ed1 ho\u1eb7c khi\u1ebfu n\u1ea1i.<\/p>\n\n\n\n

3. X\u00e1c nh\u1eadn v\u00e0 hi\u1ec7u chu\u1ea9n thi\u1ebft b\u1ecb:<\/strong><\/p>\n\n\n\n

Thi\u1ebft b\u1ecb s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m tra ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng minh l\u00e0 ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang y\u00eau c\u1ea7u. \u0110i\u1ec1u n\u00e0y \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n th\u00f4ng qua c\u00e1c b\u01b0\u1edbc x\u00e1c nh\u1eadn nh\u01b0 IQ (Installation Qualification \u2013 x\u00e1c nh\u1eadn l\u1eafp \u0111\u1eb7t), OQ (Operational Qualification \u2013 x\u00e1c nh\u1eadn v\u1eadn h\u00e0nh) v\u00e0 PQ (Performance Qualification \u2013 x\u00e1c nh\u1eadn hi\u1ec7u n\u0103ng). C\u00e1c thi\u1ebft b\u1ecb \u0111o nh\u01b0 c\u00e2n, nhi\u1ec7t k\u1ebf, m\u00e1y \u0111o pH ph\u1ea3i \u0111\u01b0\u1ee3c hi\u1ec7u chu\u1ea9n \u0111\u1ecbnh k\u1ef3 theo chu\u1ea9n \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn v\u00e0 d\u00e1n tem ghi r\u00f5 th\u1eddi h\u1ea1n hi\u1ec7u chu\u1ea9n. V\u00ed d\u1ee5, c\u00e2n d\u00f9ng \u0111\u1ec3 c\u00e2n nguy\u00ean li\u1ec7u ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra nhanh m\u1ed7i ng\u00e0y v\u00e0 hi\u1ec7u chu\u1ea9n ch\u00ednh th\u1ee9c theo chu k\u1ef3 h\u00e0ng n\u0103m.<\/p>\n\n\n\n

4. Ki\u1ec3m so\u00e1t nguy\u00ean li\u1ec7u v\u00e0 bao b\u00ec:<\/strong><\/p>\n\n\n\n

Nguy\u00ean li\u1ec7u v\u00e0 bao b\u00ec ch\u1ec9 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng khi \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m tra v\u00e0 x\u00e1c nh\u1eadn \u0111\u1ea1t y\u00eau c\u1ea7u. GMP y\u00eau c\u1ea7u ph\u00e2n bi\u1ec7t r\u00f5 tr\u1ea1ng th\u00e1i c\u1ee7a nguy\u00ean li\u1ec7u nh\u01b0 \u201cch\u1edd ki\u1ec3m tra\u201d, \u201c\u0111\u1ea1t\u201d ho\u1eb7c \u201ckh\u00f4ng \u0111\u1ea1t\u201d b\u1eb1ng nh\u00e3n ho\u1eb7c khu v\u1ef1c l\u01b0u tr\u1eef ri\u00eang. Nguy\u00ean t\u1eafc FIFO (First In First Out \u2013 nh\u1eadp tr\u01b0\u1edbc d\u00f9ng tr\u01b0\u1edbc) ho\u1eb7c FEFO (First Expired First Out \u2013 h\u1ebft h\u1ea1n tr\u01b0\u1edbc d\u00f9ng tr\u01b0\u1edbc) \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng \u0111\u1ec3 tr\u00e1nh d\u00f9ng nguy\u00ean li\u1ec7u qu\u00e1 h\u1ea1n ho\u1eb7c suy gi\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n\n\n\n

5. Ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd quy tr\u00ecnh s\u1ea3n xu\u1ea5t:<\/strong><\/p>\n\n\n\n

Quy tr\u00ecnh s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 ki\u1ec3m so\u00e1t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o s\u1ea3n ph\u1ea9m \u1ed5n \u0111\u1ecbnh gi\u1eefa c\u00e1c l\u00f4. Nh\u1eefng th\u00f4ng s\u1ed1 quan tr\u1ecdng nh\u01b0 nhi\u1ec7t \u0111\u1ed9, th\u1eddi gian, t\u1ed1c \u0111\u1ed9 khu\u1ea5y hay \u00e1p su\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c theo d\u00f5i v\u00e0 ghi nh\u1eadn. GMP y\u00eau c\u1ea7u ki\u1ec3m tra trong qu\u00e1 tr\u00ecnh (In-Process Control \u2013 ki\u1ec3m so\u00e1t trong qu\u00e1 tr\u00ecnh) \u0111\u1ec3 ph\u00e1t hi\u1ec7n sai l\u1ec7ch s\u1edbm, thay v\u00ec ch\u1edd \u0111\u1ebfn khi s\u1ea3n ph\u1ea9m ho\u00e0n th\u00e0nh m\u1edbi ki\u1ec3m tra.<\/p>\n\n\n\n

6. \u0110\u00e0o t\u1ea1o v\u00e0 n\u00e2ng cao nh\u1eadn th\u1ee9c cho nh\u00e2n vi\u00ean:<\/strong><\/p>\n\n\n\n

Con ng\u01b0\u1eddi l\u00e0 y\u1ebfu t\u1ed1 then ch\u1ed1t trong GMP. Nh\u00e2n vi\u00ean ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o v\u1ec1 GMP c\u01a1 b\u1ea3n, v\u1ec7 sinh c\u00e1 nh\u00e2n v\u00e0 c\u00e1c quy tr\u00ecnh li\u00ean quan tr\u1ef1c ti\u1ebfp \u0111\u1ebfn c\u00f4ng vi\u1ec7c c\u1ee7a h\u1ecd. M\u1ed7i kh\u00f3a \u0111\u00e0o t\u1ea1o \u0111\u1ec1u ph\u1ea3i c\u00f3 h\u1ed3 s\u01a1 ghi nh\u1eadn v\u00e0 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3. \u0110\u00e0o t\u1ea1o kh\u00f4ng ch\u1ec9 d\u00e0nh cho nh\u00e2n vi\u00ean m\u1edbi m\u00e0 c\u00f2n ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 c\u1eadp nh\u1eadt thay \u0111\u1ed5i v\u00e0 c\u1ee7ng c\u1ed1 ki\u1ebfn th\u1ee9c.<\/p>\n\n\n\n

7. V\u1ec7 sinh v\u00e0 ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t:<\/strong><\/p>\n\n\n\n

M\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t c\u1ea7n \u0111\u01b0\u1ee3c duy tr\u00ec s\u1ea1ch s\u1ebd \u0111\u1ec3 ng\u0103n ng\u1eeba \u00f4 nhi\u1ec5m v\u00e0 nhi\u1ec5m ch\u00e9o. GMP y\u00eau c\u1ea7u c\u00f3 quy tr\u00ecnh v\u1ec7 sinh chi ti\u1ebft cho t\u1eebng khu v\u1ef1c v\u00e0 thi\u1ebft b\u1ecb, quy \u0111\u1ecbnh r\u00f5 c\u00e1ch l\u00e0m v\u00e0 t\u1ea7n su\u1ea5t. \u0110\u1ed3ng th\u1eddi, ph\u1ea3i ki\u1ec3m so\u00e1t c\u00f4n tr\u00f9ng v\u00e0 \u0111\u1ed9ng v\u1eadt g\u00e2y h\u1ea1i, c\u0169ng nh\u01b0 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng \u0111\u1ecbnh k\u1ef3 nh\u01b0 vi sinh kh\u00f4ng kh\u00ed, vi sinh b\u1ec1 m\u1eb7t ho\u1eb7c s\u1ed1 l\u01b0\u1ee3ng h\u1ea1t b\u1ee5i trong khu v\u1ef1c s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n

8. Qu\u1ea3n l\u00fd sai l\u1ec7ch v\u00e0 khi\u1ebfu n\u1ea1i:<\/strong><\/p>\n\n\n\n

M\u1ecdi sai l\u1ec7ch so v\u1edbi quy tr\u00ecnh (deviation), k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m kh\u00f4ng \u0111\u1ea1t (out of specification) ho\u1eb7c khi\u1ebfu n\u1ea1i t\u1eeb kh\u00e1ch h\u00e0ng \u0111\u1ec1u ph\u1ea3i \u0111\u01b0\u1ee3c ghi nh\u1eadn v\u00e0 \u0111i\u1ec1u tra. Doanh nghi\u1ec7p c\u1ea7n x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 (root cause analysis) v\u00e0 th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c, ph\u00f2ng ng\u1eeba (CAPA \u2013 corrective and preventive action<\/a>) \u0111\u1ec3 tr\u00e1nh l\u1eb7p l\u1ea1i l\u1ed7i t\u01b0\u01a1ng t\u1ef1.<\/p>\n\n\n\n

9. Truy xu\u1ea5t v\u00e0 thu h\u1ed3i s\u1ea3n ph\u1ea9m:<\/strong><\/p>\n\n\n\n

GMP y\u00eau c\u1ea7u h\u1ec7 th\u1ed1ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c cho ph\u00e9p x\u00e1c \u0111\u1ecbnh nhanh nguy\u00ean li\u1ec7u \u0111\u00e3 d\u00f9ng, quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 n\u01a1i ph\u00e2n ph\u1ed1i c\u1ee7a t\u1eebng l\u00f4 s\u1ea3n ph\u1ea9m. H\u1ec7 th\u1ed1ng n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra \u0111\u1ecbnh k\u1ef3 b\u1eb1ng c\u00e1c b\u00e0i t\u1eadp thu h\u1ed3i gi\u1ea3 \u0111\u1ecbnh (mock recall) \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o khi c\u00f3 s\u1ef1 c\u1ed1, doanh nghi\u1ec7p c\u00f3 th\u1ec3 thu h\u1ed3i s\u1ea3n ph\u1ea9m nhanh ch\u00f3ng.<\/p>\n\n\n\n

10. Ch\u1ec9 ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m sau khi \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t:<\/strong><\/p>\n\n\n\n

Kh\u00f4ng l\u00f4 s\u1ea3n ph\u1ea9m n\u00e0o \u0111\u01b0\u1ee3c ph\u00e9p \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng n\u1ebfu ch\u01b0a \u0111\u01b0\u1ee3c b\u1ed9 ph\u1eadn QA<\/a> ch\u00ednh th\u1ee9c ph\u00ea duy\u1ec7t. Vi\u1ec7c ph\u00ea duy\u1ec7t d\u1ef1a tr\u00ean vi\u1ec7c xem x\u00e9t to\u00e0n b\u1ed9 h\u1ed3 s\u01a1 l\u00f4, k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m v\u00e0 c\u00e1c sai l\u1ec7ch (n\u1ebfu c\u00f3). Doanh nghi\u1ec7p c\u0169ng ph\u1ea3i l\u01b0u m\u1eabu \u0111\u1ea1i di\u1ec7n c\u1ee7a m\u1ed7i l\u00f4 (retention sample) trong su\u1ed1t th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng v\u00e0 m\u1ed9t kho\u1ea3ng th\u1eddi gian sau \u0111\u00f3 \u0111\u1ec3 ph\u1ee5c v\u1ee5 \u0111i\u1ec1u tra khi c\u1ea7n.<\/p>\n\n\n

\n
\"C\u00e1c
C\u00e1c nguy\u00ean t\u1eafc c\u1ed1t l\u00f5i c\u1ee7a GMP<\/em><\/figcaption><\/figure><\/div>\n\n\n

3.2 Y\u00eau c\u1ea7u v\u1ec1 nh\u00e0 x\u01b0\u1edfng, thi\u1ebft b\u1ecb v\u00e0 v\u1ec7 sinh<\/h3>\n\n\n\n

C\u01a1 s\u1edf v\u1eadt ch\u1ea5t l\u00e0 n\u1ec1n t\u1ea3ng quan tr\u1ecdng \u0111\u1ec3 GMP \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng hi\u1ec7u qu\u1ea3. Nh\u00e0 x\u01b0\u1edfng, thi\u1ebft b\u1ecb v\u00e0 h\u1ec7 th\u1ed1ng v\u1ec7 sinh n\u1ebfu \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u s\u1ebd gi\u00fap doanh nghi\u1ec7p ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng thu\u1eadn l\u1ee3i. Ng\u01b0\u1ee3c l\u1ea1i, n\u1ebfu b\u1ed1 tr\u00ed kh\u00f4ng h\u1ee3p l\u00fd, \u0111\u00e2y s\u1ebd l\u00e0 ngu\u1ed3n ph\u00e1t sinh r\u1ee7i ro r\u1ea5t kh\u00f3 kh\u1eafc ph\u1ee5c v\u1ec1 sau.<\/p>\n\n\n\n

– Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi nh\u00e0 x\u01b0\u1edfng v\u00e0 khu v\u1ef1c s\u1ea3n xu\u1ea5t:<\/p>\n\n\n\n

Nh\u00e0 m\u00e1y c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u1eb7t \u1edf v\u1ecb tr\u00ed \u00edt nguy c\u01a1 \u00f4 nhi\u1ec5m, tr\u00e1nh xa b\u00e3i r\u00e1c, khu c\u00f4ng nghi\u1ec7p n\u1eb7ng ho\u1eb7c khu ch\u0103n nu\u00f4i. Thi\u1ebft k\u1ebf nh\u00e0 x\u01b0\u1edfng ph\u1ea3i tu\u00e2n theo nguy\u00ean t\u1eafc ph\u00e2n v\u00f9ng r\u00f5 r\u00e0ng v\u00e0 lu\u1ed3ng di chuy\u1ec3n m\u1ed9t chi\u1ec1u (one-way flow), nh\u1eb1m h\u1ea1n ch\u1ebf nhi\u1ec5m ch\u00e9o. Nguy\u00ean li\u1ec7u, b\u00e1n th\u00e0nh ph\u1ea9m v\u00e0 th\u00e0nh ph\u1ea9m di chuy\u1ec3n t\u1eeb khu v\u1ef1c \u201cb\u1ea9n\u201d h\u01a1n sang khu v\u1ef1c \u201cs\u1ea1ch\u201d h\u01a1n, kh\u00f4ng \u0111i ng\u01b0\u1ee3c chi\u1ec1u.<\/p>\n\n\n\n

Kh\u00f4ng gian s\u1ea3n xu\u1ea5t c\u1ea7n \u0111\u1ee7 r\u1ed9ng \u0111\u1ec3 b\u1ed1 tr\u00ed thi\u1ebft b\u1ecb, thao t\u00e1c thu\u1eadn ti\u1ec7n v\u00e0 tr\u00e1nh nh\u1ea7m l\u1eabn. T\u01b0\u1eddng, tr\u1ea7n v\u00e0 s\u00e0n ph\u1ea3i nh\u1eb5n, kh\u00f4ng th\u1ea5m n\u01b0\u1edbc, d\u1ec5 v\u1ec7 sinh. C\u00e1c g\u00f3c t\u01b0\u1eddng v\u00e0 g\u00f3c s\u00e0n n\u00ean \u0111\u01b0\u1ee3c bo tr\u00f2n \u0111\u1ec3 kh\u00f4ng t\u00edch t\u1ee5 b\u1ee5i b\u1ea9n. C\u1eeda ra v\u00e0o ph\u1ea3i k\u00edn, c\u00f3 c\u01a1 ch\u1ebf t\u1ef1 \u0111\u00f3ng. C\u1eeda s\u1ed5 (n\u1ebfu c\u00f3) ph\u1ea3i c\u1ed1 \u0111\u1ecbnh v\u00e0 c\u00f3 l\u01b0\u1edbi ch\u1ed1ng c\u00f4n tr\u00f9ng.<\/p>\n\n\n\n

H\u1ec7 th\u1ed1ng chi\u1ebfu s\u00e1ng c\u1ea7n \u0111\u1ea3m b\u1ea3o \u0111\u1ee7 \u0111\u1ed9 s\u00e1ng cho s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m tra. \u0110\u00e8n ph\u1ea3i c\u00f3 ch\u1ee5p b\u1ea3o v\u1ec7 \u0111\u1ec3 tr\u00e1nh m\u1ea3nh v\u1ee1 r\u01a1i v\u00e0o s\u1ea3n ph\u1ea9m. H\u1ec7 th\u1ed1ng th\u00f4ng gi\u00f3 v\u00e0 \u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed (HVAC) c\u00f3 nhi\u1ec7m v\u1ee5 ki\u1ec3m so\u00e1t nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m v\u00e0 cung c\u1ea5p kh\u00f4ng kh\u00ed s\u1ea1ch. Khu v\u1ef1c s\u1ea1ch h\u01a1n ph\u1ea3i c\u00f3 \u00e1p su\u1ea5t cao h\u01a1n \u0111\u1ec3 ng\u0103n kh\u00f4ng kh\u00ed b\u1ea9n x\u00e2m nh\u1eadp.<\/p>\n\n\n\n

– Checklist c\u01a1 b\u1ea3n cho nh\u00e0 x\u01b0\u1edfng \u0111\u1ea1t GMP:<\/p>\n\n\n\n