{"id":6839,"date":"2026-07-07T14:57:04","date_gmt":"2026-07-07T14:57:04","guid":{"rendered":"https:\/\/unilaw.vn\/jp\/?p=6839"},"modified":"2026-08-10T14:00:12","modified_gmt":"2026-08-10T14:00:12","slug":"gmp-certification-pharma-vietnam","status":"publish","type":"post","link":"https:\/\/unilaw.vn\/jp\/gmp-certification-pharma-vietnam.html","title":{"rendered":"gmp \u8a8d\u8a3c\uff1a\u30d9\u30c8\u30ca\u30e0\u533b\u85ac\u54c1\u30fb\u4fdd\u5065\u696d\u754c\u306b\u304a\u3051\u308b\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\u306e\u6cd5\u7684\u89e3\u6790\u3068\u5b9f\u52d9\u30ac\u30a4\u30c9"},"content":{"rendered":"<p><meta content=\"\u30d9\u30c8\u30ca\u30e0\u306b\u304a\u3051\u308bgmp \u8a8d\u8a3c\uff08\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u898f\u5247\uff09\u306e\u6cd5\u7684\u67a0\u7d44\u307f\u3001\u53d6\u5f97\u624b\u7d9a\u304d\u3001\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u7559\u610f\u70b9\u3092\u5c02\u9580\u5f01\u8b77\u58eb\u304c\u8a73\u8aac\u30022016\u5e74\u85ac\u4e8b\u6cd5\u3001\u653f\u4ee4155\/2018\/ND-CP\u3001\u901a\u905435\/2018\/TT-BYT\u306b\u57fa\u3065\u304d\u3001\u533b\u85ac\u54c1\u304b\u3089\u5316\u7ca7\u54c1\u307e\u3067\u306e\u898f\u5236\u3068\u5b9f\u4f8b\u30922000\u5b57\u4ee5\u4e0a\u306e\u6df1\u6398\u308a\u89e3\u8aac\u3067\u63d0\u4f9b\u3057\u307e\u3059\u3002\" name=\"description\"\/><br \/>\n<meta content=\"gmp \u8a8d\u8a3c\" name=\"keywords\"\/><br \/>\n<meta content=\"corporate-law\" name=\"category\"\/><br \/>\n<meta content=\"12, 18, 30\" name=\"tags\"\/><\/p>\n<hr\/>\n<h1>gmp \u8a8d\u8a3c\uff1a\u30d9\u30c8\u30ca\u30e0\u533b\u85ac\u54c1\u30fb\u4fdd\u5065\u696d\u754c\u306b\u304a\u3051\u308b\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\u306e\u6cd5\u7684\u89e3\u6790\u3068\u5b9f\u52d9\u30ac\u30a4\u30c9<\/h1>\n<p>\u30d9\u30c8\u30ca\u30e0\u306e\u533b\u85ac\u54c1\u5e02\u5834\u304a\u3088\u3073\u4fdd\u5065\u696d\u754c\u306b\u304a\u3044\u3066\u3001\u88fd\u9020\u696d\u8005\u304c\u5e02\u5834\u53c2\u5165\u3092\u679c\u305f\u3059\u305f\u3081\u306e\u6700\u3082\u91cd\u8981\u306a\u95a2\u9580\u306e\u4e00\u3064\u304c<strong>gmp \u8a8d\u8a3c<\/strong>\uff08\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u898f\u5247\uff1aGood Manufacturing Practices\uff09\u3067\u3059\u3002\u30d9\u30c8\u30ca\u30e0\u653f\u5e9c\u306f\u3001\u56fd\u6c11\u306e\u5065\u5eb7\u3068\u5b89\u5168\u3092\u4fdd\u969c\u3059\u308b\u305f\u3081\u3001\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u304a\u3088\u3073\u4fdd\u5065\u98df\u54c1\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306b\u5bfe\u3057\u3066\u53b3\u683c\u306a\u56fd\u969b\u57fa\u6e96\u306e\u9069\u7528\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u73fe\u5728\u3001\u30d9\u30c8\u30ca\u30e0\u306e\u898f\u5236\u306f\u3001\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff08WHO\uff09\u57fa\u6e96\u304b\u3089\u3001\u6b27\u5dde\u9023\u5408\uff08EU-GMP\uff09\u3084\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u5b9a\u53ca\u3073\u533b\u85ac\u54c1\u67fb\u5bdf\u5171\u540c\u30b9\u30ad\u30fc\u30e0\uff08PIC\/S-GMP\uff09\u3068\u3044\u3063\u305f\u3001\u3088\u308a\u9ad8\u5ea6\u306a\u57fa\u6e96\u3078\u306e\u79fb\u884c\u671f\u306b\u3042\u308a\u307e\u3059\u3002\u672c\u7a3f\u3067\u306f\u3001\u5c02\u9580\u306e<a>\u56fd\u969b \u5f01\u8b77\u58eb<\/a>\u306e\u8996\u70b9\u304b\u3089\u3001\u6700\u65b0\u306e\u6cd5\u7684\u6839\u62e0\u3001\u8a8d\u8a3c\u53d6\u5f97\u306e\u30d7\u30ed\u30bb\u30b9\u3001\u304a\u3088\u3073\u4e0d\u9075\u5b88\u306b\u4f34\u3046\u6cd5\u7684\u30ea\u30b9\u30af\u3092\u3001\u5b9f\u969b\u306e\u5224\u4f8b\u3092\u4ea4\u3048\u3066\u8a73\u7d30\u306b\u5206\u6790\u3057\u307e\u3059\u3002<\/p>\n<h2>\u4e00\u3001 \u30d9\u30c8\u30ca\u30e0\u306b\u304a\u3051\u308bGMP\u8a8d\u8a3c\u306e\u6cd5\u7684\u57fa\u76e4<\/h2>\n<p>\u30d9\u30c8\u30ca\u30e0\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u304a\u3088\u3073\u95a2\u9023\u88fd\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u306f\u3001\u4e3b\u306b\u4ee5\u4e0b\u306e\u6cd5\u5f8b\u304a\u3088\u3073\u4e0b\u4f4d\u6cd5\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>2016\u5e74\u85ac\u4e8b\u6cd5\uff08\u6cd5\u5f8b\u756a\u53f7\uff1a105\/2016\/QH13\uff09\uff1a<\/strong> \u533b\u85ac\u54c1\u306e\u88fd\u9020\u3001\u6d41\u901a\u3001\u767b\u9332\u306b\u95a2\u3059\u308b\u57fa\u672c\u539f\u5247\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u7b2c2\u676139\u9805\u3067\u306f\u3001\u300c\u9069\u6b63\u5b9f\u65bd\uff08Good Practice\uff09\u300d\u3092\u3001WHO\u3084\u56fd\u969b\u7d44\u7e54\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u57fa\u3065\u304d\u4fdd\u5065\u7701\u304c\u516c\u8868\u3059\u308b\u57fa\u6e96\u3067\u3042\u308b\u3068\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong>\u653f\u4ee4\u7b2c155\/2018\/N\u0110-CP\u53f7\uff1a<\/strong> \u4fdd\u5065\u7701\u306e\u7ba1\u7406\u4e0b\u306b\u3042\u308b\u6295\u8cc7\u30fb\u4e8b\u696d\u6761\u4ef6\u3092\u5b9a\u3081\u305f\u653f\u4ee4\u3067\u3042\u308a\u3001GMP\u57fa\u6e96\u306e\u9069\u7528\u7bc4\u56f2\u3084\u8981\u4ef6\u3092\u5177\u4f53\u5316\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong>\u901a\u9054\u7b2c35\/2018\/TT-BYT\u53f7\uff1a<\/strong> \u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u54c1\u539f\u6599\u306eGMP\u9069\u5fdc\u306b\u95a2\u3059\u308b\u8a73\u7d30\u898f\u5b9a\u3067\u3059\u3002WHO-GMP\u3001PIC\/S-GMP\u3001EU-GMP\u306e\u9069\u7528\u306b\u3064\u3044\u3066\u8a73\u7d30\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong>\u901a\u9054\u7b2c03\/2024\/TT-BYT\u53f7\uff1a<\/strong> EU-GMP\u307e\u305f\u306f\u305d\u308c\u306b\u76f8\u5f53\u3059\u308b\u57fa\u6e96\u3092\u6e80\u305f\u3059\u56fd\u5185\u88fd\u9020\u30e9\u30a4\u30f3\u3067\u751f\u7523\u3055\u308c\u305f\u533b\u85ac\u54c1\u306e\u30ea\u30b9\u30c8\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u3053\u308c\u3089\u306e\u6cd5\u898f\u5236\u306b\u3088\u308a\u3001\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8005\u306f\u3001\u9069\u5207\u306a\u88fd\u9020\u62e0\u70b9\u3001\u8a2d\u5099\u3001\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u5099\u3048\u3001\u4fdd\u5065\u7701\u304b\u3089\u306e\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2>\u4e8c\u3001 \u8a8d\u8a3c\u306e\u7a2e\u985e\u3068\u9069\u7528\u57fa\u6e96\u306e\u8a73\u7d30<\/h2>\n<p>\u30d9\u30c8\u30ca\u30e0\u3067\u306f\u3001\u88fd\u54c1\u306e\u7a2e\u985e\u3084\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u5e02\u5834\u3001\u5165\u672d\u8981\u4ef6\u306b\u5fdc\u3058\u3066\u3001\u7570\u306a\u308bGMP\u57fa\u6e96\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n<h3>1. WHO-GMP<\/h3>\n<p>\u30d9\u30c8\u30ca\u30e0\u306e\u56fd\u5185\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8005\u306b\u9069\u7528\u3055\u308c\u308b\u6a19\u6e96\u7684\u306a\u57fa\u6e96\u3067\u3059\u3002\u901a\u905435\/2018\/TT-BYT\u306e\u4ed8\u9332I\u306b\u57fa\u3065\u304d\u3001\u7d44\u7e54\u3001\u4eba\u54e1\u3001\u65bd\u8a2d\u3001\u8a2d\u5099\u3001\u885b\u751f\u7ba1\u7406\u3001\u88fd\u9020\u8a18\u9332\u306a\u3069\u304c\u5be9\u67fb\u3055\u308c\u307e\u3059\u3002\u56fd\u5185\u306e\u4e00\u822c\u7684\u306a\u533b\u85ac\u54c1\u6d41\u901a\u306b\u306f\u3053\u306e\u8a8d\u8a3c\u304c\u6700\u4f4e\u9650\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<h3>2. EU-GMP\u304a\u3088\u3073PIC\/S-GMP<\/h3>\n<p>\u3088\u308a\u9ad8\u5ea6\u306a\u54c1\u8cea\u7ba1\u7406\u3092\u6c42\u3081\u308b\u57fa\u6e96\u3067\u3059\u3002\u30d9\u30c8\u30ca\u30e0\u653f\u5e9c\u306f\u3001\u7279\u306b\u516c\u5171\u533b\u7642\u6a5f\u95a2\u306e\u5165\u672d\uff08\u30b0\u30eb\u30fc\u30d71\u3001\u30b0\u30eb\u30fc\u30d72\uff09\u306b\u304a\u3044\u3066\u3001EU-GMP\u307e\u305f\u306fPIC\/S-GMP\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u88fd\u9020\u30e9\u30a4\u30f3\u3067\u751f\u7523\u3055\u308c\u305f\u88fd\u54c1\u3092\u512a\u5148\u3059\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002\u5916\u8cc7\u4f01\u696d\u304c\u30d9\u30c8\u30ca\u30e0\u306b<a>\u6d77\u5916 \u9032\u51fa<\/a>\u3059\u308b\u969b\u3001\u3053\u308c\u3089\u306e\u9ad8\u5ea6\u306a\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u305f\u88fd\u9020\u65bd\u8a2d\u3092\u8a2d\u7acb\u3059\u308b\u3053\u3068\u306f\u3001\u5e02\u5834\u7af6\u4e89\u529b\u3092\u9ad8\u3081\u308b\u305f\u3081\u306e\u6226\u7565\u7684\u9078\u629e\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<h3>3. \u4fdd\u5065\u98df\u54c1\uff08\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\uff09\u306b\u304a\u3051\u308bGMP<\/h3>\n<p>\u653f\u4ee415\/2018\/N\u0110-CP\u53f7\u306b\u57fa\u3065\u304d\u3001\u4fdd\u5065\u98df\u54c1\uff08\u4fdd\u5065\u98df\u54c1\uff1aHealth Supplements\uff09\u306e\u88fd\u9020\u696d\u8005\u3082GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f2019\u5e747\u67081\u65e5\u304b\u3089\u5b8c\u5168\u7fa9\u52d9\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u672a\u53d6\u5f97\u306e\u65bd\u8a2d\u3067\u306e\u88fd\u9020\u306f\u9055\u6cd5\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<h3>4. \u5316\u7ca7\u54c1\u306b\u304a\u3051\u308bCGMP-ASEAN<\/h3>\n<p>\u5316\u7ca7\u54c1\u88fd\u9020\u306b\u95a2\u3057\u3066\u306f\u3001ASEAN\u5316\u7ca7\u54c1\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff08CGMP-ASEAN\uff09\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u4fdd\u5065\u7701\u533b\u85ac\u54c1\u7ba1\u7406\u5c40\u306f\u3001\u8f38\u51fa\u5165\u306e\u8981\u4ef6\u3068\u3057\u3066\u3001\u3053\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u8a3c\u660e\u66f8\u3092\u767a\u884c\u3057\u307e\u3059\u3002<\/p>\n<h2>\u4e09\u3001 GMP\u8a8d\u8a3c\u53d6\u5f97\u306e\u53f8\u6cd5\u624b\u7d9a\u3068\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9<\/h2>\n<p><strong>gmp \u8a8d\u8a3c<\/strong>\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u624b\u7d9a\u304d\u306f\u3001\u4fdd\u5065\u7701\uff08\u533b\u85ac\u54c1\u7ba1\u7406\u5c40\u307e\u305f\u306f\u4f1d\u7d71\u533b\u5b66\u7ba1\u7406\u5c40\uff09\u306b\u5bfe\u3057\u3066\u884c\u308f\u308c\u307e\u3059\u3002<\/p>\n<h3>1. \u7533\u8acb\u66f8\u985e\u306e\u6e96\u5099<\/h3>\n<p>\u901a\u905435\/2018\/TT-BYT\u7b2c5\u6761\u306b\u57fa\u3065\u304d\u3001\u4ee5\u4e0b\u306e\u66f8\u985e\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\uff1a<\/p>\n<ul>\n<li>\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8a31\u53ef\u7533\u8acb\u66f8\uff08GMP\u8a55\u4fa1\u5e0c\u671b\u306e\u65e8\u3092\u660e\u8a18\uff09<\/li>\n<li>\u30b5\u30a4\u30c8\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08SMF\uff09\uff1a\u5de5\u5834\u306e\u5168\u4f53\u69cb\u9020\u3001\u88fd\u9020\u5de5\u7a0b\u3001\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u3092\u8a73\u8ff0\u3057\u305f\u6280\u8853\u8cc7\u6599<\/li>\n<li>\u4e8b\u696d\u767b\u9332\u8a3c\u660e\u66f8\u304a\u3088\u3073\u6cd5\u4eba\u4ee3\u8868\u8005\u306e\u8cc7\u683c\u8a3c\u660e\u66f8<\/li>\n<\/ul>\n<p>\u3053\u308c\u3089\u306e\u66f8\u985e\u306f\u3001<a>\u6cd5\u52d9 \u30c7\u30e5\u30fc \u30c7\u30ea \u30b8\u30a7\u30f3\u30b9<\/a>\u306e\u904e\u7a0b\u3067\u53b3\u683c\u306b\u7cbe\u67fb\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3>2. \u5b9f\u5730\u5be9\u67fb\u3068\u8a55\u4fa1<\/h3>\n<p>\u7533\u8acb\u53d7\u7406\u5f8c\u3001\u4fdd\u5065\u7701\u306f\u8a55\u4fa1\u56e3\u3092\u7d50\u6210\u3057\u300115\u65e5\u4ee5\u5185\u306b\u5de5\u5834\u3078\u306e\u5b9f\u5730\u8abf\u67fb\u3092\u884c\u3044\u307e\u3059\u3002\u8a55\u4fa1\u306e\u7d50\u679c\u306f\u4ee5\u4e0b\u306e4\u3064\u306e\u30ec\u30d9\u30eb\u306b\u5206\u985e\u3055\u308c\u307e\u3059\uff1a<\/p>\n<ul>\n<li><strong>\u30ec\u30d9\u30eb1\uff1a<\/strong> \u91cd\u5927\u306a\u6b20\u9665\u304c\u306a\u304f\u3001\u57fa\u6e96\u3092\u5b8c\u5168\u306b\u6e80\u305f\u3057\u3066\u3044\u308b\u5834\u5408\u300210\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u8a8d\u8a3c\u304c\u4ea4\u4ed8\u3055\u308c\u307e\u3059\u3002<\/li>\n<li><strong>\u30ec\u30d9\u30eb2\uff1a<\/strong> \u8efd\u5fae\u306a\u662f\u6b63\u304c\u5fc5\u8981\u306a\u5834\u5408\u3002\u696d\u8005\u306f\u6539\u5584\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u3001\u4fdd\u5065\u7701\u304c\u518d\u5be9\u67fb\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u30ec\u30d9\u30eb3\uff1a<\/strong> \u91cd\u5927\u306a\u662f\u6b63\u304c\u5fc5\u8981\u306a\u5834\u5408\u3002\u662f\u6b63\u5f8c\u306e\u5b9f\u5730\u518d\u8a55\u4fa1\u304c\u5fc5\u8981\u3068\u306a\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li><strong>\u30ec\u30d9\u30eb4\uff1a<\/strong> \u57fa\u6e96\u3092\u5168\u304f\u6e80\u305f\u3057\u3066\u304a\u3089\u305a\u3001\u8a8d\u8a3c\u304c\u62d2\u5426\u3055\u308c\u308b\u5834\u5408\u3002<\/li>\n<\/ul>\n<h3>3. \u8a8d\u8a3c\u306e\u6709\u52b9\u671f\u9650\u3068\u7dad\u6301<\/h3>\n<p>\u4ea4\u4ed8\u3055\u308c\u305fGMP\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9650\u306f\u901a\u5e383\u5e74\u3067\u3059\u3002\u6709\u52b9\u671f\u9650\u304c\u5207\u308c\u308b3\u30f6\u6708\u524d\u307e\u3067\u306b\u518d\u8a55\u4fa1\u306e\u7533\u8acb\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u88fd\u9020\u30e9\u30a4\u30f3\u306e\u62e1\u5f35\u3084\u91cd\u5927\u306a\u5909\u66f4\u304c\u3042\u308b\u5834\u5408\u306b\u306f\u3001\u5909\u66f4\u5831\u544a\u307e\u305f\u306f\u8ffd\u52a0\u306e\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2>\u56db\u3001 GMP\u4e0d\u9075\u5b88\u306b\u4f34\u3046\u6cd5\u7684\u30ea\u30b9\u30af\u3068\u30da\u30ca\u30eb\u30c6\u30a3<\/h2>\n<p>GMP\u57fa\u6e96\u3092\u9075\u5b88\u3057\u306a\u3044\u3001\u307e\u305f\u306f\u8a8d\u8a3c\u3092\u4e0d\u6b63\u306b\u53d6\u5f97\u30fb\u7dad\u6301\u3057\u305f\u5834\u5408\u3001\u696d\u8005\u306f\u91cd\u3044\u6cd5\u7684\u8cac\u4efb\u3092\u554f\u308f\u308c\u307e\u3059\u3002<\/p>\n<h3>1. \u884c\u653f\u51e6\u5206<\/h3>\n<p>\u653f\u4ee4117\/2020\/N\u0110-CP\u53f7\u304a\u3088\u3073\u653f\u4ee498\/2020\/N\u0110-CP\u53f7\u306b\u57fa\u3065\u304d\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u7f70\u91d1\u3084\u51e6\u5206\u304c\u79d1\u3055\u308c\u307e\u3059\uff1a<\/p>\n<ul>\n<li>GMP\u8a8d\u8a3c\u306a\u3057\u3067\u533b\u85ac\u54c1\u3092\u88fd\u9020\u3057\u305f\u5834\u5408\uff1a3,000\u4e07\u30c9\u30f3\u304b\u30894,000\u4e07\u30c9\u30f3\u306e\u7f70\u91d1\u3001\u304a\u3088\u3073\u88fd\u9020\u6d3b\u52d5\u306e\u505c\u6b62\u3002<\/li>\n<li>GMP\u306e\u7dad\u6301\u5831\u544a\u3092\u6020\u3063\u305f\u5834\u5408\uff1a1,000\u4e07\u30c9\u30f3\u304b\u30892,000\u4e07\u30c9\u30f3\u306e\u7f70\u91d1\u3002<\/li>\n<li>\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3044\u533b\u85ac\u54c1\u3092\u5e02\u5834\u306b\u6d41\u901a\u3055\u305b\u305f\u5834\u5408\uff1a\u88fd\u54c1\u306e\u56de\u53ce\u3001\u5ec3\u68c4\u3001\u304a\u3088\u3073\u6700\u5927\u3067\u58f2\u4e0a\u9ad8\u306e\u6570\u500d\u306b\u76f8\u5f53\u3059\u308b\u7f70\u91d1\u3002<\/li>\n<\/ul>\n<h3>2. \u88fd\u9020\u30fb\u8ca9\u58f2\u627f\u8a8d\u306e\u53d6\u6d88\u3057<\/h3>\n<p>\u85ac\u4e8b\u6cd5\u7b2c58\u6761\u306b\u57fa\u3065\u304d\u3001\u88fd\u9020\u65bd\u8a2d\u304cGMP\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u304f\u306a\u3063\u305f\u5834\u5408\u3001\u4fdd\u5065\u7701\u306f\u5f53\u8a72\u65bd\u8a2d\u306e\u88fd\u9020\u767b\u9332\u756a\u53f7\uff08\u6d41\u901a\u8a31\u53ef\u756a\u53f7\uff09\u3092\u53d6\u308a\u6d88\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u6cd5\u7684\u30fb\u5546\u696d\u7684\u306b\u5e02\u5834\u304b\u3089\u306e\u6392\u9664\u3092\u610f\u5473\u3057\u307e\u3059\u3002<\/p>\n<h2>\u4e94\u3001 \u95a2\u9023\u5224\u4f8b\uff1aGMP\u3068\u77e5\u7684\u8ca1\u7523\u6a29\u30fb\u6d41\u901a\u8a31\u53ef\u306e\u7d1b\u4e89<\/h2>\n<p>GMP\u8a8d\u8a3c\u306f\u5358\u306a\u308b\u5de5\u5834\u7ba1\u7406\u306e\u57fa\u6e96\u3067\u306f\u306a\u304f\u3001\u88fd\u54c1\u306e\u5e02\u5834\u6d41\u901a\u8a31\u53ef\uff08Marketing Authorization\uff09\u3068\u5bc6\u63a5\u306b\u95a2\u9023\u3057\u3066\u304a\u308a\u3001\u305d\u308c\u304c\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u7d1b\u4e89\u306b\u767a\u5c55\u3059\u308b\u30b1\u30fc\u30b9\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3>1. \u30ce\u30d0\u30eb\u30c6\u30a3\u30b9\u5bfe\u56fd\u5185\u88fd\u85ac\u4f1a\u793e\u306e\u4e8b\u4f8b\uff08\u533b\u85ac\u54c1\u767b\u9332\u756a\u53f7\u306e\u53d6\u6d88\u3057\uff09<\/h3>\n<p><strong>\u5224\u6c7a\u756a\u53f7\uff1a110\/2023\/KDTM-PT\uff082023\u5e7410\u670817\u65e5\u3001\u30db\u30fc\u30c1\u30df\u30f3\u5e02\u9ad8\u7d1a\u4eba\u6c11\u6cd5\u9662\uff09\uff1a<\/strong> \u3053\u306e\u4e8b\u4ef6\u3067\u306f\u3001\u5916\u8cc7\u5927\u624b\u306e\u30ce\u30d0\u30eb\u30c6\u30a3\u30b9\u304c\u3001\u81ea\u793e\u306e\u7279\u8a31\u6a29\u3092\u4fb5\u5bb3\u3057\u3066\u3044\u308b\u3068\u3057\u3066\u3001\u56fd\u5185\u4f01\u696d\uff08DVP\u793e\u306a\u3069\uff09\u306b\u3088\u308b\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u8ca9\u58f2\u505c\u6b62\u3092\u6c42\u3081\u307e\u3057\u305f\u3002\u7126\u70b9\u3068\u306a\u3063\u305f\u306e\u306f\u3001\u4fdd\u5065\u7701\u304c\u767a\u884c\u3057\u305f\u533b\u85ac\u54c1\u767b\u9332\u756a\u53f7\uff08VD-21483-14\u7b49\uff09\u306e\u6709\u52b9\u6027\u3067\u3059\u3002<\/p>\n<p><\/p>\n<p>\u88c1\u5224\u6240\u306f\u3001\u88ab\u544a\u304cGMP\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u5de5\u5834\u3067\u88fd\u9020\u3057\u3001\u4fdd\u5065\u7701\u304b\u3089\u6b63\u5f0f\u306b\u767b\u9332\u756a\u53f7\u3092\u5f97\u3066\u3044\u305f\u3068\u3057\u3066\u3082\u3001\u305d\u306e\u88fd\u54c1\u304c\u4ed6\u8005\u306e\u7279\u8a31\u6a29\uff08Sitagliptin\u5408\u6210\u5206\u7b49\uff09\u3092\u4fb5\u5bb3\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u306e\u767b\u9332\u756a\u53f7\u306e\u53d6\u308a\u4e0b\u3052\u3084\u3001\u5e02\u5834\u304b\u3089\u306e\u56de\u53ce\u30fb\u5ec3\u68c4\u3092\u547d\u3058\u308b\u6c7a\u5b9a\u3092\u4e0b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p><\/p>\n<p>\u3053\u306e\u5224\u4f8b\u306f\u3001\u88fd\u9020\u696d\u8005\u304c<strong>gmp \u8a8d\u8a3c<\/strong>\u3092\u53d6\u5f97\u3057\u3001\u884c\u653f\u4e0a\u306e\u6d41\u901a\u8a31\u53ef\u3092\u5f97\u3066\u3044\u308b\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3042\u308a\u3001<a>\u77e5\u7684 \u8ca1\u7523 \u6a29<\/a>\u306e\u4fb5\u5bb3\u304c\u306a\u3044\u3053\u3068\u3092\u5225\u9014\u78ba\u8a8d\u3059\u308b<a>\u30ea\u30fc\u30ac\u30eb \u30b5\u30fc\u30d3\u30b9<\/a>\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3>2. \u54c1\u8cea\u7ba1\u7406\u66f8\u985e\u306e\u507d\u9020\u3068\u5951\u7d04\u89e3\u9664\u306e\u7d1b\u4e89<\/h3>\n<p><strong>\u5224\u6c7a\u756a\u53f7\uff1a05\/2023\/KDTM-PT\uff082023\u5e743\u670817\u65e5\uff09\uff1a<\/strong> \u533b\u85ac\u54c1\u306e\u58f2\u8cb7\u5951\u7d04\u306b\u304a\u3044\u3066\u3001\u4f9b\u7d66\u5074\u304c\u63d0\u4f9b\u3057\u305f\u54c1\u8cea\u8a3c\u660e\u66f8\uff08COA\uff09\u3084GMP\u95a2\u9023\u66f8\u985e\u306b\u4e0d\u5099\u304c\u3042\u3063\u305f\u305f\u3081\u3001\u8cb7\u4e3b\u304c\u53d7\u9818\u3092\u62d2\u5426\u3057\u305f\u4e8b\u4f8b\u3067\u3059\u3002\u88c1\u5224\u6240\u306f\u3001GMP\u57fa\u6e96\u306b\u57fa\u3065\u304f\u54c1\u8cea\u8a3c\u660e\u306f\u5951\u7d04\u306e\u300c\u672c\u8cea\u7684\u8981\u7d20\u300d\u3067\u3042\u308a\u3001\u305d\u306e\u4e0d\u5c65\u884c\u306f\u91cd\u5927\u306a\u5951\u7d04\u9055\u53cd\uff08default\uff09\u3092\u69cb\u6210\u3059\u308b\u3068\u5224\u65ad\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u3001\u30d3\u30b8\u30cd\u30b9\u4e0a\u306e<a>JV \u5951\u7d04<\/a>\u3084\u4f9b\u7d66\u5951\u7d04\u306b\u304a\u3044\u3066\u3082\u3001GMP\u9075\u5b88\u304c\u6cd5\u7684\u306a\u7fa9\u52d9\u3067\u3042\u308b\u3053\u3068\u3092\u88cf\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2>\u516d\u3001 \u5916\u8cc7\u6295\u8cc7\u5bb6\u306e\u305f\u3081\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6226\u7565<\/h2>\n<p>\u30d9\u30c8\u30ca\u30e0\u3067\u533b\u85ac\u54c1\u30fb\u4fdd\u5065\u98df\u54c1\u30d3\u30b8\u30cd\u30b9\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u5358\u306a\u308b\u6280\u8853\u7684\u306aGMP\u5bfe\u5fdc\u3092\u8d85\u3048\u305f\u5305\u62ec\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4f53\u5236\u306e\u69cb\u7bc9\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<ol>\n<li><strong>\u8a2d\u8a08\u6bb5\u968e\u304b\u3089\u306e\u4ecb\u5165\uff1a<\/strong> \u5de5\u5834\u306e\u5efa\u8a2d\u307e\u305f\u306f\u8cb7\u53ce\u306b\u5148\u7acb\u3061\u3001EU-GMP\u3084WHO-GMP\u306e\u57fa\u6e96\u3092\u5b8c\u5168\u306b\u6e80\u305f\u3059\u8a2d\u8a08\u3067\u3042\u308b\u304b\u3092\u3001\u5c02\u9580\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u304a\u3088\u3073<a>\u56fd\u969b \u5f01\u8b77\u58eb<\/a>\u306b\u3088\u3063\u3066\u691c\u8a3c\u3059\u308b\u3053\u3068\u3002<\/li>\n<li><strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u76e3\u67fb\uff1a<\/strong> \u533b\u85ac\u54c1\u539f\u6599\uff08API\uff09\u3084\u76f4\u63a5\u5bb9\u5668\u306e\u4f9b\u7d66\u5143\u3082GMP\u307e\u305f\u306f\u305d\u308c\u3068\u540c\u7b49\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u901a\u905435\/2018\/TT-BYT\u7b2c20\u6761\u306b\u57fa\u3065\u304d\u3001\u539f\u6599\u4f9b\u7d66\u5143\u306e\u81ea\u5df1\u8a55\u4fa1\u304a\u3088\u3073\u516c\u8868\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/li>\n<li><strong>\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u4e8b\u524d\u8abf\u67fb\uff1a<\/strong> GMP\u8a8d\u8a3c\u306b\u57fa\u3065\u304f\u88fd\u54c1\u767b\u9332\u3092\u884c\u3046\u524d\u306b\u3001\u30d9\u30c8\u30ca\u30e0\u56fd\u5185\u3067\u306e\u7279\u8a31\u3001\u5546\u6a19\u306e\u5148\u884c\u767b\u9332\u72b6\u6cc1\u3092\u78ba\u8a8d\u3059\u308b\u3002\u5224\u4f8b\u304c\u793a\u3059\u901a\u308a\u3001\u884c\u653f\u8a31\u53ef\u306f\u7279\u8a31\u4fb5\u5bb3\u306e\u514d\u7f6a\u7b26\u306b\u306f\u306a\u308a\u307e\u305b\u3093\u3002<\/li>\n<li><strong>\u6587\u66f8\u7ba1\u7406\u306e\u5fb9\u5e95\uff1a<\/strong> \u5b9f\u5730\u5be9\u67fb\u306b\u304a\u3044\u3066\u6700\u3082\u91cd\u8981\u8996\u3055\u308c\u308b\u306e\u306f\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u518d\u73fe\u6027\u3068\u8ffd\u8de1\u53ef\u80fd\u6027\uff08Traceability\uff09\u3067\u3059\u3002\u5168\u3066\u306eSOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u3068\u88fd\u9020\u8a18\u9332\u304c\u6cd5\u7684\u306b\u6709\u52b9\u306a\u5f62\u5f0f\u3067\u4fdd\u7ba1\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<\/ol>\n<h2>\u4e03\u3001 \u7d50\u8ad6<\/h2>\n<p>\u30d9\u30c8\u30ca\u30e0\u306b\u304a\u3051\u308b<strong>gmp \u8a8d\u8a3c<\/strong>\u306f\u3001\u5358\u306a\u308b\u54c1\u8cea\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u306a\u304f\u3001\u6cd5\u7684\u9075\u5b88\uff08\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\uff09\u306e\u6838\u5fc3\u3067\u3059\u30022016\u5e74\u85ac\u4e8b\u6cd5\u4ee5\u964d\u3001\u898f\u5236\u306e\u900f\u660e\u6027\u306f\u5411\u4e0a\u3057\u307e\u3057\u305f\u304c\u3001\u540c\u6642\u306b\u9055\u53cd\u306b\u5bfe\u3059\u308b\u7f70\u5247\u3082\u5f37\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7279\u306b\u516c\u5171\u5165\u672d\u5e02\u5834\u3092\u76ee\u6307\u3059\u4f01\u696d\u306b\u3068\u3063\u3066\u3001WHO-GMP\u304b\u3089EU-GMP\u3078\u306e\u30b9\u30c6\u30c3\u30d7\u30a2\u30c3\u30d7\u306f\u907f\u3051\u3066\u901a\u308c\u306a\u3044\u8ab2\u984c\u3067\u3059\u3002<\/p>\n<p>\u8907\u96d1\u306a\u53f8\u6cd5\u624b\u7d9a\u3084\u3001GMP\u3068\u77e5\u7684\u8ca1\u7523\u6a29\u304c\u4ea4\u932f\u3059\u308b\u6cd5\u7684\u7d1b\u4e89\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u73fe\u5730\u306e\u898f\u5236\u5f53\u5c40\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u5186\u6ed1\u306b\u3057\u3001\u6700\u65b0\u306e\u53f8\u6cd5\u89e3\u91c8\u306b\u57fa\u3065\u3044\u305f\u52a9\u8a00\u3092\u63d0\u4f9b\u3067\u304d\u308b\u5c02\u9580\u5bb6\u306e\u5b58\u5728\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u5f53\u4e8b\u52d9\u6240\u306f\u3001<a>\u30ea\u30fc\u30ac\u30eb \u30b5\u30fc\u30d3\u30b9<\/a>\u3092\u901a\u3058\u3066\u3001\u4f01\u696d\u306e\u88fd\u9020\u62e0\u70b9\u306e\u9078\u5b9a\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u7533\u8acb\u3001\u304a\u3088\u3073\u5951\u7d04\u4e0a\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u307e\u3067\u3092\u5305\u62ec\u7684\u306b\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u7686\u69d8\u306e\u30d9\u30c8\u30ca\u30e0\u3067\u306e\u4e8b\u696d\u6d3b\u52d5\u306e\u6cd5\u7684\u5b89\u5b9a\u6027\u3092\u78ba\u4fdd\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n<table border=\"1\" style=\"width:100%; border-collapse: collapse;\">\n<tr style=\"background-color: #f2f2f2;\">\n<th>\u9805\u76ee<\/th>\n<th>\u8a73\u7d30\u30fb\u6cd5\u7684\u6839\u62e0<\/th>\n<\/tr>\n<tr>\n<td>\u8a8d\u8a3c\u6a5f\u95a2<\/td>\n<td>\u4fdd\u5065\u7701 \u533b\u85ac\u54c1\u7ba1\u7406\u5c40 (Drug Administration of Vietnam)<\/td>\n<\/tr>\n<tr>\n<td>\u6709\u52b9\u671f\u9593<\/td>\n<td>3\u5e74\uff08\u671f\u9593\u6e80\u4e86\u306e3\u30f6\u6708\u524d\u306b\u66f4\u65b0\u7533\u8acb\u304c\u5fc5\u8981\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u4e3b\u306a\u5be9\u67fb\u5185\u5bb9<\/td>\n<td>\u7d44\u7e54\u30fb\u4eba\u54e1\u3001\u65bd\u8a2d\u3001\u8a2d\u5099\u3001\u885b\u751f\u3001\u88fd\u9020\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u6587\u66f8\u5316<\/td>\n<\/tr>\n<tr>\n<td>\u9055\u53cd\u6642\u306e\u7f70\u5247<\/td>\n<td>\u7f70\u91d1\u3001\u696d\u52d9\u505c\u6b62\u3001\u6d41\u901a\u767b\u9332\u756a\u53f7\u306e\u53d6\u6d88\u3057\u3001\u88fd\u54c1\u56de\u53ce\u30fb\u5ec3\u68c4<\/td>\n<\/tr>\n<tr>\n<td>\u95a2\u9023\u57fa\u6e96<\/td>\n<td>WHO-GMP, EU-GMP, PIC\/S-GMP, CGMP-ASEAN<\/td>\n<\/tr>\n<\/table>\n<p>\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u767b\u9332\u3001\u307e\u305f\u306fGMP\u5de5\u5834\u306e<a>\u4f01\u696d 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