{"id":753,"date":"2026-06-18T05:20:23","date_gmt":"2026-06-18T05:20:23","guid":{"rendered":"https:\/\/lvynfiltration.com\/?p=753"},"modified":"2026-07-06T07:52:25","modified_gmt":"2026-07-06T07:52:25","slug":"gmp-documentation-for-sintered-filters-coc-coa-and-mtcs","status":"publish","type":"post","link":"https:\/\/lvynfiltration.com\/ja\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/","title":{"rendered":"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\uff1aCoC\u3001CoA\u3001\u304a\u3088\u3073MTC"},"content":{"rendered":"

\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30d1\u30c3\u30af\u306f\u3001\u898b\u305f\u76ee\u304c\u5b8c\u74a7\u306b\u898b\u3048\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u305d\u308c\u3067\u3082\u5f79\u306b\u7acb\u305f\u306a\u3044\u3002.<\/p>\n\n\n\n

QA\u30c1\u30fc\u30e0\u304c\u3001CoC\u3001CoA\u3001 MTC\u3001ISO\u8a8d\u8a3c\u66f8\u3001\u5149\u6ca2\u306e\u3042\u308b\u88fd\u54c1\u56f3\u9762\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u300c\u98df\u54c1\u30b0\u30ec\u30fc\u30c9\u300d\u306e\u5ba3\u8a00\u66f8\u306a\u3069\u2014\u2014\u3092\u53d7\u3051\u53d6\u308a\u3001\u5168\u54e1\u304c10\u5206\u307b\u3069\u307b\u3063\u3068\u4e00\u606f\u3064\u304f\u306e\u3067\u3059\u304c\u3001\u3084\u304c\u3066\u8ab0\u304b\u304c\u5384\u4ecb\u306a\u8cea\u554f\u3092\u6295\u3052\u304b\u3051\u307e\u3059\u3002\u300c\u3053\u308c\u3089\u306e\u66f8\u985e\u306f\u3001\u5b9f\u969b\u306b\u3001\u305d\u306e\u7279\u5b9a\u306e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u3001\u7279\u5b9a\u306e\u6750\u6599\u71b1\u51e6\u7406\u3001\u7279\u5b9a\u306e\u30ed\u30c3\u30c8\u3001\u7279\u5b9a\u306e\u5b54\u5f84\u3001\u7279\u5b9a\u306e\u8868\u9762\u4ed5\u4e0a\u3052\u3001\u305d\u3057\u3066\u7279\u5b9a\u306eGMP\u4f7f\u7528\u4e8b\u4f8b\u3092\u6b63\u78ba\u306b\u7db2\u7f85\u3057\u3066\u3044\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u300d<\/p>\n\n\n\n

\u305d\u306e\u77ac\u9593\u3001\u90e8\u5c4b\u306f\u9759\u307e\u308a\u8fd4\u308b\u3002.<\/p>\n\n\n\n

GMP\u6587\u66f8\u306f\u3001\u5358\u306a\u308b\u5f62\u5f0f\u7684\u306a\u66f8\u985e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u9023\u9396\u305d\u306e\u3082\u306e\u3067\u3059\u3002\u3042\u308b\u3044\u306f\u3001\u305d\u3046\u3042\u308b\u3079\u304d\u3082\u306e\u3067\u3059\u3002 \u88fd\u85ac\u3001\u98df\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3001\u7121\u83cc\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u3001\u9ad8\u7d14\u5ea6\u30ac\u30b9\u3001\u304a\u3088\u3073\u898f\u5236\u5bfe\u8c61\u306e\u7523\u696d\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3044\u3066\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u306f\u5358\u306b\u30cf\u30a6\u30b8\u30f3\u30b0\u306b\u53ce\u3081\u3089\u308c\u305f\u591a\u5b54\u8cea\u306e\u90e8\u54c1\u3068\u3044\u3046\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u3001\u88fd\u54c1\u63a5\u89e6\u90e8\u54c1\u3068\u306a\u308a\u5f97\u308b\u307b\u304b\u3001\u6c5a\u67d3\u9632\u6b62\u306e\u30d0\u30ea\u30a2\u3068\u306a\u308a\u5f97\u308b\u4e00\u65b9\u3067\u3001\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u30b7\u30b9\u30c6\u30e0\u306e\u30ea\u30b9\u30af\u3068\u306a\u308a\u5f97\u305f\u308a\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5bfe\u8c61\u3068\u306a\u308a\u5f97\u305f\u308a\u3001\u3042\u308b\u3044\u306f\u3044\u3064\u767a\u751f\u3057\u3066\u3082\u304a\u304b\u3057\u304f\u306a\u3044\u9038\u8131\u8981\u56e0\u3068\u306a\u308a\u5f97\u308b\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n

\u3053\u3053\u306b\u3001\u3042\u307e\u308a\u805e\u304d\u305f\u304f\u306a\u3044\u771f\u5b9f\u304c\u3042\u308a\u307e\u3059\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u300c\u6a19\u6e96\u7684\u306a\u66f8\u985e\u300d\u3092\u9001\u308b\u3053\u3068\u3092\u597d\u307f\u307e\u3059\u304c\u3001\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u306b\u306f\u3001\u305d\u306e\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u7279\u5316\u3057\u305f\u8a3c\u62e0\u304c\u5fc5\u8981\u306a\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n

\u5927\u304d\u306a\u9055\u3044\u3060\u3002.<\/p>\n\n\n\n

\u88fd\u54c1\u3084\u4ed5\u69d8\u306e\u80cc\u666f\u3092\u7406\u89e3\u3059\u308b\u306b\u306f\u3001\u3053\u306e\u8a18\u4e8b\u3092\u4ee5\u4e0b\u306e\u8a18\u4e8b\u3068\u4f75\u305b\u3066\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 \u713c\u7d50\u91d1\u5c5e\u30d5\u30a3\u30eb\u30bf\u30fc\u30ab\u30fc\u30c8\u30ea\u30c3\u30b8<\/a>, \u713c\u7d50\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u88fd\u30d5\u30a3\u30eb\u30bf\u30fc\u30ab\u30fc\u30c8\u30ea\u30c3\u30b8<\/a>, \u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u8a8d\u8a3c\u8981\u4ef6<\/a>, \u30ab\u30b9\u30bf\u30e0\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u88fd\u9020<\/a>, \u3001\u304a\u3088\u3073 \u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u6750\u306e\u9078\u5b9a<\/a>. GMP\u6587\u66f8\u306f\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5b9f\u969b\u306e\u6750\u8cea\u3001\u5f62\u72b6\u3001\u30d7\u30ed\u30bb\u30b9\u3068\u306e\u63a5\u89e6\u72b6\u6cc1\u3001\u304a\u3088\u3073\u9069\u683c\u6027\u8a55\u4fa1\u4e0a\u306e\u30ea\u30b9\u30af\u3068\u7d50\u3073\u3064\u3044\u3066\u521d\u3081\u3066\u610f\u5473\u3092\u6301\u3064\u3002.<\/p>\n\n\n\n

\u307e\u305a\u306f\u3001\u6700\u521d\u306b\u53d7\u3051\u5165\u308c\u304c\u305f\u3044\u4e8b\u5b9f\u304b\u3089\u59cb\u3081\u307e\u3057\u3087\u3046<\/h2>\n\n\n\n

CoC\u306fCoA\u3068\u306f\u7570\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

CoA\u306fMTC\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u307e\u305f\u3001MTC\u306f\u5b8c\u6210\u3057\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u30ea\u30ea\u30fc\u30b9\u30d5\u30a1\u30a4\u30eb\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u4eba\u3005\u306f\u3053\u308c\u3089\u3092\u5e38\u306b\u6df7\u540c\u3057\u304c\u3061\u3067\u3059\u304c\u3001\u305d\u306e\u539f\u56e0\u306f\u305f\u3044\u3066\u3044\u3001\u30d5\u30a9\u30eb\u30c0\u306e\u898b\u51fa\u3057\u306b\u300c\u54c1\u8cea\u95a2\u9023\u6587\u66f8\u300d\u3068\u66f8\u304b\u308c\u3066\u3044\u308b\u3060\u3051\u3067\u3001\u8ab0\u3082\u304c\u305d\u308c\u4ee5\u4e0a\u8aad\u307f\u9032\u3081\u306a\u304f\u306a\u3063\u3066\u3057\u307e\u3046\u304b\u3089\u3067\u3059\u3002\u3057\u304b\u3057\u3001GMP\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u6587\u66f8\u306f\u3001\u7d30\u90e8\u306b\u3053\u305d\u6210\u5426\u304c\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002 \u9069\u5408\u8a3c\u660e\u66f8\u306b\u306f\u3001\u7d0d\u5165\u3055\u308c\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u8cfc\u5165\u6ce8\u6587\u66f8\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u6709\u7528\u3067\u3059\u3002\u5206\u6790\u8a3c\u660e\u66f8\u306b\u306f\u3001\u30d0\u30c3\u30c1\u3084\u30ed\u30c3\u30c8\u3054\u3068\u306e\u5b9f\u969b\u306e\u8a66\u9a13\u7d50\u679c\u304c\u793a\u3055\u308c\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3055\u3089\u306b\u6709\u7528\u3067\u3059\u3002\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\u306b\u306f\u3001\u7279\u5b9a\u306e\u30d2\u30fc\u30c8\u3084\u30d0\u30c3\u30c1\u306e\u91d1\u5c5e\u7d44\u6210\u3084\u6a5f\u68b0\u7684\u7279\u6027\u304c\u78ba\u8a8d\u3055\u308c\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3053\u308c\u3082\u307e\u305f\u6709\u7528\u3067\u3059\u3002.<\/p>\n\n\n\n

\u3057\u304b\u3057\u3001\u305d\u306e\u3044\u305a\u308c\u3082\u304c\u3001\u305d\u306e\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u8cb4\u793e\u306eGMP\u30d7\u30ed\u30bb\u30b9\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u81ea\u52d5\u7684\u306b\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u5fc5\u305a\u3057\u3082\u305d\u3046\u3068\u306f\u9650\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

FDA\u306e21 CFR 211.84\u3067\u306f\u3001\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8005\u304c\u4f9b\u7d66\u696d\u8005\u304b\u3089\u306e\u6210\u5206\u306e\u5206\u6790\u5831\u544a\u66f8\u3092\u53d7\u3051\u5165\u308c\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u306f\u3001\u5f53\u8a72\u88fd\u9020\u696d\u8005\u304c\u5c11\u306a\u304f\u3068\u30821\u3064\u306e\u7279\u5b9a\u306e\u540c\u5b9a\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3001\u9069\u5207\u306a\u9593\u9694\u3067\u4f9b\u7d66\u696d\u8005\u306e\u5206\u6790\u306e\u4fe1\u983c\u6027\u3092\u78ba\u8a8d\u3057\u305f\u5834\u5408\u306b\u9650\u3089\u308c\u308b\u3068\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\uff1a FDA 21 CFR 211.84 \u306b\u57fa\u3065\u304f\u6210\u5206\u8a66\u9a13<\/a>. \u3002\u3053\u306e\u4e00\u6587\u306f\u3001\u6020\u60f0\u306a\u30d0\u30a4\u30e4\u30fc\u3092\u5c11\u3057\u306f\u6016\u304c\u3089\u305b\u308b\u306f\u305a\u3060\u3002\u3064\u307e\u308a\u3001\u300c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304cCoA\u3092\u9001\u3063\u3066\u304d\u305f\u300d\u304b\u3089\u3068\u3044\u3063\u3066\u3001\u8cac\u4efb\u304c\u7d42\u308f\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3060\u3002.<\/p>\n\n\n\n

\u3053\u3053\u304b\u3089\u304c\u5236\u5fa1\u306e\u59cb\u307e\u308a\u3060\u3002.<\/p>\n\n\n\n

\"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\"<\/a><\/figure>\n\n\n\n

CoC\uff1a\u904e\u4fe1\u3055\u308c\u304c\u3061\u306a\u6587\u66f8<\/h2>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u306e\u9069\u5408\u8a3c\u660e\u66f8\u306f\u3001\u901a\u5e38\u3001\u5ba3\u8a00\u66f8\u3067\u3059\u3002.<\/p>\n\n\n\n

\u300c\u7d0d\u5165\u3055\u308c\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u306f\u3001\u767a\u6ce8\u66f8\u3001\u56f3\u9762\u3001\u4ed5\u69d8\u66f8\u3001\u307e\u305f\u306f\u5408\u610f\u3055\u308c\u305f\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u300d\u3068\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u3042\u3001\u3044\u3044\u3067\u3057\u3087\u3046\u3002CoC\u306f\u3001\u5177\u4f53\u7684\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u6c17\u306b\u5165\u3063\u3066\u3044\u307e\u3059\u304c\u3001\u5b9a\u578b\u6587\u306e\u3088\u3046\u306b\u66f8\u304b\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u5acc\u3044\u3067\u3059\u3002.<\/p>\n\n\n\n

\u5f37\u529b\u306a\u884c\u52d5\u898f\u7bc4\uff08CoC\uff09\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u8981\u7d20\u304c\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3059\uff1a<\/p>\n\n\n\n

\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u6b63\u5f0f\u540d\u79f0\u3002.<\/p>\n\n\n\n

\u8cfc\u5165\u8005\u306e\u767a\u6ce8\u66f8\u756a\u53f7\u3002.<\/p>\n\n\n\n

\u90e8\u54c1\u756a\u53f7\u3092\u7d5e\u308a\u8fbc\u3080\u3002.<\/p>\n\n\n\n

\u6539\u8a02\u30ec\u30d9\u30eb\u3002.<\/p>\n\n\n\n

\u30ed\u30c3\u30c8\u756a\u53f7\u307e\u305f\u306f\u30d0\u30c3\u30c1\u756a\u53f7\u3002.<\/p>\n\n\n\n

\u51fa\u8377\u6570\u91cf\u3002.<\/p>\n\n\n\n

\u6750\u6599\u306e\u30b0\u30ec\u30fc\u30c9\u3002.<\/p>\n\n\n\n

\u30df\u30af\u30ed\u30f3\u307e\u305f\u306f\u5b54\u5f84\u898f\u683c\u3002.<\/p>\n\n\n\n

\u56f3\u9762\u756a\u53f7\u3002.<\/p>\n\n\n\n

\u9069\u7528\u3055\u308c\u308b\u4ed5\u69d8\u3002.<\/p>\n\n\n\n

\u9069\u5408\u5ba3\u8a00\u66f8\u3002.<\/p>\n\n\n\n

\u7f72\u540d\u6a29\u9650\u3042\u308a\u3002.<\/p>\n\n\n\n

\u65e5\u4ed8\u3002.<\/p>\n\n\n\n

\u4e0d\u5341\u5206\u306aCoC\u306b\u306f\u3001\u300c\u5f53\u8a72\u5546\u54c1\u304c\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u300d\u3068\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002\u201c<\/p>\n\n\n\n

\u4ee5\u4e0a\u3067\u3059\u3002.<\/p>\n\n\n\n

\u30ed\u30c3\u30c8\u756a\u53f7\u306a\u3057\u3002\u56f3\u9762\u306e\u6539\u8a02\u5c65\u6b74\u306a\u3057\u3002\u6750\u6599\u306a\u3057\u3002\u8a66\u9a13\u57fa\u6e96\u306a\u3057\u3002\u751f\u7523\u8a18\u9332\u3068\u306e\u95a2\u9023\u6027\u306a\u3057\u3002\u8981\u3059\u308b\u306b\u3001PDF\u3068\u3044\u3046\u8863\u88c5\u3092\u307e\u3068\u3063\u305f\u300c\u63e1\u624b\u300d\u306b\u904e\u304e\u306a\u3044\u3002.<\/p>\n\n\n\n

\u79c1\u306e\u7d4c\u9a13\u4e0a\u3001CoC\u306f\u30c8\u30c3\u30d7\u30ec\u30d9\u30eb\u306e\u30ea\u30ea\u30fc\u30b9\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3068\u3057\u3066\u8a31\u5bb9\u3055\u308c\u307e\u3059\u3002\u7279\u306b\u3001\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u7523\u696d\u7528\u9014\u3084\u88fd\u54c1\u3068\u63a5\u89e6\u3057\u306a\u3044\u7528\u9014\u306b\u304a\u3044\u3066\u306f\u305d\u3046\u3067\u3059\u3002\u3057\u304b\u3057\u3001GMP\u3001\u88fd\u85ac\u3001\u98df\u54c1\u63a5\u89e6\u3001\u533b\u7642\u3001\u3042\u308b\u3044\u306f\u898f\u5236\u5bfe\u8c61\u306e\u7528\u9014\u306b\u304a\u3044\u3066\u306f\u3001CoC\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002\u3042\u307e\u308a\u306b\u3082\u4e0d\u5341\u5206\u3067\u3059\u3002.<\/p>\n\n\n\n

\u3053\u308c\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u9069\u5408\u6027\u3092\u4e3b\u5f35\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

\u30c7\u30fc\u30bf\u304c\u8868\u793a\u3055\u308c\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

CoA\uff1a\u6570\u5024\u3092\u914d\u7f6e\u3059\u3079\u304d\u5834\u6240<\/h2>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5206\u6790\u8a3c\u660e\u66f8\u306b\u306f\u3001\u5b9f\u969b\u306e\u6e2c\u5b9a\u7d50\u679c\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n\n\n\n

\u9858\u3044\u4e8b\u3067\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5834\u5408\u3001\u6709\u7528\u306aCoA\u306b\u306f\u3001\u7528\u9014\u306b\u5fdc\u3058\u3066\u3001\u7d30\u5b54\u5f84\u307e\u305f\u306f\u30df\u30af\u30ed\u30f3\u5b9a\u683c\u306e\u8a66\u9a13\u7d50\u679c\u3001\u30d0\u30d6\u30eb\u30dd\u30a4\u30f3\u30c8\u3001\u901a\u6c17\u6027\u3001\u6d41\u91cf\u3001\u5727\u529b\u640d\u5931\u3001\u6e05\u6d44\u5ea6\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u62bd\u51fa\u7269\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u30a8\u30f3\u30c9\u30c8\u30ad\u30b7\u30f3\u3001\u7c92\u5b50\u653e\u51fa\u3001\u5bf8\u6cd5\u691c\u67fb\u3001\u307e\u305f\u306f\u8868\u9762\u4ed5\u4e0a\u3052\u306e\u30c7\u30fc\u30bf\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002 \u30dd\u30ea\u30de\u30fc\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5834\u5408\u3001\u6a39\u8102\u30ed\u30c3\u30c8\u3001\u6dfb\u52a0\u7269\u5ba3\u8a00\u3001USP\u30af\u30e9\u30b9VI\u306e\u53c2\u7167\u60c5\u5831\u3001FDA\u306e\u98df\u54c1\u63a5\u89e6\u9069\u5408\u58f0\u660e\u3001\u307e\u305f\u306f\u751f\u4f53\u9069\u5408\u6027\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u53c2\u7167\u60c5\u5831\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5834\u5408\u3001MTC\uff08\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\uff09\u3001\u4e0d\u52d5\u614b\u5316\u8a3c\u660e\u66f8\u3001\u8868\u9762\u7c97\u3055\u3001\u307e\u305f\u306f\u6eb6\u63a5\u691c\u67fb\u3078\u306e\u30ea\u30f3\u30af\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

EU GMP\u7b2c5\u7ae0\u306e\u88fd\u9020\u6307\u91dd\u306b\u3088\u308b\u3068\u3001\u539f\u6599\u30e1\u30fc\u30ab\u30fc\u307e\u305f\u306f\u4f9b\u7d66\u696d\u8005\u304b\u3089\u63d0\u4f9b\u3055\u308c\u308b\u5206\u6790\u8a3c\u660e\u66f8\u306b\u306f\u3001\u9069\u5207\u306a\u8cc7\u683c\u3068\u7d4c\u9a13\u3092\u6709\u3059\u308b\u6307\u5b9a\u3055\u308c\u305f\u62c5\u5f53\u8005\u304c\u7f72\u540d\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3055\u308c\u3066\u3044\u308b\uff1a EU GMP \u7b2c5\u7ae0 \u88fd\u9020<\/a>. \u3002\u6587\u8108\u306f\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u3053\u306e\u539f\u5247\u306f\u898f\u5236\u5bfe\u8c61\u306e\u90e8\u54c1\u8abf\u9054\u306b\u3082\u5341\u5206\u306b\u5f53\u3066\u306f\u307e\u308a\u307e\u3059\u3002\u3064\u307e\u308a\u3001CoA\u306f\u7ba1\u7406\u3055\u308c\u3001\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308a\u3001\u691c\u8a3c\u3055\u308c\u3001\u304b\u3064\u6709\u610f\u7fa9\u306a\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u8a66\u9a13\u65b9\u6cd5\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u306a\u3044CoA\u306f\u4fe1\u983c\u6027\u306b\u6b20\u3051\u308b\u3002.<\/p>\n\n\n\n

\u4ed5\u69d8\u9650\u754c\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u306a\u3044CoA\u306f\u3001\u4fe1\u983c\u6027\u304c\u4f4e\u3044\u3002.<\/p>\n\n\n\n

\u30ed\u30c3\u30c8\u306e\u8ffd\u8de1\u53ef\u80fd\u6027\u304c\u306a\u3044CoA\u306f\u3001GMP\u30d5\u30a1\u30a4\u30eb\u306b\u542b\u3081\u308b\u306b\u306f\u4fe1\u983c\u3067\u304d\u306a\u3044CoA\u3067\u3059\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306eCoA\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8a18\u8f09\u304c\u3042\u308b\u3053\u3068\u3092\u671b\u307f\u307e\u3059\uff1a<\/p>\n\n\n\n

\u30ed\u30c3\u30c8\u756a\u53f7\u3002.<\/p>\n\n\n\n

\u90e8\u54c1\u756a\u53f7\u3092\u7d5e\u308a\u8fbc\u3080\u3002.<\/p>\n\n\n\n

\u6750\u6599\u306e\u30b0\u30ec\u30fc\u30c9\u3002.<\/p>\n\n\n\n

\u5b54\u5f84\u898f\u683c\u307e\u305f\u306f\u30df\u30af\u30ed\u30f3\u898f\u683c\u3002.<\/p>\n\n\n\n

\u8a66\u9a13\u65b9\u6cd5\u3002.<\/p>\n\n\n\n

\u53d7\u3051\u5165\u308c\u57fa\u6e96\u3002.<\/p>\n\n\n\n

\u5b9f\u969b\u306e\u7d50\u679c\u3002.<\/p>\n\n\n\n

\u691c\u67fb\u65e5\u3002.<\/p>\n\n\n\n

QA\u627f\u8a8d\u3002.<\/p>\n\n\n\n

\u7f72\u540d\u3001\u307e\u305f\u306f\u7ba1\u7406\u3055\u308c\u305f\u96fb\u5b50\u627f\u8a8d\u3002.<\/p>\n\n\n\n

\u56f3\u9762\u306e\u6539\u8a02\u7248\u3078\u306e\u53c2\u7167\u3002.<\/p>\n\n\n\n

\u767a\u6ce8\u66f8\uff08PO\uff09\u307e\u305f\u306f\u30ed\u30c3\u30c8\u756a\u53f7\u306e\u53c2\u7167\u3002.<\/p>\n\n\n\n

CoA\u304c\u30ab\u30bf\u30ed\u30b0\u306e\u5024\u3092\u5358\u306b\u7e70\u308a\u8fd4\u3057\u3066\u3044\u308b\u3060\u3051\u306a\u3089\u3001\u7570\u8b70\u3092\u7533\u3057\u7acb\u3066\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n

\u30ab\u30bf\u30ed\u30b0\u30c7\u30fc\u30bf\u306f\u30d0\u30c3\u30c1\u30c7\u30fc\u30bf\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

MTC\uff1a\u91d1\u5c5e\u306b\u95a2\u3059\u308b\u8a71\u3067\u3042\u308a\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u5168\u822c\u306e\u8a71\u3067\u306f\u306a\u3044<\/h2>\n\n\n\n

\u91d1\u5c5e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u3068\u3063\u3066\u3001\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\u306f\u6700\u3082\u91cd\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n

\u7279\u306b\u3001316L\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3001304\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3001\u30cf\u30b9\u30c6\u30ed\u30a4\u3001\u30a4\u30f3\u30b3\u30cd\u30eb\u3001\u30c1\u30bf\u30f3\u3001\u30cb\u30c3\u30b1\u30eb\u3001\u9752\u9285\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u91d1\u5c5e\u88fd\u591a\u5b54\u8cea\u5a92\u4f53\u3067\u3001\u88fd\u85ac\u7528\u8a2d\u5099\u3001\u84b8\u6c17\u3001\u9ad8\u7d14\u5ea6\u30ac\u30b9\u3001\u8150\u98df\u6027\u74b0\u5883\u3001\u6c34\u7d20\u3001\u89e6\u5a92\u56de\u53ce\u3001\u3042\u308b\u3044\u306f\u9ad8\u6e29\u30b7\u30b9\u30c6\u30e0\u3067\u4f7f\u7528\u3055\u308c\u308b\u3082\u306e\u3002.<\/p>\n\n\n\n

MTC\uff08\u30df\u30eb\u30c6\u30b9\u30c8\u8a3c\u660e\u66f8\u307e\u305f\u306f\u6750\u6599\u8a66\u9a13\u5831\u544a\u66f8\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u306f\u3001\u901a\u5e38\u3001\u91d1\u5c5e\u6750\u6599\u306e\u5316\u5b66\u7d44\u6210\u3092\u691c\u8a3c\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u6a5f\u68b0\u7684\u7279\u6027\u3082\u691c\u8a3c\u3057\u307e\u3059\u3002 EN 10204\u306e\u30bf\u30a4\u30d73.1\u8a3c\u660e\u66f8\u306f\u3001\u91d1\u5c5e\u88fd\u54c1\u306b\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u304a\u308a\u3001\u305d\u306e\u6750\u6599\u30ed\u30c3\u30c8\u304b\u3089\u306e\u5177\u4f53\u7684\u306a\u8a66\u9a13\u7d50\u679c\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u696d\u754c\u306b\u304a\u3051\u308b\u8aac\u660e\u306e\u4e00\u3064\u3067\u306f\u3001\u30bf\u30a4\u30d73.1\u3092\u300c\u4f9b\u7d66\u3055\u308c\u305f\u30ed\u30c3\u30c8\u304b\u3089\u306e\u5b9f\u969b\u306e\u8a66\u9a13\u7d50\u679c\u3067\u3042\u308a\u3001\u751f\u7523\u90e8\u9580\u304b\u3089\u72ec\u7acb\u3057\u305f\u88fd\u9020\u696d\u8005\u306e\u691c\u67fb\u62c5\u5f53\u8005\u304c\u627f\u8a8d\u3057\u305f\u3082\u306e\u300d\u3068\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\uff1a EN 10204 3.1 \u8a3c\u660e\u66f8\u306e\u8aac\u660e<\/a>.<\/p>\n\n\n\n

\u3044\u3044\u306d\u3002.<\/p>\n\n\n\n

\u305f\u3060\u3057\u3001\u5927\u3052\u3055\u306b\u4e3b\u5f35\u3057\u3059\u304e\u306a\u3044\u3088\u3046\u306b\u3002.<\/p>\n\n\n\n

MTC\uff08\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\uff09\u306f\u3001\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u306e\u5316\u5b66\u7d44\u6210\u304c316L\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3082\u306e\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u305d\u308c\u3060\u3051\u3067\u306f\u3001\u5b54\u5f84\u304c\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u6e05\u6d44\u5ea6\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3001\u6eb6\u63a5\u54c1\u8cea\u304c\u9069\u5207\u3067\u3042\u308b\u3053\u3068\u3001\u4e0d\u52d5\u614b\u5316\u304c\u9069\u5207\u306b\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3001\u3055\u3089\u306b\u306f\u5b8c\u6210\u3057\u305f\u713c\u7d50\u30ab\u30fc\u30c8\u30ea\u30c3\u30b8\u304c\u6b63\u3057\u304f\u7d44\u307f\u7acb\u3066\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3084\u3001GMP\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u305f\u4f7f\u7528\u306b\u5099\u3048\u3066\u6d17\u6d44\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u305d\u308c\u304c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u5e38\u5957\u624b\u6bb5\u3060\u3002.<\/p>\n\n\n\n

\u5f7c\u3089\u306fMTC\u3092\u9001\u3063\u3066\u304d\u3066\u3001\u3082\u3046\u805e\u304b\u306a\u3044\u3067\u307b\u3057\u3044\u3068\u601d\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n

\u3084\u3081\u3066\u3002.<\/p>\n\n\n\n

CoC \u5bfe CoA \u5bfe MTC\uff1a\u308f\u304b\u308a\u3084\u3059\u3044\u6bd4\u8f03<\/h2>\n\n\n\n
\u6587\u66f8<\/th>\u305d\u308c\u304c\u4f55\u3092\u8a3c\u660e\u3059\u3079\u304d\u304b<\/th>\u8a18\u8f09\u3059\u3079\u304d\u5185\u5bb9<\/th>\u305d\u308c\u304c\u8a3c\u660e\u3057\u3066\u3044\u306a\u3044\u3053\u3068<\/th>\u79c1\u306e\u7387\u76f4\u306aQA\u306e\u898b\u89e3<\/th><\/tr><\/thead>
CoC \u2014 \u9069\u5408\u8a3c\u660e\u66f8<\/td>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u88fd\u54c1\u304c\u767a\u6ce8\u66f8\uff0f\u4ed5\u69d8\u66f8\uff0f\u56f3\u9762\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5ba3\u8a00\u3059\u308b<\/td>\u767a\u6ce8\u66f8\u3001\u90e8\u54c1\u756a\u53f7\u3001\u6539\u8a02\u7248\u3001\u30ed\u30c3\u30c8\u3001\u6750\u6599\u3001\u6570\u91cf\u3001\u9069\u5408\u8a3c\u660e\u66f8\u3001\u7f72\u540d<\/td>\u7279\u306b\u8a18\u8f09\u304c\u306a\u3044\u9650\u308a\u3001\u5b9f\u969b\u306e\u30c6\u30b9\u30c8\u30c7\u30fc\u30bf\u3067\u3059<\/td>\u4fbf\u5229\u306a\u8868\u7d19\u3067\u3059\u304c\u3001GMP\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u306b\u306f\u3053\u308c\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059<\/td><\/tr>
CoA \u2014 \u5206\u6790\u8a3c\u660e\u66f8<\/td>\u30ed\u30c3\u30c8\uff0f\u30d0\u30c3\u30c1\u306e\u8a66\u9a13\u7d50\u679c\u306f\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u5408\u683c\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b<\/td>\u8a66\u9a13\u65b9\u6cd5\u3001\u898f\u683c\u9650\u754c\u5024\u3001\u5b9f\u6e2c\u5024\u3001\u30ed\u30c3\u30c8\u3001\u65e5\u4ed8\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u627f\u8a8d<\/td>\u7279\u306b\u6307\u5b9a\u304c\u306a\u3044\u9650\u308a\u3001\u751f\u306e\u30c7\u30fc\u30bf\u3092\u3059\u3079\u3066\u63d0\u4f9b\u3057\u307e\u3059<\/td>\u30ea\u30ea\u30fc\u30b9\u30c7\u30fc\u30bf\u306e\u4e3b\u8981\u306a\u6587\u66f8<\/td><\/tr>
MTC \/ MTR \u2014 \u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8<\/td>\u91d1\u5c5e\u306e\u71b1\u30fb\u30d0\u30c3\u30c1\u5316\u5b66\u3001\u304a\u3088\u3073\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u6a5f\u68b0\u7684\u7279\u6027<\/td>\u71b1\u756a\u53f7\u3001\u5408\u91d1\u7a2e\u3001\u5316\u5b66\u6210\u5206\u3001\u898f\u683c\u3001\u8a66\u9a13\u7d50\u679c<\/td>\u5b8c\u6210\u3057\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u6027\u80fd<\/td>\u5b8c\u6210\u54c1\u306e\u51fa\u8377\u3067\u306f\u306a\u304f\u3001\u6750\u6599\u306e\u5fb9\u5e95\u3057\u305f\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/td><\/tr>
\u56f3\u9762\uff0f\u4ed5\u69d8\u66f8<\/td>\u5f62\u72b6\u304a\u3088\u3073\u6280\u8853\u7684\u8981\u4ef6\u3092\u5b9a\u7fa9\u3059\u308b<\/td>\u5bf8\u6cd5\u3001\u516c\u5dee\u3001\u6750\u8cea\u3001\u5b54\u5f84\u3001\u63a5\u7d9a\u90e8\u3001\u6539\u8a02\u7248<\/td>\u30ed\u30c3\u30c8\u306e\u54c1\u8cea<\/td>\u767a\u6ce8\u66f8\uff08PO\uff09\u304a\u3088\u3073\u95a2\u9023\u66f8\u985e\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059<\/td><\/tr>
\u30d0\u30c3\u30c1\u8a18\u9332\uff0f\u30c8\u30e9\u30d9\u30e9\u30fc<\/td>\u751f\u7523\u5de5\u7a0b\u3068\u691c\u67fb\u306e\u72b6\u6cc1\u3092\u8868\u793a\u3057\u307e\u3059<\/td>\u5de5\u7a0b\u3001\u4f5c\u696d\u62c5\u5f53\u8005\u3001\u65e5\u4ed8\u3001\u691c\u67fb\u3001\u9038\u8131\u4e8b\u9805<\/td>\u5916\u90e8\u8a8d\u8a3c<\/td>\u901a\u5e38\u306f\u4efb\u610f\u3067\u3059\u304c\u3001\u76e3\u67fb\u306b\u304a\u3044\u3066\u306f\u975e\u5e38\u306b\u6709\u52b9\u3067\u3059<\/td><\/tr>
\u4e0d\u52d5\u614b\u5316\u30fb\u6d17\u6d44\u8a3c\u660e\u66f8<\/td>\u8868\u9762\u51e6\u7406\u307e\u305f\u306f\u6d17\u6d44\u5de5\u7a0b\u3092\u78ba\u8a8d\u3059\u308b<\/td>\u65b9\u6cd5\u3001\u5316\u5b66\u3001\u6642\u9593\u3001\u53d7\u5165\u7d50\u679c<\/td>\u6c17\u5b54\u7387\u307e\u305f\u306f\u6750\u6599\u306e\u71b1<\/td>\u88fd\u85ac\u30fb\u98df\u54c1\u63a5\u89e6\u7528\u91d1\u5c5e\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u5fc5\u8981<\/td><\/tr>
\u6ec5\u83cc\u8a3c\u660e\u66f8<\/td>\u6ec5\u83cc\u6e08\u307f\u3067\u63d0\u4f9b\u3055\u308c\u305f\u5834\u5408\u306f\u3001\u6ec5\u83cc\u30b5\u30a4\u30af\u30eb\u3092\u78ba\u8a8d\u3059\u308b<\/td>\u65b9\u6cd5\u3001\u6295\u4e0e\u91cf\uff0f\u6295\u4e0e\u30b5\u30a4\u30af\u30eb\u3001\u30ed\u30c3\u30c8\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306fSAL\u8acb\u6c42<\/td>\u691c\u8a3c\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306e\u6750\u6599\u306e\u9069\u5408\u6027<\/td>\u6ec5\u83cc\u6e08\u307f\u7528\u54c1\u304c\u5fc5\u8981\u306a\u5834\u5408\u3092\u9664\u304d\u3001\u4f9d\u983c\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\"<\/a><\/figure>\n\n\n\n

GMP\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u6587\u66f8\u306f\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u304c\u91cd\u8981\u3067\u3042\u308a\u3001\u30d5\u30a9\u30eb\u30c0\u306e\u30b5\u30a4\u30ba\u3067\u306f\u306a\u3044<\/h2>\n\n\n\n

30\u30da\u30fc\u30b8\u306b\u53ca\u3076\u6587\u66f8\u4e00\u5f0f\u304c\u76e3\u67fb\u306b\u901a\u3089\u306a\u304b\u3063\u305f\u4f8b\u3092\u76ee\u306b\u3057\u305f\u3053\u3068\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n

6\u30da\u30fc\u30b8\u5206\u306e\u30d1\u30c3\u30af\u304c\u554f\u984c\u306a\u304f\u901a\u904e\u3057\u305f\u4f8b\u3082\u898b\u305f\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u306a\u305c\u3067\u3057\u3087\u3046\u304b\uff1f\u3000\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n

\u9069\u5207\u306aGMP\u6587\u66f8\u4e00\u5f0f\u304c\u3042\u308c\u3070\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u62c5\u5f53\u8005\u306f\u3001\u63a2\u5075\u3054\u3063\u3053\u3092\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u767a\u6ce8\u66f8\u304b\u3089\u5b8c\u6210\u3057\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u3001\u539f\u6750\u6599\u306e\u30ed\u30c3\u30c8\u3001\u8a66\u9a13\u7d50\u679c\u3001\u305d\u3057\u3066\u51fa\u8377\u6c7a\u5b9a\u306b\u81f3\u308b\u307e\u3067\u306e\u6d41\u308c\u3092\u305f\u3069\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306f\u305a\u3067\u3059\u3002\u305d\u306e\u4e00\u9023\u306e\u6d41\u308c\u306f\u300c\u9000\u5c48\u300d\u3067\u3042\u308b\u3079\u304d\u3067\u3059\u3002\u9000\u5c48\u3067\u3042\u308b\u3053\u3068\u306f\u826f\u3044\u3053\u3068\u3067\u3059\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306eGMP\u6587\u66f8\u306b\u95a2\u3057\u3066\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u30d5\u30a1\u30a4\u30eb\u306b\u304a\u3044\u3066\u4ee5\u4e0b\u306e\u70b9\u306b\u3064\u3044\u3066\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n

\u4f55\u3092\u8cb7\u3063\u305f\u306e\uff1f<\/p>\n\n\n\n

\u3069\u306e\u56f3\u9762\u306e\u6539\u8a02\u7248\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u7d20\u6750\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u30ed\u30c3\u30c8\u3001\u3042\u308b\u3044\u306f\u3069\u306e\u30d2\u30fc\u30c8\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u30dd\u30a2\u5b9a\u683c\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u8a66\u9a13\u65b9\u6cd5\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u53d7\u3051\u5165\u308c\u57fa\u6e96\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u5177\u4f53\u7684\u306b\u3069\u306e\u7d50\u679c\u306e\u3053\u3068\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u8ab0\u304c\u627f\u8a8d\u3057\u305f\u306e\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3044\u3064\u767a\u58f2\u3055\u308c\u305f\u306e\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u9038\u8131\u306f\u3042\u308a\u307e\u3057\u305f\u304b\uff1f<\/p>\n\n\n\n

\u6750\u6599\u306e\u4ee3\u66ff\u306f\u3042\u308a\u307e\u3057\u305f\u304b\uff1f<\/p>\n\n\n\n

\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u5909\u66f4\u306e\u9023\u7d61\u306f\u3042\u308a\u307e\u3057\u305f\u304b\uff1f<\/p>\n\n\n\n

\u3082\u3057\u305d\u306e\u30d5\u30a1\u30a4\u30eb\u304c\u3053\u308c\u3089\u306e\u8cea\u554f\u306b\u7b54\u3048\u3089\u308c\u306a\u3044\u306e\u3067\u3042\u308c\u3070\u3001PDF\u3092\u3044\u304f\u3089\u5897\u3084\u3057\u3066\u3082\u4e8b\u614b\u306f\u597d\u8ee2\u3057\u306a\u3044\u3067\u3057\u3087\u3046\u3002.<\/p>\n\n\n\n

\u7d19\u306e\u5d69\u306f\u5236\u5fa1\u5bfe\u8c61\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

FDA\u306e\u8b66\u544a\u66f8\u306f\u3001\u300c\u6587\u66f8\u5316\u300d\u304c\u5358\u306a\u308b\u4e8b\u52d9\u7684\u306a\u554f\u984c\u3067\u306f\u306a\u3044\u7406\u7531\u3092\u793a\u3057\u3066\u3044\u308b<\/h2>\n\n\n\n

\u3057\u304b\u3057\u3001\u3053\u308c\u306f\u5358\u306b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u9078\u597d\u306b\u3088\u308b\u3082\u306e\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u898f\u5236\u5f53\u5c40\u306f\u3001\u8a18\u9332\u304c\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u5b8c\u5168\u3067\u3042\u308a\u3001\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u91cd\u8996\u3057\u3066\u3044\u307e\u3059\u3002FDA\u306eCGMP\u306b\u95a2\u3059\u308b\u30da\u30fc\u30b8\u306b\u3088\u308b\u3068\u3001\u533b\u85ac\u54c1\u306eCGMP\u898f\u5236\u306b\u306f\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u3001\u52a0\u5de5\u3001\u5305\u88c5\u306b\u4f7f\u7528\u3055\u308c\u308b\u65b9\u6cd5\u3001\u65bd\u8a2d\u3001\u304a\u3088\u3073\u7ba1\u7406\u306b\u95a2\u3059\u308b\u6700\u4f4e\u8981\u4ef6\u304c\u5b9a\u3081\u3089\u308c\u3066\u304a\u308a\u3001\u88fd\u54c1\u304c\u5b89\u5168\u3067\u3042\u308a\u3001\u8868\u793a\u3055\u308c\u305f\u6210\u5206\u3068\u52b9\u529b\u3092\u5099\u3048\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\uff1a FDA\u306eCGMP\u898f\u5236<\/a>.<\/p>\n\n\n\n

\u307e\u305f\u3001FDA\u306e\u8b66\u544a\u66f8\u306b\u306f\u3001\u4e00\u8cab\u3057\u3066\u540c\u3058\u30d1\u30bf\u30fc\u30f3\u304c\u898b\u3089\u308c\u307e\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u7ba1\u7406\u4f53\u5236\u306e\u4e0d\u5099\u3001\u8a18\u9332\u7ba1\u7406\u306e\u4e0d\u5099\u3001\u8abf\u67fb\u4f53\u5236\u306e\u4e0d\u5099\u3001\u305d\u3057\u3066\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u691c\u67fb\u6a5f\u95a2\u306b\u5bfe\u3059\u308b\u76e3\u7763\u4f53\u5236\u306e\u4e0d\u5099\u3067\u3059\u30022024\u5e74\u3001FDA\u304cOptikem International\u793e\u306b\u9001\u4ed8\u3057\u305f\u8b66\u544a\u66f8\u3067\u306f\u30012024\u5e741\u670817\u65e5\u304b\u308926\u65e5\u306b\u304b\u3051\u3066\u5b9f\u65bd\u3055\u308c\u305f\u67fb\u5bdf\u306e\u7d50\u679c\u3001\u533b\u85ac\u54c1\u88fd\u5264\u306b\u95a2\u3059\u308b\u91cd\u5927\u306aCGMP\u9055\u53cd\u304c\u307e\u3068\u3081\u3089\u308c\u3066\u3044\u307e\u3059\uff1a FDA\u306b\u3088\u308b\u30aa\u30d7\u30c6\u30a3\u30b1\u30e0\u30fb\u30a4\u30f3\u30bf\u30fc\u30ca\u30b7\u30e7\u30ca\u30eb\u3078\u306e\u8b66\u544a\u66f8 2024\u5e74<\/a>. 2024\u5e74\u306bFDA\u304cViatris\u793e\u306b\u9001\u4ed8\u3057\u305f\u5225\u306e\u8b66\u544a\u66f8\u3067\u3082\u3001\u91cd\u5927\u306aCGMP\u9055\u53cd\u304c\u307e\u3068\u3081\u3089\u308c\u3066\u304a\u308a\u300121 CFR\u7b2c210\u6761\u304a\u3088\u3073\u7b2c211\u6761\u304c\u5f15\u7528\u3055\u308c\u3066\u3044\u305f\uff1a FDA\u306b\u3088\u308bViatris\u793e\u3078\u306e\u8b66\u544a\u66f8 2024\u5e74<\/a>.<\/p>\n\n\n\n

\u3044\u3044\u3048\u3001\u3053\u308c\u3089\u306f\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u30b1\u30fc\u30b9\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u3057\u304b\u3057\u3001\u3053\u3053\u304b\u3089\u5f97\u3089\u308c\u308b\u6559\u8a13\u306f\u6b21\u306e\u901a\u308a\u3067\u3059\u3002\u898f\u5236\u5bfe\u8c61\u306e\u696d\u52d9\u304c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u6587\u66f8\u306b\u4f9d\u5b58\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u308c\u3089\u306e\u6587\u66f8\u306f\u7ba1\u7406\u30fb\u691c\u8a3c\u3055\u308c\u3001\u6b63\u5f53\u6027\u3092\u7acb\u8a3c\u3067\u304d\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u300c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u4e86\u627f\u3057\u305f\u300d\u3068\u3044\u3046\u3060\u3051\u3067\u306f\u3001GMP\u6226\u7565\u3068\u306f\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u3053\u308c\u306f\u672a\u6765\u3078\u306e\u9038\u8131\u3060\u3002.<\/p>\n\n\n\n

GMP\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u66f8\u985e\u304c\u540c\u68b1\u3055\u308c\u308b\u3079\u304d\u3067\u3059\u304b\uff1f<\/h2>\n\n\n\n

\u4e07\u4eba\u306b\u5408\u3046\u3088\u3046\u306a\u30d1\u30c3\u30af\u306a\u3069\u5b58\u5728\u3057\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u88fd\u54c1\u3068\u63a5\u89e6\u3057\u306a\u3044\u5727\u7e2e\u7a7a\u6c17\u7528\u30d7\u30ec\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u3064\u3044\u3066\u306f\u3001WFI\u30d9\u30f3\u30c8\u3001\u7121\u83cc\u30ac\u30b9\u30e9\u30a4\u30f3\u3001\u88fd\u85ac\u30d7\u30ed\u30bb\u30b9\u30b9\u30ad\u30c3\u30c9\u3001\u98df\u54c1\u3068\u63a5\u89e6\u3059\u308b\u84b8\u6c17\u7d4c\u8def\u3001\u307e\u305f\u306f\u533b\u7642\u6a5f\u5668\u306e\u69cb\u6210\u90e8\u54c1\u306b\u4f7f\u7528\u3055\u308c\u308b\u30d5\u30a3\u30eb\u30bf\u30fc\u3068\u540c\u3058\u3088\u3046\u306a\u6587\u66f8\u5316\u306f\u4e0d\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n

\u3068\u306f\u3044\u3048\u3001\u79c1\u306f\u6587\u66f8\u3092\u300c\u5fc5\u9808\u300d\u3068\u300c\u4efb\u610f\u300d\u306b\u5206\u985e\u3059\u308b\u3064\u3082\u308a\u3067\u3059\u3002.<\/p>\n\n\n\n

\u898f\u5236\u5bfe\u8c61\u306e\u8cfc\u5165\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff1a<\/p>\n\n\n\n

CoC\u3002.<\/p>\n\n\n\n

CoA\u3002.<\/p>\n\n\n\n

\u6750\u6599\u8a3c\u660e\u66f8\u307e\u305f\u306fMTC\u3002.<\/p>\n\n\n\n

\u4fee\u6b63\u3092\u52a0\u3048\u306a\u304c\u3089\u306e\u30c7\u30c3\u30b5\u30f3\u3002.<\/p>\n\n\n\n

\u88fd\u54c1\u4ed5\u69d8\u66f8\u3002.<\/p>\n\n\n\n

\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308b\u58f0\u660e\u3002.<\/p>\n\n\n\n

\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u30e9\u30d9\u30eb\u60c5\u5831\u3002.<\/p>\n\n\n\n

\u8f38\u5165\u306b\u539f\u7523\u5730\u8a3c\u660e\u66f8\u304c\u5fc5\u8981\u306a\u5834\u5408\u306f\u3001\u305d\u308c\u3092\u63d0\u51fa\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n

\u5909\u66f4\u7ba1\u7406\u6587\u3002.<\/p>\n\n\n\n

\u30aa\u30d7\u30b7\u30e7\u30f3\u307e\u305f\u306f\u7528\u9014\u306b\u5fdc\u3058\u305f\uff1a<\/p>\n\n\n\n

USP\u30af\u30e9\u30b9VI\u3002.<\/p>\n\n\n\n

FDA\u306e\u98df\u54c1\u63a5\u89e6\u306b\u95a2\u3059\u308b\u5ba3\u8a00\u3002.<\/p>\n\n\n\n

EU\u898f\u52471935\/2004\u307e\u305f\u306f10\/2011\u306b\u57fa\u3065\u304f\u5ba3\u8a00\u3002.<\/p>\n\n\n\n

\u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\u3002.<\/p>\n\n\n\n

BSE\uff0fTSE\u306e\u58f0\u660e\u3002.<\/p>\n\n\n\n

\u52d5\u7269\u7531\u6765\u6210\u5206\u4e0d\u4f7f\u7528\u306e\u8868\u660e\u3002.<\/p>\n\n\n\n

\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u8a3c\u660e\u66f8\u3002.<\/p>\n\n\n\n

\u6e05\u6383\u8a3c\u660e\u66f8\u3002.<\/p>\n\n\n\n

\u6ec5\u83cc\u8a3c\u660e\u66f8\u3002.<\/p>\n\n\n\n

\u30a8\u30f3\u30c9\u30c8\u30ad\u30b7\u30f3\u8a66\u9a13\u3002.<\/p>\n\n\n\n

\u30d0\u30a4\u30aa\u30d0\u30fc\u30c7\u30f3\u8a66\u9a13\u3002.<\/p>\n\n\n\n

\u8868\u9762\u7c97\u3055\u5831\u544a\u66f8\u3002.<\/p>\n\n\n\n

\u6eb6\u63a5\u691c\u67fb\u5831\u544a\u66f8\u3002.<\/p>\n\n\n\n

\u6574\u5408\u6027\u30c6\u30b9\u30c8\u3002.<\/p>\n\n\n\n

\u30d0\u30d6\u30eb\u30dd\u30a4\u30f3\u30c8\u8a66\u9a13\u307e\u305f\u306f\u900f\u6c34\u6027\u8a66\u9a13\u3002.<\/p>\n\n\n\n

\u8f38\u9001\u6e29\u5ea6\u306e\u8a18\u9332\u3002.<\/p>\n\n\n\n

\u4fdd\u5b58\u671f\u9593\u306b\u95a2\u3059\u308b\u8868\u793a\u3002.<\/p>\n\n\n\n

\u305d\u306e\u6700\u5f8c\u306e\u30ea\u30b9\u30c8\u306f\u3001\u3042\u3063\u3068\u3044\u3046\u9593\u306b\u9ad8\u984d\u306b\u306a\u3063\u3066\u3057\u307e\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u3060\u304b\u3089\u3001\u7fd2\u6163\u7684\u306b\u4f55\u3067\u3082\u304b\u3093\u3067\u3082\u8981\u6c42\u3057\u3066\u306f\u3044\u3051\u306a\u3044\u3002\u30ea\u30b9\u30af\u3092\u8e0f\u307e\u3048\u3066\u8981\u6c42\u3059\u3079\u304d\u3060\u3002.<\/p>\n\n\n\n

\"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\"<\/a><\/figure>\n\n\n\n

\u6a19\u6e96\u4ed5\u69d8\u3068\u30aa\u30d7\u30b7\u30e7\u30f3\u4ed5\u69d8\uff1a\u767a\u6ce8\u3092\u9045\u3089\u305b\u308b\u54c1\u8cea\u7ba1\u7406\u4e0a\u306e\u30df\u30b9<\/h2>\n\n\n\n

QA\u30c1\u30fc\u30e0\u306f\u3001\u4ed5\u69d8\u3092\u904e\u5270\u306b\u5b9a\u7fa9\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n

\u8abf\u9054\u90e8\u9580\u306f\u3053\u308c\u3092\u5acc\u304c\u308b\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3082\u3053\u308c\u3092\u5acc\u304c\u308b\u3002\u305d\u3057\u3066\u3001\u7387\u76f4\u306b\u8a00\u3063\u3066\u3001\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u304c\u82e6\u60c5\u3092\u53d7\u3051\u308b\u306e\u3082\u5f53\u7136\u306e\u5834\u5408\u3082\u3042\u308b\u3002.<\/p>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u4e00\u822c\u7684\u306a\u5de5\u696d\u7528\u713c\u7d50\u9752\u9285\u88fd\u30d9\u30f3\u30c8\u3067\u3042\u308b\u5834\u5408\u3001USP\u30af\u30e9\u30b9VI\u3001\u30a8\u30f3\u30c9\u30c8\u30ad\u30b7\u30f3\u3001\u62bd\u51fa\u7269\u3001\u30ac\u30f3\u30de\u7dda\u6ec5\u83cc\u3001\u304a\u3088\u3073EN 10204 3.2\u3092\u8981\u6c42\u3059\u308b\u306e\u306f\u7121\u610f\u5473\u304b\u3082\u3057\u308c\u306a\u3044\u3002\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u7121\u83cc\u306e\u88fd\u54c1\u30ac\u30b9\u306b\u63a5\u89e6\u3059\u308b\u5834\u5408\u3001CoC\u306e\u307f\u3092\u6c42\u3081\u308b\u306e\u306f\u7121\u8b00\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n

\u6587\u66f8\u4e00\u5f0f\u306f\u3001\u30ea\u30b9\u30af\u306b\u898b\u5408\u3063\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n\n\n\n

GMP\u3001\u88fd\u85ac\u3001\u98df\u54c1\u3001\u533b\u7642\u5206\u91ce\u3067\u306e\u7528\u9014\u306b\u304a\u3044\u3066\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u627f\u8a8d\u3084\u767a\u6ce8\u66f8\u306e\u627f\u8a8d\u3092\u884c\u3046\u524d\u306b\u3001\u6587\u66f8\u5316\u306e\u30ec\u30d9\u30eb\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u3046\u3057\u306a\u3044\u3068\u3001\u5165\u8377\u691c\u67fb\u3084\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5be9\u67fb\u306e\u6bb5\u968e\u3067\u3001\u3042\u308b\u3044\u306f\u3055\u3089\u306b\u60aa\u3044\u5834\u5408\u306b\u306f\u76e3\u67fb\u306e\u6e96\u5099\u4e2d\u306b\u3001\u4e0d\u5099\u304c\u5224\u660e\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u79c1\u306e\u5b9f\u7528\u7684\u306a\u30e2\u30c7\u30eb\uff1a<\/p>\n\n\n\n

\u30ec\u30d9\u30eb1 \u2014 \u7523\u696d\u7528\u975e\u63a5\u89e6\u691c\u67fb\uff1aCoC\u3001\u6750\u6599\u5ba3\u8a00\u66f8\u3001\u56f3\u9762\u3001\u57fa\u672c\u691c\u67fb\u3002.<\/p>\n\n\n\n

\u30ec\u30d9\u30eb 2 \u2014 \u898f\u5236\u5bfe\u8c61\u306e\u516c\u76ca\u4e8b\u696d\uff1aCoC\u3001CoA\u3001MTC\uff0f\u6750\u6599\u8a3c\u660e\u66f8\u3001\u56f3\u9762\u306e\u6539\u8a02\u3001\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u6d17\u6d44\uff0f\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u3002.<\/p>\n\n\n\n

\u30ec\u30d9\u30eb3 \u2014 \u88fd\u54c1\u63a5\u89e6\u90e8\u306b\u95a2\u3059\u308bGMP\uff1aCoC\u3001CoA\u3001MTC\uff0f\u6750\u6599\u8a3c\u660e\u66f8\u3001\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u8868\u9762\uff0f\u6d17\u6d44\u30c7\u30fc\u30bf\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u5c4a\u51fa\u3001\u5909\u66f4\u7ba1\u7406\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u9069\u683c\u6027\u8a55\u4fa1\u3002.<\/p>\n\n\n\n

\u30ec\u30d9\u30eb4 \u2014 \u6ec5\u83cc\u88fd\u54c1\uff0f\u533b\u7642\u7528\uff0f\u9ad8\u30ea\u30b9\u30af\uff1a\u30ec\u30d9\u30eb3\u306b\u52a0\u3048\u3001USP\uff0fISO 10993\u3001\u62bd\u51fa\u7269\u30fb\u6eb6\u51fa\u7269\u3001\u6ec5\u83cc\u3001\u30a8\u30f3\u30c9\u30c8\u30ad\u30b7\u30f3\uff0f\u30d0\u30a4\u30aa\u30d0\u30fc\u30c7\u30f3\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u652f\u63f4\u3001\u3088\u308a\u53b3\u683c\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u54c1\u8cea\u5408\u610f\u3002.<\/p>\n\n\n\n

\u7c21\u5358\u3067\u3059\u3002.<\/p>\n\n\n\n

\u7c21\u5358\u3058\u3083\u306a\u3044\u3002.<\/p>\n\n\n\n

GMP\u7528\u9014\u5411\u3051\u306e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u9078\u5b9a\u65b9\u6cd5<\/h2>\n\n\n\n

\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u9069\u683c\u6027\u5be9\u67fb\u306f\u3001\u5358\u306a\u308b\u7c21\u5358\u306a\u30a2\u30f3\u30b1\u30fc\u30c8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u3053\u308c\u306f\u30ea\u30b9\u30af\u30d5\u30a3\u30eb\u30bf\u30fc\u3067\u3059\u3002.<\/p>\n\n\n\n

FDA\u306e21 CFR 211.84\u300c\u6210\u5206\u304a\u3088\u3073\u533b\u85ac\u54c1\u5bb9\u5668\u30fb\u9589\u9396\u88c5\u7f6e\u306b\u95a2\u3059\u308bQ&A\u300d\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u4f9b\u7d66\u696d\u8005\u306e\u8a3c\u660e\u66f8\u306b\u4f9d\u62e0\u3059\u308b\u5834\u5408\u3001\u9069\u5207\u306a\u9593\u9694\u3067\u4f9b\u7d66\u696d\u8005\u306e\u8a66\u9a13\u7d50\u679c\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u4f9b\u7d66\u696d\u8005\u306e\u4fe1\u983c\u6027\u3092\u78ba\u7acb\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\uff1a \u6210\u5206\u306b\u95a2\u3059\u308bFDA\u306eCGMP Q&A<\/a>.<\/p>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5834\u5408\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306f\u300cISO 9001\u8a8d\u8a3c\u66f8\u306e\u53d7\u9818\u300d\u3060\u3051\u3067\u7d42\u308f\u3089\u305b\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u3001\u6750\u6599\u3001\u5b54\u5f84\u3001\u6d17\u6d44\u3001\u7d44\u7acb\u3001\u691c\u67fb\u3001\u68b1\u5305\u3001\u304a\u3088\u3073\u5909\u66f4\u901a\u77e5\u3092\u9069\u5207\u306b\u7ba1\u7406\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u79c1\u306f\u3053\u3046\u5c0b\u306d\u305f\u3044\u3068\u601d\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n

\u5f7c\u3089\u306f\u539f\u6750\u6599\u306e\u30ed\u30c3\u30c8\u3092\u7ba1\u7406\u3057\u3066\u3044\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/p>\n\n\n\n

\u5b8c\u6210\u3057\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u3092\u3001\u91d1\u5c5e\u71b1\u51e6\u7406\u5de5\u7a0b\u3084\u6a39\u8102\u30d0\u30c3\u30c1\u5de5\u7a0b\u306b\u9023\u643a\u3055\u305b\u308b\u3053\u3068\u306f\u53ef\u80fd\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u5b9f\u969b\u306e\u7d50\u679c\u304c\u8a18\u8f09\u3055\u308c\u305fCoA\u306f\u767a\u884c\u3055\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/p>\n\n\n\n

\u91d1\u5c5e\u90e8\u54c1\u7528\u306eMTC\u306f\u63d0\u4f9b\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>\n\n\n\n

\u56f3\u9762\u306e\u6539\u8a02\u5c65\u6b74\u306f\u7ba1\u7406\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>\n\n\n\n

\u6750\u6599\u3084\u5de5\u7a0b\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u306f\u901a\u77e5\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/p>\n\n\n\n

\u9038\u8131\u3084CAPA\u3078\u306e\u5bfe\u5fdc\u306f\u53ef\u80fd\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u8981\u8acb\u304c\u3042\u308c\u3070\u3001\u4fdd\u5b58\u8a18\u9332\u3092\u63d0\u4f9b\u3057\u3066\u3082\u3089\u3048\u307e\u3059\u304b\uff1f<\/p>\n\n\n\n

\u5f7c\u3089\u306f\u88fd\u85ac\u696d\u754c\u5f0f\u306e\u54c1\u8cea\u5408\u610f\u66f8\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u304b\uff1f<\/p>\n\n\n\n

\u5f7c\u3089\u306fGMP\u306e\u7528\u8a9e\u3092\u7406\u89e3\u3057\u3066\u3044\u308b\u306e\u304b\u3001\u305d\u308c\u3068\u3082\u305f\u3060\u300c\u306f\u3044\u300d\u3068\u8a00\u3063\u3066\u3044\u308b\u3060\u3051\u306a\u306e\u304b\uff1f<\/p>\n\n\n\n

\u305d\u306e\u6700\u5f8c\u306e\u70b9\u304c\u91cd\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n

GMP\u3092\u7406\u89e3\u3057\u3066\u3044\u306a\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u6700\u521d\u306e\u76e3\u67fb\u4f9d\u983c\u304c\u6765\u308b\u307e\u3067\u306f\u4f55\u3067\u3082\u627f\u8afe\u3057\u307e\u3059\u3002\u305d\u3057\u3066\u3001\u305d\u3053\u304b\u3089\u6c88\u9ed9\u304c\u59cb\u307e\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u300c\u6e2c\u5b9a\u6cd5\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u306a\u3044CoA\u300d\u306e\u554f\u984c<\/h2>\n\n\n\n

\u79c1\u304c\u5927\u5acc\u3044\u306a\u6587\u66f8\u304c\u3053\u308c\u3067\u3059\uff1a<\/p>\n\n\n\n

\u201c\u300c\u5b54\u5f84\uff1a5 \u00b5m\u3002\u7d50\u679c\uff1a\u5408\u683c\u3002\u300d\u201d<\/p>\n\n\n\n

\u300c\u30d1\u30c3\u300d\u3063\u3066\u4f55\uff1f<\/p>\n\n\n\n

\u3069\u3061\u3089\u306e\u65b9\u6cd5\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u8a31\u5bb9\u9650\u754c\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u30b5\u30f3\u30d7\u30eb\u30d7\u30e9\u30f3\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u697d\u5668\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u533a\u753b\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u3069\u306e\u901a\u4fe1\u4e8b\u696d\u8005\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n

\u5206\u6790\u8a3c\u660e\u66f8\uff08CoA\uff09\u306b\u5206\u6790\u65b9\u6cd5\u3084\u6e2c\u5b9a\u7bc4\u56f2\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u306a\u3044\u306e\u306f\u3001\u5358\u4f4d\u306e\u306a\u3044\u5727\u529b\u8a08\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3059\u3002\u4e00\u898b\u5c02\u9580\u7684\u3067\u3042\u308b\u3088\u3046\u306b\u898b\u3048\u307e\u3059\u304c\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u90e8\u9580\u304c\u305d\u306e\u6c7a\u5b9a\u3092\u6b63\u5f53\u5316\u3059\u308b\u306b\u306f\u5f79\u7acb\u3061\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5834\u5408\u3001CoA\u306e\u8a66\u9a13\u9805\u76ee\u306f\u5177\u4f53\u7684\u306b\u660e\u8a18\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\uff1a<\/p>\n\n\n\n

\u6c17\u6ce1\u767a\u751f\u70b9\uff1a20\u00b0C\u3067IPA\u3092\u4f7f\u7528\u3057\u305f\u5834\u5408\u3001\u2265 X bar\u3002.<\/p>\n\n\n\n

\u901a\u6c17\u6027\uff1aZ mbar \u306b\u304a\u3051\u308b X\u2013Y L\/min\u3002.<\/p>\n\n\n\n

\u6e05\u6d44\u6642\u306e\u5727\u529b\u640d\u5931\uff1a\u6c34\u6d41\u91cf Y L\/min\u300120\u00b0C \u306e\u6761\u4ef6\u4e0b\u3067 \u2264 X bar\u3002.<\/p>\n\n\n\n

\u5bf8\u6cd5\u691c\u67fb\uff1a\u56f3\u9762 REV C \u306b\u57fa\u3065\u304f\u3002.<\/p>\n\n\n\n

\u8868\u9762\u7c97\u3055\uff1a\u6307\u5b9a\u304c\u3042\u308b\u5834\u5408\u306f\u3001Ra \u2264 0.8 \u00b5m\u3002.<\/p>\n\n\n\n

\u5b54\u5f84\u8a55\u4fa1\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u691c\u8a3c\u6e08\u307f\u306e\u65b9\u6cd5 QP-### \u306b\u57fa\u3065\u304f\u3002.<\/p>\n\n\n\n

\u6e05\u6d44\u5ea6\uff1a\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u7c92\u5b50\u6570\u307e\u305f\u306f\u6b8b\u7559\u7269\u306e\u4e0a\u9650\u5024\u3002.<\/p>\n\n\n\n

\u305d\u308c\u306fQA\u304c\u78ba\u8a8d\u3067\u304d\u308b\u6587\u66f8\u3067\u3059\u3002.<\/p>\n\n\n\n

\u201c\u300c\u30d1\u30b9\u300d\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3060\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30b9\u30c6\u30f3\u30ec\u30b9\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u304a\u3051\u308bMTC\u306e\u6ce8\u610f\u70b9<\/h2>\n\n\n\n

316L MTC\u306f\u91cd\u5b9d\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

\u3067\u3082\u3001\u8aad\u3093\u3067\u307f\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n

\u71b1\u756a\u53f7\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5316\u5b66\u6210\u5206\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u70ad\u7d20\u542b\u6709\u91cf\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30af\u30ed\u30e0\u3001\u30cb\u30c3\u30b1\u30eb\u3001\u30e2\u30ea\u30d6\u30c7\u30f3\u306e\u542b\u6709\u91cf\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30d7\u30ed\u30bb\u30b9\u3067\u7279\u5b9a\u306e\u30b0\u30ec\u30fc\u30c9\u304c\u6307\u5b9a\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u308c\u304c\u5b9f\u969b\u306b\u300c316L\u300d\u3067\u3042\u308b\u304b\u3001\u3042\u308b\u3044\u306f\u300c316\/316L \u30c7\u30e5\u30a2\u30eb\u8a8d\u8a3c\u300d\u3067\u306f\u306a\u3044\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002 MTC\u304c\u3001\u591a\u5b54\u8cea\u5a92\u4f53\u3001\u652f\u6301\u7ba1\u3001\u30a8\u30f3\u30c9\u30ad\u30e3\u30c3\u30d7\u3001\u30a2\u30c0\u30d7\u30bf\u30fc\u306e\u3059\u3079\u3066\u306b\u30ea\u30f3\u30af\u3057\u3066\u3044\u308b\u306e\u304b\u3001\u305d\u308c\u3068\u3082\u5358\u306a\u308b1\u672c\u306e\u68d2\u6750\u306e\u307f\u3092\u30ea\u30f3\u30af\u3057\u3066\u3044\u308b\u306e\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n

\u3053\u3053\u3067\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u30a2\u30bb\u30f3\u30d6\u30ea\u306e\u51e6\u7406\u304c\u8907\u96d1\u306b\u306a\u3063\u3066\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3082\u306e\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n

\u713c\u7d50\u591a\u5b54\u8cea\u5a92\u4f53\u3002.<\/p>\n\n\n\n

\u652f\u6301\u7ba1\u3002.<\/p>\n\n\n\n

\u30a8\u30f3\u30c9\u30ad\u30e3\u30c3\u30d7\u3002.<\/p>\n\n\n\n

\u6eb6\u63a5\u30ea\u30f3\u30b0\u3002.<\/p>\n\n\n\n

\u30cd\u30b8\u4ed8\u304d\u30a2\u30c0\u30d7\u30bf\u30fc\u3002.<\/p>\n\n\n\n

\u30ac\u30b9\u30b1\u30c3\u30c8\u3002.<\/p>\n\n\n\n

\u4e00\u90e8\u306e\u8a2d\u8a08\u306b\u304a\u3051\u308b\u63a5\u7740\u6750\u3002.<\/p>\n\n\n\n

\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u3001\u7d20\u6750\u3054\u3068\u306b\u7570\u306a\u308b\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30ec\u30d9\u30eb\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u30a2\u30c0\u30d7\u30bf\u30fc\u306b\u306e\u307fMTC\u304c\u3042\u308a\u3001\u591a\u5b54\u8cea\u5a92\u4f53\u306b\u306f\u306a\u3044\u5834\u5408\u3001\u30d5\u30a1\u30a4\u30eb\u306b\u7a74\u304c\u958b\u3044\u3066\u3044\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u6bdb\u7a74\u3058\u3083\u306a\u3044\u3002.<\/p>\n\n\n\n

\u7a74\u3002.<\/p>\n\n\n\n

QA\u304c\u767a\u6ce8\u66f8\u306b\u8a18\u8f09\u3059\u3079\u304d\u4e8b\u9805<\/h2>\n\n\n\n

\u767a\u6ce8\u66f8\u306b\u306f\u3001\u5358\u306b\u300c\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u300d\u3068\u3060\u3051\u8a18\u8f09\u3059\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u201c<\/p>\n\n\n\n

\u3053\u3046\u3057\u3066\u4e89\u3044\u304c\u59cb\u307e\u308b\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n

\u6587\u66f8\u306e\u8981\u4ef6\u3092\u6ce8\u6587\u66f8\uff08PO\uff09\u307e\u305f\u306f\u54c1\u8cea\u5951\u7d04\u66f8\u306b\u8a18\u8f09\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6587\u66f8\u306b\u540d\u79f0\u3092\u4ed8\u3051\u3066\u304f\u3060\u3055\u3044\u3002\u51fa\u8377\u6642\u306b\u5fc5\u9808\u3068\u3059\u308b\u304b\u3001\u307e\u305f\u306f\u8981\u8acb\u306b\u5fdc\u3058\u3066\u63d0\u4f9b\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u96fb\u5b50\u7f72\u540d\u306e\u53ef\u5426\u3092\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6587\u66f8\u306e\u8a00\u8a9e\u3092\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6539\u8a02\u7ba1\u7406\u306b\u3064\u3044\u3066\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5909\u66f4\u901a\u77e5\u306b\u3064\u3044\u3066\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n

\u8a00\u8a9e\u306e\u4f8b\uff1a<\/p>\n\n\n\n

\u201c\u300c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u5404\u51fa\u8377\u3054\u3068\u306b\u3001CoC\u3001\u5b9f\u969b\u306e\u8a66\u9a13\u7d50\u679c\u304c\u8a18\u8f09\u3055\u308c\u305fCoA\u3001\u91d1\u5c5e\u90e8\u54c1\u306b\u95a2\u3059\u308b\u6750\u6599\u8a3c\u660e\u66f8\uff0fMTC\u3001\u56f3\u9762\u306e\u6539\u8a02\u78ba\u8a8d\u66f8\u3001\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u5909\u66f4\u7ba1\u7406\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u300d\u201d<\/p>\n\n\n\n

\u3042\u308b\u3044\u306f\uff1a<\/p>\n\n\n\n

\u201c\u300c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u9867\u5ba2\u306e\u66f8\u9762\u306b\u3088\u308b\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u6750\u6599\u306e\u30b0\u30ec\u30fc\u30c9\u3001\u5b54\u5f84\u3001\u30e1\u30c7\u30a3\u30a2\u306e\u69cb\u9020\u3001\u6d17\u6d44\u5de5\u7a0b\u3001\u4e0d\u52d5\u614b\u5316\u51e6\u7406\u3001\u30ac\u30b9\u30b1\u30c3\u30c8\u306e\u6750\u8cea\u3001\u307e\u305f\u306f\u88fd\u9020\u62e0\u70b9\u3092\u5909\u66f4\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u300d\u201d<\/p>\n\n\n\n

\u5f37\u3044\u8a00\u8449\u9063\u3044\u306f\u3001\u8aac\u5f97\u529b\u306b\u6b20\u3051\u308b\u4e3b\u5f35\u3092\u62db\u304f\u3002.<\/p>\n\n\n\n

\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306fCoC\u3060\u3051\u3067\u5341\u5206\u3060\u3068\u8003\u3048\u3066\u3044\u305f\u306e\u306b\u5bfe\u3057\u3001\u30d0\u30a4\u30e4\u30fc\u306fCoA\u3068MTC\u306e\u4e21\u65b9\u3092\u6c42\u3081\u3066\u3044\u305f\u305f\u3081\u3001\u51fa\u8377\u304c\u6570\u9031\u9593\u3082\u6ede\u3063\u3066\u3057\u307e\u3063\u305f\u4e8b\u4f8b\u3092\u76ee\u306b\u3057\u305f\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u53cc\u65b9\u304c\u4e92\u3044\u306b\u8cac\u4efb\u3092\u306a\u3059\u308a\u5408\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u767a\u6ce8\u66f8\uff08PO\uff09\u306e\u5185\u5bb9\u304c\u66d6\u6627\u3060\u3063\u305f\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n

\u305d\u306ePO\u306f\u6709\u7f6a\u3060\u3063\u305f\u3002.<\/p>\n\n\n\n

\"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\"<\/a><\/figure>\n\n\n\n

\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306eGMP\u6587\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\u3068\u306f\u3001\u88fd\u85ac\u3001\u98df\u54c1\u3001\u533b\u7642\u3001\u307e\u305f\u306f\u898f\u5236\u5bfe\u8c61\u306e\u7523\u696d\u7528\u9014\u5411\u3051\u306b\u4f9b\u7d66\u3055\u308c\u308b\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u3001\u5408\u610f\u3055\u308c\u305f\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u3001\u54c1\u8cea\u3001\u6750\u6599\u3001\u8a66\u9a13\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u51fa\u8377\u306b\u95a2\u3059\u308b\u8a18\u9332\u306e\u7d71\u5236\u3055\u308c\u305f\u4e00\u9023\u306e\u6587\u66f8\u3067\u3042\u308a\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u9069\u683c\u6027\u8a55\u4fa1\u3001\u53d7\u5165\u691c\u67fb\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u307e\u305f\u306f\u76e3\u67fb\u306e\u969b\u306b\u53c2\u7167\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

\u901a\u5e38\u3001\u3053\u308c\u306b\u306fCoC\u3001CoA\u3001MTC\u3001\u307e\u305f\u306f\u6750\u6599\u8a3c\u660e\u66f8\u3001\u56f3\u9762\u306e\u6539\u8a02\u5c65\u6b74\u3001\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u6d17\u6d44\u3001\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u3001USP\u30af\u30e9\u30b9VI\u3001FDA\u306e\u98df\u54c1\u63a5\u89e6\u57fa\u6e96\u3001\u62bd\u51fa\u7269\u30c7\u30fc\u30bf\u306a\u3069\u3001\u7528\u9014\u306b\u5fdc\u3058\u305f\u6587\u66f8\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u9069\u5408\u8a3c\u660e\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u9069\u5408\u8a3c\u660e\u66f8\u3068\u306f\u3001\u7d0d\u5165\u3055\u308c\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u8cfc\u5165\u6ce8\u6587\u66f8\u3001\u56f3\u9762\u3001\u4ed5\u69d8\u66f8\u3001\u6750\u6599\u8981\u4ef6\u3001\u307e\u305f\u306f\u5408\u610f\u3055\u308c\u305f\u54c1\u8cea\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8868\u660e\u3059\u308b\u4f9b\u7d66\u696d\u8005\u306b\u3088\u308b\u5ba3\u8a00\u66f8\u3067\u3042\u308a\u3001\u901a\u5e38\u3001\u90e8\u54c1\u756a\u53f7\u3001\u6539\u8a02\u7248\u3001\u30ed\u30c3\u30c8\u3001\u6570\u91cf\u3001\u6750\u8cea\u3001\u51fa\u8377\u65e5\u3001\u304a\u3088\u3073\u627f\u8a8d\u8005\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

CoC\u306f\u3001\u6700\u4e0a\u4f4d\u30ec\u30d9\u30eb\u306e\u30ea\u30ea\u30fc\u30b9\u58f0\u660e\u3068\u3057\u3066\u6709\u7528\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u305d\u308c\u3060\u3051\u3067\u306f\u901a\u5e38\u3001\u5b9f\u969b\u306e\u30c6\u30b9\u30c8\u7d50\u679c\u306f\u793a\u3055\u308c\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5206\u6790\u8a3c\u660e\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5206\u6790\u8a3c\u660e\u66f8\u3068\u306f\u3001\u30ed\u30c3\u30c8\u3054\u3068\u306b\u4f5c\u6210\u3055\u308c\u308b\u54c1\u8cea\u6587\u66f8\u3067\u3042\u308a\u3001\u5b54\u5f84\u3001\u30d0\u30d6\u30eb\u30dd\u30a4\u30f3\u30c8\u3001\u901a\u6c17\u6027\u3001\u5727\u529b\u640d\u5931\u3001\u5bf8\u6cd5\u3001\u6e05\u6d44\u5ea6\u3001\u8868\u9762\u4ed5\u4e0a\u3052\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u5408\u610f\u3055\u308c\u305f\u6027\u80fd\u8a66\u9a13\u304a\u3088\u3073\u51fa\u8377\u524d\u8a66\u9a13\u3068\u3044\u3063\u305f\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u5408\u683c\u57fa\u6e96\u306b\u5bfe\u3059\u308b\u5b9f\u969b\u306e\u8a66\u9a13\u7d50\u679c\u3092\u793a\u3057\u305f\u3082\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n

GMP\u3067\u306e\u4f7f\u7528\u306b\u969b\u3057\u3066\u306f\u3001CoA\u306b\u306f\u8a66\u9a13\u65b9\u6cd5\u3001\u8a31\u5bb9\u9650\u754c\u3001\u5b9f\u969b\u306e\u6e2c\u5b9a\u7d50\u679c\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u90e8\u54c1\u756a\u53f7\u3001\u65e5\u4ed8\u3001\u304a\u3088\u3073\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u306e\u627f\u8a8d\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\u3068\u306f\u3001\u4e3b\u306b\u91d1\u5c5e\u90e8\u54c1\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u6587\u66f8\u3067\u3042\u308a\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u307e\u305f\u306f\u305d\u306e\u69cb\u6210\u90e8\u54c1\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u6750\u6599\u306e\u5316\u5b66\u7d44\u6210\u3001\u71b1\u756a\u53f7\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u6a5f\u68b0\u7684\u7279\u6027\u3001\u4ed5\u69d8\u3078\u306e\u9069\u5408\u72b6\u6cc1\u3001\u304a\u3088\u3073\u691c\u67fb\u72b6\u6cc1\u3092\u8a18\u8f09\u3057\u305f\u3082\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30b9\u30c6\u30f3\u30ec\u30b9\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u5834\u5408\u3001MTC\uff08\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\uff09\u306f\u3001316L\u3001304\u3001\u30cf\u30b9\u30c6\u30ed\u30a4\u3001\u30c1\u30bf\u30f3\u3001\u30cb\u30c3\u30b1\u30eb\u3001\u9752\u9285\u3001\u305d\u306e\u4ed6\u306e\u5408\u91d1\u306e\u6750\u8cea\u3092\u78ba\u8a8d\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u304c\u3001\u5b8c\u6210\u3057\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u6027\u80fd\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

CoC\u3001CoA\u3001MTC\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

CoC\u3001CoA\u3001MTC\u306e\u9055\u3044\u306f\u3001CoC\u304c\u8981\u4ef6\u3078\u306e\u9069\u5408\u3092\u5ba3\u8a00\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001CoA\u304c\u5b9f\u969b\u306e\u30d0\u30c3\u30c1\u307e\u305f\u306f\u30ed\u30c3\u30c8\u306e\u8a66\u9a13\u7d50\u679c\u3092\u5831\u544a\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001MTC\u306f\u4e3b\u306b\u91d1\u5c5e\u539f\u6599\u3084\u90e8\u54c1\u306b\u3064\u3044\u3066\u3001\u6750\u6599\u306e\u5316\u5b66\u7684\u6027\u8cea\u3084\u6a5f\u68b0\u7684\u7279\u6027\u3092\u691c\u8a3c\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3068\u3044\u3046\u70b9\u3067\u3059\u3002.<\/p>\n\n\n\n

GMP\u306b\u57fa\u3065\u304f\u8abf\u9054\u306b\u304a\u3044\u3066\u306f\u3001\u3053\u308c\u3089\u306e\u6587\u66f8\u306f\u76f8\u4e92\u306b\u9023\u643a\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u3002\u3044\u305a\u308c\u306e\u6587\u66f8\u3082\u3001\u305d\u308c\u5358\u4f53\u3067\u306f\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u5168\u4f53\u304c\u3059\u3079\u3066\u306e\u898f\u5236\u5bfe\u8c61\u7528\u9014\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

GMP\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u66f8\u985e\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

GMP\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u5fc5\u8981\u306a\u66f8\u985e\u306b\u306f\u3001\u901a\u5e38\u3001CoC\u3001CoA\u3001\u6750\u6599\u8a3c\u660e\u66f8\u307e\u305f\u306fMTC\u3001\u7ba1\u7406\u56f3\u9762\u3001\u30ed\u30c3\u30c8\u8ffd\u8de1\u60c5\u5831\u3001\u88fd\u54c1\u4ed5\u69d8\u66f8\u3001\u5305\u88c5\u30e9\u30d9\u30eb\u60c5\u5831\u3001\u304a\u3088\u3073\u6d17\u6d44\u8a3c\u660e\u66f8\u3001\u4e0d\u52d5\u614b\u5316\u8a3c\u660e\u66f8\u3001\u6ec5\u83cc\u8a3c\u660e\u66f8\u3001USP\u30af\u30e9\u30b9VI\u3001FDA\u98df\u54c1\u63a5\u89e6\u5ba3\u8a00\u3001\u62bd\u51fa\u7269\u30c7\u30fc\u30bf\u306a\u3069\u306e\u7528\u9014\u56fa\u6709\u306e\u8a18\u9332\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u5177\u4f53\u7684\u306a\u8981\u4ef6\u306f\u3001\u88fd\u54c1\u3068\u306e\u63a5\u89e6\u72b6\u6cc1\u3001\u60a3\u8005\u3078\u306e\u30ea\u30b9\u30af\u3001\u98df\u54c1\u3068\u306e\u63a5\u89e6\u30ea\u30b9\u30af\u3001\u8a2d\u5099\u306e\u91cd\u8981\u5ea6\u3001\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u8a8d\u5b9a\u72b6\u6cc1\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

GMP\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u8cfc\u5165\u306b\u306f\u3001CoC\u3060\u3051\u3067\u5341\u5206\u3067\u3057\u3087\u3046\u304b\uff1f<\/h3>\n\n\n\n

\u30d5\u30a3\u30eb\u30bf\u30fc\u304c\u88fd\u54c1\u3001\u7121\u83cc\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u3001\u98df\u54c1\u63a5\u89e6\u6d41\u3001\u533b\u7642\u6a5f\u5668\u3001\u307e\u305f\u306f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u6c42\u3081\u3089\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u306b\u63a5\u89e6\u3059\u308b\u5834\u5408\u3001CoC\u3060\u3051\u3067\u306f\u901a\u5e38\u3001GMP\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u8cfc\u5165\u306b\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002\u3053\u308c\u306f\u3001CoC\u304c\u9069\u5408\u6027\u3092\u5ba3\u8a00\u3059\u308b\u3082\u306e\u306e\u3001\u901a\u5e38\u3001\u30ed\u30c3\u30c8\u3054\u3068\u306e\u5b9f\u969b\u306e\u8a66\u9a13\u30c7\u30fc\u30bf\u3084\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u63d0\u4f9b\u3057\u306a\u3044\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n

\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u975e\u63a5\u89e6\u578b\u306e\u7523\u696d\u7528\u9014\u3067\u3042\u308c\u3070\u3001CoC\u3067\u3082\u8a31\u5bb9\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u898f\u5236\u5bfe\u8c61\u3068\u306a\u308b\u63a5\u89e6\u7528\u9014\u306e\u5834\u5408\u306f\u3001CoA\u3001MTC\u3001\u304a\u3088\u3073\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u8a18\u9332\u306e\u63d0\u51fa\u3092\u6c42\u3081\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n

\u713c\u7d50\u30b9\u30c6\u30f3\u30ec\u30b9\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u306fMTC\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n

\u713c\u7d50\u30b9\u30c6\u30f3\u30ec\u30b9\u30d5\u30a3\u30eb\u30bf\u30fc\u306f\u3001\u5408\u91d1\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u304c\u91cd\u8981\u306a\u5834\u5408\u3001\u7279\u306b\u88fd\u85ac\u3001\u98df\u54c1\u3001\u9ad8\u7d14\u5ea6\u30ac\u30b9\u3001\u84b8\u6c17\u3001\u8150\u98df\u6027\u74b0\u5883\u3001\u5727\u529b\u30b7\u30b9\u30c6\u30e0\u3001\u533b\u7642\u3001\u6c34\u7d20\u3001\u3042\u308b\u3044\u306f316L\u3001304\u3001\u30cf\u30b9\u30c6\u30ed\u30a4\u3001\u30c1\u30bf\u30f3\u3001\u30cb\u30c3\u30b1\u30eb\u3001\u305d\u306e\u4ed6\u306e\u5408\u91d1\u306e\u5316\u5b66\u7d44\u6210\u306e\u8a3c\u660e\u304c\u6c42\u3081\u3089\u308c\u308b\u898f\u5236\u5bfe\u8c61\u306e\u7523\u696d\u7528\u9014\u306b\u304a\u3044\u3066\u306f\u3001MTC\uff08\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\uff09\u3092\u6dfb\u4ed8\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

MTC\u306b\u306f\u3001\u5358\u306b\u30e9\u30f3\u30c0\u30e0\u306b\u8cfc\u5165\u3057\u305f\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3067\u306f\u306a\u304f\u3001\u30d5\u30a3\u30eb\u30bf\u30fc\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u5b9f\u969b\u306e\u6750\u6599\u3084\u30d0\u30c3\u30c1\u3092\u95a2\u9023\u4ed8\u3051\u308b\u3079\u304d\u3067\u3059\u3002.<\/p>\n\n\n\n

GMP\u7528\u9014\u5411\u3051\u306e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u3069\u306e\u3088\u3046\u306b\u9078\u5b9a\u3059\u308c\u3070\u3088\u3044\u3067\u3057\u3087\u3046\u304b\uff1f<\/h3>\n\n\n\n

GMP\u7528\u9014\u5411\u3051\u306e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u9069\u683c\u3068\u8a8d\u5b9a\u3059\u308b\u306b\u306f\u3001\u305d\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u7ba1\u7406\u3001CoC\/CoA\/MTC\u306e\u4f5c\u6210\u80fd\u529b\u3001\u56f3\u9762\u306e\u6539\u8a02\u7ba1\u7406\u3001\u5909\u66f4\u901a\u77e5\u30d7\u30ed\u30bb\u30b9\u3001\u6750\u6599\u7ba1\u7406\u3001\u8a66\u9a13\u65b9\u6cd5\u3001\u6d17\u6d44\u307e\u305f\u306f\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u7ba1\u7406\u3001\u9038\u8131\u3078\u306e\u5bfe\u5fdc\u3001CAPA\u30d7\u30ed\u30bb\u30b9\u3001\u304a\u3088\u3073\u76e3\u67fb\u3084\u54c1\u8cea\u5408\u610f\u3078\u306e\u5bfe\u5fdc\u80fd\u529b\u3092\u5be9\u67fb\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

\u512a\u308c\u305f\u30d5\u30a3\u30eb\u30bf\u30fc\u3092\u88fd\u9020\u3067\u304d\u308b\u3082\u306e\u306e\u3001\u6587\u66f8\u7ba1\u7406\u304c\u4e0d\u5341\u5206\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001GMP\u8abf\u9054\u5be9\u67fb\u306b\u4e0d\u5408\u683c\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u8abf\u9054\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/h2>\n\n\n\n

\u3054\u7533\u8acb\u66f8\u3001\u308d\u904e\u6750\u3001\u5b54\u5f84\u5206\u5e03\u3001\u88fd\u54c1\u3068\u306e\u63a5\u89e6\u72b6\u6cc1\u3001\u8ca9\u58f2\u5148\u5e02\u5834\u3001\u5fc5\u8981\u306aGMP\u30ec\u30d9\u30eb\u3001\u304a\u3088\u3073\u66f8\u985e\u306b\u95a2\u3059\u308b\u3054\u8981\u671b\u3092\u304a\u9001\u308a\u304f\u3060\u3055\u3044\u3002\u767a\u6ce8\u304c\u76e3\u67fb\u4e0a\u306e\u554f\u984c\u3068\u306a\u308b\u524d\u306b\u3001\u9069\u5207\u306aCoC\u3001CoA\u3001MTC\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u6d17\u6d44\u3001\u4e0d\u52d5\u614b\u5316\u51e6\u7406\u3001\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u9069\u683c\u6027\u8a55\u4fa1\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u5b9a\u7fa9\u3059\u308b\u304a\u624b\u4f1d\u3044\u3092\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

GMP\u6587\u66f8\u306f\u5358\u306a\u308b\u4e8b\u52d9\u51e6\u7406\u3067\u306f\u306a\u3044\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n

\u305d\u308c\u304c\u8a3c\u62e0\u3060\u3002.<\/p>\n\n\n\n

\u7523\u696d\u7528\u30ab\u30fc\u30c8\u30ea\u30c3\u30b8\u306e\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\uff1ahttps:\/\/lvynfiltration.com\/sintered-plastic-filter-cartridges%ef%bc%88application%ef%bc%89\/<\/a><\/p>\n\n\n\n

<\/p>","protected":false},"excerpt":{"rendered":"

\u672c\u30ac\u30a4\u30c9\u3067\u306f\u3001\u88fd\u85ac\u3001\u98df\u54c1\u3001\u533b\u7642\u3001\u304a\u3088\u3073\u898f\u5236\u5bfe\u8c61\u306e\u7523\u696d\u7528\u9014\u5411\u3051\u306e\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u6dfb\u4ed8\u3055\u308c\u308b\u3079\u304dGMP\u6587\u66f8\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u516c\u5f0f\u306b\u898b\u3048\u308b\u3082\u306e\u306e\u3001\u5b9f\u969b\u306b\u306f\u307b\u3068\u3093\u3069\u8a3c\u660e\u529b\u306e\u306a\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u66f8\u985e\u3068\u3001\u6709\u7528\u306a\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u306e\u8a3c\u62e0\u3068\u3092\u533a\u5225\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>","protected":false},"author":1,"featured_media":755,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[43],"tags":[211,210,209,213,212,208],"class_list":["post-753","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sourcing-compliance","tag-filter-certificate-of-analysis","tag-filter-certificate-of-conformity","tag-gmp-documentation","tag-gmp-supplier-documentation","tag-material-test-certificate","tag-sintered-filter-gmp-documentation"],"blocksy_meta":[],"yoast_head":"\nGMP Documentation for Sintered Filters: CoC, CoA and MTCs<\/title>\n<meta name=\"description\" content=\"GMP documentation for sintered filters: CoC, CoA, MTCs, traceability, QA release files, and supplier approval mistakes.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lvynfiltration.com\/ja\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GMP Documentation for Sintered Filters: CoC, CoA and MTCs\" \/>\n<meta property=\"og:description\" content=\"GMP documentation for sintered filters: CoC, CoA, MTCs, traceability, QA release files, and supplier approval mistakes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/lvynfiltration.com\/ja\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/\" \/>\n<meta property=\"og:site_name\" content=\"lvyn\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-18T05:20:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-06T07:52:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/GMP-Documentation-for-Sintered-Filters3.png\" \/>\n\t<meta property=\"og:image:width\" content=\"960\" \/>\n\t<meta property=\"og:image:height\" content=\"720\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"lvynfiltration-admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"lvynfiltration-admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"15\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/\"},\"author\":{\"name\":\"lvynfiltration-admin\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#\\\/schema\\\/person\\\/1421fe500e5ae684de982760f4f3208e\"},\"headline\":\"GMP Documentation for Sintered Filters: CoC, CoA and MTCs\",\"datePublished\":\"2026-06-18T05:20:23+00:00\",\"dateModified\":\"2026-07-06T07:52:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/\"},\"wordCount\":3195,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/GMP-Documentation-for-Sintered-Filters3.png\",\"keywords\":[\"filter certificate of analysis\",\"filter certificate of conformity\",\"GMP documentation\",\"GMP supplier documentation\",\"material test certificate\",\"sintered filter GMP documentation\"],\"articleSection\":[\"Sourcing & Compliance\"],\"inLanguage\":\"ja\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/\",\"url\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/\",\"name\":\"GMP Documentation for Sintered Filters: CoC, CoA and MTCs\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/GMP-Documentation-for-Sintered-Filters3.png\",\"datePublished\":\"2026-06-18T05:20:23+00:00\",\"dateModified\":\"2026-07-06T07:52:25+00:00\",\"description\":\"GMP documentation for sintered filters: CoC, CoA, MTCs, traceability, QA release files, and supplier approval mistakes.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#breadcrumb\"},\"inLanguage\":\"ja\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"ja\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#primaryimage\",\"url\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/GMP-Documentation-for-Sintered-Filters3.png\",\"contentUrl\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/GMP-Documentation-for-Sintered-Filters3.png\",\"width\":960,\"height\":720,\"caption\":\"GMP Documentation for Sintered Filters\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u9996\u9875\",\"item\":\"https:\\\/\\\/lvynfiltration.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"GMP Documentation for Sintered Filters: CoC, CoA and MTCs\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#website\",\"url\":\"https:\\\/\\\/lvynfiltration.com\\\/\",\"name\":\"lvyn\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/lvynfiltration.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ja\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#organization\",\"name\":\"lvyn\",\"url\":\"https:\\\/\\\/lvynfiltration.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ja\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/site-logo-11111.png\",\"contentUrl\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/site-logo-11111.png\",\"width\":350,\"height\":120,\"caption\":\"lvyn\"},\"image\":{\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/#\\\/schema\\\/person\\\/1421fe500e5ae684de982760f4f3208e\",\"name\":\"lvynfiltration-admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ja\",\"@id\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/litespeed\\\/avatar\\\/a48106db320cee19189f9fee8e4f14a6.jpg?ver=1785153890\",\"url\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/litespeed\\\/avatar\\\/a48106db320cee19189f9fee8e4f14a6.jpg?ver=1785153890\",\"contentUrl\":\"https:\\\/\\\/lvynfiltration.com\\\/wp-content\\\/litespeed\\\/avatar\\\/a48106db320cee19189f9fee8e4f14a6.jpg?ver=1785153890\",\"caption\":\"lvynfiltration-admin\"},\"sameAs\":[\"https:\\\/\\\/lvynfiltration.com\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\uff1aCoC\u3001CoA\u3001\u304a\u3088\u3073MTC","description":"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\uff1aCoC\u3001CoA\u3001MTC\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u30ea\u30ea\u30fc\u30b9\u30d5\u30a1\u30a4\u30eb\u3001\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u627f\u8a8d\u306b\u95a2\u3059\u308b\u8aa4\u308a\u3002.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/lvynfiltration.com\/ja\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/","og_locale":"ja_JP","og_type":"article","og_title":"GMP Documentation for Sintered Filters: CoC, CoA and MTCs","og_description":"GMP documentation for sintered filters: CoC, CoA, MTCs, traceability, QA release files, and supplier approval mistakes.","og_url":"https:\/\/lvynfiltration.com\/ja\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/","og_site_name":"lvyn","article_published_time":"2026-06-18T05:20:23+00:00","article_modified_time":"2026-07-06T07:52:25+00:00","og_image":[{"width":960,"height":720,"url":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/GMP-Documentation-for-Sintered-Filters3.png","type":"image\/png"}],"author":"lvynfiltration-admin","twitter_card":"summary_large_image","twitter_misc":{"\u57f7\u7b46\u8005":"lvynfiltration-admin","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"15\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#article","isPartOf":{"@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/"},"author":{"name":"lvynfiltration-admin","@id":"https:\/\/lvynfiltration.com\/#\/schema\/person\/1421fe500e5ae684de982760f4f3208e"},"headline":"GMP Documentation for Sintered Filters: CoC, CoA and MTCs","datePublished":"2026-06-18T05:20:23+00:00","dateModified":"2026-07-06T07:52:25+00:00","mainEntityOfPage":{"@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/"},"wordCount":3195,"commentCount":0,"publisher":{"@id":"https:\/\/lvynfiltration.com\/#organization"},"image":{"@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#primaryimage"},"thumbnailUrl":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/GMP-Documentation-for-Sintered-Filters3.png","keywords":["filter certificate of analysis","filter certificate of conformity","GMP documentation","GMP supplier documentation","material test certificate","sintered filter GMP documentation"],"articleSection":["Sourcing & Compliance"],"inLanguage":"ja","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/","url":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/","name":"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\uff1aCoC\u3001CoA\u3001\u304a\u3088\u3073MTC","isPartOf":{"@id":"https:\/\/lvynfiltration.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#primaryimage"},"image":{"@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#primaryimage"},"thumbnailUrl":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/GMP-Documentation-for-Sintered-Filters3.png","datePublished":"2026-06-18T05:20:23+00:00","dateModified":"2026-07-06T07:52:25+00:00","description":"\u713c\u7d50\u30d5\u30a3\u30eb\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u6587\u66f8\uff1aCoC\u3001CoA\u3001MTC\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u30ea\u30ea\u30fc\u30b9\u30d5\u30a1\u30a4\u30eb\u3001\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u627f\u8a8d\u306b\u95a2\u3059\u308b\u8aa4\u308a\u3002.","breadcrumb":{"@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#breadcrumb"},"inLanguage":"ja","potentialAction":[{"@type":"ReadAction","target":["https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/"]}]},{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#primaryimage","url":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/GMP-Documentation-for-Sintered-Filters3.png","contentUrl":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/GMP-Documentation-for-Sintered-Filters3.png","width":960,"height":720,"caption":"GMP Documentation for Sintered Filters"},{"@type":"BreadcrumbList","@id":"https:\/\/lvynfiltration.com\/gmp-documentation-for-sintered-filters-coc-coa-and-mtcs\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u9996\u9875","item":"https:\/\/lvynfiltration.com\/"},{"@type":"ListItem","position":2,"name":"GMP Documentation for Sintered Filters: CoC, CoA and MTCs"}]},{"@type":"WebSite","@id":"https:\/\/lvynfiltration.com\/#website","url":"https:\/\/lvynfiltration.com\/","name":"lvyn","description":"","publisher":{"@id":"https:\/\/lvynfiltration.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/lvynfiltration.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ja"},{"@type":"Organization","@id":"https:\/\/lvynfiltration.com\/#organization","name":"lvyn","url":"https:\/\/lvynfiltration.com\/","logo":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/lvynfiltration.com\/#\/schema\/logo\/image\/","url":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/site-logo-11111.png","contentUrl":"https:\/\/lvynfiltration.com\/wp-content\/uploads\/2026\/06\/site-logo-11111.png","width":350,"height":120,"caption":"lvyn"},"image":{"@id":"https:\/\/lvynfiltration.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/lvynfiltration.com\/#\/schema\/person\/1421fe500e5ae684de982760f4f3208e","name":"lvynfiltration-admin","image":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/lvynfiltration.com\/wp-content\/litespeed\/avatar\/a48106db320cee19189f9fee8e4f14a6.jpg?ver=1785153890","url":"https:\/\/lvynfiltration.com\/wp-content\/litespeed\/avatar\/a48106db320cee19189f9fee8e4f14a6.jpg?ver=1785153890","contentUrl":"https:\/\/lvynfiltration.com\/wp-content\/litespeed\/avatar\/a48106db320cee19189f9fee8e4f14a6.jpg?ver=1785153890","caption":"lvynfiltration-admin"},"sameAs":["https:\/\/lvynfiltration.com"]}]}},"_links":{"self":[{"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/posts\/753","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/comments?post=753"}],"version-history":[{"count":2,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/posts\/753\/revisions"}],"predecessor-version":[{"id":2629,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/posts\/753\/revisions\/2629"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/media\/755"}],"wp:attachment":[{"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/media?parent=753"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/categories?post=753"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lvynfiltration.com\/ja\/wp-json\/wp\/v2\/tags?post=753"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}