{"id":53570,"date":"2025-01-03T11:37:55","date_gmt":"2025-01-03T11:37:55","guid":{"rendered":"https:\/\/japanmultisitebb.beingbuilt.uk\/api-chemical-development\/?page_id=53570"},"modified":"2025-09-30T14:25:01","modified_gmt":"2025-09-30T13:25:01","slug":"gmp-peptide-manufacture","status":"publish","type":"page","link":"https:\/\/almacgroup.jp\/api-chemical-development\/peptide-protein-technology\/gmp-peptide-manufacture\/","title":{"rendered":"cGMP\u30da\u30d7\u30c1\u30c9\u306e\u88fd\u9020\u00a0"},"content":{"rendered":"\n<p><strong><strong>\u5e83\u7bc4\u306a\u81e8\u5e8a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u305f\u3081\u306e\u30da\u30d7\u30c1\u30c9\u3092\u88fd\u9020&nbsp;<\/strong><\/strong><\/p>\n\n\n\n<p>\u5f53\u793e\u306f\u3001\u304a\u5ba2\u69d8\u306e\u533b\u85ac\u54c1\u958b\u767a\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u306e\u4e2d\u3067\u81e8\u5e8a\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u5fc5\u8981\u306aGMP\u30da\u30d7\u30c1\u30c9\u88fd\u9020\u306e\u4fe1\u983c\u3067\u304d\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002\u958b\u767a\u88fd\u9020\u30ad\u30e3\u30f3\u30da\u30fc\u30f3\u3092\u304a\u5c4a\u3051\u3059\u308b\u3046\u3048\u3067\u5f37\u56fa\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u3063\u3066\u304a\u308a\u3001\u5f53\u793e\u65bd\u8a2d\u306f\u3059\u3067\u306bMHRA\u306e\u76e3\u67fb\u3068\u8a8d\u8a3c\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u3002&nbsp;<\/p>\n\n\n\n<p><strong>\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u3068\u7d50\u675f\u529b<\/strong><\/p>\n\n\n\n<p>\u5f53\u793e\u306f\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u4f5c\u696d\u3092\u91cd\u8996\u3057\u3001\u5f37\u56fa\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u3092\u3059\u308b\u624b\u6cd5\u3092\u3068\u3063\u3066\u3044\u307e\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3068\u5f53\u793e\u5316\u5b66\u30fb\u5206\u6790\u30b0\u30eb\u30fc\u30d7\u306e\u5c02\u9580\u5bb6\u3092\u307e\u3068\u3081\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u7d50\u6210\u3057\u307e\u3059\u3002\u3053\u306e\u30c1\u30fc\u30e0\u304c\u958b\u767a\u6bb5\u968e\u304b\u3089\u88fd\u9020\u6bb5\u968e\u3092\u901a\u3058\u3066\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u53c2\u52a0\u3059\u308b\u3053\u3068\u3067\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u671f\u9593\u5168\u4f53\u306b\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002&nbsp;<\/p>\n\n\n\n<p><strong><strong>\u88fd\u9020\u3078\u306e\u5186\u6ed1\u306a\u79fb\u884c\u3092\u78ba\u5b9f\u306a\u3082\u306e\u306b\u3059\u308b&nbsp;<\/strong><\/strong><\/p>\n\n\n\n<p>\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u306b\u5bfe\u3057\u300c\u76ee\u7684\u306b\u9069\u5408\u3057\u305f\u300d\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u53d6\u308a\u307e\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u77e5\u8b58\u304c\u6642\u9593\u3068\u3068\u3082\u306b\u6df1\u307e\u308b\u306b\u3064\u308c\u3001\u958b\u767a\u304c\u7cbe\u7dfb\u5316\u3055\u308c\u3066\u3044\u304d\u3001\u5404\u81e8\u5e8a\u958b\u767a\u6bb5\u968e\u3067\u306e\u5fc5\u8981\u5ea6\u306b\u5f93\u3063\u3066API\u3092\u88fd\u9020\u3057\u307e\u3059\u3002\u5f53\u793e\u306f\u3001\u30da\u30d7\u30c1\u30c9\u3068\u4f4e\u5206\u5b50\u5316\u5408\u7269\u3068\u306e\u4e21\u65b9\u306b\u304a\u3044\u3066\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u304b\u3089\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u307e\u3067\u5e83\u304f\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002&nbsp;<\/p>\n\n\n\n<p><strong><strong>\u3042\u3089\u3086\u308b\u30b9\u30c6\u30c3\u30d7\u3092\u30b5\u30dd\u30fc\u30c8&nbsp;<\/strong><\/strong><\/p>\n\n\n\n<p>Almac\u30b0\u30eb\u30fc\u30d7\u306b\u306f180\u540d\u306e\u5206\u6790\u5c02\u9580\u5bb6\u304c\u5728\u7c4d\u3057\u3066\u304a\u308a\u3001\u304a\u5ba2\u69d8\u306e\u30da\u30d7\u30c1\u30c9\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u304f\u307e\u306a\u304f\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002ICH\u6761\u4ef6\u4e0b\u3067\u306e\u65b9\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u539f\u6599\u3068\u6700\u7d42API\u306eQC\u30ea\u30ea\u30fc\u30b9\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u533b\u85ac\u54c1\u304a\u3088\u3073\u539f\u85ac\u306e\u8a66\u9a13\u306b\u95a2\u3057\u3066\u3082\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002&nbsp;<\/p>\n\n\n\n<p><strong><strong>\u5f53\u793e\u306e\u5b9f\u7e3e&nbsp;<\/strong><\/strong><\/p>\n\n\n\n<p>\u5f53\u793e\u306f\u3001\u82f1\u56fd\u3001\u6b27\u5dde\u3001\u7c73\u56fd\u306eGMP\u30da\u30d7\u30c1\u30c9\u88fd\u54c1\u3092\u53d6\u308a\u6271\u3046\u5b66\u8853\u30b0\u30eb\u30fc\u30d7\u3001\u30d0\u30a4\u30aa\u30c6\u30c3\u30af\u4f01\u696d\u3001\u5927\u624b\u88fd\u85ac\u4f1a\u793e\u3068\u826f\u597d\u306a\u63d0\u643a\u95a2\u4fc2\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u69d8\u3005\u306a\u30da\u30d7\u30c1\u30c9\u3092\u88fd\u9020\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u4f8b\u3048\u3070\u3001\u30ef\u30af\u30c1\u30f3\u3084\u9577\u9396\u30da\u30d7\u30c1\u30c9\u5411\u3051\u306e\u30da\u30d7\u30c1\u30c9\u30ab\u30af\u30c6\u30eb\u306e\u88fd\u9020\u5b9f\u7e3e\u3084\u300170\u4ee5\u4e0a\u306e\u30a2\u30df\u30ce\u9178\u304b\u3089\u69cb\u6210\u3055\u308c\u308bGMP\u88fd\u54c1\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u4e16\u754c\u521d\u3068\u306a\u308b100\u6b8b\u57fa\u4ee5\u4e0a\u306e\u30a2\u30df\u30ce\u9178\u304b\u3089\u306a\u308b\u30da\u30d7\u30c1\u30c9\u306e\u5408\u6210\u3082\u5b9f\u65bd\u3057\u307e\u3057\u305f\u3002&nbsp;<\/p>\n\n\n\n<p><a href=\"\/contact-us\/\">\u304a\u554f\u3044\u5408\u308f\u305b\u7a93\u53e3 <\/a><a href=\"https:\/\/almacgroup.jp\/api-chemical-development\/api-development-manufacture\/api-manufacturing-facilities\/\"><\/a><\/p>\n\n\n\n<div style=\"height:64px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<article class=\"o-grid o-grid--full\">\n\n\t\t<div class=\"o-grid__item u-width-full u-m-t6 u-m-t4@m u-m-b4\">\n\t\t\t<h2 class=\"u-normal u-a-center\">\u95a2\u9023\u30ea\u30bd\u30fc\u30b9 <\/h2>\n\t\t<\/div>\n\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-news-panels__slider js-news-panels\">\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/a-digital-approach-to-building-better-peptides\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/api-chemical-development\/wp-content\/uploads\/sites\/4\/2022\/08\/A-digital-approach-to-building-better-peptides.jpg');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u8ad6\u6587 <\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u3088\u308a\u826f\u3044\u30da\u30d7\u30c1\u30c9\u3092\u69cb\u7bc9\u3059\u308b\u305f\u3081\u306e\u30c7\u30b8\u30bf\u30eb\u30a2\u30d7\u30ed\u30fc\u30c1 <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/modern-perspectives-on-peptide-synthesis\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/api-chemical-development\/wp-content\/uploads\/sites\/4\/2020\/03\/Modern-Perspectives-on-Peptide-Synthesis.png');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u767d\u66f8 <\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u30da\u30d7\u30c1\u30c9\u5408\u6210\u306b\u95a2\u3059\u308b\u6700\u65b0\u306e\u8996\u70b9 <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/transitioning-your-therapeutic-peptide-programme-from-research-to-clinic\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/api-chemical-development\/wp-content\/uploads\/sites\/4\/2020\/03\/Custom-Peptides-for-Research-Use-1600x555-1.png');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u8ad6\u6587 <\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u6cbb\u7642\u30da\u30d7\u30c1\u30c9\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u7814\u7a76\u304b\u3089\u81e8\u5e8a\u3078\u3068\u79fb\u884c\u3055\u305b\u308b <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/improved-peptide-analytical-technologies-and-the-impact-on-process-development\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/api-chemical-development\/wp-content\/uploads\/sites\/4\/2022\/02\/peptides-tech-banner-2-e1647968333389.png');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u8ad6\u6587 <\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u30da\u30d7\u30c1\u30c9\u5206\u6790\u6280\u8853\u306e\u5411\u4e0a\u3068\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u3078\u306e\u5f71\u97ff <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/identification-and-structural-elucidation-by-amino-acid-sequencing-of-peptide-impurities-by-2d-lc-ms-ms\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/api-chemical-development\/wp-content\/uploads\/sites\/4\/2022\/02\/peptides-tech-banner-2-e1647968333389.png');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u30dd\u30b9\u30bf\u30fc <\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u30a2\u30df\u30ce\u9178\u306b\u3088\u308b\u540c\u5b9a\u304a\u3088\u3073\u69cb\u9020\u89e3\u6790<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\n\n<!-- <article 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class=\"u-normal\">\u30da\u30d7\u30c1\u30c9\u5206\u6790\u6280\u8853\u306e\u5411\u4e0a\u3068\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u3078\u306e\u5f71\u97ff <\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-1\/3 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/identification-and-structural-elucidation-by-amino-acid-sequencing-of-peptide-impurities-by-2d-lc-ms-ms\/\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center\" style=\"background-image: url('https:\/\/almacgroup.jp\/api-chemical-development\/wp-content\/uploads\/sites\/4\/2022\/02\/peptides-tech-banner-2-e1647968333389.png');\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">\u30dd\u30b9\u30bf\u30fc <\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">\u30a2\u30df\u30ce\u9178\u306b\u3088\u308b\u540c\u5b9a\u304a\u3088\u3073\u69cb\u9020\u89e3\u6790<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/article> -->\n","protected":false},"excerpt":{"rendered":"<p>\u5e83\u7bc4\u306a\u81e8\u5e8a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u305f\u3081\u306e\u30da\u30d7\u30c1\u30c9\u3092\u88fd\u9020&nbsp; \u5f53\u793e\u306f\u3001\u304a\u5ba2\u69d8\u306e\u533b\u85ac\u54c1\u958b\u767a\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u306e\u4e2d\u3067\u81e8\u5e8a\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u5fc5\u8981\u306aGMP\u30da\u30d7\u30c1\u30c9\u88fd\u9020\u306e\u4fe1\u983c\u3067\u304d\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002\u958b\u767a\u88fd\u9020\u30ad\u30e3\u30f3\u30da\u30fc\u30f3\u3092\u304a\u5c4a\u3051\u3059\u308b\u3046\u3048\u3067\u5f37\u56fa\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u3063\u3066\u304a\u308a\u3001\u5f53\u793e\u65bd\u8a2d\u306f\u3059\u3067\u306bMHRA\u306e\u76e3\u67fb\u3068\u8a8d\u8a3c\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u3002&nbsp; \u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u3068\u7d50\u675f\u529b \u5f53\u793e\u306f\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u4f5c\u696d\u3092\u91cd\u8996\u3057\u3001\u5f37\u56fa\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u3092\u3059\u308b\u624b\u6cd5\u3092\u3068\u3063\u3066\u3044\u307e\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3068\u5f53\u793e\u5316\u5b66\u30fb\u5206\u6790\u30b0\u30eb\u30fc\u30d7\u306e\u5c02\u9580\u5bb6\u3092\u307e\u3068\u3081\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u7d50\u6210\u3057\u307e\u3059\u3002\u3053\u306e\u30c1\u30fc\u30e0\u304c\u958b\u767a\u6bb5\u968e\u304b\u3089\u88fd\u9020\u6bb5\u968e\u3092\u901a\u3058\u3066\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u53c2\u52a0\u3059\u308b\u3053\u3068\u3067\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u671f\u9593\u5168\u4f53\u306b\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002&nbsp; \u88fd\u9020\u3078\u306e\u5186\u6ed1\u306a\u79fb\u884c\u3092\u78ba\u5b9f\u306a\u3082\u306e\u306b\u3059\u308b&nbsp; \u30d7\u30ed\u30bb\u30b9\u958b\u767a\u306b\u5bfe\u3057\u300c\u76ee\u7684\u306b\u9069\u5408\u3057\u305f\u300d\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u53d6\u308a\u307e\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u77e5\u8b58\u304c\u6642\u9593\u3068\u3068\u3082\u306b\u6df1\u307e\u308b\u306b\u3064\u308c\u3001\u958b\u767a\u304c\u7cbe\u7dfb\u5316\u3055\u308c\u3066\u3044\u304d\u3001\u5404\u81e8\u5e8a\u958b\u767a\u6bb5\u968e\u3067\u306e\u5fc5\u8981\u5ea6\u306b\u5f93\u3063\u3066API\u3092\u88fd\u9020\u3057\u307e\u3059\u3002\u5f53\u793e\u306f\u3001\u30da\u30d7\u30c1\u30c9\u3068\u4f4e\u5206\u5b50\u5316\u5408\u7269\u3068\u306e\u4e21\u65b9\u306b\u304a\u3044\u3066\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u304b\u3089\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u307e\u3067\u5e83\u304f\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002&nbsp; \u3042\u3089\u3086\u308b\u30b9\u30c6\u30c3\u30d7\u3092\u30b5\u30dd\u30fc\u30c8&nbsp; Almac\u30b0\u30eb\u30fc\u30d7\u306b\u306f180\u540d\u306e\u5206\u6790\u5c02\u9580\u5bb6\u304c\u5728\u7c4d\u3057\u3066\u304a\u308a\u3001\u304a\u5ba2\u69d8\u306e\u30da\u30d7\u30c1\u30c9\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u304f\u307e\u306a\u304f\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002ICH\u6761\u4ef6\u4e0b\u3067\u306e\u65b9\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u539f\u6599\u3068\u6700\u7d42API\u306eQC\u30ea\u30ea\u30fc\u30b9\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u533b\u85ac\u54c1\u304a\u3088\u3073\u539f\u85ac\u306e\u8a66\u9a13\u306b\u95a2\u3057\u3066\u3082\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002&nbsp; \u5f53\u793e\u306e\u5b9f\u7e3e&nbsp; \u5f53\u793e\u306f\u3001\u82f1\u56fd\u3001\u6b27\u5dde\u3001\u7c73\u56fd\u306eGMP\u30da\u30d7\u30c1\u30c9\u88fd\u54c1\u3092\u53d6\u308a\u6271\u3046\u5b66\u8853\u30b0\u30eb\u30fc\u30d7\u3001\u30d0\u30a4\u30aa\u30c6\u30c3\u30af\u4f01\u696d\u3001\u5927\u624b\u88fd\u85ac\u4f1a\u793e\u3068\u826f\u597d\u306a\u63d0\u643a\u95a2\u4fc2\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u69d8\u3005\u306a\u30da\u30d7\u30c1\u30c9\u3092\u88fd\u9020\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u4f8b\u3048\u3070\u3001\u30ef\u30af\u30c1\u30f3\u3084\u9577\u9396\u30da\u30d7\u30c1\u30c9\u5411\u3051\u306e\u30da\u30d7\u30c1\u30c9\u30ab\u30af\u30c6\u30eb\u306e\u88fd\u9020\u5b9f\u7e3e\u3084\u300170\u4ee5\u4e0a\u306e\u30a2\u30df\u30ce\u9178\u304b\u3089\u69cb\u6210\u3055\u308c\u308bGMP\u88fd\u54c1\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u4e16\u754c\u521d\u3068\u306a\u308b100\u6b8b\u57fa\u4ee5\u4e0a\u306e\u30a2\u30df\u30ce\u9178\u304b\u3089\u306a\u308b\u30da\u30d7\u30c1\u30c9\u306e\u5408\u6210\u3082\u5b9f\u65bd\u3057\u307e\u3057\u305f\u3002&nbsp; 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