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\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u4fdd\u6301\u8005\u306e\u8cac\u52d9\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u5206\u91ce\u304c\u542b\u307e\u308c\u308b\uff1a<\/p>\n

    \n
  1. \u76e3\u67fb\u3068\u8cc7\u683c\u8a8d\u5b9a\u6d3b\u52d5\uff1a<\/strong>\u76e3\u67fb\u3092\u5b9f\u65bd\u3057\u3001\u88fd\u9020\u62e0\u70b9\u306e\u9069\u683c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002<\/li>\n
  2. \u88fd\u9020\u62e0\u70b9\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\uff1a<\/strong>MAH \u306f\u3001MA \u95a2\u4fc2\u66f8\u985e\u60c5\u5831\u306e\u5171\u6709\u3001\u3070\u3089\u3064\u304d\u3078\u306e\u5bfe\u5fdc\u3001\u898f\u5236\u4e0a\u306e\u7fa9\u52d9\u3078\u306e\u5bfe\u5fdc\u306a\u3069\u306b\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002<\/li>\n
  3. \u88fd\u54c1\u306e\u54c1\u8cea\u30ec\u30d3\u30e5\u30fc\uff1a<\/strong>MAH\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u8a55\u4fa1\u3057\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u5b9a\u671f\u7684\u306a\u30ec\u30d3\u30e5\u30fc\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n
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    \u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068<\/strong><\/h3>\n

    \u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001  MAH\u3068\u30e1\u30fc\u30ab\u30fc\u53cc\u65b9\u306e\u8cac\u4efb\u3092\u8a73\u7d30\u306b\u898f\u5b9a\u3057\u305f\u5305\u62ec\u7684\u306a \u6280\u8853\u5354\u5b9a\u306e\u4f5c\u6210\u304b\u3089\u59cb\u307e\u308b\u3002 <\/p>\n

      \n
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    • \u5171\u6709\u30ea\u30dd\u30b8\u30c8\u30ea\u306f\u3001MA\u767b\u9332\u306e\u8a73\u7d30\u3001\u73fe\u5728\u306e\u8868\u793a\u3068\u30a2\u30fc\u30c8\u30ef\u30fc\u30af\u3001\u88fd\u54c1\u306e\u8a73\u7d30\u3001\u627f\u8a8d\u3055\u308c\u305f\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u3001\u63d0\u6848\u3055\u308c\u305f\u5909\u66f4\u306e\u5f71\u97ff\u8a55\u4fa1\u3001\u9038\u8131\u8a18\u9332\u3001\u76e3\u67fb\u5831\u544a\u66f8\u3001\u5206\u6790\u8a3c\u660e\u66f8\u3001\u54c1\u8cea\u62c5\u5f53\u8005\uff08QP\uff09\u306e\u5ba3\u8a00\u6587\u3092\u542b\u3080\u91cd\u8981\u306a\u60c5\u5831\u3092\u4f53\u7cfb\u7684\u306b\u4fdd\u5b58\u3059\u308b\u305f\u3081\u306b\u78ba\u7acb\u3055\u308c\u308b\u3002\u3053\u306e\u30ea\u30dd\u30b8\u30c8\u30ea\u30fc\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\uff08MAH\uff09\u3068\u30e1\u30fc\u30ab\u30fc\u9593\u306e\u4e0d\u53ef\u6b20\u306a\u53cc\u65b9\u5411\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306e\u30d0\u30c3\u30af\u30dc\u30fc\u30f3\u3068\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u3002 <\/li>\n
    • \u3057\u304b\u3057\u3001\u30ea\u30dd\u30b8\u30c8\u30ea\u3092\u69cb\u9020\u5316\u3055\u308c\u3066\u3044\u306a\u3044\u30c7\u30fc\u30bf\u306e\u6368\u3066\u5834\u306b\u3059\u308b\u3053\u3068\u306f\u907f\u3051\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5171\u6709\u30ea\u30dd\u30b8\u30c8\u30ea\u306b\u306f\u3001\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u30ec\u30b3\u30fc\u30c9\u3001\u30c6\u30b9\u30c8\u4ed5\u69d8\u66f8\u3001\u4f1a\u8b70\u8b70\u4e8b\u9332\u3001\u30d0\u30c3\u30c1\u30ea\u30b9\u30c8\u306a\u3069\u3001\u7279\u5b9a\u306e\u6587\u66f8\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5408\u308f\u305b\u3066\u660e\u78ba\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u30d5\u30a9\u30eb\u30c0\u3092\u8a2d\u3051\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u3055\u3089\u306b\u3001\u30ea\u30dd\u30b8\u30c8\u30ea\u5185\u306b\u65b0\u3057\u3044\u6587\u66f8\u304c\u8ffd\u52a0\u3055\u308c\u305f\u308a\u3001\u65e2\u5b58\u306e\u6587\u66f8\u304c\u66f4\u65b0\u3055\u308c\u305f\u308a\u3057\u305f\u3068\u304d\u306b\u3001\u4e3b\u8981\u306a\u5229\u5bb3\u95a2\u4fc2\u8005\u306b\u8fc5\u901f\u306b\u901a\u77e5\u3059\u308b\u30a2\u30e9\u30fc\u30c8\u901a\u77e5\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u304c\u671b\u307e\u3057\u3044\u3002\u660e\u78ba\u5316\u3068\u7ba1\u7406\u306e\u305f\u3081\u306b\u3001\u3053\u308c\u3089\u306e\u6587\u66f8\u304c\u53ef\u8996\u5316\u3055\u308c\u3001\u6587\u66f8\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u3084\u65e5\u4ed8\u306e\u5272\u308a\u5f53\u3066\u306b\u3088\u3063\u3066\u8ffd\u8de1\u3055\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u3002 <\/li>\n
    • \u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u8cac\u4efb\u306e\u66d6\u6627\u3055\u3092\u306a\u304f\u3059\u3053\u3068\u306f\u3001GMP\u30b3\u30f3\u30d7\u30e9 \u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002\u3069\u306e\u3088\u3046\u306a\u3084\u308a\u3068\u308a\u304c\u3001\u6b63\u5f0f\u306a\u624b\u9806\u306e\u4e00\u90e8\u3067\u3042\u308b\u304b\u3001\u53ca\u3073\uff0f\u53c8\u306f\u3001\u6280\u8853\u5354\u5b9a\u306e \u4e00\u90e8\u3067\u3042\u308b\u304b\u3092\u691c\u8a0e\u3059\u308b\u3002\u4f8b\u3048\u3070\u3001\u88fd\u54c1\u306e\u958b\u767a\u3001\u5909\u66f4\u3001\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u304c\u6642\u9593\u306e\u7d4c\u904e\u3068\u3068\u3082\u306b\u6e1b\u5c11\u3059\u308b\u5834\u5408\u306a\u3069\u3067\u3042\u308b\u3002 <\/li>\n<\/ul>\n

      MAH\u3068\u30e1\u30fc\u30ab\u30fc\u306e\u53cc\u65b9\u306f\u3001\u67fb\u5bdf\u306e\u969b\u306b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30fb\u30d7\u30ed\u30bb\u30b9\u306e\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3067\u304d\u308b\u3088\u3046\u6e96\u5099\u3059\u3079\u304d\u3067\u3042\u308b\u3002GMP\u898f\u5247\u3067\u306f\u3001\u3069\u3061\u3089\u304b\u4e00\u65b9\u304c\u60c5\u5831\u3092\u4fdd\u6301\u3059\u308b\u3053\u3068\u306f\u8a8d\u3081\u3089\u308c\u3066\u304a\u3089\u305a\u3001\u30c1\u30fc\u30e0\u5185\u306e\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30ea\u30ba\u30e0\u3068\u30aa\u30fc\u30d7\u30f3\u3055\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002 <\/p>\n\n\n\n

      \u88fd\u54c1\u306e\u4f9b\u7d66\u306b\u3064\u3044\u3066\u306f\u3069\u3046\u3060\u308d\u3046\uff1f<\/strong><\/h2>\n

      \u4f9b\u7d66\u5236\u9650\u3084\u4f9b\u7d66\u4e0d\u8db3\u306b\u3064\u306a\u304c\u308b\u88fd\u54c1\u306e\u54c1\u8cea\u6b20\u9665\u3084\u30ea\u30b3\u30fc\u30eb\u306f\u3001\u5fc5\u7136\u7684\u306bMAH\u3084\u30e1\u30fc\u30ab\u30fc\u306b\u8ca0\u62c5\u3092\u304b\u3051\u308b\u3002  MAH\u306f\u3001\u60a3\u8005\u306e\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u533b\u85ac\u54c1\u306e\u7d99\u7d9a\u7684\u306a\u5165\u624b\u53ef\u80fd\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u8cac\u4efb\u3092\u8ca0\u3046\u3002\u3053\u306e\u3088\u3046\u306a\u91cd\u8981\u306a\u5834\u9762\u3067\u306f\u3001\u4e21\u8005\u9593\u306e\u30aa\u30fc\u30d7\u30f3\u3067\u8aa0\u5b9f\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u7dad\u6301\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u6280\u8853\u5354\u5b9a\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u304a\u3051\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30fb\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5305\u62ec\u7684\u306b\u5bfe\u51e6\u3057\u3001MAH\u304c\u7ba1\u8f44\u5f53\u5c40\u306b\u901f\u3084\u304b\u306b\u901a\u77e5\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n

      \u305d\u3057\u3066\u6700\u5f8c\u306b…\u3002<\/strong><\/h2>\n

      GMP\u57fa\u6e96\u3092\u6210\u529f\u88cf\u306b\u6e80\u305f\u3059\u306b\u306f\u3001\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u306a\u884c\u52d5\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u4e21\u8005\u304c\u30b7\u30fc\u30e0\u30ec\u30b9\u306b\u5354\u529b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 <\/p>\n

      GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u306f\u3001MAH\u3068\u88fd\u9020\u59d4\u8a17\u5148\u3068\u306e\u9593\u306e\u660e\u78ba\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001\u660e\u78ba\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u8cac\u4efb\u3001\u5354\u529b\u4f53\u5236\u3078\u306e\u69cb\u9020\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u5fc5\u8981\u3067\u3059\u3002\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u88fd\u85ac\u696d\u754c\u306b\u304a\u3044\u3066\u3053\u306e\u3088\u3046\u306a\u900f\u660e\u6027\u3068\u5c02\u9580\u6027\u306e\u30ec\u30d9\u30eb\u304c\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002 <\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":39,"featured_media":375046,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[518],"tags":[282,290,301,302,345,351,353,360,375],"resource-featured-status":[],"resource-type":[],"class_list":["post-375043","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gmp","tag-annex-1","tag-quality-risk-mgt","tag-fda","tag-ema","tag-regulatory-compliance","tag-gmp","tag-eu-gmp","tag-qcr","tag-mah"],"acf":[],"featured_image_src":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2023\/11\/Geraldine-Carr-Mulry_Reflecting-Again-on-GMP-Requirements.jpg","featured_image_src_square":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2023\/11\/Geraldine-Carr-Mulry_Reflecting-Again-on-GMP-Requirements.jpg","author_info":{"display_name":"Rachel Glennie","author_link":"https:\/\/caiready.com\/life-sciences\/ja\/blog\/author\/rachel-glennie\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts\/375043","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/comments?post=375043"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts\/375043\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/media\/375046"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/media?parent=375043"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/categories?post=375043"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/tags?post=375043"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/resource-featured-status?post=375043"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/resource-type?post=375043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}