{"id":11063,"date":"2026-11-06T19:55:49","date_gmt":"2026-11-06T10:55:49","guid":{"rendered":"https:\/\/japan-ai.geniee.co.jp\/media\/?p=11063"},"modified":"2026-11-06T19:58:58","modified_gmt":"2026-11-06T10:58:58","slug":"gxp%e3%81%a8%e3%81%af%ef%bc%9f%e6%84%8f%e5%91%b3%e3%83%bb%e7%a8%ae%e9%a1%9e%e3%83%bb%e4%bb%a3%e8%a1%a8%e7%9a%84%e3%81%aa%e5%9f%ba%e6%ba%96%e3%82%92%e3%82%8f%e3%81%8b%e3%82%8a%e3%82%84%e3%81%99","status":"publish","type":"post","link":"https:\/\/japan-ai.co.jp\/media\/11063\/","title":{"rendered":"GxP\u3068\u306f\uff1f\u610f\u5473\u30fb\u7a2e\u985e\u30fb\u4ee3\u8868\u7684\u306a\u57fa\u6e96\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac"},"content":{"rendered":"\n<p>\u533b\u85ac\u54c1\u306e\u958b\u767a\u3001\u88fd\u9020\u3001\u8ca9\u58f2\u3001\u6d41\u901a\u306b\u95a2\u308f\u308b\u696d\u52d9\u3067\u306f\u3001\u300cGxP\u300d\u3068\u3044\u3046\u7528\u8a9e\u306b\u906d\u9047\u3059\u308b\u5834\u9762\u304c\u591a\u304f\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305d\u3082\u305d\u3082GxP\u3068\u306f\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u304b\u3001\u306a\u305c\u3053\u308c\u307b\u3069GMP\u3001GCP\u3001GLP\u306a\u3069\u591a\u304f\u306e\u7a2e\u985e\u304c\u3042\u308b\u306e\u304b\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3084CSV\u30fbCSA\u3068\u306f\u3069\u306e\u3088\u3046\u306a\u95a2\u4fc2\u306b\u3042\u308b\u306e\u304b\u3001\u672c\u8a18\u4e8b\u3067\u306f\u3053\u3046\u3057\u305f\u7591\u554f\u3092\u6574\u7406\u3059\u308b\u305f\u3081\u3001<mark>GxP\u306e\u57fa\u672c\u7684\u306a\u610f\u5473\u304b\u3089\u4ee3\u8868\u7684\u306a7\u7a2e\u985e\u306e\u7279\u5fb4\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30fbCSV\u30fbCSA\u3068\u306e\u95a2\u4fc2\u3001\u305d\u3057\u3066AI\u30fb\u30c7\u30b8\u30bf\u30eb\u5bfe\u5fdc\u306e\u6700\u65b0\u898f\u5236\u52d5\u5411<\/mark>\u307e\u3067\u3001<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">\u88fd\u85ac\u696d\u754c\u5411\u3051AI\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u63d0\u4f9b\u3059\u308bJAPAN AI<\/a>\u304c\u7db2\u7f85\u7684\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"toc\">    <div id=\"toc_container\" class=\"toc_container toc-container sgb-toc--bullets js-smooth-scroll\" data-dialog-title=\"Table of Contents\">\n      <p class=\"toc_title\">\u76ee\u6b21 <\/p>\n      <ul class=\"toc_list\">  <li class=\"first\">    <a href=\"#i-0\">GxP\u3068\u306f\uff1f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-1\">\u306a\u305cGxP\u306f\u3053\u308c\u307b\u3069\u591a\u3044\u306e\u304b<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-2\">GxP\u304c\u91cd\u8981\u306a\u7406\u7531<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-7\">\u4ee3\u8868\u7684\u306aGxP\u306e\u7a2e\u985e\u3068\u7279\u5fb4<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-8\">GLP\uff08\u5b89\u5168\u6027\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09<\/a>      <\/li>      <li>        <a href=\"#i-9\">GCP\uff08\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09<\/a>      <\/li>      <li>        <a href=\"#i-10\">GMP\uff08\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/a>      <\/li>      <li>        <a href=\"#i-11\">GQP\uff08\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/a>      <\/li>      <li>        <a href=\"#i-12\">GVP\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/a>      <\/li>      <li>        <a href=\"#i-13\">GDP\uff08\u9069\u6b63\u6d41\u901a\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-14\">GPSP\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u53ca\u3073\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff09<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-15\">GxP\u3068\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3<\/a>  <\/li>  <li>    <a href=\"#i-16\">GxP\u3068CSV\u30fbCSA<\/a>  <\/li>  <li>    <a href=\"#i-17\">GxP\u3068AI\u30fb\u30c7\u30b8\u30bf\u30eb\u5bfe\u5fdc<\/a>  <\/li>  <li>    <a href=\"#i-18\">GxP\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-19\">GxP\u3068GMP\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-20\">GxP\u306f\u533b\u85ac\u54c1\u696d\u754c\u4ee5\u5916\u306b\u3082\u95a2\u4fc2\u3057\u307e\u3059\u304b\uff1f<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-21\">GxP\u306b\u9055\u53cd\u3059\u308b\u3068\u3069\u3046\u306a\u308a\u307e\u3059\u304b\uff1f<\/a>      <\/li>    <\/ul>  <\/li>  <li class=\"last\">    <a href=\"#i-22\">GxP\u306e\u7406\u89e3\u304c\u73fe\u5834\u306e\u54c1\u8cea\u610f\u8b58\u3092\u5909\u3048\u308b<\/a>  <\/li><\/ul>\n      \n    <\/div><\/div><h2 class=\"wp-block-heading\" id=\"i-0\">GxP\u3068\u306f\uff1f<\/h2>\n\n\n\n<p>GxP\u3068\u306f\u300cGood x Practice\u300d\u306e\u7565\u79f0\u3067\u3001Good\u306f\u9069\u6b63\u3001Practice\u306f\u5b9f\u65bd\u57fa\u6e96\u3092\u610f\u5473\u3057\u3001\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u3001\u88fd\u9020\u3001\u8ca9\u58f2\u3001\u6d41\u901a\u3001\u5e02\u8ca9\u5f8c\u307e\u3067\u306e\u5168\u5de5\u7a0b\u306b\u304a\u3044\u3066\u54c1\u8cea\u30fb\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u5404\u56fd\u306e\u653f\u5e9c\u3084\u516c\u7684\u6a5f\u95a2\uff08\u65e5\u672c\u3067\u306f\u539a\u751f\u52b4\u50cd\u7701\u3084PMDA\uff08\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff09\u3001\u7c73\u56fd\u3067\u306fFDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u3001\u6b27\u5dde\u3067\u306fEMA\uff08\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff09\uff09\u306b\u3088\u308a\u5b9a\u3081\u3089\u308c\u305f<mark>\u5404\u7a2e\u6cd5\u4ee4\u3084\u7701\u4ee4\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u7dcf\u79f0<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u300cx\u300d\u306b\u306f\u696d\u52d9\u9818\u57df\u3092\u8868\u3059\u82f1\u5358\u8a9e\u306e\u982d\u6587\u5b57\u304c\u5165\u308a\u3001\u300cGLP\u300d\u300cGCP\u300d\u300cGMP\u300d\u300cGQP\u300d\u300cGDP\u300d\u300cGVP\u300d\u300cGPSP\u300d\u306e\u3088\u3046\u306b\u3001\u5bfe\u8c61\u5206\u91ce\u3054\u3068\u306b\u5404\u696d\u52d9\u306e\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u7ba1\u7406\u306e\u67a0\u7d44\u307f\u3092\u4f53\u7cfb\u7684\u306b\u5f62\u6210\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u306e\u533b\u85ac\u54c1\u95a2\u9023\u696d\u52d9\u3082\u4f8b\u5916\u306a\u304f\u4ee5\u4e0b\u306e\u4ee3\u8868\u7684\u306a7\u3064\u306eGxP\u306b\u3066\u6210\u308a\u7acb\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GxP\u306e\u4ed5\u7d44\u307f\u306f\u30011960\u5e74\u4ee3\u306e\u30b5\u30ea\u30c9\u30de\u30a4\u30c9\u4e8b\u4ef6\u7b49\u306e\u85ac\u5bb3\u3092\u304d\u3063\u304b\u3051\u306b\u3001\u30a2\u30e1\u30ea\u30abFDA\u304c\u533b\u85ac\u54c1\u306e\u88fd\u9020\u3084\u8a66\u9a13\u306b\u95a2\u3059\u308b\u57fa\u6e96\u3092\u6574\u5099\u3057\u3066\u3044\u3063\u305f\u3053\u3068\u304c\u59cb\u307e\u308a\u306e\u4e00\u3064\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u306eGxP\u306b\u306f\u3001\u6d77\u5916\u3084\u56fd\u969b\u7684\u306a\u67a0\u7d44\u307f\u3067\u793a\u3055\u308c\u305f\u57fa\u6e96\u3068\u95a2\u308f\u308a\u306e\u6df1\u3044\u3082\u306e\u3068\u3001\u85ac\u6a5f\u6cd5\u306e\u4f53\u7cfb\u306b\u7d44\u307f\u8fbc\u307e\u308c\u308b\u904e\u7a0b\u3067\u65e5\u672c\u72ec\u81ea\u306e\u57fa\u6e96\u3068\u3057\u3066\u767a\u5c55\u3057\u305f\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u524d\u8005\u3068\u3057\u3066\u306f\u3001\u30a2\u30e1\u30ea\u30abFDA\u3084\u6b27\u5ddeEMA\u3001\u56fd\u969b\u6a5f\u95a2\u3067\u3042\u308bWHO\u3084ICH\u306a\u3069\u304c\u793a\u3059\u57fa\u6e96\u30fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u95a2\u308f\u308a\u306e\u6df1\u3044\u300cGLP\uff08Good Laboratory Practice\uff1a\u5b89\u5168\u6027\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09\u300d\u300cGCP\uff08Good Clinical Practice\uff1a\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09\u300d\u300cGMP\uff08Good Manufacturing Practice\uff1a\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09\u300d\u300cGDP\uff08Good Distribution Practice\uff1a\u9069\u6b63\u6d41\u901a\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u300d\u300cGVP\uff08Good Vigilance Practice\uff1a\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\uff09\u300d\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5f8c\u8005\u3068\u3057\u3066\u306f\u3001\u65e5\u672c\u306e\u5e02\u5834\u3084\u5b89\u5168\u7ba1\u7406\u3001\u5e02\u8ca9\u5f8c\u696d\u52d9\u306e\u7279\u6027\u3092\u8e0f\u307e\u3048\u3066\u539a\u751f\u52b4\u50cd\u7701\u304c\u5b9a\u3081\u305f\u300cGQP\uff08Good Quality Practice\uff1a\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09\u300d\u300cGPSP\uff08Good Post-marketing Study Practice\uff1a\u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u53ca\u3073\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff09\u300d\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002GQP\u30fbGPSP\u306e\u540d\u79f0\u306f\u65e5\u672c\u7279\u6709\u3067\u3059\u304c\u30012005\u5e74\u65bd\u884c\u306e\u6539\u6b63\u85ac\u4e8b\u6cd5\u3067\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u8cac\u52d9\u304c\u660e\u78ba\u5316\u3055\u308c\u305f\u3053\u3068\u306b\u4f34\u3044\u3001GMP\u3084\u88fd\u9020\u8ca9\u58f2\u696d\u8005\uff08MAH\uff09\u306e\u8cac\u52d9\u3068\u3044\u3063\u305f\u56fd\u969b\u7684\u306a\u898f\u5236\u306e\u8003\u3048\u65b9\u3092\u8e0f\u307e\u3048\u3001\u56fd\u5185\u306e\u7701\u4ee4\u3068\u3057\u3066\u6574\u5099\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u3067\u306f<mark>\u85ac\u6a5f\u6cd5\u3092\u9802\u70b9\u3068\u3057\u3066\u3001\u8a73\u7d30\u306a\u7701\u4ee4\u3084\u901a\u77e5\u3067GxP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u88dc\u5b8c\u3059\u308b\u6cd5\u4f53\u7cfb<\/mark>\u306e\u69cb\u9020\u3092\u3068\u3063\u3066\u304a\u308a\u3001GMP\u30fbGQP\u30fbGVP\u30fbGPSP\u306a\u3069\u306f\u85ac\u6a5f\u6cd5\u306b\u57fa\u3065\u304f\u7701\u4ee4\u3068\u3057\u3066\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3061\u3001GDP\u306f\u7701\u4ee4\u3067\u306f\u306a\u304f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3001\u6cd5\u7684\u6027\u8cea\u304c\u7570\u306a\u308b\u3059\u3079\u3066\u306eGxP\u304c\u9023\u52d5\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3092\u5404\u6bb5\u968e\u3067\u7ba1\u7406\u3057\u3001\u88fd\u85ac\u4f01\u696d\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u652f\u3048\u308b\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u85ac\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3068GxP\u306e\u95a2\u4fc2<\/p>\n\n\n<div id=\"id-5211dba4-1fff-4b4f-905f-1c79877463f5\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u6bb5\u968e<\/th><th>\u4e3b\u306a\u696d\u52d9\u9818\u57df<\/th><th>\u5bfe\u5fdc\u3059\u308bGxP<\/th><\/tr><tr><td>\u975e\u81e8\u5e8a\u8a66\u9a13<\/td><td>\u6bd2\u6027\u8a66\u9a13\u30fb\u5b89\u5168\u6027\u85ac\u7406\u8a66\u9a13\u7b49\u306e\u975e\u81e8\u5e8a\u5b89\u5168\u6027\u8a66\u9a13<\/td><td>GLP\uff08Good Laboratory Practice\uff09<\/td><\/tr><tr><td>\u81e8\u5e8a\u8a66\u9a13<\/td><td>\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30c7\u30fc\u30bf\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3057\u305f\u6cbb\u9a13\u306e\u5b9f\u65bd<\/td><td>GCP\uff08Good Clinical Practice\uff09<\/td><\/tr><tr><td>\u88fd\u9020<\/td><td>\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406<\/td><td>GMP\uff08Good Manufacturing Practice\uff09<\/td><\/tr><tr><td>\u5e02\u5834\u51fa\u8377<\/td><td>\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u54c1\u8cea\u7ba1\u7406\u30fb\u51fa\u8377\u5224\u5b9a<\/td><td>GQP\uff08Good Quality Practice\uff09<\/td><\/tr><tr><td>\u6d41\u901a<\/td><td>\u4fdd\u7ba1\u30fb\u8f38\u9001\u306b\u304a\u3051\u308b\u54c1\u8cea\u7dad\u6301<\/td><td>GDP\uff08Good Distribution Practice\uff09<\/td><\/tr><tr><td>\u5e02\u8ca9\u5f8c\u5b89\u5168\u7ba1\u7406<\/td><td>\u5b89\u5168\u7ba1\u7406\u60c5\u5831\u306e\u53ce\u96c6\u30fb\u691c\u8a0e\u30fb\u5b89\u5168\u78ba\u4fdd\u63aa\u7f6e<\/td><td>GVP\uff08Good Vigilance Practice\uff09<\/td><\/tr><tr><td>\u5e02\u8ca9\u5f8c\u8abf\u67fb<\/td><td>\u4f7f\u7528\u6210\u7e3e\u8abf\u67fb\u30fb\u88fd\u9020\u8ca9\u58f2\u5f8c\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u8abf\u67fb\u30fb\u88fd\u9020\u8ca9\u58f2\u5f8c\u81e8\u5e8a\u8a66\u9a13\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u81e8\u5e8a\u8a66\u9a13\u306b\u306fGCP\u3082\u9069\u7528\uff09<\/td><td>GPSP\uff08Good Post-marketing Study Practice\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<h3 class=\"wp-block-heading\" id=\"i-1\">\u306a\u305cGxP\u306f\u3053\u308c\u307b\u3069\u591a\u3044\u306e\u304b<\/h3>\n\n\n\n<p>GxP\u304c\u8907\u6570\u5b58\u5728\u3059\u308b\u7406\u7531\u306f\u3001\u533b\u85ac\u54c1\u306e\u958b\u767a\u304b\u3089\u5e02\u8ca9\u5f8c\u307e\u3067\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u5404\u6bb5\u968e\u304c\u3001\u305d\u308c\u305e\u308c<mark>\u7570\u306a\u308b\u54c1\u8cea\u4e0a\u306e\u30ea\u30b9\u30af<\/mark>\u3092\u62b1\u3048\u3066\u3044\u308b\u305f\u3081\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u975e\u81e8\u5e8a\u8a66\u9a13\u306e\u6bb5\u968e\u3067\u306f\u3001\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u304c\u6700\u5927\u306e\u95a2\u5fc3\u4e8b\u3067\u3059\u3002\u6bd2\u6027\u8a66\u9a13\u3084\u5b89\u5168\u6027\u85ac\u7406\u8a66\u9a13\u3067\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u306b\u8aa4\u308a\u3084\u6539\u3056\u3093\u304c\u3042\u308c\u3070\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u9032\u3080\u3079\u304d\u3067\u306a\u3044\u5019\u88dc\u7269\u8cea\u304c\u6b21\u306e\u30d5\u30a7\u30fc\u30ba\u3078\u79fb\u884c\u3057\u3066\u3057\u307e\u3046\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e00\u65b9\u3067\u3001\u88fd\u9020\u5de5\u7a0b\u3067\u306f\u539f\u6750\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u6700\u7d42\u88fd\u54c1\u306e\u51fa\u8377\u307e\u3067\u3001\u4ea4\u53c9\u6c5a\u67d3\u306e\u9632\u6b62\u3084\u88fd\u9020\u6761\u4ef6\u306e\u5747\u4e00\u6027\u304c\u4e2d\u5fc3\u7684\u306a\u8ab2\u984c\u3067\u3059\u3002\u3055\u3089\u306b\u6d41\u901a\u6bb5\u968e\u306b\u306a\u308b\u3068\u3001\u6e29\u5ea6\u9038\u8131\u306b\u3088\u308b\u54c1\u8cea\u52a3\u5316\u3084\u507d\u9020\u533b\u85ac\u54c1\u306e\u6df7\u5165\u30ea\u30b9\u30af\u3078\u306e\u5bfe\u51e6\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u3088\u3046\u306b\u3001<mark>\u6bb5\u968e\u3054\u3068\u306b\u7ba1\u7406\u3059\u3079\u304d\u5bfe\u8c61\u3084\u8a55\u4fa1\u306e\u8996\u70b9\u304c\u6839\u672c\u7684\u306b\u7570\u306a\u308b<\/mark>\u305f\u3081\u3001\u4e00\u3064\u306e\u6c4e\u7528\u7684\u306a\u57fa\u6e96\u3067\u306f\u30ab\u30d0\u30fc\u3057\u304d\u308c\u305a\u3001\u5404\u6bb5\u968e\u306b\u7279\u5316\u3057\u305f\u5c02\u9580\u7684\u306a\u57fa\u6e96\u304c\u305d\u308c\u305e\u308c\u8a2d\u3051\u3089\u308c\u305f\u7d50\u679c\u3001GxP\u306f\u4f53\u7cfb\u7684\u306b\u8907\u6570\u5b58\u5728\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-2\">GxP\u304c\u91cd\u8981\u306a\u7406\u7531<\/h3>\n\n\n\n<p>GxP\u304c\u533b\u85ac\u54c1\u696d\u754c\u3067\u91cd\u8996\u3055\u308c\u308b\u80cc\u666f\u306b\u306f\u3001<mark>\u5927\u304d\u304f4\u3064\u306e\u89b3\u70b9<\/mark>\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u60a3\u8005\u306e\u5b89\u5168\u3092\u5b88\u308b\u305f\u3081<\/li>\n\n\n\n<li>\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u4e00\u5b9a\u6c34\u6e96\u306b\u4fdd\u3064\u305f\u3081<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u7dad\u6301<\/li>\n\n\n\n<li>\u6cd5\u898f\u5236\u306e\u9075\u5b88\uff08\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\uff09\u306e\u305f\u3081<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"i-3\">\u60a3\u8005\u306e\u5b89\u5168\u3092\u5b88\u308b\u305f\u3081<\/h4>\n\n\n\n<p>GxP\u304c\u533b\u85ac\u54c1\u696d\u754c\u3067\u91cd\u8996\u3055\u308c\u308b\u7406\u7531\u306e\u4e00\u3064\u304c\u3001\u60a3\u8005\u306e\u5b89\u5168\u3092\u5b88\u308b\u3068\u3044\u3046\u5927\u524d\u63d0\u306e\u305f\u3081\u3067\u3059\u3002\u533b\u85ac\u54c1\u306f\u76f4\u63a5\u4eba\u4f53\u306b\u4f5c\u7528\u3059\u308b\u305f\u3081\u3001\u54c1\u8cea\u4e0a\u306e\u6b20\u9665\u3084\u5b89\u5168\u6027\u306e\u898b\u843d\u3068\u3057\u306f\u91cd\u7be4\u306a\u5065\u5eb7\u88ab\u5bb3\u306b\u76f4\u7d50\u3057\u307e\u3059\u3002GxP\u306b\u57fa\u3065\u304f\u7ba1\u7406\u306f\u3001\u54c1\u8cea\u4e0a\u306e\u3070\u3089\u3064\u304d\u3084\u30ea\u30b9\u30af\u3092\u7ba1\u7406\u3057\u3001<mark>\u60a3\u8005\u4fdd\u8b77\u3068\u4fe1\u983c\u3067\u304d\u308b\u88fd\u54c1\u306e\u7d99\u7d9a\u7684\u306a\u4f9b\u7d66<\/mark>\u3092\u652f\u3048\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"i-4\">\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u4e00\u5b9a\u6c34\u6e96\u306b\u4fdd\u3064\u305f\u3081<\/h4>\n\n\n\n<p>\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u4e00\u5b9a\u6c34\u6e96\u306b\u4fdd\u3064\u3068\u3044\u3046\u70b9\u3067\u3082\u3001GxP\u304c\u91cd\u8981\u3067\u3059\u3002\u88fd\u9020\u30ed\u30c3\u30c8\u9593\u3067\u306e\u54c1\u8cea\u306e\u3070\u3089\u3064\u304d\u306f\u3001\u6709\u52b9\u6027\u3084\u5b89\u5168\u6027\u306b\u4e88\u6e2c\u3067\u304d\u306a\u3044\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002GxP\u306b\u57fa\u3065\u3044\u3066\u6a19\u6e96\u5316\u3055\u308c\u305f\u624b\u9806\u3068\u7ba1\u7406\u57fa\u6e96\u3092\u904b\u7528\u3059\u308b\u3053\u3068\u3067\u3001<mark>\u30ed\u30c3\u30c8\u9593\u306e\u54c1\u8cea\u306e\u3070\u3089\u3064\u304d\u3092\u7ba1\u7406\u3057\u3001\u5b89\u5b9a\u3057\u305f\u54c1\u8cea\u306e\u88fd\u54c1\u3092\u4f9b\u7d66\u3067\u304d\u307e\u3059<\/mark>\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"i-5\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u7dad\u6301<\/h4>\n\n\n\n<p>\u8a66\u9a13\u7d50\u679c\u3084\u88fd\u9020\u8a18\u9332\u7b49\u306e\u6539\u3056\u3093\u30fb\u634f\u9020\u3092\u9632\u304e\u3001ALCOA\u539f\u5247\uff08A\u5e30\u5c5e\u53ef\u80fd\u30fbL\u5224\u8aad\u53ef\u80fd\u30fbC\u540c\u6642\u7684\u30fbO\u539f\u672c\u30fbA\u6b63\u78ba\uff09\u306b\u57fa\u3065\u3044\u3066<mark>\u5ba2\u89b3\u7684\u3067\u8ffd\u8de1\u53ef\u80fd\u306a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u78ba\u4fdd<\/mark>\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"i-6\">\u6cd5\u898f\u5236\u306e\u9075\u5b88\u306e\u305f\u3081<\/h4>\n\n\n\n<p>GxP\u304c\u91cd\u8996\u3055\u308c\u308b\u7406\u7531\u306b\u306f\u3001\u6cd5\u898f\u5236\u306e\u9075\u5b88\u306e\u305f\u3081\u3082\u3042\u308a\u307e\u3059\u3002GxP\u306e\u591a\u304f\u306f\u85ac\u6a5f\u6cd5\u306b\u57fa\u3065\u304f\u7701\u4ee4\u3068\u3057\u3066\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3061\u307e\u3059\u3002GMP\u7b49\u3078\u306e\u4e0d\u9069\u5408\u3067\u306f\u3001\u9055\u53cd\u306e\u5185\u5bb9\u3084\u6cd5\u4ee4\u4e0a\u306e\u8981\u4ef6\u306b\u5fdc\u3058\u3066\u6539\u5584\u547d\u4ee4\u3084\u696d\u52d9\u505c\u6b62\u3001\u8a31\u53ef\u53d6\u6d88\u3057\u7b49\u306e\u5bfe\u8c61\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u88fd\u54c1\u56de\u53ce\uff08\u30ea\u30b3\u30fc\u30eb\uff09\u304c\u5fc5\u8981\u3068\u306a\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u5211\u4e8b\u7f70\u306e\u9069\u7528\u306f\u3001\u500b\u5225\u306e\u6cd5\u5f8b\u9055\u53cd\u3068\u7f70\u5247\u898f\u5b9a\u306e\u8981\u4ef6\u306b\u57fa\u3065\u3044\u3066\u5224\u65ad\u3055\u308c\u307e\u3059\u3002\u4f01\u696d\u306e\u793e\u4f1a\u7684\u4fe1\u983c\u3084\u30d6\u30e9\u30f3\u30c9\u4fa1\u5024\u3092\u7dad\u6301\u3059\u308b\u3046\u3048\u3067\u3082\u3001<mark>GxP\u9075\u5b88\u306f\u7d4c\u55b6\u4e0a\u306e\u5fc5\u9808\u4e8b\u9805<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-7\">\u4ee3\u8868\u7684\u306aGxP\u306e\u7a2e\u985e\u3068\u7279\u5fb4<\/h2>\n\n\n\n<p>\u4ee5\u4e0b\u306f\u65e5\u672c\u306e\u533b\u85ac\u54c1\u696d\u52d9\u306b\u95a2\u4fc2\u3059\u308b\u4ee3\u8868\u7684\u306a7\u3064\u306eGxP\u3067\u3059\u3002\u305d\u308c\u305e\u308c\u306e\u6982\u8981\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u3067\u3001<mark>\u81ea\u8eab\u306e\u696d\u52d9\u304c\u3069\u306eGxP\u306b\u95a2\u9023\u3057\u3001\u3069\u306e\u3088\u3046\u306a\u7ba1\u7406\u8981\u4ef6\u304c\u6c42\u3081\u3089\u308c\u308b\u304b<\/mark>\u3092\u7406\u89e3\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GLP\uff08\u5b89\u5168\u6027\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09<\/li>\n\n\n\n<li>GCP\uff08\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09<\/li>\n\n\n\n<li>GMP\uff08\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/li>\n\n\n\n<li>GQP\uff08\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/li>\n\n\n\n<li>GVP\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/li>\n\n\n\n<li>GDP\uff08\u9069\u6b63\u6d41\u901a\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09<\/li>\n\n\n\n<li>GPSP\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u53ca\u3073\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff09<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-8\">GLP\uff08\u5b89\u5168\u6027\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09<\/h3>\n\n\n\n<p>GLP\uff08Good Laboratory Practice\uff09\u306f\u3001\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u7533\u8acb\u3084\u518d\u5be9\u67fb\u30fb\u518d\u8a55\u4fa1\u7b49\u306e\u8cc7\u6599\u306b\u7528\u3044\u308b\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u975e\u81e8\u5e8a\u8a66\u9a13\u306b\u3064\u3044\u3066\u3001<mark>\u8a08\u753b\u30fb\u5b9f\u65bd\u30fb\u8a18\u9332\u30fb\u5831\u544a\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u57fa\u6e96<\/mark>\u3067\u3059\u3002\u6bd2\u6027\u8a66\u9a13\u3084\u5b89\u5168\u6027\u85ac\u7406\u8a66\u9a13\u306e\u8a08\u753b\u30fb\u5b9f\u65bd\u30fb\u8a18\u9332\u30fb\u5831\u544a\u306b\u308f\u305f\u308a\u3001\u65bd\u8a2d\u306e\u7ba1\u7406\u4f53\u5236\u3084\u8a66\u9a13\u624b\u9806\u306e\u6a19\u6e96\u5316\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GLP\u306b\u57fa\u3065\u304f\u7ba1\u7406\u4f53\u5236\u3067\u306f\u3001\u8a66\u9a13\u8cac\u4efb\u8005\u306e\u6a29\u9650\u3068\u8cac\u4efb\u304c\u660e\u78ba\u306b\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u8a66\u9a13\u8a08\u753b\u66f8\u3068\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u66f8\u306b\u5f93\u3063\u3066\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3001\u8a08\u753b\u306e\u5909\u66f4\u3084\u624b\u9806\u304b\u3089\u306e\u9038\u8131\u304c\u751f\u3058\u305f\u5834\u5408\u306b\u306f\u3001\u6240\u5b9a\u306e\u624b\u9806\u3067\u7406\u7531\u30fb\u5185\u5bb9\u7b49\u3092\u8a18\u9332\u30fb\u7ba1\u7406\u3057\u307e\u3059\u3002<mark>\u8a66\u9a13\u304b\u3089\u72ec\u7acb\u3057\u305f\u4fe1\u983c\u6027\u4fdd\u8a3c\u90e8\u9580\uff08QAU\uff09\u306b\u3088\u308b\u8abf\u67fb\u30fb\u78ba\u8a8d<\/mark>\u3082\u7fa9\u52d9\u3065\u3051\u3089\u308c\u3066\u304a\u308a\u3001\u8a66\u9a13\u306e\u5ba2\u89b3\u6027\u3068\u4fe1\u983c\u6027\u3092\u7d44\u7e54\u7684\u306b\u62c5\u4fdd\u3059\u308b\u4ed5\u7d44\u307f\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u751f\u30c7\u30fc\u30bf\u306f\u767a\u751f\u6642\u306b\u9069\u6642\u30fb\u6b63\u78ba\u306b\u8a18\u9332\u3057\u3001\u96fb\u5b50\u8a18\u9332\u3067\u306f\u5fc5\u8981\u306a\u30e1\u30bf\u30c7\u30fc\u30bf\u3084\u5909\u66f4\u5c65\u6b74\u3082\u542b\u3081\u3066\u3001\u8a66\u9a13\u306e\u518d\u69cb\u6210\u306b\u5fc5\u8981\u306a\u8a18\u9332\u3092\u6240\u5b9a\u671f\u9593\u4fdd\u5b58\u3057\u307e\u3059\u3002\u8a66\u9a13\u65bd\u8a2d\u306eGLP\u9069\u5408\u6027\u306f\u898f\u5236\u5f53\u5c40\uff08\u65e5\u672c\u3067\u306fPMDA\uff09\u306e\u9069\u5408\u6027\u8abf\u67fb\u3067\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/review-services\/inspections\/drugs\/0004.html\" rel=\"nofollow\">PMDA\u300c\u627f\u8a8d\u7533\u8acb\u6642\u306e\u8abf\u67fb\uff08GLP\u8abf\u67fb\uff09\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-9\">GCP\uff08\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09<\/h3>\n\n\n\n<p>GCP\uff08Good Clinical Practice\uff09\u306f\u3001\u6cbb\u9a13\u3068\u88fd\u9020\u8ca9\u58f2\u5f8c\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3057\u3066\u3001<mark>\u53c2\u52a0\u8005\u306e\u4eba\u6a29\u30fb\u5b89\u5168\u30fb\u798f\u7949\u3068\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u57fa\u6e96<\/mark>\u3067\u3059\u3002\u3053\u308c\u306f\u3059\u3079\u3066\u306e\u81e8\u5e8a\u7814\u7a76\u306b\u4e00\u5f8b\u306b\u9069\u7528\u3055\u308c\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>GCP\u304c\u5b9a\u3081\u308b\u8981\u4ef6\u306f\u591a\u5c90\u306b\u308f\u305f\u308a\u307e\u3059\u304c\u3001\u4e2d\u6838\u3092\u306a\u3059\u306e\u306f<mark>\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u306b\u3088\u308b\u4e8b\u524d\u5be9\u67fb\u3068\u3001\u88ab\u9a13\u8005\u304b\u3089\u306e\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u53d6\u5f97<\/mark>\u3067\u3059\u3002IRB\u306f\u6cbb\u9a13\u306e\u79d1\u5b66\u7684\u30fb\u502b\u7406\u7684\u59a5\u5f53\u6027\u3092\u72ec\u7acb\u3057\u305f\u7acb\u5834\u3067\u5be9\u67fb\u3057\u3001\u88ab\u9a13\u8005\u4fdd\u8b77\u306e\u7b2c\u4e00\u306e\u9632\u6ce2\u5824\u3068\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u3002\u4f01\u696d\u6cbb\u9a13\u3067\u306f\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306f\u5831\u544a\u5bfe\u8c61\u306e\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u3092\u76f4\u3061\u306b\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u306e\u9577\u3078\u5831\u544a\u3057\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u3078\u901a\u77e5\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u91cd\u7be4\u6027\u3084\u4e88\u6e2c\u6027\u3001\u56e0\u679c\u95a2\u4fc2\u7b49\u306b\u57fa\u3065\u304f\u6cd5\u5b9a\u306e\u5831\u544a\u5bfe\u8c61\u3092\u5224\u65ad\u3057\u3001\u6240\u5b9a\u306e\u671f\u9650\u5185\u306b\u5f53\u5c40\u3078\u5831\u544a\u3057\u307e\u3059\u3002\u533b\u5e2b\u4e3b\u5c0e\u6cbb\u9a13\u3067\u306f\u5831\u544a\u7d4c\u8def\u304c\u7570\u306a\u308a\u307e\u3059\u3002\u6cbb\u9a13\u4f9d\u983c\u8005\u306b\u3088\u308b\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u3001\u958b\u767a\u90e8\u9580\u53ca\u3073\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u90e8\u9580\u304b\u3089\u72ec\u7acb\u3057\u305f\u76e3\u67fb\u62c5\u5f53\u8005\u306b\u3088\u308b\u76e3\u67fb\u3092\u901a\u3058\u3066\u3001\u6cbb\u9a13\u306e\u5b9f\u65bd\u72b6\u6cc1\u3068\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>ICH E6\uff08R3\uff09\u306ePrinciples\u53ca\u3073Annex 1\u306f2025\u5e741\u67086\u65e5\u3001Annex 2\u306f2026\u5e746\u67083\u65e5\u306bStep 4\u3067\u63a1\u629e\u3055\u308c\u307e\u3057\u305f\u3002ICH\u306eStep 4\u63a1\u629e\u3068\u56fd\u5185\u6cd5\u4ee4\u30fb\u901a\u77e5\u3078\u306e\u5b9f\u88c5\u306f\u5225\u3067\u3042\u308a\u3001\u5b9f\u52d9\u306b\u306f\u56fd\u5185\u306e\u9069\u7528\u901a\u77e5\u30fb\u65bd\u884c\u72b6\u6cc1\u3082\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0028.html\" rel=\"nofollow\">PMDA\u300cICH-E6 GCP\uff08\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff09\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-10\">GMP\uff08\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/h3>\n\n\n\n<p>GMP\uff08Good Manufacturing Practice\uff09\u306f\u3001\u9069\u7528\u5bfe\u8c61\u3068\u306a\u308b\u533b\u85ac\u54c1\u7b49\u306e<mark>\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96<\/mark>\u3067\u3059\u3002\u539f\u6599\u7b49\u306e\u53d7\u5165\u308c\u3001\u88fd\u9020\u3084\u8a66\u9a13\u3001\u8a18\u9332\u3001\u88fd\u9020\u6240\u304b\u3089\u306e\u51fa\u8377\u53ef\u5426\u6c7a\u5b9a\u306a\u3069\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>2021\u5e748\u6708\u65bd\u884c\u306e\u6539\u6b63GMP\u7701\u4ee4\u306f\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff08PQS\uff09\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001\u88fd\u54c1\u54c1\u8cea\u7167\u67fb\u3001\u4f9b\u7d66\u8005\u7ba1\u7406\u7b49\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u7b2c8\u6761\u7b2c2\u9805\u3067\u306f\u6587\u66f8\u30fb\u8a18\u9332\u306e\u4fe1\u983c\u6027\u3092\u7d99\u7d9a\u7684\u306b\u78ba\u4fdd\u3059\u308b\u7ba1\u7406\u65b9\u6cd5\u3092\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u3092\u6c42\u3081\u3066\u304a\u308a\u3001<mark>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u78ba\u4fdd\u306b\u3064\u306a\u304c\u308b\u8981\u6c42<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u307b\u304b\u3001\u69cb\u9020\u8a2d\u5099\u8981\u4ef6\u30fb\u88fd\u9020\u624b\u9806\u306e\u6587\u66f8\u5316\uff08SOP\uff09\u30fb\u5de5\u7a0b\u5185\u7ba1\u7406\u30fb\u54c1\u8cea\u8a66\u9a13\u30fb\u9038\u8131\u7ba1\u7406\u30fb\u5909\u66f4\u7ba1\u7406\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306a\u3069\u306e\u8981\u4ef6\u3092\u4f53\u7cfb\u7684\u306b\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002GMP\u7701\u4ee4\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u69cb\u9020\u8a2d\u5099\u3084\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u65b9\u6cd5\u304c\u671f\u5f85\u3055\u308c\u308b\u7d50\u679c\u3092\u4e0e\u3048\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u3001\u6587\u66f8\u5316\u3059\u308b\u6d3b\u52d5\u3067\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u305d\u306e\u4e00\u90e8\u3068\u3057\u3066\u3001\u88fd\u9020\u5de5\u7a0b\u304c\u4e00\u8cab\u3057\u3066\u6240\u5b9a\u306e\u54c1\u8cea\u3092\u3082\u3064\u88fd\u54c1\u3092\u751f\u307f\u51fa\u305b\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u6539\u6b63GMP\u7701\u4ee4 \u65bd\u884c\u901a\u77e5\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-11\">GQP\uff08\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/h3>\n\n\n\n<p>GQP\uff08Good Quality Practice\uff09\u306f\u3001<mark>\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u304c\u884c\u3046\u54c1\u8cea\u7ba1\u7406\u3068\u5e02\u5834\u3078\u306e\u51fa\u8377\u53ef\u5426\u306e\u6c7a\u5b9a\uff08\u5e02\u5834\u51fa\u8377\u5224\u5b9a\uff09\u306e\u4f53\u5236\u3092\u898f\u5b9a\u3059\u308b\u57fa\u6e96<\/mark>\u3067\u3059\u3002\u6b63\u5f0f\u540d\u79f0\u306f\u300c\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d\u3067\u3059\u3002<\/p>\n\n\n\n<p>GMP\u306e\u300c\u88fd\u9020\u6240\u304b\u3089\u306e\u51fa\u8377\u306e\u53ef\u5426\u306e\u6c7a\u5b9a\u300d\u3068\u3001GQP\u306e\u300c\u5e02\u5834\u3078\u306e\u51fa\u8377\u306e\u53ef\u5426\u306e\u6c7a\u5b9a\u300d\u306f\u533a\u5225\u3055\u308c\u307e\u3059\u3002\u5e02\u5834\u51fa\u8377\u306f\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u8cac\u4efb\u3067\u7ba1\u7406\u3057\u307e\u3059\u304c\u3001GQP\u7b2c9\u6761\u306b\u5b9a\u3081\u308b\u4e8b\u524d\u53d6\u6c7a\u3081\u30fb\u6307\u5b9a\u30fb\u5831\u544a\u30fb\u78ba\u8a8d\u7b49\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3059\u5834\u5408\u306b\u306f\u3001\u5f53\u8a72\u88fd\u54c1\u306e\u88fd\u9020\u696d\u8005\u306b\u5224\u5b9a\u696d\u52d9\u3092\u884c\u308f\u305b\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>GQP\u7701\u4ee4\u7b2c7\u6761\u306b\u57fa\u3065\u304d\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306f\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u3092\u8a2d\u7f6e\u3057\u3001\u88fd\u9020\u696d\u8005\u7b49\u3068\u306e\u9593\u3067\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\u3001\u54c1\u8cea\u60c5\u5831\u306e\u9023\u7d61\u3001\u54c1\u8cea\u306b\u5f71\u97ff\u3059\u308b\u5909\u66f4\u306e\u4e8b\u524d\u9023\u7d61\u7b49\u3092\u53d6\u308a\u6c7a\u3081\u3001\u54c1\u8cea\u7ba1\u7406\u696d\u52d9\u624b\u9806\u66f8\u7b49\u306b\u8a18\u8f09\u3057\u307e\u3059\u3002\u5b9f\u52d9\u3067\u306f\u3053\u306e\u53d6\u6c7a\u3081\u306f\u54c1\u8cea\u53d6\u6c7a\u3081\u3084Quality Agreement\u3068\u547c\u3070\u308c\u307e\u3059\u3002\u51fa\u8377\u524d\u306e\u54c1\u8cea\u8a55\u4fa1\u3084\u54c1\u8cea\u60c5\u5831\u306e\u53ce\u96c6\u30fb\u5bfe\u5fdc\u3082\u4f53\u7cfb\u7684\u306b\u5b9f\u65bd\u3055\u308c\u3001\u88fd\u9020\u6240\u306eGMP\u3068\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u5e02\u5834\u306b\u4f9b\u7d66\u3055\u308c\u308b\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u304c\u7ba1\u7406\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>2025\u5e74\u516c\u5e03\u306e\u6539\u6b63\u85ac\u6a5f\u6cd5\u3067\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u30fb\u533b\u85ac\u54c1\u5b89\u5168\u7ba1\u7406\u8cac\u4efb\u8005\u306e\u8a2d\u7f6e\u3092\u6cd5\u5f8b\u4e0a\u306b\u660e\u6587\u5316\u3059\u308b\u6539\u6b63\u304c\u5b9a\u3081\u3089\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u6539\u6b63\u90e8\u5206\u306e\u65bd\u884c\u65e5\u306f2027\u5e745\u670820\u65e5\u3067\u3059\u3002\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u30fb\u5b89\u5168\u7ba1\u7406\u8cac\u4efb\u8005\u306e\u8a2d\u7f6e\u30fb\u696d\u52d9\u306b\u95a2\u3059\u308b\u7fa9\u52d9\u306f\u5f93\u524d\u304b\u3089GQP\u30fbGVP\u7701\u4ee4\u306b\u7f6e\u304b\u308c\u3066\u304a\u308a\u3001\u4eca\u56de\u306e\u6cd5\u5f8b\u4e0a\u306e\u4f4d\u7f6e\u3065\u3051\u3068\u533a\u5225\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/content\/11120000\/001492021.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u6539\u6b63\u85ac\u6a5f\u6cd5\u306e\u6982\u8981\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-12\">GVP\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\uff09<\/h3>\n\n\n\n<p>GVP\uff08Good Vigilance Practice\uff09\u306f\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30fb\u6709\u52b9\u6027\u30fb\u5b89\u5168\u6027\u305d\u306e\u4ed6\u9069\u6b63\u4f7f\u7528\u306b\u5fc5\u8981\u306a<mark>\u5b89\u5168\u7ba1\u7406\u60c5\u5831\u3092\u53ce\u96c6\u30fb\u691c\u8a0e\u3057\u3001\u5b89\u5168\u78ba\u4fdd\u63aa\u7f6e\u3092\u7acb\u6848\u30fb\u5b9f\u65bd\u3059\u308b\u57fa\u6e96<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>GVP\u7701\u4ee4\u3067\u306f\u3001\u5b89\u5168\u7ba1\u7406\u8cac\u4efb\u8005\u306e\u8a2d\u7f6e\u304c\u7fa9\u52d9\u3065\u3051\u3089\u308c\u3001\u533b\u7642\u95a2\u4fc2\u8005\u3001\u5b66\u4f1a\u30fb\u6587\u732e\u3001\u56fd\u5185\u5916\u306e\u5f53\u5c40\u3001\u4ed6\u306e\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u304b\u3089\u5fc5\u8981\u306a\u60c5\u5831\u3092\u9069\u5207\u306b\u53ce\u96c6\u3059\u308b\u4f53\u5236\u3092\u6574\u5099\u3057\u307e\u3059\u3002\u5bfe\u8c61\u54c1\u76ee\u3067\u306fRMP\uff08\u533b\u85ac\u54c1\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\uff09\u306b\u57fa\u3065\u304f\u5b89\u5168\u6027\u76e3\u8996\u6d3b\u52d5\u30fb\u30ea\u30b9\u30af\u6700\u5c0f\u5316\u6d3b\u52d5\u3092\u884c\u3044\u3001<mark>\u65b0\u533b\u85ac\u54c1\u3067\u306f\u539f\u5247\u3068\u3057\u3066\u8ca9\u58f2\u958b\u59cb\u5f8c6\u304b\u6708\u9593\u306e\u5e02\u8ca9\u76f4\u5f8c\u8abf\u67fb<\/mark>\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u5fc5\u8981\u306a\u6d3b\u52d5\u306f\u54c1\u76ee\u306e\u30ea\u30b9\u30af\u3084\u627f\u8a8d\u6761\u4ef6\u7b49\u306b\u5fdc\u3058\u3066\u5b9a\u3081\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u53ce\u96c6\u3057\u305f\u5b89\u5168\u7ba1\u7406\u60c5\u5831\u306f\u9045\u6ede\u306a\u304f\u691c\u8a0e\u3057\u3001\u5fc5\u8981\u306a\u5b89\u5168\u78ba\u4fdd\u63aa\u7f6e\u3092\u7acb\u6848\u30fb\u5b9f\u65bd\u3057\u307e\u3059\u3002\u65b0\u305f\u306a\u30ea\u30b9\u30af\u306e\u53ef\u80fd\u6027\u3092\u793a\u3059\u60c5\u5831\u304c\u5f97\u3089\u308c\u305f\u5834\u5408\u306f\u3001\u305d\u306e\u5185\u5bb9\u3092\u8a55\u4fa1\u3057\u3001\u5fc5\u8981\u6027\u30fb\u7dca\u6025\u6027\u306b\u5fdc\u3058\u3066\u6ce8\u610f\u4e8b\u9805\u7b49\u60c5\u5831\u306e\u6539\u8a02\u3001\u533b\u7642\u95a2\u4fc2\u8005\u3078\u306e\u60c5\u5831\u63d0\u4f9b\u3001\u56de\u53ce\u7b49\u306e\u5b89\u5168\u78ba\u4fdd\u63aa\u7f6e\u3092\u691c\u8a0e\u30fb\u5b9f\u65bd\u3057\u307e\u3059\u3002\u526f\u4f5c\u7528\u7b49\u306e\u5f53\u5c40\u5831\u544a\u3084\u3001\u5bfe\u8c61\u3068\u306a\u308b\u65b0\u533b\u7642\u7528\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u5b9a\u671f\u5831\u544a\u306f\u3001\u85ac\u6a5f\u6cd5\u30fb\u65bd\u884c\u898f\u5247\u7b49\u306b\u57fa\u3065\u304f\u5831\u544a\u5236\u5ea6\u306b\u3082\u5f93\u3063\u3066\u884c\u3044\u307e\u3059\u3002GVP\u306f\u3001\u3053\u308c\u3089\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u5b89\u5168\u7ba1\u7406\u4f53\u5236\u3068\u696d\u52d9\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-13\">GDP\uff08\u9069\u6b63\u6d41\u901a\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09<\/h3>\n\n\n\n<p>GDP\uff08Good Distribution Practice\uff09\u306f\u3001\u5e02\u5834\u51fa\u8377\u5f8c\u304b\u3089\u85ac\u5c40\u3001\u533b\u85ac\u54c1\u8ca9\u58f2\u696d\u8005\u3001\u533b\u7642\u6a5f\u95a2\u306b\u6e21\u308b\u307e\u3067\u306e\u4ed5\u5165\u308c\u30fb\u4fdd\u7ba1\u30fb\u4f9b\u7d66\u696d\u52d9\u306b\u304a\u3051\u308b\u54c1\u8cea\u78ba\u4fdd\u3092\u6271\u3044\u3001\u6700\u7d42\u7684\u306a\u60a3\u8005\u4fdd\u8b77\u3092\u652f\u3048\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3059\u3002<mark>\u6d41\u901a\u904e\u7a0b\u3067\u306e\u6e29\u5ea6\u9038\u8131\u3084\u507d\u9020\u533b\u85ac\u54c1\u306e\u6df7\u5165\u3092\u9632\u6b62<\/mark>\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u3067\u306f\u539a\u751f\u52b4\u50cd\u7701\u304c2018\u5e7412\u6708\u306b\u300c\u533b\u85ac\u54c1\u306e\u9069\u6b63\u6d41\u901a\uff08GDP\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u3092\u4e8b\u52d9\u9023\u7d61\u3068\u3057\u3066\u767a\u51fa\u3057\u3001PIC\/S\uff08\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u5b9a\u30fb\u533b\u85ac\u54c1\u67fb\u5bdf\u5171\u540c\u30b9\u30ad\u30fc\u30e0\uff09\u306eGDP\u30ac\u30a4\u30c9\u3092\u8e0f\u307e\u3048\u305f\u54c1\u8cea\u7ba1\u7406\u306e\u5b9f\u8df5\u3092\u4fc3\u3057\u3066\u3044\u307e\u3059\u3002GMP\u7701\u4ee4\u3084GQP\u7701\u4ee4\u306e\u3088\u3046\u306a\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u7701\u4ee4\u3068\u306f\u7570\u306a\u308a\u3001\u4e3b\u306b\u5378\u58f2\u8ca9\u58f2\u696d\u8005\u53ca\u3073\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u3092\u5bfe\u8c61\u3068\u3057\u3001\u8f38\u9001\u3092\u59d4\u8a17\u3055\u308c\u308b\u7269\u6d41\u4e8b\u696d\u8005\u3092\u542b\u3080\u6d41\u901a\u95a2\u4fc2\u4e8b\u696d\u8005\u304c<mark>\u81ea\u4e3b\u7684\u306b\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u3092\u69cb\u7bc9\u30fb\u904b\u7528\u3059\u308b\u305f\u3081\u306e\u6307\u91dd<\/mark>\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u54c1\u306b\u5b9a\u3081\u3089\u308c\u305f\u4fdd\u7ba1\u6761\u4ef6\u3068\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u3001\u4fdd\u7ba1\u5834\u6240\u306e\u4f7f\u7528\u524d\u306e\u6e29\u5ea6\u30de\u30c3\u30d4\u30f3\u30b0\u3084\u6e29\u5ea6\u76e3\u8996\u3001\u8f38\u9001\u6761\u4ef6\u306e\u7ba1\u7406\u3001\u6d41\u901a\u7d4c\u8def\u306e\u8ffd\u8de1\u6027\u78ba\u4fdd\u7b49\u3092\u884c\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/content\/11120000\/000466214.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u306e\u9069\u6b63\u6d41\u901a\uff08GDP\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-14\">GPSP\uff08\u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u53ca\u3073\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff09<\/h3>\n\n\n\n<p>GPSP\uff08Good Post-marketing Study Practice\uff09\u306f\u3001\u4f7f\u7528\u6210\u7e3e\u8abf\u67fb\u3001\u88fd\u9020\u8ca9\u58f2\u5f8c\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u8abf\u67fb\uff082018\u5e744\u6708\u65bd\u884c\u306e\u6539\u6b63\u3067\u65b0\u8a2d\uff09\u3001\u88fd\u9020\u8ca9\u58f2\u5f8c\u81e8\u5e8a\u8a66\u9a13\u306e\u8a08\u753b\u30fb\u5b9f\u65bd\u30fb\u5831\u544a\u306b\u95a2\u3059\u308b\u57fa\u6e96\u3067\u3059\u3002\u306a\u304a\u3001\u88fd\u9020\u8ca9\u58f2\u5f8c\u81e8\u5e8a\u8a66\u9a13\u306b\u306fGCP\u7701\u4ee4\u3082\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>GPSP\u306b\u57fa\u3065\u304f\u88fd\u9020\u8ca9\u58f2\u5f8c\u8abf\u67fb\u7b49\u306f\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30fb\u6709\u52b9\u6027\u30fb\u5b89\u5168\u6027\u306b\u3064\u3044\u3066\u3001<mark>\u60c5\u5831\u3092\u8a08\u753b\u7684\u306b\u53ce\u96c6\u3057\u3001\u691c\u51fa\u30fb\u78ba\u8a8d\u30fb\u691c\u8a3c\u3059\u308b\u6d3b\u52d5<\/mark>\u3067\u3059\u3002\u8a55\u4fa1\u5bfe\u8c61\u306f\u9577\u671f\u4f7f\u7528\u306e\u5f71\u97ff\u306b\u9650\u3089\u308c\u307e\u305b\u3093\u3002\u6cbb\u9a13\u3067\u306f\u3001\u5bfe\u8c61\u8005\u6570\u3084\u53c2\u52a0\u6761\u4ef6\u3001\u89b3\u5bdf\u671f\u9593\u306b\u5236\u7d04\u304c\u3042\u308a\u307e\u3059\u3002\u5e02\u8ca9\u5f8c\u306b\u306f\u4f7f\u7528\u8005\u306e\u80cc\u666f\u3084\u4f7f\u7528\u6761\u4ef6\u304c\u591a\u69d8\u5316\u3059\u308b\u305f\u3081\u3001<mark>\u6cbb\u9a13\u3067\u628a\u63e1\u3055\u308c\u306a\u304b\u3063\u305f\u526f\u4f5c\u7528\u7b49<\/mark>\u304c\u660e\u3089\u304b\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5f97\u3089\u308c\u305f\u7d50\u679c\u306f\u3001\u518d\u5be9\u67fb\u30fb\u518d\u8a55\u4fa1\u7b49\u306e\u8a72\u5f53\u3059\u308b\u898f\u5236\u624b\u7d9a\u3084\u5b89\u5168\u6027\u8a55\u4fa1\u3001\u9069\u6b63\u4f7f\u7528\u60c5\u5831\u306e\u66f4\u65b0\u306b\u6d3b\u7528\u3055\u308c\u307e\u3059\u3002\u63d0\u51fa\u8cc7\u6599\u30fb\u5831\u544a\u6642\u671f\u306f\u5bfe\u8c61\u54c1\u76ee\u3068\u5236\u5ea6\u306b\u5fdc\u3058\u3066\u5b9a\u307e\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/content\/11120000\/000342780.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300cGPSP\u7701\u4ee4\u306e\u6539\u6b63\u3068\u88fd\u9020\u8ca9\u58f2\u5f8c\u8abf\u67fb\u7b49\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-15\">GxP\u3068\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3<\/h2>\n\n\n\n<p>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\uff08\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\uff09\u306f\u3001<mark>\u3059\u3079\u3066\u306eGxP\u306b\u5171\u901a\u3059\u308b\u57fa\u76e4\u7684\u306a\u8981\u4ef6<\/mark>\u3067\u3059\u3002GxP\u696d\u52d9\u3067\u751f\u6210\u30fb\u7ba1\u7406\u3055\u308c\u308b\u30c7\u30fc\u30bf\u3084\u8a18\u9332\u304c\u6b63\u78ba\u3067\u4fe1\u983c\u3067\u304d\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u3001\u3044\u304b\u306a\u308b\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96\u3082\u5b9f\u8cea\u7684\u306b\u6a5f\u80fd\u3057\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>ALCOA+\u306f\u3001<mark>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u8aac\u660e\u3059\u308b\u305f\u3081\u306b\u5e83\u304f\u7528\u3044\u3089\u308c\u308b9\u3064\u306e\u5c5e\u6027\u306e\u6574\u7406<\/mark>\u3067\u3059\u3002PIC\/S\u3084OECD\u7b49\u306e\u6587\u66f8\u3067\u793a\u3055\u308c\u3066\u304a\u308a\u3001\u5b9f\u969b\u306e\u7ba1\u7406\u306b\u306f\u5bfe\u8c61\u696d\u52d9\u306e\u6cd5\u4ee4\u30fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u8e0f\u307e\u3048\u3066\u9069\u7528\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Attributable\uff08\u5e30\u5c5e\u53ef\u80fd\uff09\uff1a\u8ab0\u304c\u3044\u3064\u8a18\u9332\u3057\u305f\u304b\u304c\u660e\u78ba\u306b\u7279\u5b9a\u3067\u304d\u308b<\/li>\n\n\n\n<li>Legible\uff08\u5224\u8aad\u53ef\u80fd\uff09\uff1a\u8a18\u9332\u304c\u8aad\u307f\u53d6\u308c\u308b\u72b6\u614b\u3067\u7dad\u6301\u3055\u308c\u3066\u3044\u308b<\/li>\n\n\n\n<li>Contemporaneous\uff08\u540c\u6642\u7684\uff09\uff1a\u884c\u70ba\u306e\u5b9f\u65bd\u3068\u540c\u6642\u306b\u8a18\u9332\u3055\u308c\u308b<\/li>\n\n\n\n<li>Original\uff08\u539f\u672c\uff09\uff1a\u539f\u8a18\u9332\u307e\u305f\u306f\u305d\u306e\u771f\u6b63\u306a\u5199\u3057\u3067\u3042\u308b<\/li>\n\n\n\n<li>Accurate\uff08\u6b63\u78ba\uff09\uff1a\u8aa4\u308a\u304c\u306a\u304f\u3001\u4e8b\u5b9f\u3092\u6b63\u3057\u304f\u53cd\u6620\u3057\u3066\u3044\u308b<\/li>\n\n\n\n<li>Complete\uff08\u5b8c\u5168\uff09\uff1a\u4e8b\u8c61\u306e\u518d\u69cb\u6210\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u3001\u95a2\u9023\u30e1\u30bf\u30c7\u30fc\u30bf\u3001\u5909\u66f4\u5c65\u6b74\u7b49\u304c\u4fdd\u6301\u3055\u308c\u3066\u3044\u308b<\/li>\n\n\n\n<li>Consistent\uff08\u4e00\u8cab\u6027\uff09\uff1a\u8a18\u9332\u304c\u8ad6\u7406\u7684\u306a\u9806\u5e8f\u3067\u4f5c\u6210\u3055\u308c\u3001\u6642\u7cfb\u5217\u3001\u65e5\u4ed8\u30fb\u6642\u523b\u306e\u8868\u8a18\u3001\u5358\u4f4d\u7b49\u304c\u4e00\u8cab\u3057\u3066\u3044\u308b<\/li>\n\n\n\n<li>Enduring\uff08\u6c38\u7d9a\uff09\uff1a\u898f\u5b9a\u306e\u4fdd\u5b58\u671f\u9593\u3092\u901a\u3058\u3066\u7dad\u6301\u3055\u308c\u308b<\/li>\n\n\n\n<li>Available\uff08\u5229\u7528\u53ef\u80fd\uff09\uff1a\u5fc5\u8981\u306a\u3068\u304d\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u72b6\u614b\u306b\u3042\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u7d19\u306e\u8a18\u9332\u3067\u3042\u3063\u3066\u3082\u96fb\u5b50\u8a18\u9332\u3067\u3042\u3063\u3066\u3082\u3001\u3053\u308c\u3089\u306e\u5c5e\u6027\u306b\u57fa\u3065\u3044\u305f\u7ba1\u7406\u4f53\u5236\u306e\u69cb\u7bc9\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u65e5\u672c\u3067\u306f\u30012021\u5e74\u6539\u6b63GMP\u7701\u4ee4\u3067\u6587\u66f8\u30fb\u8a18\u9332\u306e\u4fe1\u983c\u6027\u3092\u7d99\u7d9a\u7684\u306b\u78ba\u4fdd\u3059\u308b\u7ba1\u7406\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u307b\u304b\u3001\u533b\u85ac\u54c1\u7b49\u306e\u7533\u8acb\u8cc7\u6599\u30fb\u539f\u8cc7\u6599\u3084\u6cd5\u4ee4\u4e0a\u4fdd\u5b58\u304c\u5fc5\u8981\u306a\u8cc7\u6599\u3092\u96fb\u5b50\u5316\u3059\u308b\u5834\u5408\u306f\u3001ER\/ES\u6307\u91dd\u306e\u9069\u7528\u7bc4\u56f2\u3092\u78ba\u8a8d\u3057\u3001\u771f\u6b63\u6027\u30fb\u898b\u8aad\u6027\u30fb\u4fdd\u5b58\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u96fb\u5b50\u8a18\u9332\u3067\u306f\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u5fc5\u8981\u306a\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u524a\u9664\u306e\u5c65\u6b74\u3001\u64cd\u4f5c\u8005\u3001\u65e5\u6642\u3001\u5909\u66f4\u7406\u7531\u7b49\u3092\u8a18\u9332\u3057\u3001<mark>\u76e3\u67fb\u8a3c\u8de1\u3092\u4fdd\u8b77\u30fb\u4fdd\u5b58\u30fb\u53ef\u8aad\u5316<\/mark>\u3057\u307e\u3059\u3002\u30a2\u30af\u30bb\u30b9\u6a29\u9650\u3084\u6642\u523b\u7ba1\u7406\u3068\u7d44\u307f\u5408\u308f\u305b\u3001\u9069\u5207\u306a\u983b\u5ea6\u3067\u30ec\u30d3\u30e5\u30fc\u3057\u3066\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/data-integrity-and-compliance-drug-cgmp-questions-and-answers\" rel=\"nofollow\">FDA\u300cData Integrity and Compliance With Drug CGMP: Questions and Answers\u300d\uff08ALCOA\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cPI 041-1 Good Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\u300d\uff08ALCOA+\uff09<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-16\">GxP\u3068CSV\u30fbCSA<\/h2>\n\n\n\n<p>GxP\u304c\u9069\u7528\u3055\u308c\u308b\u696d\u52d9\u3067\u306f\u3001\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u30fb\u6709\u52b9\u6027\u30fb\u5b89\u5168\u6027\u3092\u62c5\u4fdd\u3059\u308b\u305f\u3081\u3001\u305d\u306e\u9818\u57df\u3067\u4f7f\u7528\u3055\u308c\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3057\u305f\u901a\u308a\u306b\u6b63\u3057\u304f\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u3001CSV\uff08Computerized System Validation\uff09\u3068\u3057\u3066\u52d5\u4f5c\u691c\u8a3c\u3057\u3001\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3068\u3042\u308f\u305b\u3066\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u4e00\u65b9\u3067\u30012025\u5e749\u6708\u306b\u306f\u30a2\u30e1\u30ea\u30abFDA\u304b\u3089\u3001RPA\u3084\u30ed\u30dc\u30c6\u30a3\u30af\u30b9\u3001\u30af\u30e9\u30a6\u30c9\u3084AI\u7b49\u306e\u8fd1\u5e74\u306e\u6280\u8853\u9769\u65b0\u3092\u8e0f\u307e\u3048\u3001CSA\uff08Computer Software Assurance\uff1a\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a2\u30b7\u30e5\u30a2\u30e9\u30f3\u30b9\uff09\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u793a\u3055\u308c\u307e\u3057\u305f\u3002CSA\u306f\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u4fdd\u8a3c\u6d3b\u52d5\u306b\u3088\u3063\u3066\u3001\u5f93\u6765\u306eCSV\u306b\u304a\u3051\u308b\u904e\u5270\u306a\u691c\u8a3c\u30b9\u30af\u30ea\u30d7\u30c8\u306b\u8d77\u56e0\u3059\u308b\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u3001<mark>\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u3092\u91cd\u8996\u3059\u308b\u30a2\u30d7\u30ed\u30fc\u30c1<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>CSA\u306e\u8003\u3048\u65b9\u306fGAMP 5 \u7b2c2\u7248\uff082022\u5e74\u767a\u884c\uff09\u306b\u3082\u53d6\u308a\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002GAMP 5 \u7b2c2\u7248\u3067\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u4f7f\u7528\u76ee\u7684\u3068\u6545\u969c\u6642\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u30c6\u30b9\u30c8\u306e\u53b3\u5bc6\u3055\u3001\u624b\u6cd5\u3001\u5ba2\u89b3\u7684\u8a3c\u62e0\u306e\u7bc4\u56f2\u3092\u6c7a\u3081\u308b\u3053\u3068\u3084\u3001\u4f4e\u30ea\u30b9\u30af\u3067\u3042\u3063\u3066\u3082\u610f\u56f3\u3057\u305f\u7528\u9014\u306b\u9069\u3059\u308b\u3053\u3068\u3092\u793a\u3059\u5ba2\u89b3\u7684\u6839\u62e0\u3092\u8a18\u9332\u3059\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>FDA\u306f2025\u5e749\u6708\u306bCSA\u306e\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u51fa\u3057\u30012026\u5e742\u6708\u306b\u306fQMSR\uff08ISO 13485\u3092\u53d6\u308a\u8fbc\u3093\u3060\u6539\u6b6321 CFR Part 820\u30012026\u5e742\u67082\u65e5\u65bd\u884c\uff09\u306b\u5408\u308f\u305b\u3066\u6539\u8a02\u3057\u307e\u3057\u305f\uff08\u73fe\u884c\u30bf\u30a4\u30c8\u30eb\uff1a\u300cComputer Software Assurance for Production and Quality Management System Software\u300d\uff09\u3002<\/p>\n\n\n\n<p>FDA\u306eCSA\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u53c8\u306f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3067\u7528\u3044\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u5bfe\u8c61\u3068\u3057\u3066\u304a\u308a\u3001<mark>\u533b\u85ac\u54c1GxP\u696d\u52d9\u306b\u76f4\u63a5\u4e00\u5f8b\u9069\u7528\u3055\u308c\u308b\u6587\u66f8\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/mark>\u3002\u533b\u85ac\u54c1\u3067\u306f\u9069\u7528\u6cd5\u4ee4\u30fb\u56fd\u5185\u901a\u77e5\u3092\u6e80\u305f\u3057\u305f\u3046\u3048\u3067\u3001GAMP 5\u7b49\u3068\u3068\u3082\u306b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u8003\u3048\u65b9\u3092\u53c2\u8003\u306b\u3067\u304d\u307e\u3059\u3002\u65e5\u672c\u306eGQP\u30fbGMP\u696d\u52d9\u306b\u7528\u3044\u308b\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u30012010\u5e74\u306e\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u3092\u53c2\u7167\u3057\u307e\u3059\u3002GLP\u30fbGCP\u7b49\u3067\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u6cd5\u4ee4\u30fb\u95a2\u9023\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3082\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>GxP\u95a2\u9023\u306e\u6587\u66f8\u6539\u8a02\u696d\u52d9\u306bAI\u3092\u6d3b\u7528\u3059\u308b\u5834\u5408\u306f\u3001<mark>\u898f\u5236\u5bfe\u8c61\u4f01\u696d\u3068\u3057\u3066\u4f7f\u7528\u76ee\u7684\u3068GxP\u30ea\u30b9\u30af\u3092\u8a55\u4fa1<\/mark>\u3057\u3001\u81ea\u793e\u306e\u69cb\u6210\u30fb\u696d\u52d9\u30fb\u904b\u7528\u306b\u5fc5\u8981\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u53ca\u3073\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u3092\u5b9f\u65bd\u3067\u304d\u308b\u304b\u78ba\u8a8d\u3057\u305f\u3046\u3048\u3067\u3001\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u9078\u5b9a\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/computer-software-assurance-production-and-quality-management-system-software\" rel=\"nofollow\">FDA\u300cComputer Software Assurance for Production and Quality Management System Software\u300d<\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\">\n\n\n\n<p><b>GxP\u696d\u52d9\u306e\u6587\u66f8\u6539\u8a02\u306bAI\u3092\u6d3b\u304b\u3059\u306a\u3089\u300cJAPAN AI \u88fd\u85ac\u300d<\/b><br>GxP\u74b0\u5883\u3067\u306e\u6587\u66f8\u6539\u8a02\u696d\u52d9\u306b\u306f\u3001\u898f\u5236\u5bfe\u5fdc\u3068\u696d\u52d9\u52b9\u7387\u5316\u306e\u4e21\u7acb\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">JAPAN AI \u88fd\u85ac<\/a>\u306f\u3001\u88fd\u85ac\u696d\u754c\u306e\u6587\u66f8\u6539\u8a02\u306b\u7279\u5316\u3057\u305fAI\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u958b\u767a\u6642\u306e\u30c6\u30b9\u30c8\u8a18\u9332\u3092CSV\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u6599\u3068\u3057\u3066\u53ef\u80fd\u306a\u7bc4\u56f2\u3067\u63d0\u4f9b\u3057\u3001GAMP 5\u306e\u8003\u3048\u65b9\u306b\u6cbf\u3063\u305f\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u6574\u7406\u7b49\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u5c0e\u5165\u6642\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u5c0e\u5165\u4f01\u696d\u306e\u8cac\u4efb\u7bc4\u56f2\u3067\u3059\u3002<\/p>\n\n\n\n<p>Human-in-the-Loop\u3092\u8a2d\u8a08\u601d\u60f3\u306b\u63b2\u3052\u3066\u304a\u308a\u3001\u5c0e\u5165\u4f01\u696d\u306f\u627f\u8a8d\u6a29\u9650\u3084\u30ec\u30d3\u30e5\u30fc\u624b\u9806\u3001\u8a18\u9332\u4fdd\u5b58\u7b49\u3092\u81ea\u793e\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u7d44\u307f\u8fbc\u3080\u3053\u3068\u3067\u3001\u4eba\u306b\u3088\u308b\u6700\u7d42\u78ba\u8a8d\u30fb\u627f\u8a8d\u304c\u78ba\u5b9f\u306b\u884c\u308f\u308c\u308b\u904b\u7528\u3092\u8a2d\u8a08\u3067\u304d\u307e\u3059\u3002SOP\u7b49\u306e\u6539\u8a02\u306b\u304a\u3051\u308b\u95a2\u9023\u7b87\u6240\u306e\u62bd\u51fa\u3084\u6539\u8a02\u6848\u306e\u8d77\u6848\u3001\u898f\u5236\u6587\u66f8\u3068\u306e\u7167\u5408\u3092\u3001\u56fd\u5185\u30c7\u30fc\u30bf\u30bb\u30f3\u30bf\u30fc\u3068\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3092\u7528\u3044\u305f\u74b0\u5883\u3067\u652f\u63f4\u3057\u307e\u3059\u3002<\/p>\n\n\n<div class=\"\"><div class=\"sgb-content-block post-11084 js-sgb-content-block\" data-id=\"11084\">\n<figure class=\"wp-block-image size-full\"><a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\"><img loading=\"lazy\" decoding=\"async\" width=\"2348\" height=\"1330\" src=\"https:\/\/japan-ai.geniee.co.jp\/media\/wp-content\/uploads\/2026\/10\/\uc2a4\ud06c\ub9b0\uc0f7-2026-10-21-15.40.12.png\" alt=\"\" class=\"wp-image-11085\" srcset=\"https:\/\/japan-ai.co.jp\/media\/wp-content\/uploads\/2026\/10\/\uc2a4\ud06c\ub9b0\uc0f7-2026-10-21-15.40.12.png 2348w, https:\/\/japan-ai.co.jp\/media\/wp-content\/uploads\/2026\/10\/\uc2a4\ud06c\ub9b0\uc0f7-2026-10-21-15.40.12-768x435.png 768w, https:\/\/japan-ai.co.jp\/media\/wp-content\/uploads\/2026\/10\/\uc2a4\ud06c\ub9b0\uc0f7-2026-10-21-15.40.12-1536x870.png 1536w, https:\/\/japan-ai.co.jp\/media\/wp-content\/uploads\/2026\/10\/\uc2a4\ud06c\ub9b0\uc0f7-2026-10-21-15.40.12-2048x1160.png 2048w, https:\/\/japan-ai.co.jp\/media\/wp-content\/uploads\/2026\/10\/\uc2a4\ud06c\ub9b0\uc0f7-2026-10-21-15.40.12-940x532.png 940w\" sizes=\"auto, (max-width: 2348px) 100vw, 2348px\"><\/a><\/figure>\n<\/div><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"i-17\">GxP\u3068AI\u30fb\u30c7\u30b8\u30bf\u30eb\u5bfe\u5fdc<\/h2>\n\n\n\n<p>GxP\u74b0\u5883\u3067\u306eAI\u30fb\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u306e\u6d3b\u7528\u304c\u9032\u3080\u306a\u304b\u3001\u898f\u5236\u5f53\u5c40\u3082\u5bfe\u5fdc\u3092\u52a0\u901f\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>FDA\u306f2025\u5e741\u6708\u306b\u3001\u533b\u85ac\u54c1\u30fb\u751f\u7269\u88fd\u54c1\u306e\u898f\u5236\u4e0a\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u3048\u308bAI\u5229\u7528\u306b\u95a2\u3059\u308b\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\uff08\u300cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products\u300d\uff09\u3092\u516c\u8868\u3057\u3001<mark>AI\u30e2\u30c7\u30eb\u306e\u4f7f\u7528\u76ee\u7684\uff08Context of Use\uff09\u3068\u30e2\u30c7\u30eb\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u4fe1\u983c\u6027\u8a55\u4fa1\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af<\/mark>\u3092\u793a\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>2026\u5e7410\u6708\u6642\u70b9\u3067\u3082\u540c\u30c9\u30e9\u30d5\u30c8\u306f\u78ba\u5b9a\u7248\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u540c\u30c9\u30e9\u30d5\u30c8\u306f\u5275\u85ac\u306e\u5229\u7528\u3068\u3001\u60a3\u8005\u5b89\u5168\u30fb\u533b\u85ac\u54c1\u54c1\u8cea\u30fb\u975e\u81e8\u5e8a\u53c8\u306f\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u306e\u4fe1\u983c\u6027\u306b\u5f71\u97ff\u3057\u306a\u3044\u696d\u52d9\u52b9\u7387\u5316\u76ee\u7684\u306e\u5229\u7528\u3092\u5bfe\u8c61\u5916\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u7533\u8acb\u8cc7\u6599\u3084SOP\u306e\u8d77\u6848\u652f\u63f4\u3067\u3082\u3001\u7528\u9014\u3068\u5f71\u97ff\u306b\u5fdc\u3058\u3066\u4ed6\u306eGxP\u8981\u6c42\u3078\u306e\u5bfe\u5fdc\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<p>2026\u5e741\u670814\u65e5\u306b\u306f\u3001FDA\u3068EMA\uff08\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff09\u304c<mark>\u533b\u85ac\u54c1\u958b\u767a\u306b\u304a\u3051\u308bAI\u5229\u7528\u306b\u95a2\u3059\u308b10\u9805\u76ee\u306e\u5171\u540c\u539f\u5247<\/mark>\u300cGuiding Principles of Good AI Practice in Drug Development\u300d\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u4eba\u9593\u4e2d\u5fc3\u306e\u8a2d\u8a08\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3001GxP\u306a\u3069\u65e2\u5b58\u57fa\u6e96\u3078\u306e\u6e96\u62e0\u3001\u660e\u78ba\u306a\u4f7f\u7528\u76ee\u7684\u306e\u5b9a\u7fa9\u3001\u30c7\u30fc\u30bf\u30ac\u30d0\u30ca\u30f3\u30b9\u3068\u6587\u66f8\u5316\u306b\u52a0\u3048\u3001\u6027\u80fd\u306e\u76e3\u8996\u30fb\u518d\u8a55\u4fa1\u3092\u542b\u3080\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u500b\u5225\u7528\u9014\u306e\u6cd5\u4ee4\u30fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3078\u306e\u9069\u5408\u306f\u5225\u9014\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u533b\u85ac\u54c1GMP\u5206\u91ce\u3067\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1aDG SANTE\u304c2025\u5e747\u67087\u65e5\u301c10\u67087\u65e5\u306bEMA\u306eGMDP\u67fb\u5bdf\u5b98\u4f5c\u696d\u90e8\u4f1a\u3068PIC\/S\u306e\u5354\u529b\u3067\u4f5c\u6210\u3057\u305fChapter 4\u53ca\u3073Annex 11\u306e\u6539\u8a02\u6848\u3001\u65b0Annex 22\uff08AI\uff09\u6848\u306b\u3064\u3044\u3066\u516c\u958b\u5354\u8b70\u3092\u884c\u3044\u307e\u3057\u305f\u30022026\u5e7410\u6708\u6642\u70b9\u3067\u6700\u7d42\u5316\u30fb\u9069\u7528\u958b\u59cb\u306f\u78ba\u8a8d\u3067\u304d\u305a\u3001<mark>\u73fe\u884cAnnex 11\u3068\u8349\u6848\u3092\u533a\u5225\u3059\u308b\u5fc5\u8981<\/mark>\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u306a\u304a\u30012025\u5e74\u516c\u958b\u8349\u6848\u3067\u306f\u3001\u751f\u6210AI\u30fbLLM\u306f\u5bfe\u8c61\u5916\u3068\u3055\u308c\u3001\u4f7f\u7528\u4e2d\u306b\u81ea\u52d5\u5b66\u7fd2\u30fb\u9069\u5fdc\u3059\u308b\u52d5\u7684\u30e2\u30c7\u30eb\u306f\u5bfe\u8c61\u5916\u3067\u3001critical GMP applications\u3067\u4f7f\u7528\u3059\u3079\u304d\u3067\u306a\u3044\u3068\u306e\u6587\u8a00\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u3053\u308c\u306f\u6700\u7d42\u5316\u524d\u306e\u8349\u6848\u3067\u3042\u308a\u3001\u4eca\u5f8c\u306e\u6700\u7d42\u6587\u66f8\u3092\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.federalregister.gov\/documents\/2025\/01\/07\/2024-31542\/\" rel=\"nofollow\">FDA\u300cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/about-fda\/artificial-intelligence-drug-development\/guiding-principles-good-ai-practice-drug-development\" rel=\"nofollow\">FDA\u30fbEMA\u300cGuiding Principles of Good AI Practice in Drug Development\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\" rel=\"nofollow\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u300cStakeholders consultation \u2013 EudraLex Volume 4: Chapter 4, Annex 11 and new Annex 22\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-18\">GxP\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-19\">GxP\u3068GMP\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>GxP\u306f\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30fb\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u5404\u7a2e\u57fa\u6e96\u306e\u7dcf\u79f0\u3067\u3042\u308a\u3001GMP\u306f\u305d\u306e\u4e2d\u306e\u4e00\u3064\u3067\u3059\u3002GMP\u306f\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306b\u7279\u5316\u3057\u305f\u57fa\u6e96\u3067\u3042\u308a\u3001GxP\u3068GMP\u306f<mark>\u300cGxP \u2283 GMP\u300d\u3068\u3044\u3046\u5305\u542b\u95a2\u4fc2<\/mark>\u306b\u3042\u308a\u307e\u3059\u3002GLP\u3084GCP\u306a\u3069\u4ed6\u306e\u57fa\u6e96\u3082\u3059\u3079\u3066GxP\u306b\u542b\u307e\u308c\u308b\u305f\u3081\u3001GxP\u3092\u300c\u4e0a\u4f4d\u6982\u5ff5\u300d\u3001GMP\u3092\u300c\u4e0b\u4f4d\u6982\u5ff5\u300d\u3068\u6574\u7406\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-20\">GxP\u306f\u533b\u85ac\u54c1\u696d\u754c\u4ee5\u5916\u306b\u3082\u95a2\u4fc2\u3057\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u672c\u8a18\u4e8b\u306f\u65e5\u672c\u306e\u533b\u85ac\u54c1\u95a2\u9023\u696d\u52d9\u3092\u4e3b\u306a\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u304c\u3001<mark>GxP\u306e\u8003\u3048\u65b9\u306f\u533b\u85ac\u54c1\u696d\u754c\u306b\u9650\u5b9a\u3055\u308c\u305f\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/mark>\u3002\u533b\u7642\u6a5f\u5668\u53ca\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306b\u306f\u300c\u533b\u7642\u6a5f\u5668\u53ca\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d\uff08QMS\u7701\u4ee4\uff09\u304c\u95a2\u4fc2\u3057\u3001\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306b\u306fGCTP\u7701\u4ee4\u7b49\u304c\u95a2\u4fc2\u3057\u307e\u3059\u3002\u4ed6\u5206\u91ce\u306e\u54c1\u8cea\u7ba1\u7406\u5236\u5ea6\u306f\u3001\u88fd\u54c1\u30fb\u5730\u57df\u30fb\u5236\u5ea6\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u305f\u3081\u3001\u5404\u5206\u91ce\u306e\u6cd5\u4ee4\u30fb\u57fa\u6e96\u3092\u500b\u5225\u306b\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" 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