{"id":11064,"date":"2026-11-06T19:22:31","date_gmt":"2026-11-06T10:22:31","guid":{"rendered":"https:\/\/japan-ai.geniee.co.jp\/media\/?p=11064"},"modified":"2026-11-06T19:23:11","modified_gmt":"2026-11-06T10:23:11","slug":"gamp5%e3%81%a8%e3%81%af%e4%bd%95%e3%81%8b%ef%bc%9f%e8%a3%bd%e8%96%ac%e6%a5%ad%e7%95%8c%e3%81%ae%e3%82%b3%e3%83%b3%e3%83%94%e3%83%a5%e3%83%bc%e3%82%bf%e5%8c%96%e3%82%b7%e3%82%b9%e3%83%86%e3%83%a0","status":"publish","type":"post","link":"https:\/\/japan-ai.co.jp\/media\/11064\/","title":{"rendered":"GAMP5\u3068\u306f\u4f55\u304b\uff1f\u88fd\u85ac\u696d\u754c\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u5fb9\u5e95\u89e3\u8aac"},"content":{"rendered":"\n<p>\u88fd\u85ac\u3084\u533b\u85ac\u54c1\u696d\u754c\u3092\u4e2d\u5fc3\u306b\u3001GxP\uff08GMP\u30fbGLP\u30fbGCP\u306a\u3069\u3001\u533b\u85ac\u54c1\u7b49\u306e\u54c1\u8cea\u3084\u4fe1\u983c\u6027\u306b\u95a2\u308f\u308b\u898f\u5236\u306e\u7dcf\u79f0\uff09\u306e\u3082\u3068\u3067\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u30fb\u904b\u7528\u3059\u308b\u969b\u306e\u4ee3\u8868\u7684\u306a\u696d\u754c\u30ac\u30a4\u30c9\u304c\u300cGAMP5\u300d\u3067\u3059\u30022022\u5e747\u6708\u306b\u7b2c2\u7248\u304c\u767a\u884c\u3055\u308c\u305f\u3053\u3068\u306b\u52a0\u3048\u30012025\u5e74\u306b\u306f\u6b27\u5dde\u3067EU GMP Annex 11\uff08\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u6539\u8a02\u6848\u3068\u3001AI\u3092\u5bfe\u8c61\u3068\u3059\u308b\u65b0\u3057\u3044Annex 22\u306e\u6848\u304c\u516c\u958b\u5354\u8b70\u306b\u304b\u3051\u3089\u308c\u3001\u7c73\u56fd\u3067\u306fFDA\u306eCSA\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u6700\u7d42\u5316\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u3046\u3057\u305f\u52d5\u304d\u3092\u53d7\u3051\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u57fa\u3065\u304f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u3042\u308a\u65b9\u304c\u6539\u3081\u3066\u6ce8\u76ee\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u672c\u8a18\u4e8b\u3067\u306f\u3001<mark>GAMP5\u306e\u5b9a\u7fa9\u3084\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u304b\u3089\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u8003\u3048\u65b9\u3001\u7b2c2\u7248\u306e\u5909\u66f4\u70b9\u3001\u5404\u56fd\u898f\u5236\u3068\u306e\u95a2\u4fc2\u307e\u3067<\/mark>\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\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\">GAMP5\u3068\u306f\uff1f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first last\">        <a href=\"#i-1\">GAMP5\u3068GMP\u30fbGLP\u30fbGCP\u306e\u95a2\u4fc2<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-2\">GAMP5\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-3\">\u30ab\u30c6\u30b4\u30ea1\uff08\u57fa\u76e4\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09<\/a>      <\/li>      <li>        <a href=\"#i-4\">\u30ab\u30c6\u30b4\u30ea3\uff08\u69cb\u6210\u8a2d\u5b9a\u3057\u3066\u3044\u306a\u3044\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09<\/a>      <\/li>      <li>        <a href=\"#i-5\">\u30ab\u30c6\u30b4\u30ea4\uff08\u69cb\u6210\u8a2d\u5b9a\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-6\">\u30ab\u30c6\u30b4\u30ea5\uff08\u30ab\u30b9\u30bf\u30e0\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-7\">GAMP5\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-8\">\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u306f\u4f55\u304b<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-9\">\u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5de5\u6570\u306e\u9055\u3044<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-10\">GAMP5\u3068CSV\u306e\u95a2\u4fc2<\/a>    <ul class=\"menu_level_1\">      <li class=\"first last\">        <a href=\"#i-11\">GAMP5\u306eV\u30e2\u30c7\u30eb\u3068\u691c\u8a3c\u306e\u5bfe\u5fdc<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-12\">GAMP5 \u7b2c2\u7248\uff082nd Edition\uff09\u306e\u5909\u66f4\u70b9<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-13\">\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306e\u91cd\u8996<\/a>      <\/li>      <li>        <a href=\"#i-14\">CSA\uff08Computer Software Assurance\uff09\u306e\u8003\u3048\u65b9\u3068\u306e\u95a2\u9023<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-15\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3059\u308b\u30d7\u30ed\u30bb\u30b9<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-16\">GAMP5\u3068\u5404\u56fd\u898f\u5236\u306e\u95a2\u4fc2<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-17\">\u65e5\u672c\u306e\u898f\u5236\uff08PMDA\/\u539a\u52b4\u7701\uff09<\/a>      <\/li>      <li>        <a href=\"#i-18\">\u7c73\u56fdFDA\u306e\u898f\u5236<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-19\">\u6b27\u5dde\u306e\u898f\u5236\uff08\u6b27\u5dde\u59d4\u54e1\u4f1a\/EMA\u7b49\uff09<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-20\">GAMP5\u306e\u5b9f\u52d9\u30dd\u30a4\u30f3\u30c8<\/a>    <ul class=\"menu_level_1\">      <li class=\"first last\">        <a href=\"#i-21\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u81ea\u52d5\u5316\u3068RTM<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-22\">GAMP5\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-23\">GAMP5\u3068CSV\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-24\">GAMP5\u306e\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u3067\u30ab\u30c6\u30b4\u30ea2\u306f\u306a\u305c\u5ec3\u6b62\u3055\u308c\u305f\u306e\u3067\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-25\">GAMP5 \u7b2c2\u7248\u306b\u306f\u3044\u3064\u307e\u3067\u306b\u5bfe\u5fdc\u3059\u3079\u304d\u3067\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-26\">GAMP5\u306b\u6cd5\u7684\u62d8\u675f\u529b\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-27\">GAMP5\u3068CSA\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/a>      <\/li>    <\/ul>  <\/li>  <li class=\"last\">    <a href=\"#i-28\">GAMP5\u3092\u7406\u89e3\u3057\u3066\u9069\u5207\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u5b9f\u73fe\u3057\u3088\u3046<\/a>  <\/li><\/ul>\n      \n    <\/div><\/div><h2 class=\"wp-block-heading\" id=\"i-0\">GAMP5\u3068\u306f\uff1f<\/h2>\n\n\n\n<p>GAMP5\uff08GAMP\u306fGood Automated Manufacturing Practice\u306e\u7565\u30015\u306f\u7248\u306e\u756a\u53f7\uff09\u3068\u306f\u3001ISPE\uff08International Society for Pharmaceutical Engineering\uff09\u304c\u767a\u884c\u3059\u308b\u3001<mark>GxP\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u9069\u5408\u6027\u78ba\u4fdd\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u3059\u308b\u696d\u754c\u30ac\u30a4\u30c9<\/mark>\u3067\u3059\u3002\u6b63\u5f0f\u306a\u66f8\u540d\u306f\u300cISPE GAMP\u00ae 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems\u300d\u3067\u3059\u3002\u610f\u56f3\u3057\u305f\u7528\u9014\u3078\u306e\u9069\u5408\u6027\u3092\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u6d3b\u52d5\u3068\u5ba2\u89b3\u7684\u8a3c\u62e0\u306b\u3088\u3063\u3066\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u8003\u3048\u65b9\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u85ac\u30fb\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u306f\u3001\u88fd\u9020\u7ba1\u7406\u3084\u54c1\u8cea\u7ba1\u7406\u306b\u3055\u307e\u3056\u307e\u306a\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u304c\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30b7\u30b9\u30c6\u30e0\u304c\u6b63\u3057\u304f\u52d5\u4f5c\u3057\u3001\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u691c\u8a3c\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u304cCSV\uff08\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff09\u3067\u3059\u3002GAMP5\u306f\u3001\u3053\u306eCSV\u3092\u52b9\u7387\u7684\u304b\u3064\u52b9\u679c\u7684\u306b\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u8003\u3048\u65b9\u3068\u5177\u4f53\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u4f9b\u3059\u308b\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3067\u3001<mark>\u6700\u3082\u5e83\u304f\u53c2\u7167\u3055\u308c\u3066\u3044\u308b\u696d\u754c\u30ac\u30a4\u30c9\u306e\u4e00\u3064<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>GAMP5\u306e\u521d\u7248\u306f2008\u5e74\u306b\u767a\u884c\u3055\u308c\u307e\u3057\u305f\u3002\u4ee5\u6765\u3001\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5171\u901a\u8a00\u8a9e\u3068\u3057\u3066\u5e83\u304f\u6d3b\u7528\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u3002\u305d\u306e\u5f8c\u3001\u6280\u8853\u74b0\u5883\u306e\u5909\u5316\u3084\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306e\u9032\u5316\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u30012022\u5e747\u6708\u306b\u7b2c2\u7248\uff08GAMP5 2nd Edition\uff09\u304c\u767a\u884c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GAMP5\u306e\u6839\u5e95\u306b\u3042\u308b\u8003\u3048\u65b9\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u306e\u5927\u304d\u3055\u306b\u5fdc\u3058\u3066\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u7a0b\u5ea6\u3092\u8abf\u6574\u3059\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3059\u3002\u3053\u306e\u8003\u3048\u65b9\u306b\u3088\u308a\u3001\u9650\u3089\u308c\u305f\u30ea\u30bd\u30fc\u30b9\u3092\u52b9\u679c\u7684\u306b\u914d\u5206\u3057\u3001\u60a3\u8005\u5b89\u5168\u30fb\u88fd\u54c1\u54c1\u8cea\u30fb\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u5f71\u97ff\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u3084\u6a5f\u80fd\u306b\u91cd\u70b9\u7684\u306a\u691c\u8a3c\u3092\u884c\u3046\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-1\">GAMP5\u3068GMP\u30fbGLP\u30fbGCP\u306e\u95a2\u4fc2<\/h3>\n\n\n\n<p>GAMP5\u306f\u3001GMP\uff08Good Manufacturing Practice\uff1a\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09\u3060\u3051\u3067\u306a\u304f\u3001GLP\uff08Good Laboratory Practice\uff1a\u975e\u81e8\u5e8a\u5b89\u5168\u6027\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\uff09\u3084GCP\uff08Good Clinical Practice\uff1a\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\uff09\u3092\u542b\u3080\u3001<mark>GxP\u9818\u57df\u3067\u53c2\u7167\u3067\u304d\u308b\u696d\u754c\u30ac\u30a4\u30c9<\/mark>\u3067\u3059\u3002\u9069\u7528\u5bfe\u8c61\u3068\u5fc5\u8981\u306a\u4fdd\u8a3c\u6d3b\u52d5\u306f\u3001\u4f7f\u7528\u76ee\u7684\u3084\u898f\u5236\u5bfe\u8c61\u30c7\u30fc\u30bf\u3078\u306e\u5f71\u97ff\u3001\u5404\u9818\u57df\u306e\u6cd5\u4ee4\u30fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u57fa\u3065\u3044\u3066\u5224\u65ad\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305d\u308c\u305e\u308c\u306eGxP\u9818\u57df\u306b\u304a\u3051\u308bGAMP5\u306e\u95a2\u308f\u308a\u306f\u3001\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GMP\u9818\u57df\uff1a\u88fd\u9020\u5b9f\u884c\u30b7\u30b9\u30c6\u30e0\uff08MES\uff09\u3084ERP\u30b7\u30b9\u30c6\u30e0\u3001\u30e9\u30dc\u60c5\u5831\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08LIMS\uff09\u306a\u3069\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u308f\u308b\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306bGAMP5\u304c\u6d3b\u7528\u3055\u308c\u307e\u3059\u3002\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3092\u5de6\u53f3\u3059\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u4fe1\u983c\u6027\u3092\u62c5\u4fdd\u3059\u308b\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\n\n\n<li>GLP\u9818\u57df\uff1a\u975e\u81e8\u5e8a\u8a66\u9a13\u3067\u4f7f\u7528\u3055\u308c\u308b\u30c7\u30fc\u30bf\u53ce\u96c6\u30fb\u89e3\u6790\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306bGAMP5\u306e\u8003\u3048\u65b9\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u78ba\u4fdd\u306e\u305f\u3081\u306b\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u9069\u683c\u6027\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/li>\n\n\n\n<li>GCP\u9818\u57df\uff1a\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u7ba1\u7406\u306b\u4f7f\u7528\u3055\u308c\u308bEDC\uff08Electronic Data Capture\uff09\u30b7\u30b9\u30c6\u30e0\u3084IRT\uff08Interactive Response Technology\uff09\u306a\u3069\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306bGAMP5\u304c\u53c2\u7167\u3055\u308c\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>GAMP5\u306fGxP\u898f\u5236\u4e0b\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306b\u6a2a\u65ad\u7684\u306b\u53c2\u7167\u3055\u308c\u307e\u3059\u3002\u305f\u3060\u3057\u3001GLP\u3067\u306fOECD GLP\u6587\u66f8No.17\u3001GCP\u3067\u306fICH E6\uff08R3\uff09\u3001\u56fd\u5185\u3067\u306f\u300c\u533b\u85ac\u54c1\u7b49\u306e\u627f\u8a8d\u53c8\u306f\u8a31\u53ef\u7b49\u306b\u4fc2\u308b\u7533\u8acb\u7b49\u306b\u304a\u3051\u308b\u96fb\u78c1\u7684\u8a18\u9332\u53ca\u3073\u96fb\u5b50\u7f72\u540d\u5229\u7528\u306e\u305f\u3081\u306e\u6307\u91dd\u300d\uff08ER\/ES\u6307\u91dd\uff09\u306a\u3069\u3001<mark>\u9818\u57df\u3054\u3068\u306e\u8981\u4ef6\u3082\u3042\u308f\u305b\u3066\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059<\/mark>\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-2\">GAMP5\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e<\/h2>\n\n\n\n<p>GAMP5\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u306f\u3001<mark>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6027\u8cea\u306b\u5fdc\u3058\u305f\u8a55\u4fa1\u306e\u7740\u773c\u70b9\u3092\u793a\u3059\u67a0\u7d44\u307f<\/mark>\u3067\u3059\u3002\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u52b9\u7387\u7684\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u3092\u7acb\u3066\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>GAMP5\u3067\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u30ab\u30c6\u30b4\u30ea1\u30fb3\u30fb4\u30fb5\u306e4\u3064\u306b\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002\u306a\u304a\u3001GAMP4\u3067\u306f\u30ab\u30c6\u30b4\u30ea2\uff08\u30d5\u30a1\u30fc\u30e0\u30a6\u30a7\u30a2\uff09\u304c\u5b58\u5728\u3057\u3066\u3044\u307e\u3057\u305f\u304c\u3001GAMP5\uff082008\u5e74\u306e\u521d\u7248\uff09\u3067\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u304c\u6539\u8a02\u3055\u308c\u3001\u30ab\u30c6\u30b4\u30ea1\u30fb3\u30fb4\u30fb5\u306e4\u5206\u985e\u3067\u904b\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u4ee5\u4e0b\u306e\u8868\u306b\u3001GAMP5\u306e\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u306e\u5168\u4f53\u50cf\u3092\u307e\u3068\u3081\u307e\u3059\u3002<\/p>\n\n\n<div id=\"id-a1b21dcb-c929-4762-a819-22ebdf9e74cb\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30ab\u30c6\u30b4\u30ea<\/th><th>\u540d\u79f0<\/th><th>\u8a72\u5f53\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4f8b<\/th><th>\u4e3b\u306a\u8a55\u4fa1\u30fb\u7ba1\u7406\u4e0a\u306e\u7740\u773c\u70b9<\/th><\/tr><\/thead><tbody><tr><td>\u30ab\u30c6\u30b4\u30ea1<\/td><td>\u57fa\u76e4\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/td><td>OS\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u7ba1\u7406\u30fb\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u7ba1\u7406\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u7b49<\/td><td>\u30a4\u30f3\u30d5\u30e9\u306e\u9069\u683c\u6027\u3001\u8a2d\u7f6e\u30fb\u7248\u30fb\u69cb\u6210\u3001\u30a2\u30af\u30bb\u30b9\u30fb\u5909\u66f4\u7ba1\u7406\u7b49\u3002\u95a2\u9023\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u306e\u7d44\u5408\u305b\u3067\u8a55\u4fa1<\/td><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea3<\/td><td>\u69cb\u6210\u8a2d\u5b9a\u3057\u3066\u3044\u306a\u3044\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/td><td>\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u5411\u3051\u306b\u69cb\u6210\u8a2d\u5b9a\u305b\u305a\u4f7f\u7528\u3059\u308b\u65e2\u88fd\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u7b49<\/td><td>\u610f\u56f3\u3057\u305f\u7528\u9014\u3001\u5fc5\u8981\u306a\u30d1\u30e9\u30e1\u30fc\u30bf\u30fb\u6a5f\u80fd\u30fb\u30c7\u30fc\u30bf\u53d6\u6271\u3044\u3092\u78ba\u8a8d\u3002\u5b9f\u884c\u6642\u30d1\u30e9\u30e1\u30fc\u30bf\u5165\u529b\u3060\u3051\u306e\u5834\u5408\u3092\u542b\u3080<\/td><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea4<\/td><td>\u69cb\u6210\u8a2d\u5b9a\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/td><td>\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u306b\u5408\u308f\u305b\u3066\u69cb\u6210\u8a2d\u5b9a\u3057\u305fLIMS\u30fbERP\u30fbMES\u30fbeQMS\u7b49\u306e\u90e8\u5206<\/td><td>\u69cb\u6210\u4ed5\u69d8\u3068\u8a2d\u5b9a\u3001\u91cd\u8981\u306a\u696d\u52d9\u30d5\u30ed\u30fc\u3001\u6a19\u6e96\u6a5f\u80fd\u3092\u542b\u3080\u8981\u4ef6\u9069\u5408\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306e\u691c\u8a3c<\/td><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea5<\/td><td>\u30ab\u30b9\u30bf\u30e0\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/td><td>\u72ec\u81ea\u696d\u52d9\u30ed\u30b8\u30c3\u30af\u3092\u30d7\u30ed\u30b0\u30e9\u30e0\u3057\u305f\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u30fb\u62e1\u5f35\u6a5f\u80fd\u7b49<\/td><td>\u72ec\u81ea\u8a2d\u8a08\u30fb\u30b3\u30fc\u30c9\u30fb\u5404\u30ec\u30d9\u30eb\u306e\u30c6\u30b9\u30c8\u3068\u5909\u66f4\u306e\u7ba1\u7406\u3002\u6587\u66f8\u30fb\u8a66\u9a13\u306e\u7d71\u5408\u3084\u7c21\u7565\u5316\u306f\u6839\u62e0\u3092\u6301\u3063\u3066\u5224\u65ad<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>\u203bISPE 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id=\"i-9\">\u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5de5\u6570\u306e\u9055\u3044<\/h3>\n\n\n\n<p>\u524d\u7ae0\u3067\u89e3\u8aac\u3057\u305fGAMP5\u306e\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u3068\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u5bc6\u63a5\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002\u30ab\u30c6\u30b4\u30ea\u306b\u3088\u3063\u3066\u3001\u4e00\u822c\u7684\u306b\u5fc5\u8981\u3068\u306a\u308b\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u6d3b\u52d5\u3084\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u7740\u773c\u70b9\u306f\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305f\u3068\u3048\u3070\u3001\u30ab\u30c6\u30b4\u30ea1\u306e\u57fa\u76e4\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u5e83\u7bc4\u306b\u666e\u53ca\u3057\u3066\u304a\u308a\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u60c5\u5831\u306e\u8a55\u4fa1\u3068\u9069\u683c\u6027\u78ba\u8a8d\u3092\u4e2d\u5fc3\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002\u4e00\u65b9\u3001\u30ab\u30c6\u30b4\u30ea5\u306e\u30ab\u30b9\u30bf\u30e0\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u56fa\u6709\u306e\u8981\u4ef6\u306b\u57fa\u3065\u3044\u3066\u958b\u767a\u3055\u308c\u308b\u305f\u3081\u4e0d\u78ba\u5b9f\u6027\u304c\u9ad8\u304f\u3001\u8a2d\u8a08\u304b\u3089\u30c6\u30b9\u30c8\u307e\u3067\u5404\u6bb5\u968e\u3067\u306e\u691c\u8a3c\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305f\u3060\u3057\u3001\u30ab\u30c6\u30b4\u30ea\u3060\u3051\u3067\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u7bc4\u56f2\u304c\u6c7a\u307e\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u540c\u3058\u30ab\u30c6\u30b4\u30ea4\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u3063\u3066\u3082\u3001GxP\u696d\u52d9\u3067\u4f7f\u7528\u3059\u308b\u6a5f\u80fd\u306e\u7bc4\u56f2\u3084\u30c7\u30fc\u30bf\u306e\u91cd\u8981\u5ea6\u306b\u3088\u3063\u3066\u30ea\u30b9\u30af\u306f\u7570\u306a\u308a\u307e\u3059\u3002\u307e\u305a\u4f7f\u7528\u76ee\u7684\u3084GxP\u5f71\u97ff\u3001\u9069\u7528\u8981\u4ef6\u3092\u7279\u5b9a\u3057\u3001\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u3001\u91cd\u8981\u30c7\u30fc\u30bf\u30fb\u6a5f\u80fd\u3001\u30ab\u30c6\u30b4\u30ea\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u60c5\u5831\u7b49\u3092\u8e0f\u307e\u3048\u3066\u6d3b\u52d5\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002<mark>\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u306f\u8a55\u4fa1\u8981\u7d20\u306e\u4e00\u3064<\/mark>\u3067\u3042\u308a\u3001\u6700\u7d42\u7684\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7bc4\u56f2\u306f\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u7d50\u679c\u306b\u3088\u3063\u3066\u500b\u5225\u306b\u5224\u65ad\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-10\">GAMP5\u3068CSV\u306e\u95a2\u4fc2<\/h2>\n\n\n\n<p>GAMP5\u3068CSV\uff08\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff09\u306e\u95a2\u4fc2\u306f\u3001CSV\u304c\u300c\u4f55\u3092\u884c\u3046\u304b\uff08\u6d3b\u52d5\u305d\u306e\u3082\u306e\uff09\u300d\u3067\u3042\u308b\u306e\u306b\u5bfe\u3057\u3001<mark>GAMP5\u304c\u300c\u3069\u306e\u3088\u3046\u306b\u884c\u3046\u304b\uff08\u65b9\u6cd5\u8ad6\u30fb\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff09\u300d\u3092\u793a\u3059\u95a2\u4fc2<\/mark>\u306b\u3042\u308a\u307e\u3059\u3002CSV\u306f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u6b63\u3057\u304f\u52d5\u4f5c\u3057\u3001\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u691c\u8a3c\u30fb\u7dad\u6301\u3059\u308b\u6d3b\u52d5\u306e\u7dcf\u79f0\u3067\u3042\u308a\u3001GAMP5\u306f\u3053\u306eCSV\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u5b9f\u8df5\u7684\u306a\u696d\u754c\u30ac\u30a4\u30c9\u3067\u3059\u3002<\/p>\n\n\n\n<h3 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id=\"i-11\">GAMP5\u306eV\u30e2\u30c7\u30eb\u3068\u691c\u8a3c\u306e\u5bfe\u5fdc<\/h3>\n\n\n\n<p>GAMP5\u3067\u306f\u3001<mark>\u4ed5\u69d8\u3068\u691c\u8a3c\u3092\u5bfe\u5fdc\u3065\u3051\u308bV\u30e2\u30c7\u30eb<\/mark>\u304c\u4ee3\u8868\u7684\u306a\u8003\u3048\u65b9\u3068\u3057\u3066\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u3057\u3066\u7b2c2\u7248\u3067\u306f\u3001\u30a2\u30b8\u30e3\u30a4\u30eb\u306a\u3069\u306e\u53cd\u5fa9\u578b\u958b\u767a\u306b\u3082\u5bfe\u5fdc\u3057\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u660e\u8a18\u3055\u308c\u3066\u3044\u307e\u3059\u3002V\u30e2\u30c7\u30eb\u3068\u306f\u3001\u958b\u767a\u5de5\u7a0b\uff08\u5de6\u5074\uff09\u3068\u691c\u8a3c\u5de5\u7a0b\uff08\u53f3\u5074\uff09\u3092\u5bfe\u5fdc\u3065\u3051\u305f\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3067\u3001\u5404\u958b\u767a\u6bb5\u968e\u306e\u6210\u679c\u7269\u306b\u5bfe\u3057\u3066\u5bfe\u5fdc\u3059\u308b\u30c6\u30b9\u30c8\u304c\u8a2d\u8a08\u3055\u308c\u308b\u4f53\u7cfb\u3067\u3059\u3002<\/p>\n\n\n\n<p>V\u30e2\u30c7\u30eb\u306e\u5177\u4f53\u4f8b\u3068\u3057\u3066\u3001\u56fd\u5185\u306e\u300c\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\uff08\u5225\u7d191\uff09\u3067\u306f\u3001\u4ed5\u69d8\u3068\u9069\u683c\u6027\u8a55\u4fa1\u306e\u5bfe\u5fdc\u95a2\u4fc2\u304c\u6b21\u306e\u3088\u3046\u306b\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\uff08URS\uff09\u2194 \u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff08PQ\uff09<\/li>\n\n\n\n<li>\u6a5f\u80fd\u4ed5\u69d8\uff08FS\uff09\u2194 \u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09<\/li>\n\n\n\n<li>\u8a2d\u8a08\u4ed5\u69d8\uff08DS\uff09\u2194 \u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u7b49<\/li>\n<\/ul>\n\n\n\n<p>IQ\u306f\u8a2d\u8a08\u30fb\u8a2d\u7f6e\u4ed5\u69d8\u7b49\u306b\u7167\u3089\u3057\u3066\u636e\u4ed8\u30fb\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u3092\u78ba\u8a8d\u3057\u3001OQ\u306f\u5fc5\u8981\u306a\u6a5f\u80fd\u30fb\u6027\u80fd\u3092\u3001PQ\u7b49\u306f\u5b9f\u969b\u306e\u4f7f\u7528\u6761\u4ef6\u3067\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u3078\u306e\u9069\u5408\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u72ec\u81ea\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8a2d\u8a08\u30fb\u30ed\u30b8\u30c3\u30af\u306f\u3001\u8a2d\u8a08\u30ec\u30d3\u30e5\u30fc\u3084\u5358\u4f53\u30fb\u7d50\u5408\u30fb\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u7b49\u3067\u3082\u78ba\u8a8d\u3057\u3001\u8981\u4ef6\u3068\u306e\u8ffd\u8de1\u53ef\u80fd\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002\u3053\u306e\u5bfe\u5fdc\u95a2\u4fc2\u306f\u6a5f\u68b0\u7684\u306a\u4e00\u5bfe\u4e00\u5bfe\u5fdc\u3084\u4e0d\u8981\u306a\u91cd\u8907\u6d3b\u52d5\u3092\u524d\u63d0\u3068\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u9069\u5207\u306a\u691c\u8a3c\u8a08\u753b\u3092\u7acb\u3066\u308b\u305f\u3081\u306e\u67a0\u7d44\u307f\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u4e00\u65b9\u3001GAMP5\u7b2c2\u7248\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u6d3b\u52d5\u3092\u8a18\u8ff0\u3059\u308b\u969b\u306bIQ\/OQ\/PQ\u306e\u3088\u3046\u306a\u5f93\u6765\u306e\u533b\u85ac\u54c1\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7528\u8a9e\u3092\u4f7f\u7528\u3057\u306a\u3044\u3068\u3057\u3066\u304a\u308a\u3001\u5f93\u6765\u7528\u8a9e\u3068\u306e\u95a2\u4fc2\u306f\u53c2\u8003\u3068\u3057\u3066\u6574\u7406\u3059\u308b\u306b\u3068\u3069\u3081\u3066\u3044\u307e\u3059\u3002GAMP5\u3067\u306f\u3001\u4ed5\u69d8\u306b\u5bfe\u5fdc\u3059\u308b\u691c\u8a3c\u3092\u300c\u8981\u6c42\u30c6\u30b9\u30c8\u300d\u300c\u6a5f\u80fd\u30c6\u30b9\u30c8\u300d\u300c\u69cb\u6210\u8a2d\u5b9a\u30c6\u30b9\u30c8\u300d\u306a\u3069\u3068\u547c\u3073\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u30ab\u30c6\u30b4\u30ea4\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u2194\u8981\u6c42\u30c6\u30b9\u30c8\u3001\u6a5f\u80fd\u4ed5\u69d8\u2194\u6a5f\u80fd\u30c6\u30b9\u30c8\u3001\u69cb\u6210\u8a2d\u5b9a\u4ed5\u69d8\u2194\u69cb\u6210\u8a2d\u5b9a\u30c6\u30b9\u30c8\u3068\u3044\u3046\u5bfe\u5fdc\u306b\u306a\u308a\u3001\u30ab\u30c6\u30b4\u30ea5\u3067\u306f\u3055\u3089\u306b\u8a2d\u8a08\u4ed5\u69d8\u2194\u7d50\u5408\u30c6\u30b9\u30c8\u3001\u30e2\u30b8\u30e5\u30fc\u30eb\u4ed5\u69d8\u2194\u30e2\u30b8\u30e5\u30fc\u30eb\u30c6\u30b9\u30c8\u304c\u52a0\u308f\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5b9f\u52d9\u3067\u306f\u3001<mark>\u81ea\u793e\u304c\u5f93\u3046\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u7528\u8a9e\uff08IQ\/OQ\/PQ\uff09\u3068GAMP5\u306e\u691c\u8a3c\u306e\u547c\u3073\u65b9\u306e\u5bfe\u5fdc<\/mark>\u3092\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u66f8\u306e\u6bb5\u968e\u3067\u6574\u7406\u3057\u3066\u304a\u304f\u3068\u3001\u5f8c\u306e\u6df7\u4e71\u3092\u9632\u3052\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\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\u306b\u3064\u3044\u3066\u300d\uff08\u5e73\u621022\u5e7410\u670821\u65e5 \u85ac\u98df\u76e3\u9ebb\u767a1021\u7b2c11\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" rel=\"nofollow\">ISPE\u300cGAMP 5 Guide 2nd Edition\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-12\">GAMP5 \u7b2c2\u7248\uff082nd Edition\uff09\u306e\u5909\u66f4\u70b9<\/h2>\n\n\n\n<p>GAMP5\u7b2c2\u7248\u306f\u30012022\u5e747\u6708\u306bISPE\u304c\u767a\u884c\u3057\u305f\u6539\u8a02\u7248\u3067\u3042\u308a\u3001<mark>\u521d\u7248\u306e\u57fa\u672c\u539f\u5247\u3068\u67a0\u7d44\u307f\u3092\u7dad\u6301\u3057\u3064\u3064\u3001\u6280\u8853\u5185\u5bb9\u3068\u5b9f\u8df5\u65b9\u6cd5\u3092\u66f4\u65b0\u3057\u305f\u5185\u5bb9<\/mark>\u3067\u3059\u3002\u521d\u7248\u767a\u884c\u304b\u308914\u5e74\u9593\u306e\u6280\u8853\u74b0\u5883\u306e\u5909\u5316\u3001\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306e\u9032\u5316\u3001\u305d\u3057\u3066\u696d\u754c\u306e\u5b9f\u52d9\u7d4c\u9a13\u306e\u84c4\u7a4d\u3092\u8e0f\u307e\u3048\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e3b\u306a\u5909\u66f4\u70b9\u306f\u3001\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306e\u91cd\u8996\u3084CSA\u306e\u52d5\u304d\u3068\u306e\u95a2\u9023\u4ed8\u3051\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fb\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u306e\u95a2\u4e0e\u306e\u91cd\u8996\u3001\u30a2\u30b8\u30e3\u30a4\u30eb\u306a\u3069\u53cd\u5fa9\u578b\u958b\u767a\u3078\u306e\u5bfe\u5fdc\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30c4\u30fc\u30eb\u30fb\u81ea\u52d5\u5316\u306e\u6d3b\u7528\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u95a2\u9023\u30ac\u30a4\u30c9\u3068\u306e\u9023\u643a\u3067\u3059\u3002\u4ed8\u9332\u3067\u306fAI\/ML\u3001\u30af\u30e9\u30a6\u30c9\u3001\u30d6\u30ed\u30c3\u30af\u30c1\u30a7\u30fc\u30f3\u3001\u30aa\u30fc\u30d7\u30f3\u30bd\u30fc\u30b9\u3068\u3044\u3063\u305f\u65b0\u3057\u3044\u30c8\u30d4\u30c3\u30af\u3082\u6271\u308f\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e3b\u306a\u5909\u66f4\u70b9\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306e\u91cd\u8996<\/li>\n\n\n\n<li>CSA\uff08Computer Software Assurance\uff09\u306e\u8003\u3048\u65b9\u3068\u306e\u95a2\u9023<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3059\u308b\u30d7\u30ed\u30bb\u30b9<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" rel=\"nofollow\">ISPE\u300cGAMP 5 Guide 2nd Edition\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-13\">\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306e\u91cd\u8996<\/h3>\n\n\n\n<p>GAMP5\u7b2c2\u7248\u3067\u7279\u306b\u91cd\u8996\u3055\u308c\u3066\u3044\u308b\u306e\u304c\u3001<mark>\u77e5\u8b58\u3068\u7d4c\u9a13\u3092\u6301\u3064\u5c02\u9580\u5bb6\uff08SME\uff09\u306b\u3088\u308b\u300c\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\uff08\u6279\u5224\u7684\u601d\u8003\uff09\u300d<\/mark>\u3067\u3059\u3002\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306f\u7b2c2\u7248\u3067\u65b0\u305f\u306b\u6301\u3061\u8fbc\u307e\u308c\u305f\u8003\u3048\u65b9\u3067\u306f\u306a\u304f\u3001\u3088\u308a\u5f37\u8abf\u3055\u308c\u308b\u3068\u3068\u3082\u306b\u3001\u5c02\u7528\u306e\u4ed8\u9332\uff08\u4ed8\u9332M12\uff09\u304c\u8ffd\u52a0\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u521d\u7248\u306e\u6642\u70b9\u3067\u3082GAMP5\u306f\u898f\u6a21\u3084\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u5bfe\u5fdc\u3092\u52e7\u3081\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u696d\u754c\u306e\u5b9f\u52d9\u3067\u306f\u3001CSV\u304c\u5f62\u5f0f\u7684\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u3088\u3046\u306b\u904b\u7528\u3055\u308c\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3057\u305f\u3002\u30c6\u30b9\u30c8\u624b\u9806\u3092\u3042\u3089\u304b\u3058\u3081\u7d30\u304b\u304f\u8a18\u8ff0\u3057\u3001\u305d\u306e\u624b\u9806\u3069\u304a\u308a\u306b\u5b9f\u884c\u3059\u308b\u3060\u3051\u306e\u4f5c\u696d\u306b\u306a\u3063\u3066\u3057\u307e\u3046\u30b1\u30fc\u30b9\u3067\u3059\u3002\u7b2c2\u7248\u3067\u306f\u3001\u300c\u306a\u305c\u3053\u306e\u30c6\u30b9\u30c8\u304c\u5fc5\u8981\u306a\u306e\u304b\u300d\u300c\u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u672c\u5f53\u306b\u54c1\u8cea\u5411\u4e0a\u306b\u5bc4\u4e0e\u3057\u3066\u3044\u308b\u306e\u304b\u300d\u3092\u5e38\u306b\u8003\u3048\u308b\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5177\u4f53\u7684\u306b\u306f\u3001\u3042\u3089\u304b\u3058\u3081\u624b\u9806\u3092\u7d30\u304b\u304f\u8a18\u8ff0\u3057\u305f\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\u3068\u3001\u30c6\u30b9\u30c8\u62c5\u5f53\u8005\u306e\u5c02\u9580\u7684\u77e5\u898b\u306b\u57fa\u3065\u304f\u975e\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\uff08\u63a2\u7d22\u7684\u30c6\u30b9\u30c8\u306a\u3069\uff09\u306e\u4f7f\u3044\u5206\u3051\u304c\u63a8\u5968\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u975e\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\u3067\u306f\u3001\u30c6\u30b9\u30c8\u62c5\u5f53\u8005\u304c\u30b7\u30b9\u30c6\u30e0\u306e\u6319\u52d5\u3092\u89b3\u5bdf\u3057\u306a\u304c\u3089\u67d4\u8edf\u306b\u30c6\u30b9\u30c8\u30b7\u30ca\u30ea\u30aa\u3092\u5c55\u958b\u3059\u308b\u305f\u3081\u3001\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\u3067\u306f\u767a\u898b\u3057\u306b\u304f\u3044\u554f\u984c\u3092\u691c\u51fa\u3067\u304d\u307e\u3059\u3002<mark>\u904e\u5ea6\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u4f5c\u6210\u304b\u3089\u8131\u5374\u3057\u3001\u5b9f\u8cea\u7684\u306a\u54c1\u8cea\u5411\u4e0a\u306b\u8cc7\u3059\u308b\u6d3b\u52d5\u3078\u306e\u6ce8\u529b<\/mark>\u304c\u7b2c2\u7248\u306e\u76ee\u6307\u3059\u65b9\u5411\u6027\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-14\">CSA\uff08Computer Software Assurance\uff09\u306e\u8003\u3048\u65b9\u3068\u306e\u95a2\u9023<\/h3>\n\n\n\n<p>GAMP5\u7b2c2\u7248\u306e\u3082\u3046\u4e00\u3064\u306e\u5927\u304d\u306a\u65b9\u5411\u6027\u304c\u3001<mark>CSA\uff08Computer Software Assurance\uff09\u306e\u8003\u3048\u65b9\u3068\u306e\u95a2\u9023<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>CSA\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u624b\u6cd5\u3092\u3088\u308a\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306b\u3057\u305f\u8003\u3048\u65b9\u3067\u3059\u3002FDA\u306f\u3001\u6a5f\u80fd\u7b49\u306e\u4e0d\u5177\u5408\u304c\u5b89\u5168\u6027\u3092\u640d\u306a\u3046\u3068\u4e88\u898b\u3055\u308c\u308b\u54c1\u8cea\u554f\u984c\u306b\u3064\u306a\u304c\u308b\u304b\u3092\u8e0f\u307e\u3048\u3001high process risk\uff08\u9ad8\u30d7\u30ed\u30bb\u30b9\u30ea\u30b9\u30af\uff09\u3068not high process risk\uff08\u975e\u9ad8\u30d7\u30ed\u30bb\u30b9\u30ea\u30b9\u30af\uff09\u3092\u533a\u5225\u3057\u307e\u3059\u3002\u4fdd\u8a3c\u6d3b\u52d5\u30fb\u30c6\u30b9\u30c8\u65b9\u6cd5\u306f\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u9078\u629e\u3057\u3001\u9ad8\u30d7\u30ed\u30bb\u30b9\u30ea\u30b9\u30af\u3067\u3082\u975e\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\u304c\u9069\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5f62\u9ab8\u5316\u3057\u305f\u6587\u66f8\u4f5c\u6210\u304b\u3089\u5b9f\u8cea\u7684\u306a\u4fdd\u8a3c\u6d3b\u52d5\u3078\u91cd\u70b9\u3092\u79fb\u3059\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u7b2c2\u7248\u306f\u3001FDA\u304c2010\u5e74\u4ee3\u5f8c\u534a\u304b\u3089\u696d\u754c\u3068\u9032\u3081\u3066\u3044\u305fCSA\u306e\u53d6\u308a\u7d44\u307f\u3092\u8e0f\u307e\u3048\u3066\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u5f8cFDA\u306f2022\u5e749\u6708\u306b\u30ac\u30a4\u30c0\u30f3\u30b9\u6848\u3092\u516c\u8868\u3057\u30012025\u5e749\u670824\u65e5\u306b\u300cComputer Software Assurance for Production and Quality System Software\u300d\u3092\u6700\u7d42\u5316\u3057\u30012026\u5e742\u67083\u65e5\u306b\u300cComputer Software Assurance for Production and Quality Management System Software\u300d\u3067\u7f6e\u304d\u63db\u3048\u307e\u3057\u305f\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u30fb\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u308f\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff0821 CFR Part 820\u5bfe\u8c61\uff09\u306b\u5bfe\u3057\u3066\u3001CSA\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u54c1\u8cea\u4fdd\u8a3c\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63a8\u5968\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u306a\u304a\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u975e\u62d8\u675f\u7684\u306a\u63a8\u5968\uff08Contains Nonbinding Recommendations\uff09\u3067\u3042\u308a\u3001\u9069\u7528\u6cd5\u4ee4\u3092\u6e80\u305f\u3059\u5225\u306e\u65b9\u6cd5\u3082\u8a8d\u3081\u3089\u308c\u307e\u3059\u3002<mark>GAMP5\u7b2c2\u7248\u306e\u65b9\u5411\u6027\u3068FDA CSA\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30fb\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306a\u3069\u306e\u70b9\u3067\u6574\u5408<\/mark>\u3057\u3066\u304a\u308a\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u3092\u4e2d\u5fc3\u306bCSA\u306b\u57fa\u3065\u304f\u30a2\u30d7\u30ed\u30fc\u30c1\u3078\u306e\u95a2\u5fc3\u304c\u9ad8\u307e\u3063\u3066\u3044\u307e\u3059\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<h3 class=\"wp-block-heading\" id=\"i-15\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3059\u308b\u30d7\u30ed\u30bb\u30b9<\/h3>\n\n\n\n<p>GAMP5\u7b2c2\u7248\u3067\u306f\u3001<mark>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\uff08\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u30fb\u6b63\u78ba\u6027\u30fb\u4e00\u8cab\u6027\u30fb\u4fe1\u983c\u6027\u306e\u78ba\u4fdd\uff09<\/mark>\u306b\u95a2\u3059\u308bISPE\/GAMP\u30ac\u30a4\u30c9\u3068\u306e\u95a2\u4fc2\u304c\u660e\u78ba\u306b\u3055\u308c\u3001\u8868\u8a08\u7b97\u7b49\u306e\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3084\u76e3\u67fb\u8a3c\u8de1\u306b\u95a2\u3059\u308b\u8003\u616e\u4e8b\u9805\u304c\u66f4\u65b0\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u7ba1\u7406\u306e\u57fa\u672c\u306b\u306a\u308b\u306e\u304c\u3001\u898f\u5236\u5f53\u5c40\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u3001GAMP Records and Data Integrity Guide\u306a\u3069\u306eISPE\u95a2\u9023\u30ac\u30a4\u30c9\u3067\u7528\u3044\u3089\u308c\u308bALCOA+\u306e\u539f\u5247\u3067\u3059\u3002ALCOA+\u306f\u3001\u4ee5\u4e0b\u3092\u6c42\u3081\u308b\u539f\u5247\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Attributable\uff08\u5e30\u5c5e\u6027\uff09<\/li>\n\n\n\n<li>Legible\uff08\u5224\u8aad\u6027\uff09<\/li>\n\n\n\n<li>Contemporaneous\uff08\u540c\u6642\u6027\uff09<\/li>\n\n\n\n<li>Original\uff08\u539f\u8a18\u9332\u307e\u305f\u306f\u771f\u6b63\u306a\u30b3\u30d4\u30fc\uff09<\/li>\n\n\n\n<li>Accurate\uff08\u6b63\u78ba\u6027\uff09<\/li>\n\n\n\n<li>Complete\uff08\u5b8c\u5168\u6027\uff09<\/li>\n\n\n\n<li>Consistent\uff08\u4e00\u8cab\u6027\uff09<\/li>\n\n\n\n<li>Enduring\uff08\u5fc5\u8981\u306a\u4fdd\u5b58\u671f\u9593\u3092\u901a\u3058\u305f\u8a18\u9332\u306e\u4fdd\u6301\uff09<\/li>\n\n\n\n<li>Available\uff08\u5fc5\u8981\u306a\u4fdd\u5b58\u671f\u9593\u4e2d\u306e\u5229\u7528\u53ef\u80fd\u6027\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u30b7\u30b9\u30c6\u30e0\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u3001\u30c7\u30fc\u30bf\u306e\u4f5c\u6210\u30fb\u51e6\u7406\u30fb\u30ec\u30d3\u30e5\u30fc\u30fb\u5831\u544a\uff0f\u4f7f\u7528\u30fb\u4fdd\u7ba1\uff0f\u691c\u7d22\u30fb\u5ec3\u68c4\u306e\u5404\u6bb5\u968e\u3067\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u304c\u7dad\u6301\u3055\u308c\u308b\u3088\u3046\u3001\u6280\u8853\u7684\u306a\u5bfe\u7b56\u3068\u904b\u7528\u4e0a\u306e\u7ba1\u7406\u3092\u7d44\u307f\u5408\u308f\u305b\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305f\u3068\u3048\u3070\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u76e3\u67fb\u8a3c\u8de1\u306e\u8a18\u9332\u30fb\u30ec\u30d3\u30e5\u30fc\u3001\u6a29\u9650\u3068\u5909\u66f4\u306e\u7ba1\u7406\u3001\u95a2\u9023\u30e1\u30bf\u30c7\u30fc\u30bf\u3092\u542b\u3080\u8a18\u9332\u306e\u4fdd\u6301\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3068\u5fa9\u5143\u53ef\u80fd\u6027\u306e\u78ba\u8a8d\u3092\u7d44\u307f\u5408\u308f\u305b\u307e\u3059\u3002\u4fdd\u5b58\u671f\u9593\u4e2d\u306e\u898b\u8aad\u6027\u30fb\u691c\u7d22\u6027\u30fb\u5229\u7528\u53ef\u80fd\u6027\u3092\u78ba\u4fdd\u3057\u3001\u30b7\u30b9\u30c6\u30e0\u5ec3\u6b62\u30fb\u79fb\u884c\u5f8c\u3082\u5fc5\u8981\u306a\u8a18\u9332\u3092\u4fdd\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6642\u306e\u4e00\u56de\u9650\u308a\u306e\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001<mark>\u30b7\u30b9\u30c6\u30e0\u904b\u7528\u671f\u9593\u3092\u901a\u3058\u305f\u7d99\u7d9a\u7684\u306a\u7ba1\u7406\u6d3b\u52d5<\/mark>\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-16\">GAMP5\u3068\u5404\u56fd\u898f\u5236\u306e\u95a2\u4fc2<\/h2>\n\n\n\n<p>GAMP5\u3068\u5404\u56fd\u898f\u5236\u306e\u95a2\u4fc2\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u306e\u306f\u3001GAMP5\u81ea\u4f53\u306f\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u898f\u5236\u6587\u66f8\u3067\u306f\u306a\u3044\u3082\u306e\u306e\u3001<mark>\u5404\u56fd\u306e\u898f\u5236\u5f53\u5c40\u304c\u6c42\u3081\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u7ba1\u7406\u8981\u4ef6\u3068\u5bc6\u63a5\u306b\u95a2\u9023<\/mark>\u3057\u3066\u304a\u308a\u3001\u5b9f\u8cea\u7684\u306a\u696d\u754c\u6a19\u6e96\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3066\u3044\u308b\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u65e5\u672c\u306e\u898f\u5236\uff08PMDA\/\u539a\u52b4\u7701\uff09<\/li>\n\n\n\n<li>\u7c73\u56fdFDA\u306e\u898f\u5236<\/li>\n\n\n\n<li>\u6b27\u5dde\u306e\u898f\u5236\uff08\u6b27\u5dde\u59d4\u54e1\u4f1a\/EMA\u7b49\uff09<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-17\">\u65e5\u672c\u306e\u898f\u5236\uff08PMDA\/\u539a\u52b4\u7701\uff09<\/h3>\n\n\n\n<p>\u65e5\u672c\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u5206\u91ce\u3067\u306eGAMP5\u306e\u4f4d\u7f6e\u3065\u3051\u306f\u3001\u539a\u751f\u52b4\u50cd\u7701\u304c2010\u5e74\u306b\u767a\u51fa\u3057\u305f<mark>\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<\/mark>\uff08\u85ac\u98df\u76e3\u9ebb\u767a1021\u7b2c11\u53f7\u30012012\u5e744\u67081\u65e5\u9069\u7528\u958b\u59cb\uff09\u3068\u306e\u95a2\u4fc2\u3067\u7406\u89e3\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u540c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306eGQP\u30fbGMP\u696d\u52d9\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u9069\u6b63\u7ba1\u7406\u3092\u5b9a\u3081\u3066\u304a\u308a\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u7ba1\u7406\u3084\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u306b\u95a2\u3059\u308b\u8003\u3048\u65b9\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002GAMP5\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u3084\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u3068\u306e\u89aa\u548c\u6027\u304c\u9ad8\u304f\u3001\u65e5\u672c\u56fd\u5185\u3067CSV\u3092\u5b9f\u65bd\u3059\u308b\u969b\u306b\u306f\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306b\u3064\u3044\u3066\u540c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u30012021\u5e74\u6539\u6b63GMP\u7701\u4ee4\u3067\u660e\u78ba\u5316\u3055\u308c\u305f\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u8981\u4ef6\u3082\u3075\u307e\u3048\u305f\u3046\u3048\u3067\u3001GAMP5\u3092\u5b9f\u52d9\u306e\u6307\u91dd\u3068\u3057\u3066\u6d3b\u7528\u3059\u308b\u306e\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u307e\u305f\u3001\u65e5\u672c\u306f2014\u5e747\u6708\u306bPIC\/S\uff08\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u5b9a\u30fb\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u540c\u30b9\u30ad\u30fc\u30e0\uff09\u306b\u52a0\u76df\u3057\u3066\u304a\u308a\u3001PIC\/S\u306eGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\uff08PI 041\uff09\u3082\u5b9f\u52d9\u3067\u3088\u304f\u53c2\u7167\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>PMDA\u3084\u90fd\u9053\u5e9c\u770c\u306b\u3088\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u306b\u304a\u3044\u3066\u3082\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u72b6\u6cc1\u306f\u78ba\u8a8d\u5bfe\u8c61\u3067\u3059\u3002\u8abf\u67fb\u306b\u5099\u3048\u3001\u4f7f\u7528\u76ee\u7684\u3001\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3001\u691c\u8a3c\u30fb\u904b\u7528\u7ba1\u7406\u306e\u6839\u62e0\u3068\u8a18\u9332\u3092\u8aac\u660e\u3067\u304d\u308b\u72b6\u614b\u306b\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\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\uff08\u85ac\u98df\u76e3\u9ebb\u767a1021\u7b2c11\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/en\/members\" rel=\"nofollow\">PIC\/S\u300cMembers\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-18\">\u7c73\u56fdFDA\u306e\u898f\u5236<\/h3>\n\n\n\n<p>\u7c73\u56fd\u3067\u306f\u3001\u533b\u85ac\u54c1\u306ecGMP\uff0821 CFR 211.68\uff09\u3084\u533b\u7642\u6a5f\u5668\u306eQMSR\uff0821 CFR Part 820\u30012026\u5e742\u67082\u65e5\u65bd\u884c\uff09\u306a\u3069\u306e<mark>\u57fa\u790e\u898f\u5247\uff08\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u30eb\u30fc\u30eb\uff09\u306b\u57fa\u3065\u304f\u7ba1\u7406\u8981\u4ef6<\/mark>\u3092\u307e\u305a\u78ba\u8a8d\u3057\u307e\u3059\u3002\u5bfe\u8c61\u3068\u306a\u308b\u8a18\u9332\u3092\u96fb\u5b50\u7684\u306b\u6271\u3046\u5834\u5408\u306a\u3069\u306b\u306f21 CFR Part 11\u306e\u9069\u7528\u3092\u8a55\u4fa1\u3057\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3084\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u76e3\u67fb\u8a3c\u8de1\u7b49\u306e\u5fc5\u8981\u306a\u7ba1\u7406\u3092\u884c\u3044\u307e\u3059\u3002FDA\u306e\u9069\u7528\u7bc4\u56f2\u30fb\u57f7\u884c\u88c1\u91cf\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3082\u4f75\u305b\u3066\u53c2\u7167\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002GAMP5\u306f\u3001\u3053\u308c\u3089\u306e\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u5b9f\u8df5\u7684\u306a\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3068\u3057\u3066\u5e83\u304f\u6d3b\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3055\u3089\u306b\u3001FDA\u304c2025\u5e749\u6708\u306b\u6700\u7d42\u5316\u3057\u30012026\u5e742\u6708\u306bQMSR\u5bfe\u5fdc\u7248\u3067\u7f6e\u304d\u63db\u3048\u305fCSA\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u30fb\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u7528\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u95a2\u3057\u3066\u3001GAMP5\u7b2c2\u7248\u306e\u65b9\u5411\u6027\u3068\u6574\u5408\u3059\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u63a8\u9032\u3092\u6253\u3061\u51fa\u3057\u3066\u3044\u307e\u3059\u3002\u306a\u304a\u3001CSA\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u533b\u85ac\u54c1\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u305b\u3093\u304c\u3001\u305d\u306e\u8003\u3048\u65b9\u306f\u533b\u85ac\u54c1\u306eCSV\u3067\u3082\u53c2\u8003\u306b\u3055\u308c\u3066\u3044\u307e\u3059\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<h3 class=\"wp-block-heading\" id=\"i-19\">\u6b27\u5dde\u306e\u898f\u5236\uff08\u6b27\u5dde\u59d4\u54e1\u4f1a\/EMA\u7b49\uff09<\/h3>\n\n\n\n<p>\u6b27\u5dde\u3067\u306f\u3001<mark>EU GMP Annex 11\uff08\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u88dc\u5247\u30012011\u5e74\u7248\uff09<\/mark>\u304c\u3001\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u7ba1\u7406\u8981\u4ef6\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002Annex 11\u306f\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u9069\u7528\u3059\u308b\u3053\u3068\u3092\u6c42\u3081\u3066\u304a\u308a\u3001GAMP5\u306f\u305d\u306e\u5b9f\u8df5\u306e\u53c2\u8003\u306b\u3067\u304d\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u305d\u306e\u3082\u306e\u304cAnnex 11\u306e\u8981\u6c42\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>2025\u5e747\u67087\u65e5\u304b\u308910\u67087\u65e5\u306b\u304b\u3051\u3066\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306fChapter 4\uff08\u6587\u66f8\uff09\u3001Annex 11\uff08\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u6539\u8a02\u3068\u3001\u65b0Annex 22\uff08AI\uff09\u306b\u3064\u3044\u3066\u516c\u958b\u5354\u8b70\u3092\u884c\u3044\u307e\u3057\u305f\u3002Annex 22\u306fAnnex 11\u3092\u88dc\u5b8c\u3059\u308b\u5225\u306e\u65b0Annex\u3068\u3057\u3066\u63d0\u6848\u3055\u308c\u3066\u304a\u308a\u3001Annex 11\u306e\u4e00\u90e8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u6539\u8a02\u7248\u306e\u6700\u7d42\u5316\u3084\u9069\u7528\u958b\u59cb\u306e\u6642\u671f\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u3084EMA\u306e\u516c\u5f0f\u767a\u8868\u3067\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u306a\u304a\u30012025\u5e74\u516c\u958b\u5354\u8b70\u306eAnnex 22\u8349\u6848\u306f\u3001\u9759\u7684\u3067\u6c7a\u5b9a\u8ad6\u7684\u306aAI\/ML\u30e2\u30c7\u30eb\u306e\u91cd\u8981\u306aGMP\u7528\u9014\u7b49\u3092\u4e3b\u306a\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u751f\u6210AI\u3084LLM\u7b49\u306f\u5bfe\u8c61\u5916\u3068\u3057\u3001\u91cd\u8981\u306aGMP\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\uff08critical GMP applications\uff09\u3067\u306f\u4f7f\u3046\u3079\u304d\u3067\u306a\u3044\u3068\u3059\u308b\u63d0\u6848\u3092\u542b\u307f\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u307e\u3060\u8349\u6848\u306e\u6bb5\u968e\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6b27\u5dde\u5e02\u5834\u5411\u3051\u306e\u533b\u85ac\u54c1\u88fd\u9020\u3092\u884c\u3046\u4f01\u696d\u306f\u3001\u73fe\u884c\u306eAnnex 11\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3046\u3048\u3067GAMP5\u3092\u6d3b\u7528\u3057\u3064\u3064\u3001\u6539\u8a02\u7248\u306e\u516c\u8868\u52d5\u5411\u3082\u7d99\u7d9a\u7684\u306b\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002\u9069\u7528\u3059\u308b\u56fd\u30fb\u88fd\u54c1\u30fbGxP\u9818\u57df\u306e\u8981\u6c42\u3092\u7279\u5b9a\u3057\u305f\u3046\u3048\u3067\u3001GAMP5\u3092\u5b9f\u52d9\u4e0a\u306e\u53c2\u8003\u3068\u3057\u3001<mark>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306eCSV\u4f53\u5236\u3092\u6574\u5099\u3059\u308b\u3053\u3068<\/mark>\u306f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306b\u4e8b\u696d\u5c55\u958b\u3059\u308b\u88fd\u85ac\u4f01\u696d\u306b\u3068\u3063\u3066\u5408\u7406\u7684\u306a\u9078\u629e\u80a2\u3068\u3044\u3048\u307e\u3059\u3002<\/p>\n\n\n\n<p>\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\u2019 Consultation on EudraLex Volume 4 \u2013 Chapter 4, Annex 11 and New Annex 22\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-20\">GAMP5\u306e\u5b9f\u52d9\u30dd\u30a4\u30f3\u30c8<\/h2>\n\n\n\n<p>GAMP5\u306b\u57fa\u3065\u304f\u5b9f\u52d9\u3092\u52b9\u7387\u7684\u306b\u9032\u3081\u308b\u305f\u3081\u306b\u306f\u3001<mark>\u30b5\u30d7\u30e9\u30a4\u30e4\u306e\u6d3b\u7528\u3084\u5909\u66f4\u7ba1\u7406\u306e\u5fb9\u5e95\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd<\/mark>\u3068\u3044\u30463\u3064\u306e\u30dd\u30a4\u30f3\u30c8\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b5\u30d7\u30e9\u30a4\u30e4\u306e\u6d3b\u7528\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\uff08\u30b7\u30b9\u30c6\u30e0\u30d9\u30f3\u30c0\u30fc\uff09\u304c\u63d0\u4f9b\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u8a18\u9332\u3084\u30c6\u30b9\u30c8\u7d50\u679c\u3092\u9069\u5207\u306b\u6d3b\u7528\u3057\u3001\u30e6\u30fc\u30b6\u30fc\u5074\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5de5\u6570\u3092\u6700\u9069\u5316\u3059\u308b\u3002\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u3092\u9078\u5b9a\u3057\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u901a\u3058\u3066\u54c1\u8cea\u4f53\u5236\u3092\u8a55\u4fa1\u3059\u308b<\/li>\n\n\n\n<li>\u5909\u66f4\u7ba1\u7406\u306e\u5fb9\u5e95\uff1a\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u5f8c\u3082\u3001\u69cb\u6210\u5909\u66f4\u3084\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\u306b\u5bfe\u3059\u308b\u5909\u66f4\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3092\u7dad\u6301\u3057\u3001\u5909\u66f4\u304c\u54c1\u8cea\u3084\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u8a55\u4fa1\u30fb\u7ba1\u7406\u3059\u308b<\/li>\n\n\n\n<li>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\uff1a\u8981\u4ef6\u304b\u3089\u30c6\u30b9\u30c8\u307e\u3067\u306e\u4e00\u8cab\u3057\u305f\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306f\u3001GAMP5\u306b\u57fa\u3065\u304f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u57fa\u672c\u3068\u306a\u308b\u6d3b\u52d5\u3067\u3042\u308b<\/li>\n<\/ul>\n\n\n\n<p>3\u3064\u306e\u30dd\u30a4\u30f3\u30c8\u306f\u3044\u305a\u308c\u3082\u3001\u5c0e\u5165\u6642\u3060\u3051\u3067\u306a\u304f\u904b\u7528\u671f\u9593\u3092\u901a\u3058\u3066\u7d99\u7d9a\u3059\u308b\u3053\u3068\u3067\u3001\u76e3\u67fb\u3084\u5909\u66f4\u6642\u306b\u3082\u8aac\u660e\u53ef\u80fd\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u72b6\u614b\u3092\u4fdd\u3066\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-21\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u81ea\u52d5\u5316\u3068RTM<\/h3>\n\n\n\n<p>\u8ffd\u8de1\u53ef\u80fd\u6027\u306f\u3001<mark>RTM\uff08\u8981\u4ef6\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30af\u30b9\uff09<\/mark>\u3084\u8981\u4ef6\u7ba1\u7406\u30fb\u30c6\u30b9\u30c8\u7ba1\u7406\u30c4\u30fc\u30eb\u7b49\u3067\u78ba\u4fdd\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>RTM\u306f\u3001URS\uff08\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff09\u306e\u5404\u8981\u4ef6\u9805\u76ee\u3068\u3001\u5bfe\u5fdc\u3059\u308b\u8a2d\u8a08\u4ed5\u69d8\u30fb\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3092\u7d10\u3065\u3051\u305f\u4e00\u89a7\u8868\uff08\u6587\u66f8\uff09\u3067\u3059\u3002RTM\u7b49\u3092\u7528\u3044\u308b\u3068\u3001\u8981\u4ef6\u3068\u8a2d\u8a08\u30fb\u691c\u8a3c\u8a3c\u62e0\u306e\u5bfe\u5fdc\u95a2\u4fc2\u3092\u78ba\u8a8d\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u8868\u3092\u4f5c\u3063\u305f\u3060\u3051\u3067\u306f\u8981\u4ef6\u306e\u6f0f\u308c\u306f\u9632\u3052\u306a\u3044\u305f\u3081\u3001\u5185\u5bb9\u306e\u30ec\u30d3\u30e5\u30fc\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>RTM\u306e\u69cb\u9020\u306f\u3001\u8981\u4ef6ID\u306b\u5bfe\u3057\u3066\u8a2d\u8a08\u4ed5\u69d8\u306e\u8a72\u5f53\u7b87\u6240\u3068\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9ID\u3092\u5bfe\u5fdc\u3065\u3051\u308b\u30de\u30c8\u30ea\u30af\u30b9\u5f62\u5f0f\u3067\u3059\u3002\u65b0\u305f\u306a\u8981\u4ef6\u304c\u8ffd\u52a0\u3055\u308c\u305f\u5834\u5408\u3084\u8a2d\u8a08\u5909\u66f4\u304c\u751f\u3058\u305f\u5834\u5408\u306b\u306f\u3001RTM\u3092\u66f4\u65b0\u3057\u3066\u5f71\u97ff\u7bc4\u56f2\u3092\u7279\u5b9a\u3057\u3001\u5bfe\u5fdc\u3059\u308b\u30c6\u30b9\u30c8\u306e\u8ffd\u52a0\u30fb\u4fee\u6b63\u3092\u884c\u3044\u307e\u3059\u3002\u3053\u306e\u904b\u7528\u306b\u3088\u308a\u3001<mark>\u5909\u66f4\u7ba1\u7406\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u6574\u5408\u6027<\/mark>\u3092\u7dad\u6301\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e00\u65b9\u3067\u3001RTM\u3092\u624b\u4f5c\u696d\u3067\u7ba1\u7406\u3059\u308b\u8ca0\u62c5\u306f\u5c0f\u3055\u304f\u3042\u308a\u307e\u305b\u3093\u3002\u305f\u3068\u3048\u3070\u3001\u8981\u4ef6\u306e\u8ffd\u52a0\u3084\u8a2d\u8a08\u5909\u66f4\u306e\u305f\u3073\u306b\u6570\u767e\u884c\u306b\u53ca\u3076\u8868\u3092\u624b\u3067\u66f4\u65b0\u3057\u3001\u95a2\u9023\u3059\u308b\u8a2d\u8a08\u66f8\u3084\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3068\u306e\u5bfe\u5fdc\u3092\u4e00\u3064\u305a\u3064\u78ba\u8a8d\u3059\u308b\u4f5c\u696d\u306f\u3001\u62c5\u5f53\u8005\u306e\u5de5\u6570\u3092\u5727\u8feb\u3059\u308b\u3046\u3048\u3001\u8ee2\u8a18\u30df\u30b9\u3084\u66f4\u65b0\u6f0f\u308c\u306e\u539f\u56e0\u306b\u3082\u306a\u308a\u307e\u3059\u3002\u3053\u3046\u3057\u305f\u80cc\u666f\u304b\u3089\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u95a2\u9023\u6587\u66f8\u306e\u4f5c\u6210\u30fb\u7ba1\u7406\u3092\u52b9\u7387\u5316\u3059\u308b\u305f\u3081\u306e\u30c4\u30fc\u30eb\u6d3b\u7528\u304c\u9032\u3093\u3067\u3044\u307e\u3059\u3002\u81ea\u52d5\u5316\u3059\u308b\u5834\u5408\u3082\u3001\u610f\u56f3\u3057\u305f\u7528\u9014\u3068\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u30c4\u30fc\u30eb\u306e\u9069\u5207\u6027\u3084\u30ea\u30f3\u30af\u30fb\u5f71\u97ff\u5206\u6790\u306e\u6b63\u78ba\u6027\u3001\u5909\u66f4\u7ba1\u7406\u3068\u30ec\u30d3\u30e5\u30fc\u65b9\u6cd5\u3092\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\">\n\n\n\n<p><b>\u88fd\u85ac\u696d\u754c\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\u7ba1\u7406\u3092\u52b9\u7387\u5316\u3059\u308b\u306a\u3089\u300cJAPAN AI \u88fd\u85ac\u300d<\/b><br>\u88fd\u85ac\u4f01\u696d\u3067\u306f\u3001GMP\u7b49\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u57fa\u3065\u304fSOP\u3084\u54c1\u8cea\u6587\u66f8\u306e\u5909\u66f4\u7ba1\u7406\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\u95a2\u9023\u6587\u66f8\u306e\u5f71\u97ff\u7bc4\u56f2\u306e\u7279\u5b9a\u304b\u3089\u6539\u8a02\u6848\u306e\u30c9\u30e9\u30d5\u30c8\u4f5c\u6210\u3001\u6574\u5408\u78ba\u8a8d\u307e\u3067\u3092\u652f\u63f4\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u307e\u305f\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u3067\u5b9f\u65bd\u3057\u305f\u958b\u767a\u6642\u306e\u30c6\u30b9\u30c8\u8a18\u9332\u7b49\u3092\u3001\u53ef\u80fd\u306a\u7bc4\u56f2\u3067CSV\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u8cc7\u6599\u3068\u3057\u3066\u63d0\u4f9b\u3057\u3001\u304a\u5ba2\u69d8\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6d3b\u52d5\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u5bfe\u8c61\u696d\u52d9\u30fb\u69cb\u6210\u306b\u5fdc\u3058\u305f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5b9f\u65bd\u4e3b\u4f53\u306f\u5c0e\u5165\u4f01\u696d\u3067\u3042\u308a\u3001\u8cc7\u6599\u63d0\u4f9b\u306f\u305d\u306e\u6d3b\u52d5\u3092\u652f\u63f4\u3059\u308b\u3082\u306e\u3067\u3059\u3002Human-in-the-Loop\u8a2d\u8a08\u306b\u3088\u308aAI\u306e\u51fa\u529b\u306f\u30c9\u30e9\u30d5\u30c8\u30fb\u63d0\u6848\u3068\u3057\u3066\u6271\u3044\u3001\u6700\u7d42\u5224\u65ad\u30fb\u627f\u8a8d\u306f\u5fc5\u305a\u62c5\u5f53\u8005\u304c\u884c\u3046\u4ed5\u7d44\u307f\u3067\u3059\u3002\u56fd\u5185\u30c7\u30fc\u30bf\u30bb\u30f3\u30bf\u30fc\u3092\u5229\u7528\u3067\u304d\u3001JAPAN AI\u682a\u5f0f\u4f1a\u793e\u306fISO\/IEC 27001\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\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-22\">GAMP5\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n<p>GAMP5\u306b\u3064\u3044\u3066\u3001\u7279\u306b\u591a\u304f\u5bc4\u305b\u3089\u308c\u308b\u8cea\u554f\u3068\u305d\u306e\u56de\u7b54\u3092\u307e\u3068\u3081\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-23\">GAMP5\u3068CSV\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>GAMP5\u306f\u3001ISPE\u304c\u767a\u884c\u3059\u308b<mark>CSV\u5b9f\u65bd\u306e\u305f\u3081\u306e\u696d\u754c\u30ac\u30a4\u30c9\uff08\u5b9f\u8df5\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff09<\/mark>\u3067\u3059\u3002\u4e00\u65b9\u3001CSV\u306f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3069\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u691c\u8a3c\u30fb\u7dad\u6301\u3059\u308b\u6d3b\u52d5\u305d\u306e\u3082\u306e\u3092\u6307\u3057\u307e\u3059\u3002GAMP5\u306fCSV\u306e\u300c\u3084\u308a\u65b9\u300d\u3092\u4f53\u7cfb\u7684\u306b\u793a\u3057\u305f\u3082\u306e\u3067\u3042\u308a\u3001CSV\u6d3b\u52d5\u306e\u67a0\u7d44\u307f\u3068\u3057\u3066GAMP5\u304c\u53c2\u7167\u3055\u308c\u308b\u95a2\u4fc2\u306b\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-24\">GAMP5\u306e\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u3067\u30ab\u30c6\u30b4\u30ea2\u306f\u306a\u305c\u5ec3\u6b62\u3055\u308c\u305f\u306e\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><mark>\u30d5\u30a1\u30fc\u30e0\u30a6\u30a7\u30a2\u304c\u9ad8\u5ea6\u306b\u306a\u308a\u3001\u69cb\u6210\u8a2d\u5b9a\u3084\u30ab\u30b9\u30bf\u30e0\u958b\u767a\u304c\u3067\u304d\u308b\u3082\u306e\u3082\u5897\u3048\u305f<\/mark>\u305f\u3081\u3001\u300c\u30d5\u30a1\u30fc\u30e0\u30a6\u30a7\u30a2\u300d\u3068\u3057\u3066\u4e00\u5f8b\u306b\u5206\u985e\u3059\u308b\u610f\u5473\u304c\u8584\u308c\u305f\u304b\u3089\u3067\u3059\u3002\u305d\u306e\u305f\u30812008\u5e74\u306eGAMP5\u521d\u7248\u3067\u30ab\u30c6\u30b4\u30ea2\u306f\u5ec3\u6b62\u3055\u308c\u3001\u73fe\u5728\uff08\u7b2c2\u7248\u3092\u542b\u3080\uff09\u306f\u3001\u5b9f\u969b\u306e\u6027\u8cea\u306b\u5fdc\u3058\u3066\u30ab\u30c6\u30b4\u30ea1\u30fb3\u30fb4\u30fb5\u306e\u3044\u305a\u308c\u304b\u3068\u3057\u3066\u6271\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 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