{"id":11107,"date":"2026-11-11T19:55:09","date_gmt":"2026-11-11T10:55:09","guid":{"rendered":"https:\/\/japan-ai.geniee.co.jp\/media\/?p=11107"},"modified":"2026-11-11T19:55:13","modified_gmt":"2026-11-11T10:55:13","slug":"%e8%a3%bd%e8%96%ac%e3%81%aegmp%e6%96%87%e6%9b%b8%e7%ae%a1%e7%90%86%e3%81%a8%e3%81%af%ef%bc%9f%e7%a8%ae%e9%a1%9e%e3%83%bb%e3%83%87%e3%83%bc%e3%82%bf%e3%82%a4%e3%83%b3%e3%83%86%e3%82%b0%e3%83%aa","status":"publish","type":"post","link":"https:\/\/japan-ai.co.jp\/media\/11107\/","title":{"rendered":"\u88fd\u85ac\u306eGMP\u6587\u66f8\u7ba1\u7406\u3068\u306f\uff1f\u7a2e\u985e\u30fb\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30fb\u96fb\u5b50\u5316\u307e\u3067\u89e3\u8aac"},"content":{"rendered":"\n<p>GMP\uff08Good Manufacturing Practice\uff1a\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09\u306b\u57fa\u3065\u304f\u6587\u66f8\u7ba1\u7406\u3068\u306f\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u308f\u308b\u624b\u9806\u66f8\u3084\u8a18\u9332\u3092\u3001\u4f5c\u6210\u304b\u3089\u5ec3\u68c4\u307e\u3067\u4e00\u8cab\u3057\u305f\u30eb\u30fc\u30eb\u3067\u7ba1\u7406\u3059\u308b\u6d3b\u52d5\u3067\u3059\u3002\u56fd\u5185\u3067\u306f2021\uff08\u4ee4\u548c3\uff09\u5e744\u670828\u65e5\u306b\u6539\u6b63GMP\u7701\u4ee4\u304c\u516c\u5e03\u3055\u308c\u3001\u540c\u5e748\u67081\u65e5\u306b\u65bd\u884c\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u6539\u6b63\u3067\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3084\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u52a0\u3048\u3001\u624b\u9806\u66f8\u30fb\u8a18\u9332\u306e\u4fe1\u983c\u6027\u3092\u7d99\u7d9a\u7684\u306b\u78ba\u4fdd\u3059\u308b\u696d\u52d9\u3082\u660e\u6587\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08U.S. Food and Drug Administration\u3001\u4ee5\u4e0bFDA\uff09\u3082\u3001\u67fb\u5bdf\u3067\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308bCGMP\u9055\u53cd\u304c\u898b\u3064\u304b\u308b\u4f8b\u304c\u5897\u3048\u305f\u3053\u3068\u3092\u53d7\u3051\u3066\u30012018\u5e7412\u6708\u306b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u6587\u66f8\u3068\u8a18\u9332\u306e\u7ba1\u7406\u6c34\u6e96\u306f\u3001\u56fd\u5185\u5916\u306e\u67fb\u5bdf\u3067\u78ba\u8a8d\u3055\u308c\u308b\u8ad6\u70b9\u306e\u4e00\u3064\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001GMP\u6587\u66f8\u7ba1\u7406\u3068\u306f\u305d\u3082\u305d\u3082\u4f55\u3092\u7ba1\u7406\u3059\u308b\u6d3b\u52d5\u306a\u306e\u304b\u3001\u6539\u6b63GMP\u7701\u4ee4\u3084\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u3069\u3046\u5bfe\u5fdc\u3059\u3079\u304d\u304b\u3001\u96fb\u5b50\u5316\u3084AI\u6d3b\u7528\u306f\u3069\u3053\u307e\u3067\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u306e\u304b\u3001\u3068\u3044\u3063\u305f\u7591\u554f\u3092\u6301\u3064\u65b9\u3082\u591a\u3044\u306e\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u304b\u3002<\/p>\n\n\n\n<p>\u672c\u8a18\u4e8b\u3067\u306f\u3001<mark>GMP\u6587\u66f8\u7ba1\u7406\u306e\u5b9a\u7fa9\u3084\u6587\u66f8\u306e\u7a2e\u985e\u304b\u3089\u3001ALCOA+\u3068\u898f\u5236\u8981\u4ef6\u3001\u96fb\u5b50\u5316\u3068\u67fb\u5bdf\u5bfe\u5fdc\u3001AI\u6d3b\u7528\u306e\u7559\u610f\u70b9<\/mark>\u307e\u3067\u3001<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">\u88fd\u85ac\u696d\u754c\u5411\u3051\u6587\u66f8\u6539\u8a02\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<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><br>\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<\/a><\/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\">GMP\u6587\u66f8\u7ba1\u7406\u3068\u306f\uff1f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-1\">GMP\u306b\u304a\u3051\u308b\u6587\u66f8\u7ba1\u7406\u306e\u5f79\u5272<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-2\">\u6587\u66f8\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3068\u306f<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-3\">GMP\u6587\u66f8\u306e\u7a2e\u985e\u3068\u7ba1\u7406\u5bfe\u8c61<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-4\">SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09<\/a>      <\/li>      <li>        <a href=\"#i-5\">\u88fd\u54c1\u6a19\u6e96\u66f8\u30fb\u88fd\u9020\u6307\u56f3\u66f8<\/a>      <\/li>      <li>        <a href=\"#i-6\">\u88fd\u9020\u8a18\u9332\u30fb\u8a66\u9a13\u8a18\u9332<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-7\">\u6559\u80b2\u8a18\u9332\u30fb\u5909\u66f4\u7ba1\u7406\u6587\u66f8<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-8\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3068ALCOA\u539f\u5247<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-9\">ALCOA\u539f\u5247\u306e5\u3064\u306e\u8981\u7d20<\/a>      <\/li>      <li>        <a href=\"#i-10\">\u30c7\u30fc\u30bf\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u7ba1\u7406<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-11\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u8105\u304b\u3059\u8981\u56e0<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-12\">\u6539\u6b63GMP\u7701\u4ee4\u3068\u898f\u5236\u8981\u4ef6<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-13\">\u6539\u6b63GMP\u7701\u4ee4\u306e\u30dd\u30a4\u30f3\u30c8<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-14\">21 CFR Part 11\u3068ER\/ES\u6307\u91dd<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-15\">GMP\u6587\u66f8\u7ba1\u7406\u306e\u8ab2\u984c<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-16\">\u7d19\u30d9\u30fc\u30b9\u7ba1\u7406\u306e\u9650\u754c<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-17\">\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u3068\u5c5e\u4eba\u5316<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-18\">\u6587\u66f8\u7ba1\u7406\u306e\u96fb\u5b50\u5316\u30fbDX<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-19\">\u96fb\u5b50\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08EDMS\uff09\u306e\u6a5f\u80fd<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-20\">\u5c0e\u5165\u306e\u9032\u3081\u65b9\u3068\u8cbb\u7528\u76f8\u5834<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-21\">GMP\u67fb\u5bdf\u3068\u6587\u66f8\u7ba1\u7406\u306e\u5bfe\u5fdc<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-22\">FDA\u67fb\u5bdf\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u6307\u6458\u306e\u50be\u5411<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-23\">\u67fb\u5bdf\u306b\u5099\u3048\u305f\u6587\u66f8\u7ba1\u7406\u4f53\u5236<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-24\">GMP\u6587\u66f8\u7ba1\u7406\u306b\u304a\u3051\u308bAI\u6d3b\u7528<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-25\">AI\u306b\u4efb\u305b\u3089\u308c\u308b\u696d\u52d9\u3068\u4eba\u9593\u304c\u78ba\u8a8d\u3059\u3079\u304d\u696d\u52d9<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-26\">AI\u6d3b\u7528\u6642\u306e\u898f\u5236\u4e0a\u306e\u7559\u610f\u70b9<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-27\">GMP\u6587\u66f8\u7ba1\u7406\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-28\">SharePoint\u306a\u3069\u306e\u6c4e\u7528\u30b9\u30c8\u30ec\u30fc\u30b8\u3060\u3051\u3067GMP\u6587\u66f8\u3092\u7ba1\u7406\u3067\u304d\u307e\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-29\">\u96fb\u5b50\u7f72\u540d\u304c\u3042\u308c\u307021 CFR Part 11\u306b\u81ea\u52d5\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u304b\uff1f<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-30\">\u7d19\u306e\u6587\u66f8\u30fb\u8a18\u9332\u3092\u5b8c\u5168\u306b\u5ec3\u6b62\u3067\u304d\u307e\u3059\u304b\uff1f<\/a>      <\/li>    <\/ul>  <\/li>  <li class=\"last\">    <a href=\"#i-31\">\u88fd\u85ac\u306eGMP\u6587\u66f8\u7ba1\u7406\u3092\u9069\u5207\u306b\u904b\u7528\u3059\u308b\u305f\u3081\u306b<\/a>  <\/li><\/ul>\n      \n    <\/div><\/div><h2 class=\"wp-block-heading\" id=\"i-0\">GMP\u6587\u66f8\u7ba1\u7406\u3068\u306f\uff1f<\/h2>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u3068\u306f\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3067\u3042\u308bGMP\uff08Good Manufacturing Practice\uff09\u306b\u57fa\u3065\u304d\u3001<mark>\u624b\u9806\u66f8\u7b49\u3068\u8a18\u9332\u3092\u4f5c\u6210\u304b\u3089\u5ec3\u68c4\u307e\u3067\u4e00\u8cab\u3057\u3066\u7ba1\u7406\u3059\u308b\u6d3b\u52d5<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>GMP\u7701\u4ee4\u7b2c20\u6761\u3067\u306f\u3001\u6587\u66f8\u306e\u4f5c\u6210\u30fb\u6539\u8a02\u6642\u306e\u627f\u8a8d\u3001\u914d\u4ed8\u3001\u4fdd\u7ba1\u306b\u52a0\u3048\u3001\u624b\u9806\u66f8\u7b49\u3078\u306e\u65e5\u4ed8\u306e\u8a18\u8f09\u3068\u6539\u8a02\u5c65\u6b74\u306e\u4fdd\u7ba1\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u4fdd\u7ba1\u671f\u9593\u306f\u3001\u4f5c\u6210\u306e\u65e5\uff08\u624b\u9806\u66f8\u7b49\u306f\u4f7f\u7528\u3057\u306a\u304f\u306a\u3063\u305f\u65e5\uff09\u304b\u30895\u5e74\u9593\u3067\u3059\u3002\u305f\u3060\u3057\u3001\u88fd\u54c1\u306e\u6709\u52b9\u671f\u9593\u306b1\u5e74\u3092\u52a0\u3048\u305f\u671f\u9593\u304c5\u5e74\u3088\u308a\u9577\u3044\u5834\u5408\u306f\u3001\u6559\u80b2\u8a13\u7df4\u306b\u4fc2\u308b\u8a18\u9332\u3092\u9664\u304d\u3001\u305d\u306e\u671f\u9593\u3092\u4fdd\u7ba1\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u306e\u57fa\u672c\u306b\u306f\u3001\u300c\u3084\u308b\u3079\u304d\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9a\u3081\u3001\u5b9a\u3081\u305f\u3068\u304a\u308a\u306b\u5b9f\u884c\u3057\u3001\u5b9f\u884c\u3057\u305f\u3053\u3068\u3092\u8a18\u9332\u306b\u6b8b\u3059\u300d\u3068\u3044\u3046\u8003\u3048\u65b9\u304c\u3042\u308a\u307e\u3059\u3002\u624b\u9806\u304c\u6587\u66f8\u3067\u6c7a\u307e\u3063\u3066\u3044\u306a\u3051\u308c\u3070\u4f5c\u696d\u306e\u6b63\u3057\u3055\u3092\u5224\u65ad\u3059\u308b\u57fa\u6e96\u304c\u306a\u304f\u3001\u8a18\u9332\u304c\u306a\u3051\u308c\u3070\u6b63\u3057\u304f\u4f5c\u696d\u3057\u305f\u3053\u3068\u3092\u5f8c\u304b\u3089\u793a\u305b\u307e\u305b\u3093\u3002\u6587\u66f8\u7ba1\u7406\u306b\u4e0d\u5099\u304c\u3042\u308b\u3068\u3001\u88fd\u9020\u306e\u518d\u73fe\u6027\u3084\u51fa\u8377\u5224\u5b9a\u306e\u6839\u62e0\u3092\u8aac\u660e\u3067\u304d\u305a\u3001GMP\u9069\u5408\u6027\u8abf\u67fb\u3084\u6d77\u5916\u5f53\u5c40\u306e\u67fb\u5bdf\u3067\u6307\u6458\u3092\u53d7\u3051\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-1\">GMP\u306b\u304a\u3051\u308b\u6587\u66f8\u7ba1\u7406\u306e\u5f79\u5272<\/h3>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u306f\u3001\u4e00\u822c\u306bGMP\u306e\u4e09\u539f\u5247\u3068\u3055\u308c\u308b\u300c\u4eba\u70ba\u7684\u306a\u8aa4\u308a\u3092\u6700\u5c0f\u9650\u306b\u3059\u308b\u3053\u3068\u300d\u300c\u88fd\u54c1\u306e\u6c5a\u67d3\u53ca\u3073\u54c1\u8cea\u4f4e\u4e0b\u3092\u9632\u6b62\u3059\u308b\u3053\u3068\u300d\u300c\u9ad8\u3044\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u3092\u8a2d\u8a08\u3059\u308b\u3053\u3068\u300d\u3092\u3001<mark>\u624b\u9806\u3068\u8a18\u9332\u306e\u4e21\u9762\u304b\u3089\u652f\u3048\u308b\u4ed5\u7d44\u307f<\/mark>\u3067\u3059\u3002<\/p>\n\n\n\n<p>GMP\u7701\u4ee4\u7b2c8\u6761\u3067\u306f\u3001\u88fd\u9020\u6240\u3054\u3068\u306b\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3057\u3001\u9069\u5207\u306b\u5099\u3048\u7f6e\u304f\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u7b2c10\u6761\u3067\u306f\u3001\u88fd\u9020\u6307\u56f3\u66f8\u306b\u57fa\u3065\u3044\u3066\u88fd\u9020\u4f5c\u696d\u3092\u884c\u3044\u3001\u88fd\u9020\u306b\u95a2\u3059\u308b\u8a18\u9332\u3092\u30ed\u30c3\u30c8\u3054\u3068\u306b\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b\u3053\u3068\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u624b\u9806\u66f8\u3068\u6559\u80b2\u8a13\u7df4\u306b\u3088\u3063\u3066\u4f5c\u696d\u8005\u3054\u3068\u306e\u5224\u65ad\u306e\u3070\u3089\u3064\u304d\u3092\u6291\u3048\u308c\u3070\u3001\u4eba\u70ba\u7684\u306a\u8aa4\u308a\u3092\u69cb\u9020\u7684\u306b\u6e1b\u3089\u3059\u3053\u3068\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u4f5c\u696d\u3068\u540c\u6642\u306b\u6b63\u78ba\u306a\u8a18\u9332\u3092\u6b8b\u3057\u3066\u304a\u3051\u3070\u3001\u54c1\u8cea\u306e\u7570\u5e38\u304c\u8d77\u304d\u305f\u3068\u304d\u306b\u3001\u3069\u306e\u5de5\u7a0b\u3067\u4f55\u304c\u8d77\u304d\u305f\u304b\u3092\u3055\u304b\u306e\u307c\u3063\u3066\u8abf\u67fb\u53ef\u80fd\u3067\u3059\u3002\u3055\u3089\u306b\u3001\u6587\u66f8\u3068\u8a18\u9332\u3092\u4f53\u7cfb\u7684\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u3067\u3001\u54c1\u8cea\u4fdd\u8a3c\u306e\u4ed5\u7d44\u307f\u304c\u8a2d\u8a08\u3069\u304a\u308a\u306b\u52d5\u3044\u3066\u3044\u308b\u3053\u3068\u3092\u3001\u7b2c\u4e09\u8005\u306b\u5ba2\u89b3\u7684\u306b\u793a\u305b\u307e\u3059\u3002\u6587\u66f8\u7ba1\u7406\u306f\u66f8\u985e\u6574\u7406\u3067\u306f\u306a\u304f\u3001<mark>\u54c1\u8cea\u3092\u4f5c\u308a\u8fbc\u307f\u3001\u305d\u306e\u8a3c\u62e0\u3092\u6b8b\u3059\u305f\u3081\u306e\u4ed5\u7d44\u307f<\/mark>\u3068\u3044\u3048\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pref.shizuoka.jp\/kenkofukushi\/eiseiyakuji\/yakuji\/1003159\/1025365.html\" rel=\"nofollow\">\u9759\u5ca1\u770c\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff08GMP\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-2\">\u6587\u66f8\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3068\u306f<\/h3>\n\n\n\n<p>\u6587\u66f8\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3068\u306f\u3001<mark>GMP\u6587\u66f8\u304c\u8d77\u6848\u3055\u308c\u3066\u304b\u3089\u5ec3\u68c4\u3055\u308c\u308b\u307e\u3067\u306e\u4e00\u9023\u306e\u6bb5\u968e<\/mark>\u3092\u6307\u3057\u307e\u3059\u3002GMP\u6587\u66f8\u7ba1\u7406\u3067\u306f\u3001\u5404\u6bb5\u968e\u3067\u7ba1\u7406\u65b9\u6cd5\u3092\u6c7a\u3081\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e3b\u306a\u6bb5\u968e\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8d77\u6848\u30fb\u4f5c\u6210\uff1a\u6587\u66f8\u306e\u8349\u6848\u3092\u4f5c\u6210\u3057\u3001\u5fc5\u8981\u306a\u5185\u5bb9\u3092\u76db\u308a\u8fbc\u3080<\/li>\n\n\n\n<li>\u30ec\u30d3\u30e5\u30fc\u30fb\u627f\u8a8d\uff1a\u6a29\u9650\u3092\u6301\u3064\u8cac\u4efb\u8005\u304c\u5185\u5bb9\u3092\u78ba\u8a8d\u3057\u3001\u6b63\u5f0f\u306b\u627f\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u767a\u884c\u30fb\u914d\u4ed8\uff1a\u627f\u8a8d\u6e08\u307f\u306e\u6587\u66f8\u3092\u5fc5\u8981\u306a\u90e8\u9580\u30fb\u62c5\u5f53\u8005\u306b\u914d\u4ed8\u3059\u308b<\/li>\n\n\n\n<li>\u6559\u80b2\u8a13\u7df4\uff1a\u6587\u66f8\u306e\u5185\u5bb9\u306b\u3064\u3044\u3066\u95a2\u4fc2\u8005\u306b\u6559\u80b2\u3092\u884c\u3044\u3001\u8a18\u9332\u3092\u6b8b\u3059<\/li>\n\n\n\n<li>\u904b\u7528\u30fb\u7ba1\u7406\uff1a\u6709\u52b9\u306a\u7248\u3060\u3051\u304c\u4f7f\u308f\u308c\u308b\u3088\u3046\u3001\u95b2\u89a7\u3084\u5229\u7528\u3092\u7ba1\u7406\u3059\u308b<\/li>\n\n\n\n<li>\u6539\u8a02\uff1a\u898f\u683c\u3084\u624b\u9806\u306a\u3069\u306e\u5909\u66f4\u304c\u5fc5\u8981\u306a\u5834\u5408\u3001\u5909\u66f4\u7ba1\u7406\u306e\u624b\u7d9a\u304d\u3092\u7d4c\u3066\u95a2\u9023\u3059\u308b\u6587\u66f8\u3092\u6539\u8a02\u3057\u3001\u65b0\u7248\u3092\u767a\u884c\u3057\u3001\u6539\u8a02\u5c65\u6b74\u3092\u4fdd\u7ba1\u3059\u308b<\/li>\n\n\n\n<li>\u4f7f\u7528\u505c\u6b62\u30fb\u5ec3\u68c4\uff1a\u4f7f\u308f\u306a\u304f\u306a\u3063\u305f\u6587\u66f8\u3092\u56de\u53ce\u3057\u3001\u65e7\u7248\u306e\u8aa4\u4f7f\u7528\u3092\u9632\u304e\u3001\u5b9a\u3081\u3089\u308c\u305f\u671f\u9593\u306e\u4fdd\u7ba1\u5f8c\u306b\u5ec3\u68c4\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u5404\u6bb5\u968e\u3067\u306f\u3001\u8ab0\u304c\u3044\u3064\u4f55\u3092\u884c\u3063\u305f\u304b\u3092\u627f\u8a8d\u8a18\u9332\u3084\u6539\u8a02\u5c65\u6b74\u3068\u3057\u3066\u6b8b\u3057\u3001\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u76e3\u67fb\u8a3c\u8de1\u3068\u3057\u3066\u6b8b\u3057\u307e\u3059\u3002GMP\u7701\u4ee4\u7b2c20\u6761\u306f\u3001\u6539\u8a02\u6642\u306e\u65e5\u4ed8\u306e\u8a18\u8f09\u3084\u6539\u8a02\u5c65\u6b74\u306e\u4fdd\u7ba1\u3001\u4f7f\u7528\u3057\u306a\u304f\u306a\u3063\u305f\u65e5\u3092\u8d77\u70b9\u3068\u3059\u308b\u4fdd\u7ba1\u671f\u9593\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u6587\u66f8\u306e\u5185\u5bb9\u304c\u512a\u308c\u3066\u3044\u3066\u3082\u3001<mark>\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u305f\u7ba1\u7406\u304c\u9069\u5207\u3067\u306a\u3051\u308c\u3070\u3001GMP\u4e0a\u306e\u9069\u5408\u6027\u3092\u793a\u305b\u307e\u305b\u3093<\/mark>\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00ta8216&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u9577\u901a\u77e5\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\u306e\u5229\u7528\u306b\u3064\u3044\u3066\u300d\uff08\u5e73\u621017\u5e744\u67081\u65e5\u4ed8\u3051\u85ac\u98df\u767a\u7b2c0401022\u53f7\uff09<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-3\">GMP\u6587\u66f8\u306e\u7a2e\u985e\u3068\u7ba1\u7406\u5bfe\u8c61<\/h2>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u306e\u5bfe\u8c61\u306f\u3001<mark>\u624b\u9806\u66f8\u3084\u88fd\u54c1\u6a19\u6e96\u66f8\u3001\u88fd\u9020\u6307\u56f3\u66f8\u3001\u5404\u7a2e\u8a18\u9332<\/mark>\u306a\u3069\u591a\u5c90\u306b\u308f\u305f\u308a\u307e\u3059\u3002\u4ee3\u8868\u7684\u306aGMP\u6587\u66f8\u306f\u4ee5\u4e0b\u306e4\u3064\u306b\u6574\u7406\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09<\/li>\n\n\n\n<li>\u88fd\u54c1\u6a19\u6e96\u66f8\u30fb\u88fd\u9020\u6307\u56f3\u66f8<\/li>\n\n\n\n<li>\u88fd\u9020\u8a18\u9332\u30fb\u8a66\u9a13\u8a18\u9332<\/li>\n\n\n\n<li>\u6559\u80b2\u8a18\u9332\u30fb\u5909\u66f4\u7ba1\u7406\u6587\u66f8<\/li>\n<\/ul>\n\n\n\n<p>\u3069\u306e\u6587\u66f8\u3067\u3082\u3001\u6587\u66f8\u756a\u53f7\u3084\u7248\u756a\u53f7\u3001\u767a\u52b9\u65e5\u3001\u4f5c\u6210\u8005\u3001\u627f\u8a8d\u8005\u306a\u3069\u306e\u7ba1\u7406\u9805\u76ee\u3092\u6c7a\u3081\u3066\u304a\u304f\u3053\u3068\u3067\u3001\u3069\u306e\u7248\u304c\u3044\u3064\u304b\u3089\u6709\u52b9\u306a\u306e\u304b\u3092\u8ffd\u8de1\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-4\">SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09<\/h3>\n\n\n\n<p>SOP\uff08Standard Operating Procedure\uff1a\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u306f\u3001<mark>\u696d\u52d9\u3092\u300c\u8ab0\u304c\u30fb\u4f55\u3092\u30fb\u3069\u306e\u3088\u3046\u306b\u300d\u884c\u3046\u304b\u3092\u6a19\u6e96\u5316\u3057\u305f\u6587\u66f8<\/mark>\u3067\u3059\u3002GMP\u7701\u4ee4\u4e0a\u306f\u300c\u624b\u9806\u66f8\u300d\u3068\u547c\u3070\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u7701\u4ee4\u7b2c8\u6761\u306f\u3001\u885b\u751f\u7ba1\u7406\u3084\u88fd\u9020\u5de5\u7a0b\u306e\u7ba1\u7406\u3001\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u4f5c\u6210\u30fb\u6539\u8a02\u30fb\u4fdd\u7ba1\u306a\u3069\u306b\u3064\u3044\u3066\u300117\u9805\u76ee\u306e\u624b\u9806\u66f8\u306e\u4f5c\u6210\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u306e21 CFR 211.100\u3082\u3001\u88fd\u9020\u30fb\u5de5\u7a0b\u7ba1\u7406\u306e\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3057\u3001\u305d\u306e\u624b\u9806\u306b\u5f93\u3063\u3066\u4f5c\u696d\u3057\u3001\u5b9f\u65bd\u6642\u306b\u8a18\u9332\u3059\u308b\u3053\u3068\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002SOP\u304c\u6574\u5099\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u62c5\u5f53\u8005\u306b\u3088\u3063\u3066\u624b\u9806\u304c\u5909\u308f\u308a\u3001\u54c1\u8cea\u306b\u3070\u3089\u3064\u304d\u304c\u751f\u3058\u307e\u3059\u3002\u307e\u305f\u3001SOP\u306e\u5185\u5bb9\u3068\u73fe\u5834\u306e\u5b9f\u4f5c\u696d\u304c\u305a\u308c\u3066\u3044\u308c\u3070\u3001\u8abf\u67fb\u3084\u67fb\u5bdf\u3067\u6307\u6458\u3092\u53d7\u3051\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>SOP\u3068\u4e00\u822c\u7684\u306a\u30de\u30cb\u30e5\u30a2\u30eb\u306e\u9055\u3044\u306f\u3001SOP\u304cGMP\u306b\u57fa\u3065\u304f\u898f\u5236\u6587\u66f8\u3068\u3057\u3066\u3001\u627f\u8a8d\u3084\u7248\u7ba1\u7406\u3001\u6559\u80b2\u8a18\u9332\u3068\u306e\u9023\u52d5\u306e\u3082\u3068\u3067\u7ba1\u7406\u3055\u308c\u308b\u70b9\u3067\u3059\u3002<mark>\u73fe\u5834\u306e\u4f5c\u696d\u3068SOP\u306e\u8a18\u8f09\u3092\u5e38\u306b\u4e00\u81f4\u3055\u305b\u308b\u3053\u3068<\/mark>\u304c\u3001SOP\u7ba1\u7406\u306e\u5b9f\u52d9\u4e0a\u306e\u8981\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-211\/subpart-F\/section-211.100\" rel=\"nofollow\">eCFR\u300c21 CFR 211.100 \u2013 Written procedures; deviations\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-5\">\u88fd\u54c1\u6a19\u6e96\u66f8\u30fb\u88fd\u9020\u6307\u56f3\u66f8<\/h3>\n\n\n\n<p>\u88fd\u54c1\u6a19\u6e96\u66f8\u306f<mark>\u88fd\u54c1\u3054\u3068\u30fb\u88fd\u9020\u6240\u3054\u3068\u306b\u88fd\u9020\u306e\u57fa\u6e96\u3092\u307e\u3068\u3081\u305f\u57fa\u672c\u6587\u66f8<\/mark>\u3067\u3001\u88fd\u9020\u6307\u56f3\u66f8\u306f\u305d\u306e\u57fa\u6e96\u3092\u3082\u3068\u306b\u5b9f\u969b\u306e\u88fd\u9020\u4f5c\u696d\u3092\u6307\u793a\u3059\u308b\u6587\u66f8\u3067\u3059\u3002<\/p>\n\n\n\n<p>GMP\u7701\u4ee4\u7b2c7\u6761\u3067\u306f\u3001\u88fd\u54c1\u6a19\u6e96\u66f8\uff08\u7701\u4ee4\u4e0a\u306e\u540d\u79f0\u306f\u300c\u533b\u85ac\u54c1\u88fd\u54c1\u6a19\u6e96\u66f8\u300d\uff09\u3092\u3001\u4e2d\u9593\u88fd\u54c1\u3092\u9664\u304f\u88fd\u54c1\u3054\u3068\u306b\u3001\u88fd\u9020\u6240\u3054\u3068\u306b\u4f5c\u6210\u3057\u3001\u54c1\u8cea\u90e8\u9580\u306e\u627f\u8a8d\u3092\u53d7\u3051\u305f\u3046\u3048\u3067\u3001\u88fd\u9020\u6240\u306b\u5099\u3048\u7f6e\u304f\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u8a18\u8f09\u4e8b\u9805\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u627f\u8a8d\u4e8b\u9805\u306e\u3046\u3061\u3001\u5f53\u8a72\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u88fd\u9020\u65b9\u6cd5\u3001\u898f\u683c\u53ca\u3073\u8a66\u9a13\u65b9\u6cd5\u306a\u3069\u306e\u4e8b\u9805<\/li>\n\n\n\n<li>\u54c1\u8cea\u306b\u95a2\u3059\u308b\u85ac\u4e8b\u95a2\u4fc2\u6cd5\u4ee4\u306e\u4e8b\u9805<\/li>\n\n\n\n<li>\u88fd\u9020\u624b\u9806<\/li>\n\n\n\n<li>\u305d\u306e\u4ed6\u6240\u8981\u306e\u4e8b\u9805<\/li>\n<\/ul>\n\n\n\n<p>\u88fd\u9020\u6307\u56f3\u66f8\u306f\u3001\u7b2c10\u6761\u306b\u57fa\u3065\u3044\u3066\u88fd\u9020\u90e8\u9580\u304c\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3057\u3001\u88fd\u9020\u90e8\u9580\u306e\u8cac\u4efb\u8005\u304c\u88fd\u9020\u6307\u56f3\u66f8\u306b\u57fa\u3065\u3044\u3066\u4f5c\u696d\u8005\u306b\u4f5c\u696d\u3092\u6307\u793a\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u539f\u5247\u3068\u3057\u3066\u30011\u3064\u306e\u88fd\u9020\u6307\u56f3\u66f8\u3067\u88fd\u9020\u3055\u308c\u305f\u88fd\u54c1\u306e\u4e00\u7fa4\u304c1\u30ed\u30c3\u30c8\u306b\u306a\u308b\u3088\u3046\u88fd\u9020\u4f5c\u696d\u3092\u884c\u3044\u307e\u3059\u3002\u88fd\u54c1\u6a19\u6e96\u66f8\u3092\u6539\u8a02\u3057\u305f\u306e\u306b\u88fd\u9020\u6307\u56f3\u66f8\u306e\u6539\u8a02\u304c\u6f0f\u308c\u308b\u3068\u3001\u65e7\u7248\u306e\u6307\u793a\u3067\u88fd\u9020\u3057\u3066\u3057\u307e\u3046\u304a\u305d\u308c\u304c\u3042\u308b\u305f\u3081\u3001<mark>\u88fd\u54c1\u6a19\u6e96\u66f8\u3068\u88fd\u9020\u6307\u56f3\u66f8\u306e\u9023\u52d5\u7ba1\u7406<\/mark>\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-6\">\u88fd\u9020\u8a18\u9332\u30fb\u8a66\u9a13\u8a18\u9332<\/h3>\n\n\n\n<p>\u88fd\u9020\u8a18\u9332\u306f\u88fd\u9020\u6307\u56f3\u66f8\u306b\u57fa\u3065\u3044\u3066\u5b9f\u969b\u306b\u884c\u3063\u305f\u4f5c\u696d\u306e\u5185\u5bb9\u3068\u7d50\u679c\u3092\u3001\u8a66\u9a13\u8a18\u9332\u306f\u8a66\u9a13\u691c\u67fb\u3067\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u3068\u5224\u5b9a\u7d50\u679c\u3092\u6b8b\u3059\u6587\u66f8\u3067\u3059\u3002\u3069\u3061\u3089\u3082<mark>\u4f5c\u696d\u3068\u540c\u6642\u306b\u3001\u6b63\u78ba\u304b\u3064\u6b20\u843d\u306a\u304f\u8a18\u9332\u3059\u308b\u3053\u3068<\/mark>\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u9020\u8a18\u9332\u306b\u306f\u3001\u88fd\u9020\u5de5\u7a0b\u7b49\u306b\u5fdc\u3058\u3066\u3001\u539f\u6599\u306e\u79e4\u91cf\u5024\u3084\u6e29\u5ea6\u30fb\u6642\u9593\u306a\u3069\u306e\u91cd\u8981\u306a\u5de5\u7a0b\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u7d50\u679c\u3001\u4f5c\u696d\u8005\u306e\u6c0f\u540d\u307e\u305f\u306f\u30a4\u30cb\u30b7\u30e3\u30eb\u3001\u4f5c\u696d\u65e5\u6642\u3001\u5de5\u7a0b\u5185\u691c\u67fb\u306e\u7d50\u679c\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002GMP\u7701\u4ee4\u7b2c10\u6761\u306f\u3001\u88fd\u9020\u306b\u95a2\u3059\u308b\u8a18\u9332\u3092\u30ed\u30c3\u30c8\u3054\u3068\u306b\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b\u3088\u3046\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u8a02\u6b63\u3059\u308b\u3068\u304d\u306f\u3001\u5143\u306e\u8a18\u8f09\u304c\u8aad\u3081\u308b\u3088\u30461\u672c\u7dda\u3092\u5f15\u3044\u3066\u8a02\u6b63\u3057\u3001\u8a02\u6b63\u8005\u306e\u7f72\u540d\u307e\u305f\u306f\u30a4\u30cb\u30b7\u30e3\u30eb\u3068\u8a02\u6b63\u65e5\u3092\u6b8b\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u8a02\u6b63\u7406\u7531\u3082\u8a18\u9332\u3059\u308b\u306e\u304c\u57fa\u672c\u3067\u3059\u3002\u8a18\u9332\u3092\u5f8c\u304b\u3089\u307e\u3068\u3081\u3066\u4f5c\u6210\u3057\u305f\u308a\u3001\u8a02\u6b63\u306e\u7d4c\u7def\u304c\u308f\u304b\u3089\u306a\u304b\u3063\u305f\u308a\u3059\u308b\u3068\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u4e0a\u306e\u4e0d\u5099\u306b\u3042\u305f\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u539a\u751f\u52b4\u50cd\u7701\u306eGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001\u6e2c\u5b9a\u6a5f\u5668\u306e\u51fa\u529b\u30c7\u30fc\u30bf\u3084\u30c1\u30e3\u30fc\u30c8\u3001\u8a08\u7b97\u30fb\u63db\u7b97\u306e\u904e\u7a0b\u306e\u8a18\u9332\u306a\u3069\u3092\u8a66\u9a13\u691c\u67fb\u306e\u751f\u30c7\u30fc\u30bf\u306e\u4f8b\u306b\u6319\u3052\u3001<mark>\u751f\u30c7\u30fc\u30bf\u3092\u5f97\u3089\u308c\u305f\u3068\u304d\u306e\u72b6\u614b\u3067\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u4fdd\u5b58\u3059\u308b\u3053\u3068<\/mark>\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00ta7831&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u5c40\u9577\u901a\u77e5\u300c\u539f\u85acGMP\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d\uff08\u5e73\u621013\u5e7411\u67082\u65e5\u4ed8\u3051\u533b\u85ac\u767a\u7b2c1200\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cGood Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\uff08PI 041-1\uff09\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-7\">\u6559\u80b2\u8a18\u9332\u30fb\u5909\u66f4\u7ba1\u7406\u6587\u66f8<\/h3>\n\n\n\n<p>\u6559\u80b2\u8a18\u9332\u3068\u5909\u66f4\u7ba1\u7406\u6587\u66f8\u306f\u3001<mark>\u4eba\u3068\u5909\u66f4\u304c\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u8a18\u9332<\/mark>\u3067\u3059\u3002GMP\u7701\u4ee4\u7b2c19\u6761\u306f\u3001\u6559\u80b2\u8a13\u7df4\u306b\u3064\u3044\u3066\u6b21\u306e\u696d\u52d9\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u9020\u30fb\u54c1\u8cea\u95a2\u9023\u696d\u52d9\u306b\u5f93\u4e8b\u3059\u308b\u8077\u54e1\u3078\u306e\u6559\u80b2\u8a13\u7df4\u3092\u8a08\u753b\u7684\u306b\u884c\u3046<\/li>\n\n\n\n<li>\u5b9f\u65bd\u72b6\u6cc1\u3092\u54c1\u8cea\u4fdd\u8a3c\u306b\u4fc2\u308b\u7d44\u7e54\u3068\u88fd\u9020\u7ba1\u7406\u8005\u3078\u6587\u66f8\u3067\u5831\u544a\u3059\u308b<\/li>\n\n\n\n<li>\u6559\u80b2\u8a13\u7df4\u306e\u5b9f\u65bd\u8a18\u9332\u3092\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b<\/li>\n\n\n\n<li>\u6559\u80b2\u8a13\u7df4\u306e\u5b9f\u52b9\u6027\u3092\u5b9a\u671f\u7684\u306b\u8a55\u4fa1\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>SOP\u3092\u65b0\u898f\u306b\u767a\u884c\u3057\u305f\u3068\u304d\u3084\u6539\u8a02\u3057\u305f\u3068\u304d\u306b\u6559\u80b2\u8a18\u9332\u304c\u306a\u3051\u308c\u3070\u3001\u62c5\u5f53\u8005\u304c\u6700\u65b0\u306e\u624b\u9806\u3092\u7406\u89e3\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u305b\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u5909\u66f4\u7ba1\u7406\u6587\u66f8\u306f\u3001\u88fd\u9020\u65b9\u6cd5\u3084\u8a2d\u5099\u3001\u539f\u6599\u306e\u4f9b\u7d66\u8005\u306a\u3069\u3092\u5909\u66f4\u3059\u308b\u969b\u306e\u8a55\u4fa1\u30fb\u627f\u8a8d\u30fb\u5b9f\u65bd\u306a\u3069\u306e\u8a18\u9332\u3067\u3001\u54c1\u8cea\u3078\u306e\u5f71\u97ff\u8a55\u4fa1\u3092\u4f34\u3044\u3001\u5909\u66f4\u306e\u59a5\u5f53\u6027\u3092\u6587\u66f8\u3067\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u9038\u8131\u304c\u8d77\u304d\u305f\u969b\u306e\u5185\u5bb9\u3068\u5f71\u97ff\u8abf\u67fb\u306e\u7d50\u679c\u3001\u54c1\u8cea\u4fdd\u8a3c\u306b\u4fc2\u308b\u7d44\u7e54\u3078\u306e\u6587\u66f8\u306b\u3088\u308b\u5831\u544a\u3068\u78ba\u8a8d\u306e\u8a18\u9332\u3082\u91cd\u8981\u306a\u7ba1\u7406\u5bfe\u8c61\u3067\u3059\u3002\u91cd\u5927\u306a\u9038\u8131\u3067\u306f\u3001\u3053\u308c\u3089\u306b\u52a0\u3048\u3066\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u3078\u306e\u9023\u7d61\u3084\u539f\u56e0\u7a76\u660e\u3001<a href=\"https:\/\/japan-ai.co.jp\/media\/5592\/\">\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09<\/a>\u3092\u884c\u3044\u3001\u305d\u306e\u5185\u5bb9\u3082\u54c1\u8cea\u4fdd\u8a3c\u306b\u4fc2\u308b\u7d44\u7e54\u306b\u6587\u66f8\u3067\u5831\u544a\u3057\u3001\u78ba\u8a8d\u3092\u53d7\u3051\u307e\u3059\u3002\u7b2c8\u6761\u306f\u3001\u5909\u66f4\u306e\u7ba1\u7406\uff08\u7b2c14\u6761\uff09\u3068\u9038\u8131\u306e\u7ba1\u7406\uff08\u7b2c15\u6761\uff09\u306b\u3064\u3044\u3066\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3088\u3046\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-8\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3068ALCOA\u539f\u5247<\/h2>\n\n\n\n<p>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3068\u306f\u3001PIC\/S\uff08Pharmaceutical Inspection Co-operation Scheme\uff1a\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u540c\u30b9\u30ad\u30fc\u30e0\uff09\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u308b\u3068\u3001<mark>\u30c7\u30fc\u30bf\u304c\u5b8c\u5168\u3067\u4e00\u8cab\u6027\u304c\u3042\u308a\u3001\u6b63\u78ba\u3067\u4fe1\u983c\u3067\u304d\u308b\u72b6\u614b\u304c\u3001\u30c7\u30fc\u30bf\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u5ea6\u5408\u3044<\/mark>\u3092\u6307\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>FDA\u306f2018\u5e7412\u6708\u306b\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308bQ&amp;A\u5f62\u5f0f\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u8fd1\u5e74\u306e\u67fb\u5bdf\u3067\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308bCGMP\uff08current Good Manufacturing Practice\uff1a\u7c73\u56fd\u306e\u73fe\u884cGMP\uff09\u9055\u53cd\u304c\u898b\u3064\u304b\u308b\u4f8b\u304c\u5897\u3048\u305f\u3053\u3068\u3092\u53d7\u3051\u3066\u4f5c\u6210\u3055\u308c\u305f\u3082\u306e\u3067\u3001\u305d\u3046\u3057\u305f\u9055\u53cd\u304c\u8b66\u544a\u66f8\uff08Warning Letter\uff09\u3084\u8f38\u5165\u8b66\u544a\uff08Import Alert\uff09\u3001\u540c\u610f\u5224\u6c7a\uff08Consent Decree\uff09\u306a\u3069\u306e\u898f\u5236\u63aa\u7f6e\u306b\u3064\u306a\u304c\u3063\u3066\u304d\u305f\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u56fd\u5185\u3067\u3082\u3001GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u304c\u3001GMP\u7701\u4ee4\u7b2c8\u6761\u7b2c2\u9805\u3092\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\u306b\u95a2\u3059\u308b\u898f\u5b9a\u3068\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ALCOA\u539f\u5247\u306e5\u3064\u306e\u8981\u7d20<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u7ba1\u7406<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u8105\u304b\u3059\u8981\u56e0<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cGood Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\uff08PI 041-1\uff09\u300d<\/a><br>\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<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-9\">ALCOA\u539f\u5247\u306e5\u3064\u306e\u8981\u7d20<\/h3>\n\n\n\n<p>ALCOA\u539f\u5247\u306f\u3001<mark>\u8a18\u9332\u304c\u6e80\u305f\u3059\u3079\u304d5\u3064\u306e\u8981\u4ef6\u306e\u982d\u6587\u5b57\u3092\u3068\u3063\u305f\u67a0\u7d44\u307f<\/mark>\u3067\u3059\u3002FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3082\u3001\u5b8c\u5168\u3067\u4e00\u8cab\u6027\u304c\u3042\u308a\u6b63\u78ba\u306a\u30c7\u30fc\u30bf\u306fALCOA\u3067\u3042\u308b\u3079\u304d\u3060\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n<div id=\"id-3b1cc06c-4072-48a8-a6e0-86122ad38e73\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u8981\u7d20<\/th><th>\u82f1\u8a9e<\/th><th>\u610f\u5473<\/th><th>\u5177\u4f53\u4f8b<\/th><\/tr><tr><td>A<\/td><td>Attributable\uff08\u5e30\u5c5e\u6027\uff09<\/td><td>\u4f5c\u6210\u8005\u30fb\u8a18\u9332\u8005\u30fb\u78ba\u8a8d\u8005\u30fb\u627f\u8a8d\u8005\u306a\u3069\u3092\u7279\u5b9a\u3067\u304d\u308b\u3053\u3068<\/td><td>\u8a18\u9332\u3078\u306e\u7f72\u540d\u3068\u65e5\u4ed8\u3001\u96fb\u5b50\u8a18\u9332\u306e\u500b\u4eba\u5225\u30e6\u30fc\u30b6\u30fcID<\/td><\/tr><tr><td>L<\/td><td>Legible\uff08\u5224\u8aad\u6027\uff09<\/td><td>\u8aad\u3081\u3066\u3001\u7406\u89e3\u3067\u304d\u308b\u3053\u3068<\/td><td>\u6d88\u3048\u306a\u3044\u7b46\u8a18\u5177\u306e\u4f7f\u7528\u3001\u8a02\u6b63\u6642\u3082\u5143\u306e\u8a18\u8f09\u304c\u8aad\u3081\u308b\u3053\u3068<\/td><\/tr><tr><td>C<\/td><td>Contemporaneous\uff08\u540c\u6642\u6027\uff09<\/td><td>\u5b9f\u65bd\u3057\u305f\u3068\u304d\u306b\u5373\u6642\u306b\u8a18\u9332\u3055\u308c\u308b\u3053\u3068<\/td><td>\u4f5c\u696d\u4e2d\u306e\u8a18\u9332\u3001\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u306e\u81ea\u52d5\u4ed8\u4e0e<\/td><\/tr><tr><td>O<\/td><td>Original\uff08\u539f\u672c\u6027\uff09<\/td><td>\u6700\u521d\u306e\u72b6\u614b\u3067\u3042\u308b\u3053\u3068<\/td><td>\u539f\u672c\u306e\u4fdd\u7ba1\u3001\u771f\u6b63\u30b3\u30d4\u30fc\u306e\u5b9a\u7fa9\u3068\u7ba1\u7406\u624b\u9806\u306e\u6574\u5099<\/td><\/tr><tr><td>A<\/td><td>Accurate\uff08\u6b63\u78ba\u6027\uff09<\/td><td>\u8aa4\u308a\u304c\u306a\u3044\u3053\u3068<\/td><td>\u6821\u6b63\u6e08\u307f\u6a5f\u5668\u306e\u4f7f\u7528\u3001\u8a08\u7b97\u30fb\u8ee2\u8a18\u306e\u30c0\u30d6\u30eb\u30c1\u30a7\u30c3\u30af<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>ALCOA\u3092\u62e1\u5f35\u3057\u305fALCOA+\u3067\u306f\u3001Complete\uff08\u5b8c\u5168\u6027\uff09\u3001Consistent\uff08\u4e00\u8cab\u6027\uff09\u3001Enduring\uff08\u8010\u4e45\uff09\u3001Available\uff08\u5165\u624b\u53ef\u80fd\u6027\uff09\u306e4\u8981\u7d20\u304c\u52a0\u308f\u308a\u307e\u3059\u3002GMP\u4e8b\u4f8b\u96c6\u306fALCOA+\u306e9\u8981\u4ef6\u3092\u793a\u3057\u3066\u304a\u308a\u3001<mark>\u7d19\u3068\u96fb\u5b50\u306e\u3069\u3061\u3089\u306e\u8a18\u9332\u306b\u3082\u9069\u7528\u3055\u308c\u308b<\/mark>\u3068\u660e\u8a18\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><br>\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<\/a><br>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cGood Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\uff08PI 041-1\uff09\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00ta7831&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u5c40\u9577\u901a\u77e5\u300c\u539f\u85acGMP\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d\uff08\u5e73\u621013\u5e7411\u67082\u65e5\u4ed8\u3051\u533b\u85ac\u767a\u7b2c1200\u53f7\uff09<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-10\">\u30c7\u30fc\u30bf\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u7ba1\u7406<\/h3>\n\n\n\n<p>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306f\u3001\u30c7\u30fc\u30bf\u304c\u751f\u307e\u308c\u305f\u77ac\u9593\u3060\u3051\u3067\u306a\u304f\u3001<mark>\u4fdd\u5b58\u671f\u9593\u304c\u7d42\u308f\u308b\u307e\u3067\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u3067\u78ba\u4fdd\u3059\u308b\u5fc5\u8981<\/mark>\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001\u30c7\u30fc\u30bf\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u3001\u30c7\u30fc\u30bf\u306e\u63a1\u53d6\u3084\u8a18\u9332\u3001\u7167\u67fb\u3001\u627f\u8a8d\u306b\u59cb\u307e\u308a\u3001\u51fa\u8377\u5224\u5b9a\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5224\u5b9a\u30fb\u9038\u8131\u8abf\u67fb\u3068\u3044\u3063\u305f\u610f\u601d\u6c7a\u5b9a\u306e\u6839\u62e0\u3068\u3057\u3066\u306e\u4f7f\u7528\u3001\u4fdd\u5b58\u3001\u5ec3\u68c4\u307e\u3067\u3092\u542b\u3080\u3001\u4fdd\u5b58\u671f\u9593\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u3068\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u7279\u306b\u3001\u30b7\u30b9\u30c6\u30e0\u9593\u306e\u30c7\u30fc\u30bf\u8ee2\u9001\u3084\u5a92\u4f53\u5909\u63db\u306a\u3069\u30c7\u30fc\u30bf\u3092\u79fb\u3059\u5834\u9762\u3067\u306f\u3001\u6b20\u640d\u3084\u6539\u5909\u306e\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u5206\u6790\u88c5\u7f6e\u304b\u3089LIMS\uff08\u30e9\u30dc\u60c5\u5831\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff09\u3078\u30c7\u30fc\u30bf\u3092\u79fb\u3059\u5834\u5408\u306f\u3001\u79fb\u884c\u524d\u5f8c\u3067\u30c7\u30fc\u30bf\u304c\u4e00\u81f4\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001\u305d\u306e\u7d50\u679c\u3092\u8a18\u9332\u306b\u6b8b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u7ba1\u7406\u306b\u304b\u3051\u308b\u624b\u9593\u306f\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u6c7a\u3081\u307e\u3059\u3002GMP\u4e8b\u4f8b\u96c6\u306f\u3001\u76e3\u67fb\u8a3c\u8de1\u6a5f\u80fd\u3084\u30c7\u30fc\u30bf\u306e\u4e0a\u66f8\u304d\u30fb\u6539\u3056\u3093\u3092\u9632\u6b62\u3059\u308b\u6a5f\u80fd\u3001\u30e6\u30fc\u30b6\u30fc\u3054\u3068\u306e\u64cd\u4f5c\u6a29\u9650\u306e\u8a2d\u5b9a\u6a5f\u80fd\u3092\u3001ALCOA+\u306e\u8981\u4ef6\u3092\u6e80\u305f\u305b\u308b\u6a5f\u80fd\u306e\u4f8b\u306b\u6319\u3052\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u3046\u3048\u3067\u3001\u3069\u306e\u6a5f\u80fd\u304c\u5fc5\u8981\u304b\u3001\u3069\u306e\u7a0b\u5ea6\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3092\u884c\u3046\u304b\u306f\u3001<mark>\u30c7\u30fc\u30bf\u306e\u88fd\u54c1\u54c1\u8cea\u4e0a\u306e\u91cd\u8981\u6027\u3084\u30b7\u30b9\u30c6\u30e0\u306e\u8907\u96d1\u3055\u3092\u8003\u616e\u3057\u305f\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/mark>\u3067\u5224\u65ad\u3059\u308b\u3088\u3046\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cGood Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\uff08PI 041-1\uff09\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-11\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u8105\u304b\u3059\u8981\u56e0<\/h3>\n\n\n\n<p>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u30ea\u30b9\u30af\u306f\u60aa\u610f\u3042\u308b\u6539\u3056\u3093\u3060\u3051\u3067\u306f\u306a\u304f\u3001<mark>\u65e5\u5e38\u696d\u52d9\u306b\u6f5c\u3080\u624b\u9806\u30fb\u30b7\u30b9\u30c6\u30e0\u30fb\u7d44\u7e54\u6587\u5316\u306e\u554f\u984c<\/mark>\u3082\u5927\u304d\u306a\u8981\u56e0\u3067\u3059\u3002\u8981\u56e0\u3068\u3057\u3066\u3001\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u624b\u9806\u306e\u7406\u89e3\u4e0d\u8db3\uff1aSOP\u3092\u5341\u5206\u306b\u7406\u89e3\u3057\u306a\u3044\u307e\u307e\u4f5c\u696d\u3057\u3001\u4e0d\u9069\u5207\u306a\u8a18\u9332\u3084\u4fee\u6b63\u3092\u3057\u3066\u3057\u307e\u3046<\/li>\n\n\n\n<li>\u30b7\u30b9\u30c6\u30e0\u306e\u554f\u984c\uff1a\u5171\u6709ID\u306e\u4f7f\u7528\u3001\u76e3\u67fb\u8a3c\u8de1\u6a5f\u80fd\u306e\u7121\u52b9\u5316\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u306e\u4e0d\u8db3<\/li>\n\n\n\n<li>\u7d44\u7e54\u6587\u5316\u306e\u554f\u984c\uff1a\u554f\u984c\u3092\u5831\u544a\u3057\u306b\u304f\u3044\u98a8\u571f\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u512a\u5148\u306b\u3088\u308b\u8a18\u9332\u306e\u4e8b\u5f8c\u4f5c\u6210<\/li>\n<\/ul>\n\n\n\n<p>PIC\/S\u306e\u30ac\u30a4\u30c0\u30f3\u30b9PI 041-1\u306f\u3001\u624b\u9806\u66f8\u306e\u3088\u3046\u306a\u76f4\u63a5\u7684\u306a\u7ba1\u7406\u306b\u52a0\u3048\u3066\u3001\u904e\u5ea6\u306a\u30d7\u30ec\u30c3\u30b7\u30e3\u30fc\u3084\u5de5\u7a0b\u80fd\u529b\u3092\u8d85\u3048\u308b\u751f\u7523\u6027\u3078\u306e\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6\u306a\u3069\u3001\u5f93\u696d\u54e1\u306e\u884c\u52d5\u3078\u306e\u9593\u63a5\u7684\u306a\u5f71\u97ff\u3082\u7406\u89e3\u3057\u3066\u5bfe\u51e6\u3059\u3079\u304d\u3060\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u300c\u7d0d\u671f\u306b\u9045\u308c\u3066\u306f\u306a\u3089\u306a\u3044\u300d\u3068\u3044\u3046\u6697\u9ed9\u306e\u5727\u529b\u304c\u3001\u8a18\u9332\u306e\u4e8b\u5f8c\u4f5c\u6210\u3084\u4e0d\u9069\u5207\u306a\u518d\u8a66\u9a13\u3092\u62db\u304f\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002\u5b9a\u671f\u7684\u306a\u6559\u80b2\u3001\u9069\u5207\u306a\u30b7\u30b9\u30c6\u30e0\u8a2d\u8a08\u3001\u554f\u984c\u3092\u5831\u544a\u3057\u3084\u3059\u3044\u54c1\u8cea\u6587\u5316\u3065\u304f\u308a\u3092\u4e26\u884c\u3057\u3066\u9032\u3081\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cGood Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\uff08PI 041-1\uff09\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-12\">\u6539\u6b63GMP\u7701\u4ee4\u3068\u898f\u5236\u8981\u4ef6<\/h2>\n\n\n\n<p>\u6539\u6b63GMP\u7701\u4ee4\uff08\u4ee4\u548c3\u5e74\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c90\u53f7\uff09\u306f2021\uff08\u4ee4\u548c3\uff09\u5e744\u670828\u65e5\u306b\u516c\u5e03\u3055\u308c\u3001\u540c\u5e748\u67081\u65e5\u306b\u65bd\u884c\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u6539\u6b63\u3067<mark>\u624b\u9806\u66f8\u30fb\u8a18\u9332\u306e\u4fe1\u983c\u6027\u78ba\u4fdd\u304c\u660e\u6587\u5316\u3055\u308c\u305f<\/mark>\u3053\u3068\u306f\u3001GMP\u6587\u66f8\u7ba1\u7406\u306b\u76f4\u63a5\u95a2\u308f\u308b\u6539\u6b63\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u305d\u306e\u5f8c\u3082\u3001\u85ac\u6a5f\u6cd5\u6539\u6b63\u306b\u4f34\u3046\u6574\u5099\u306e\u305f\u3081\u306e\u6539\u6b63\uff082026\u5e745\u67081\u65e5\u65bd\u884c\u5206\u30012027\u5e745\u670820\u65e5\u65bd\u884c\u4e88\u5b9a\u5206\uff09\u304c\u7d9a\u3044\u3066\u3044\u307e\u3059\u3002\u6761\u6587\u756a\u53f7\u3084\u540d\u79f0\u3092\u78ba\u8a8d\u3059\u308b\u969b\u306f\u3001e-Gov\u6cd5\u4ee4\u691c\u7d22\u3067\u6700\u65b0\u306e\u6761\u6587\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6539\u6b63GMP\u7701\u4ee4\u306e\u30dd\u30a4\u30f3\u30c8<\/li>\n\n\n\n<li>21 CFR Part 11\u3068ER\/ES\u6307\u91dd<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-13\">\u6539\u6b63GMP\u7701\u4ee4\u306e\u30dd\u30a4\u30f3\u30c8<\/h3>\n\n\n\n<p>\u6539\u6b63GMP\u7701\u4ee4\u306e\u3046\u3061\u3001GMP\u6587\u66f8\u7ba1\u7406\u306b\u7279\u306b\u95a2\u308f\u308b\u306e\u306f<mark>\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001\u6587\u66f8\u30fb\u8a18\u9332\u306e\u4fe1\u983c\u6027\u78ba\u4fdd<\/mark>\u306e3\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff08\u7b2c3\u6761\u306e3\uff09<\/li>\n\n\n\n<li>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08\u7b2c3\u6761\u306e4\uff09<\/li>\n\n\n\n<li>\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u4fe1\u983c\u6027\u78ba\u4fdd\uff08\u7b2c8\u6761\u7b2c2\u9805\u30fb\u7b2c20\u6761\u7b2c2\u9805\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u7b2c3\u6761\u306e3\u3067\u306f\u3001\u54c1\u8cea\u65b9\u91dd\u306e\u6587\u66f8\u5316\u306b\u52a0\u3048\u3001\u54c1\u8cea\u76ee\u6a19\u306e\u6587\u66f8\u5316\u3001\u8077\u54e1\u3078\u306e\u5468\u77e5\u3001\u8cc7\u6e90\u306e\u914d\u5206\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u5b9a\u671f\u7684\u306a\u7167\u67fb\u304c\u6c42\u3081\u3089\u308c\u3001\u5468\u77e5\u3001\u8cc7\u6e90\u306e\u914d\u5206\u3001\u7167\u67fb\u306b\u4fc2\u308b\u8a18\u9332\u306e\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3082\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u7b2c3\u6761\u306e4\u3067\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u6d3b\u7528\u3057\u3066\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u3068\u3001\u305d\u306e\u624b\u7d9a\u304d\u306e\u6587\u66f8\u30fb\u8a18\u9332\u3092\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3044\u305a\u308c\u3082\u3001\u56fd\u969b\u7684\u306b\u306fICH\uff08International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use\uff1a\u533b\u85ac\u54c1\u898f\u5236\u8abf\u548c\u56fd\u969b\u4f1a\u8b70\uff09\u306eQ10\u30fbQ9\u3067\u793a\u3055\u308c\u3066\u3044\u308b\u8003\u3048\u65b9\u306b\u5bfe\u5fdc\u3059\u308b\u5185\u5bb9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u7b2c20\u6761\u7b2c2\u9805\u3067\u306f\u3001\u7b2c8\u6761\u7b2c2\u9805\u306e\u6587\u66f8\u306b\u57fa\u3065\u304d\u3001\u6b21\u306e\u696d\u52d9\u3092\u884c\u3046\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u624b\u9806\u66f8\u7b49\u3068\u8a18\u9332\u306b\u6b20\u843d\u304c\u306a\u3044\u3088\u3046\u3001\u7d99\u7d9a\u7684\u306b\u7ba1\u7406\u3059\u308b<\/li>\n\n\n\n<li>\u624b\u9806\u66f8\u7b49\u3068\u8a18\u9332\u306e\u5185\u5bb9\u304c\u6b63\u78ba\u3067\u3042\u308b\u3088\u3046\u3001\u7d99\u7d9a\u7684\u306b\u7ba1\u7406\u3059\u308b<\/li>\n\n\n\n<li>\u4ed6\u306e\u624b\u9806\u66f8\u7b49\u3084\u8a18\u9332\u3068\u4e0d\u6574\u5408\u304c\u306a\u3044\u3088\u3046\u3001\u7d99\u7d9a\u7684\u306b\u7ba1\u7406\u3059\u308b<\/li>\n\n\n\n<li>\u6b20\u843d\u3084\u4e0d\u6b63\u78ba\u30fb\u4e0d\u6574\u5408\u306a\u70b9\u304c\u5224\u660e\u3057\u305f\u5834\u5408\u306f\u3001\u539f\u56e0\u3092\u7a76\u660e\u3057\u3001\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3092\u3068\u308b<\/li>\n\n\n\n<li>\u305d\u306e\u4ed6\u3001\u624b\u9806\u66f8\u7b49\u3068\u8a18\u9332\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u696d\u52d9\u3092\u884c\u3046<\/li>\n\n\n\n<li>\u3053\u308c\u3089\u306e\u696d\u52d9\u306e\u8a18\u9332\u3092\u4f5c\u6210\u3057\u3001\u4fdd\u7ba1\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u6587\u66f8\u7ba1\u7406\u3092\u500b\u4eba\u306e\u6ce8\u610f\u529b\u306b\u4efb\u305b\u305a\u3001<mark>\u4f5c\u6210\u6642\u304b\u3089\u4fdd\u7ba1\u671f\u9593\u304c\u6e80\u4e86\u3059\u308b\u307e\u3067\u7d99\u7d9a\u7684\u306b\u7ba1\u7406\u3059\u308b\u4ed5\u7d44\u307f<\/mark>\u3068\u3057\u3066\u8a2d\u8a08\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc5900&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c3\u5e744\u670828\u65e5\u4ed8\u3051\u85ac\u751f\u76e3\u9ebb\u767a0428\u7b2c2\u53f7\uff09<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-14\">21 CFR Part 11\u3068ER\/ES\u6307\u91dd<\/h3>\n\n\n\n<p>21 CFR Part 11\u3068ER\/ES\uff08Electronic Records\/Electronic Signatures\uff09\u6307\u91dd\u306f\u3001<mark>\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u3092\u7d19\u306e\u8a18\u9332\u3084\u624b\u66f8\u304d\u7f72\u540d\u306b\u4ee3\u3048\u3066\u4f7f\u3046\u305f\u3081\u306e\u8981\u4ef6<\/mark>\u3092\u5b9a\u3081\u305f\u30eb\u30fc\u30eb\u3067\u3059\u3002<\/p>\n\n\n\n<p>21 CFR Part 11\u306f\u3001FDA\u304c\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u3092\u3001\u4fe1\u983c\u3067\u304d\u3001\u7d19\u306e\u8a18\u9332\u3084\u624b\u66f8\u304d\u7f72\u540d\u3068\u304a\u304a\u3080\u306d\u540c\u7b49\u3068\u307f\u306a\u3059\u305f\u3081\u306e\u57fa\u6e96\u3092\u5b9a\u3081\u305f\u7c73\u56fd\u9023\u90a6\u898f\u5247\u3067\u3059\u3002\u30af\u30ed\u30fc\u30ba\u30c9\u30b7\u30b9\u30c6\u30e0\u306e\u7ba1\u7406\u8981\u4ef6\u3068\u3057\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3084\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u4ed8\u304d\u306e\u76e3\u67fb\u8a3c\u8de1\u3001\u30a2\u30af\u30bb\u30b9\u306e\u5236\u9650\u3001\u6a29\u9650\u30c1\u30a7\u30c3\u30af\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u306a\u304a\u3001FDA\u306f2003\u5e74\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u3001Part 11\u306e\u9069\u7528\u7bc4\u56f2\u3092\u72ed\u304f\u89e3\u91c8\u3059\u308b\u65b9\u91dd\u3092\u793a\u3057\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3084\u76e3\u67fb\u8a3c\u8de1\u3001\u8a18\u9332\u306e\u4fdd\u5b58\u30fb\u30b3\u30d4\u30fc\u306b\u95a2\u3059\u308b\u4e00\u90e8\u306e\u8981\u4ef6\u306b\u3064\u3044\u3066\u306f\u57f7\u884c\u88c1\u91cf\u3092\u884c\u4f7f\u3059\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u56fd\u5185\u3067\u306f\u3001\u300c\u533b\u85ac\u54c1\u7b49\u306e\u627f\u8a8d\u53c8\u306f\u8a31\u53ef\u7b49\u306b\u4fc2\u308b\u7533\u8acb\u7b49\u306b\u95a2\u3059\u308b\u96fb\u78c1\u7684\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u5229\u7528\u306e\u305f\u3081\u306e\u6307\u91dd\u300d\uff08\u5e73\u621017\u5e744\u67081\u65e5\u85ac\u98df\u767a\u7b2c0401022\u53f7\u5225\u7d19\u3001ER\/ES\u6307\u91dd\uff09\u304c\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u306e\u8981\u4ef6\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001GMP\u7701\u4ee4\u306b\u898f\u5b9a\u3055\u308c\u305f\u6587\u66f8\u30fb\u8a18\u9332\u306f\u57fa\u672c\u7684\u306b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3067\u4f5c\u6210\u30fb\u4fdd\u7ba1\u30fb\u4ea4\u4ed8\u3067\u304d\u308b\u3068\u3057\u305f\u3046\u3048\u3067\u3001\u305d\u306e\u6761\u4ef6\u3068\u3057\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u304cER\/ES\u6307\u91dd\u306e\u8981\u4ef6\u3092\u5099\u3048\u3001\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\u306b\u57fa\u3065\u3044\u3066\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u6319\u3052\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u7c73\u56fd\u5e02\u5834\u5411\u3051\u306b\u88fd\u54c1\u3092\u4f9b\u7d66\u3059\u308b\u306a\u3069\u3001FDA\u306e\u898f\u5236\u3092\u53d7\u3051\u308b\u5834\u5408\u306f\u3001<mark>FDA\u898f\u5247\u3067\u6c42\u3081\u3089\u308c\u308b\u8a18\u9332\u3092\u96fb\u5b50\u3067\u6271\u3046\u7bc4\u56f2\u3067Part 11\u3078\u306e\u5bfe\u5fdc<\/mark>\u3082\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-11\" rel=\"nofollow\">eCFR\u300c21 CFR Part 11 \u2013 Electronic Records; Electronic Signatures\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application\" rel=\"nofollow\">FDA\u300cPart 11, Electronic Records; Electronic Signatures \u2013 Scope and Application\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00ta8216&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u9577\u901a\u77e5\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\u306e\u5229\u7528\u306b\u3064\u3044\u3066\u300d\uff08\u5e73\u621017\u5e744\u67081\u65e5\u4ed8\u3051\u85ac\u98df\u767a\u7b2c0401022\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-15\">GMP\u6587\u66f8\u7ba1\u7406\u306e\u8ab2\u984c<\/h2>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u306e\u91cd\u8981\u6027\u306f\u7406\u89e3\u3055\u308c\u3066\u3044\u3066\u3082\u3001\u73fe\u5834\u3067\u306f<mark>\u7d19\u30d9\u30fc\u30b9\u7ba1\u7406\u306e\u9650\u754c\u3068\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u30fb\u5c5e\u4eba\u5316<\/mark>\u3068\u3044\u30462\u3064\u306e\u8ab2\u984c\u304c\u8d77\u304d\u3084\u3059\u3044\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7d19\u30d9\u30fc\u30b9\u7ba1\u7406\u306e\u9650\u754c<\/li>\n\n\n\n<li>\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u3068\u5c5e\u4eba\u5316<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-16\">\u7d19\u30d9\u30fc\u30b9\u7ba1\u7406\u306e\u9650\u754c<\/h3>\n\n\n\n<p>\u7d19\u30d9\u30fc\u30b9\u306eGMP\u6587\u66f8\u7ba1\u7406\u306b\u306f\u3001<mark>\u691c\u7d22\u30fb\u7248\u7ba1\u7406\u30fb\u8ffd\u8de1\u306e\u9762\u3067\u69cb\u9020\u7684\u306a\u9650\u754c<\/mark>\u304c\u3042\u308a\u307e\u3059\u3002\u4e3b\u306a\u9650\u754c\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u691c\u7d22\u6027\u306e\u4f4e\u3055\uff1a\u5927\u91cf\u306e\u6587\u66f8\u304b\u3089\u5fc5\u8981\u306a\u3082\u306e\u3092\u63a2\u3059\u306e\u306b\u6642\u9593\u304c\u304b\u304b\u308a\u3001\u67fb\u5bdf\u6642\u306e\u6587\u66f8\u63d0\u793a\u3082\u9045\u308c\u3084\u3059\u3044<\/li>\n\n\n\n<li>\u7248\u7ba1\u7406\u306e\u8ca0\u8377\uff1a\u65e7\u7248\u306e\u56de\u53ce\u3068\u65b0\u7248\u306e\u914d\u4ed8\u3092\u78ba\u5b9f\u306b\u884c\u3046\u8ca0\u62c5\u304c\u5927\u304d\u304f\u3001\u62e0\u70b9\u304c\u8907\u6570\u3042\u308b\u3068\u3055\u3089\u306b\u8907\u96d1\u306b\u306a\u308b<\/li>\n\n\n\n<li>\u4fdd\u7ba1\u30b9\u30da\u30fc\u30b9\u3068\u30b3\u30b9\u30c8\uff1a\u4fdd\u7ba1\u671f\u9593\u304c\u9577\u3044\u305f\u3081\u3001\u7269\u7406\u7684\u306a\u4fdd\u7ba1\u5834\u6240\u306e\u78ba\u4fdd\u304c\u8ca0\u62c5\u306b\u306a\u308b<\/li>\n\n\n\n<li>\u8ffd\u8de1\u306e\u96e3\u3057\u3055\uff1a\u8ab0\u304c\u3044\u3064\u95b2\u89a7\u30fb\u5909\u66f4\u3057\u305f\u304b\u3092\u8ffd\u3044\u306b\u304f\u3044<\/li>\n\n\n\n<li>\u707d\u5bb3\u30fb\u52a3\u5316\u306e\u30ea\u30b9\u30af\uff1a\u706b\u707d\u3084\u6c34\u5bb3\u306b\u3088\u308b\u6ec5\u5931\u3001\u7d4c\u5e74\u306b\u3088\u308b\u5224\u8aad\u6027\u306e\u4f4e\u4e0b\u304c\u8d77\u3053\u308a\u3046\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306f\u500b\u5225\u306e\u904b\u7528\u6539\u5584\u3060\u3051\u3067\u306f\u89e3\u6d88\u3057\u306b\u304f\u3044\u8ab2\u984c\u306e\u305f\u3081\u3001\u6587\u66f8\u7ba1\u7406\u306e\u4ed5\u7d44\u307f\u305d\u306e\u3082\u306e\u3092\u96fb\u5b50\u5316\u306b\u3088\u3063\u3066\u898b\u76f4\u3059\u3053\u3068\u304c\u6709\u52b9\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-17\">\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u3068\u5c5e\u4eba\u5316<\/h3>\n\n\n\n<p>\u7d19\u30d9\u30fc\u30b9\u306e\u7ba1\u7406\u306b\u52a0\u3048\u3001<mark>\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u3068\u696d\u52d9\u306e\u5c5e\u4eba\u5316<\/mark>\u3082GMP\u6587\u66f8\u7ba1\u7406\u306e\u5927\u304d\u306a\u8ab2\u984c\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u5178\u578b\u7684\u306a\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u306b\u306f\u3001\u8ee2\u8a18\u30df\u30b9\u3084\u8a18\u5165\u6f0f\u308c\u3001\u8a02\u6b63\u624b\u7d9a\u304d\u306e\u4e0d\u5099\u3001\u65e7\u7248SOP\u306e\u8aa4\u4f7f\u7528\u304c\u3042\u308a\u307e\u3059\u3002\u7279\u306bSOP\u306e\u6539\u8a02\u6642\u306b\u914d\u4ed8\u30df\u30b9\u3084\u5dee\u66ff\u3048\u6642\u306e\u7db4\u3058\u9593\u9055\u3044\u304c\u751f\u3058\u308b\u3068\u3001\u7570\u306a\u308b\u7248\u306e\u624b\u9806\u66f8\u304c\u73fe\u5834\u306b\u6df7\u5728\u3057\u3001\u54c1\u8cea\u306b\u5f71\u97ff\u3059\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6587\u66f8\u7ba1\u7406\u306e\u904b\u7528\u30eb\u30fc\u30eb\u3084\u5224\u65ad\u57fa\u6e96\u304c\u7279\u5b9a\u306e\u62c5\u5f53\u8005\u306e\u7d4c\u9a13\u306b\u983c\u3063\u3066\u3044\u308b\u3068\u3001\u305d\u306e\u62c5\u5f53\u8005\u304c\u7570\u52d5\u30fb\u9000\u8077\u3057\u305f\u3068\u304d\u306b\u7ba1\u7406\u306e\u8cea\u304c\u4e0b\u304c\u308a\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002\u307e\u305f\u30011\u3064\u306e\u5909\u66f4\u304c\u8907\u6570\u306e\u95a2\u9023\u6587\u66f8\u306b\u6ce2\u53ca\u3059\u308b\u3053\u3068\u3082\u5c11\u306a\u304f\u306a\u304f\u3001\u5f71\u97ff\u7bc4\u56f2\u3092\u6f0f\u308c\u306a\u304f\u7279\u5b9a\u3057\u3066\u95a2\u9023\u6587\u66f8\u3092\u3059\u3079\u3066\u6539\u8a02\u3059\u308b\u4f5c\u696d\u306f\u3001\u4eba\u624b\u3060\u3051\u3067\u306f\u8ca0\u8377\u306e\u9ad8\u3044\u696d\u52d9\u3067\u3059\u3002<mark>\u95a2\u9023\u6587\u66f8\u3078\u306e\u5f71\u97ff\u7bc4\u56f2\u3092\u6d17\u3044\u51fa\u3059\u4ed5\u7d44\u307f<\/mark>\u3092\u6301\u3064\u3053\u3068\u3067\u3001\u6539\u8a02\u6f0f\u308c\u3068\u5c5e\u4eba\u5316\u306e\u4e21\u65b9\u3092\u6291\u3048\u308b\u3053\u3068\u304c\u671f\u5f85\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\">\n\n\n\n<p><strong>GMP\u6587\u66f8\u306e\u6539\u8a02\u696d\u52d9\u3092\u52b9\u7387\u5316\u3059\u308b\u306a\u3089\u300cJAPAN AI \u88fd\u85ac\u300d<\/strong><br>\u88fd\u85ac\u696d\u754c\u306e\u6587\u66f8\u6539\u8a02\u306b\u7279\u5316\u3057\u305fAI\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u300c<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">JAPAN AI \u88fd\u85ac<\/a>\u300d\u306f\u3001\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3068\u9023\u643a\u3057\u3001\u793e\u5185\u6587\u66f8\u306e\u81ea\u7136\u8a00\u8a9e\u691c\u7d22\u304b\u3089\u3001\u627f\u8a8d\u3055\u308c\u305f\u5909\u66f4\u8d77\u6848\u306b\u57fa\u3065\u304f\u6539\u8a02\u6848\u306e\u305f\u305f\u304d\u53f0\u4f5c\u6210\u3001\u95a2\u9023\u6587\u66f8\u3078\u306e\u5f71\u97ff\u7bc4\u56f2\u306e\u7279\u5b9a\u3001\u6539\u8a02\u6587\u66f8\u5185\u306e\u77db\u76fe\u30fb\u9f5f\u9f6c\u306e\u30c1\u30a7\u30c3\u30af\u307e\u3067\u3092\u4e00\u6c17\u901a\u8cab\u3067\u652f\u63f4\u3057\u307e\u3059\u3002AI\u306f\u63d0\u6848\u307e\u3067\u3092\u62c5\u3044\u3001\u6700\u7d42\u5224\u65ad\u3068\u627f\u8a8d\u306f\u4eba\u304c\u884c\u3046Human-in-the-Loop\u8a2d\u8a08\u3067\u3059\u3002\u5165\u529b\u30c7\u30fc\u30bf\u306f\u30d1\u30d6\u30ea\u30c3\u30af\u30e2\u30c7\u30eb\u306e\u5b66\u7fd2\u306b\u5229\u7528\u3055\u308c\u305a\u3001\u56fd\u5185\u30c7\u30fc\u30bf\u30bb\u30f3\u30bf\u30fc\u306e\u9589\u57df\u74b0\u5883\u3067\u904b\u7528\u3055\u308c\u307e\u3059\u3002ISO\/IEC 27001\uff08ISMS\uff09\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u307b\u304b\u3001GAMP5\u306b\u57fa\u3065\u304f\u958b\u767a\u30fb\u30c6\u30b9\u30c8\u8a18\u9332\u3092\u3001CSV\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u8cc7\u6599\u3068\u3057\u3066\u53ef\u80fd\u306a\u7bc4\u56f2\u3067\u63d0\u4f9b\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-18\">\u6587\u66f8\u7ba1\u7406\u306e\u96fb\u5b50\u5316\u30fbDX<\/h2>\n\n\n\n<p>\u6587\u66f8\u7ba1\u7406\u306e\u96fb\u5b50\u5316\u30fbDX\u306f\u3001<mark>\u691c\u7d22\u6027\u30fb\u7248\u7ba1\u7406\u30fb\u8ffd\u8de1\u6027\u306e\u8ab2\u984c\u3092\u307e\u3068\u3081\u3066\u89e3\u6c7a\u3059\u308b\u624b\u6bb5<\/mark>\u3067\u3059\u3002\u7d19\u304b\u3089\u30c7\u30b8\u30bf\u30eb\u306b\u79fb\u884c\u3059\u308b\u3068\u3001\u7248\u7ba1\u7406\u3084\u76e3\u67fb\u8a3c\u8de1\u3001\u30a2\u30af\u30bb\u30b9\u7ba1\u7406\u3092\u30b7\u30b9\u30c6\u30e0\u3067\u62c5\u3048\u307e\u3059\u3002\u305f\u3060\u3057\u3001ER\/ES\u6307\u91dd\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3001CSV\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u524d\u63d0\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u96fb\u5b50\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08EDMS\uff09\u306e\u6a5f\u80fd<\/li>\n\n\n\n<li>\u5c0e\u5165\u306e\u9032\u3081\u65b9\u3068\u8cbb\u7528\u76f8\u5834<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-19\">\u96fb\u5b50\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08EDMS\uff09\u306e\u6a5f\u80fd<\/h3>\n\n\n\n<p>\u96fb\u5b50\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08EDMS\uff1aElectronic Document Management System\uff09\u306f\u3001<mark>GMP\u6587\u66f8\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u30c7\u30b8\u30bf\u30eb\u74b0\u5883\u3067\u7ba1\u7406\u3059\u308b\u30b7\u30b9\u30c6\u30e0<\/mark>\u3067\u3059\u3002GMP\u5bfe\u5fdc\u306eEDMS\u304c\u5099\u3048\u308b\u4e3b\u306a\u6a5f\u80fd\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n<div id=\"id-f87bb73a-6790-4099-a309-586f6c5bd6fd\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u6a5f\u80fd<\/th><th>\u5185\u5bb9<\/th><\/tr><tr><td>\u7248\u7ba1\u7406<\/td><td>\u6539\u8a02\u5c65\u6b74\u3092\u81ea\u52d5\u3067\u7ba1\u7406\u3057\u3001\u6709\u52b9\u306a\u6700\u65b0\u7248\u3060\u3051\u3092\u53c2\u7167\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b<\/td><\/tr><tr><td>\u627f\u8a8d\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<\/td><td>\u8d77\u6848\u304b\u3089\u30ec\u30d3\u30e5\u30fc\u3001\u627f\u8a8d\u307e\u3067\u3092\u30b7\u30b9\u30c6\u30e0\u4e0a\u3067\u5b8c\u7d50\u3055\u305b\u308b<\/td><\/tr><tr><td>\u96fb\u5b50\u7f72\u540d<\/td><td>Part 11\u3084ER\/ES\u6307\u91dd\u306e\u8981\u4ef6\u306b\u6cbf\u3063\u305f\u96fb\u5b50\u7f72\u540d\u3092\u4ed8\u4e0e\u3059\u308b<\/td><\/tr><tr><td>\u76e3\u67fb\u8a3c\u8de1<\/td><td>\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u524a\u9664\u30fb\u627f\u8a8d\u306a\u3069\u306e\u64cd\u4f5c\u3092\u81ea\u52d5\u3067\u8a18\u9332\u3059\u308b<\/td><\/tr><tr><td>\u30a2\u30af\u30bb\u30b9\u6a29\u7ba1\u7406<\/td><td>\u5f79\u5272\u306b\u5fdc\u3058\u3066\u95b2\u89a7\u30fb\u7de8\u96c6\u30fb\u627f\u8a8d\u306e\u6a29\u9650\u3092\u8a2d\u5b9a\u3059\u308b<\/td><\/tr><tr><td>\u691c\u7d22\u6a5f\u80fd<\/td><td>\u6587\u66f8\u756a\u53f7\u3084\u30ad\u30fc\u30ef\u30fc\u30c9\u3001\u30e1\u30bf\u30c7\u30fc\u30bf\u3067\u6587\u66f8\u3092\u63a2\u3059<\/td><\/tr><tr><td>\u6559\u80b2\u7ba1\u7406\u3068\u306e\u9023\u643a<\/td><td>\u88fd\u54c1\u306b\u3088\u3063\u3066\u306f\u3001\u6587\u66f8\u306e\u767a\u884c\u30fb\u6539\u8a02\u6642\u306b\u5bfe\u8c61\u8005\u3078\u306e\u6559\u80b2\u30bf\u30b9\u30af\u3092\u4f5c\u6210\u3067\u304d\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001ALCOA+\u306e\u8981\u4ef6\u3092\u6e80\u305f\u305b\u308b\u6a5f\u80fd\u306e\u4f8b\u3068\u3057\u3066\u3001\u76e3\u67fb\u8a3c\u8de1\u6a5f\u80fd\u3001\u4e0a\u66f8\u304d\u30fb\u6539\u3056\u3093\u306e\u9632\u6b62\u6a5f\u80fd\u3001\u30e6\u30fc\u30b6\u30fc\u3054\u3068\u306e\u64cd\u4f5c\u6a29\u9650\u306e\u8a2d\u5b9a\u6a5f\u80fd\u3092\u6319\u3052\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u8a18\u9332\u306e\u5165\u529b\u30fb\u5909\u66f4\u30fb\u524a\u9664\u306e\u8a18\u9332\u3092PIC\/S PI 041\u306e\u300cAudit Trail\u300d\u306b\u3042\u305f\u308b\u3082\u306e\u3068\u4f4d\u7f6e\u3065\u3051\u3001\u3059\u3079\u3066\u306e\u5165\u529b\u3068\u4fee\u6b63\u3092\u8a18\u9332\u3057\u3001\u5909\u66f4\u30fb\u524a\u9664\u306e\u7406\u7531\u3082\u6b8b\u3059\u3053\u3068\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<mark>\u76e3\u67fb\u8a3c\u8de1\u3092\u81ea\u52d5\u3067\u53d6\u5f97\u3067\u304d\u308b\u70b9<\/mark>\u306f\u3001EDMS\u3092\u5c0e\u5165\u3059\u308b\u5927\u304d\u306a\u5229\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-20\">\u5c0e\u5165\u306e\u9032\u3081\u65b9\u3068\u8cbb\u7528\u76f8\u5834<\/h3>\n\n\n\n<p>EDMS\u306e\u5c0e\u5165\u306f\u3001<mark>\u8981\u4ef6\u6574\u7406\u304b\u3089\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u6bb5\u968e\u7a3c\u50cd\u307e\u3067\u3092\u9806\u306b\u9032\u3081\u308b<\/mark>\u306e\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u4e3b\u306a\u30d5\u30a7\u30fc\u30ba\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u8981\u4ef6\u6574\u7406\uff1a\u73fe\u5728\u306e\u6587\u66f8\u7ba1\u7406\u696d\u52d9\u3092\u68da\u5378\u3057\u3057\u3001GMP\u8981\u4ef6\u3068\u5b9f\u52d9\u4e0a\u306e\u8981\u4ef6\u3001\u65e2\u5b58\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u9023\u643a\u8981\u4ef6\u3092\u6574\u7406\u3059\u308b<\/li>\n\n\n\n<li>\u30b7\u30b9\u30c6\u30e0\u9078\u5b9a\uff1aGMP\u5206\u91ce\u3067\u306e\u5c0e\u5165\u5b9f\u7e3e\u3001ER\/ES\u6307\u91dd\u3084Part 11\u3078\u306e\u5bfe\u5fdc\u3001\u30b5\u30dd\u30fc\u30c8\u4f53\u5236\u306a\u3069\u3092\u8a55\u4fa1\u3057\u3066\u30d9\u30f3\u30c0\u30fc\u3092\u9078\u3076<\/li>\n\n\n\n<li>\u8a2d\u8a08\u30fb\u69cb\u7bc9\uff1a\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3084\u6a29\u9650\u3001\u6587\u66f8\u5206\u985e\u4f53\u7cfb\u3092\u8a2d\u8a08\u3057\u3001\u30c7\u30fc\u30bf\u79fb\u884c\u8a08\u753b\u3092\u7acb\u3066\u308b<\/li>\n\n\n\n<li>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066CSV\u3092\u8a08\u753b\u30fb\u5b9f\u65bd\u3057\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u8981\u4ef6\u3069\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u691c\u8a3c\u30fb\u8a18\u9332\u3059\u308b<\/li>\n\n\n\n<li>\u6bb5\u968e\u7a3c\u50cd\uff1a\u4e00\u90e8\u306e\u90e8\u9580\u30fb\u6587\u66f8\u7a2e\u985e\u304b\u3089\u904b\u7528\u3092\u59cb\u3081\u3001\u8ab2\u984c\u3092\u6d17\u3044\u51fa\u3057\u3066\u304b\u3089\u5168\u793e\u306b\u5c55\u958b\u3059\u308b<\/li>\n\n\n\n<li>\u5b9a\u7740\u30fb\u7d99\u7d9a\u6539\u5584\uff1a\u5229\u7528\u8005\u6559\u80b2\u3084\u904b\u7528\u624b\u9806\u306e\u5b9a\u7740\u3001\u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u3092\u884c\u3046<\/li>\n<\/ol>\n\n\n\n<p>\u56fd\u5185\u306e\u533b\u85ac\u54c1GMP\u3067\u306f\u3001\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\u5e73\u621022\u5e7410\u670821\u65e5\u85ac\u98df\u76e3\u9ebb\u767a1021\u7b2c11\u53f7\uff09\u306b\u6cbf\u3063\u305fCSV\u304c\u57fa\u672c\u3067\u3059\u3002ISPE\uff08International Society for Pharmaceutical Engineering\uff1a\u56fd\u969b\u88fd\u85ac\u6280\u8853\u5354\u4f1a\uff09\u306e\u696d\u754c\u30ac\u30a4\u30c9\u3067\u3042\u308bGAMP 5 Second Edition\uff082022\u5e74\u767a\u884c\uff09\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u8003\u3048\u65b9\u3082\u3001\u5e83\u304f\u53c2\u8003\u306b\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u306a\u304a\u3001FDA\u306eCSA\uff08Computer Software Assurance\uff09\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\u3067\u4f7f\u3046\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u5bfe\u8c61\u3067\u3059\u30022025\u5e749\u670824\u65e5\u306b\u6700\u7d42\u7248\u304c\u767a\u51fa\u3055\u308c\u30012026\u5e742\u67083\u65e5\u306b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u5247\uff0821 CFR Part 820\uff09\u306b\u5408\u308f\u305b\u305f\u7248\u306b\u7f6e\u304d\u63db\u3048\u3089\u308c\u307e\u3057\u305f\u3002\u533b\u85ac\u54c1GMP\u306e\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u305d\u306e\u307e\u307e\u9069\u7528\u3055\u308c\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u8cbb\u7528\u306f\u3001\u62e0\u70b9\u6570\u3084\u5229\u7528\u8005\u6570\u3001\u79fb\u884c\u3059\u308b\u6587\u66f8\u91cf\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u7bc4\u56f2\u3001\u65e2\u5b58\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u9023\u643a\u306e\u6709\u7121\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u5909\u308f\u308a\u307e\u3059\u3002\u898b\u7a4d\u3082\u308a\u3092\u4f9d\u983c\u3059\u308b\u969b\u306fRFP\uff08\u63d0\u6848\u4f9d\u983c\u66f8\uff09\u306b\u696d\u52d9\u8981\u4ef6\u3084\u30c7\u30fc\u30bf\u8981\u4ef6\u3001\u76e3\u67fb\u8a3c\u8de1\u306e\u6761\u4ef6\u3092\u660e\u8a18\u3057\u3001<mark>\u521d\u671f\u8cbb\u7528\u3060\u3051\u3067\u306a\u304f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3084\u4fdd\u5b88\u3092\u542b\u3081\u305f5\u5e74\u7a0b\u5ea6\u306eTCO\uff08\u7dcf\u4fdd\u6709\u30b3\u30b9\u30c8\uff09<\/mark>\u3067\u6bd4\u8f03\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/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><br>\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<h2 class=\"wp-block-heading\" id=\"i-21\">GMP\u67fb\u5bdf\u3068\u6587\u66f8\u7ba1\u7406\u306e\u5bfe\u5fdc<\/h2>\n\n\n\n<p>\u56fd\u5185\u306eGMP\u9069\u5408\u6027\u8abf\u67fb\u3084FDA\u306a\u3069\u6d77\u5916\u5f53\u5c40\u306e\u67fb\u5bdf\u306f\u3001<mark>\u65e5\u5e38\u306eGMP\u6587\u66f8\u7ba1\u7406\u306e\u6c34\u6e96\u304c\u78ba\u8a8d\u3055\u308c\u308b\u5834<\/mark>\u3067\u3059\u3002\u56fd\u5185\u306e\u8abf\u67fb\u306f\u3001PMDA\uff08\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff09\u307e\u305f\u306f\u90fd\u9053\u5e9c\u770c\u304c\u884c\u3044\u307e\u3059\u3002\u67fb\u5bdf\u3067\u6307\u6458\u3092\u53d7\u3051\u306a\u3044\u305f\u3081\u306b\u306f\u3001\u65e5\u9803\u304b\u3089\u306e\u7ba1\u7406\u4f53\u5236\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA\u67fb\u5bdf\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u6307\u6458\u306e\u50be\u5411<\/li>\n\n\n\n<li>\u67fb\u5bdf\u306b\u5099\u3048\u305f\u6587\u66f8\u7ba1\u7406\u4f53\u5236<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/review-services\/gmp-qms-gctp\/0001.html\" rel=\"nofollow\">\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u300cGMP\uff0fQMS\uff0fGCTP\u9069\u5408\u6027\u8abf\u67fb\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-22\">FDA\u67fb\u5bdf\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u6307\u6458\u306e\u50be\u5411<\/h3>\n\n\n\n<p>FDA\u306f2018\u5e74\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u3001<mark>\u8fd1\u5e74\u306e\u67fb\u5bdf\u3067\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308bCGMP\u9055\u53cd\u304c\u898b\u3064\u304b\u308b\u4f8b\u304c\u5897\u3048\u3066\u3044\u308b\u3053\u3068<\/mark>\u3092\u4f5c\u6210\u306e\u80cc\u666f\u306b\u6319\u3052\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u7c73\u56fd\u306eCGMP\u898f\u5247\uff0821 CFR Part 210\u30fb211\u306a\u3069\uff09\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3001\u7c73\u56fd\u5411\u3051\u306b\u533b\u85ac\u54c1\u3092\u4f9b\u7d66\u3059\u308b\u56fd\u5185\u306e\u88fd\u9020\u6240\u306fFDA\u306e\u67fb\u5bdf\u306e\u5bfe\u8c61\u306b\u306a\u308a\u3048\u307e\u3059\u3002\u56fd\u5185\u5411\u3051\u306b\u306e\u307f\u88fd\u9020\u3059\u308b\u5834\u5408\u306f\u3001\u56fd\u5185\u306eGMP\u7701\u4ee4\u3068\u9069\u5408\u6027\u8abf\u67fb\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u540c\u30ac\u30a4\u30c0\u30f3\u30b9\u3067Q&amp;A\u3068\u3057\u3066\u53d6\u308a\u4e0a\u3052\u3089\u308c\u3066\u3044\u308b\u4e3b\u306a\u8ad6\u70b9\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u30a2\u30af\u30bb\u30b9\u5236\u9650\u3068\u3001\u5171\u6709\u30ed\u30b0\u30a4\u30f3\u30a2\u30ab\u30a6\u30f3\u30c8\u306e\u4f7f\u7528<\/li>\n\n\n\n<li>\u76e3\u67fb\u8a3c\u8de1\u3092\u8ab0\u304c\u3001\u3069\u306e\u983b\u5ea6\u3067\u30ec\u30d3\u30e5\u30fc\u3059\u308b\u304b<\/li>\n\n\n\n<li>\u7a7a\u767d\u69d8\u5f0f\uff08\u30d6\u30e9\u30f3\u30af\u30d5\u30a9\u30fc\u30e0\uff09\u306e\u7ba1\u7406<\/li>\n\n\n\n<li>CGMP\u4e0a\u306e\u8a66\u9a13\u7d50\u679c\u3092\u7121\u52b9\u3068\u3057\u3066\u9664\u5916\u3067\u304d\u308b\u6761\u4ef6<\/li>\n\n\n\n<li>\u5b9f\u30b5\u30f3\u30d7\u30eb\u3092\u4f7f\u3063\u305f\u30b7\u30b9\u30c6\u30e0\u9069\u5408\u6027\u78ba\u8a8d\u306a\u3069\u306e\u300c\u8a66\u3057\u6253\u3061\u300d<\/li>\n\n\n\n<li>\u518d\u51e6\u7406\u3057\u305f\u30af\u30ed\u30de\u30c8\u30b0\u30e9\u30d5\u30a3\u30fc\u306e\u6700\u7d42\u7d50\u679c\u3060\u3051\u3092\u4fdd\u5b58\u3059\u308b\u904b\u7528<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u3046\u3061\u5b9f\u30b5\u30f3\u30d7\u30eb\u3092\u4f7f\u3063\u305f\u300c\u8a66\u3057\u6253\u3061\u300d\u306b\u3064\u3044\u3066\u306f\u3001FDA\u304c\u3053\u308c\u307e\u3067\u8b66\u544a\u66f8\u3067\u6307\u6458\u3057\u3066\u304d\u305f\u7406\u7531\u3092Q&amp;A\u3067\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u5171\u6709ID\u3084\u76e3\u67fb\u8a3c\u8de1\u306e\u30ec\u30d3\u30e5\u30fc\u4e0d\u8db3\u306e\u3088\u3046\u306b\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u7279\u6709\u306e\u8ad6\u70b9\u3082\u591a\u304f\u3001\u96fb\u5b50\u5316\u3059\u308c\u3070\u89e3\u6c7a\u3059\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u5b9a\u3068\u904b\u7528\u30eb\u30fc\u30eb\u3092\u3042\u308f\u305b\u3066\u6574\u3048\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<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-basics\" rel=\"nofollow\">FDA\u300cInspection Basics\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-23\">\u67fb\u5bdf\u306b\u5099\u3048\u305f\u6587\u66f8\u7ba1\u7406\u4f53\u5236<\/h3>\n\n\n\n<p>\u67fb\u5bdf\u306b\u5099\u3048\u308b\u306b\u306f\u3001<mark>\u81ea\u5df1\u70b9\u691c\u3068\u5185\u90e8\u76e3\u67fb\u3067\u3001\u65e5\u9803\u304b\u3089\u81ea\u793e\u306e\u6587\u66f8\u7ba1\u7406\u3092\u70b9\u691c\u3057\u3066\u304a\u304f\u3053\u3068<\/mark>\u304c\u6709\u52b9\u3067\u3059\u3002\u65e5\u5e38\u7684\u306b\u53d6\u308a\u7d44\u307f\u305f\u3044\u9805\u76ee\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u81ea\u5df1\u70b9\u691c\u306e\u5b9a\u671f\u5b9f\u65bd\uff1aALCOA+\u306e\u5404\u8981\u4ef6\u306b\u7167\u3089\u3057\u3066\u3001\u7d19\u8a18\u9332\u30fb\u96fb\u5b50\u8a18\u9332\u306e\u4e21\u65b9\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u5185\u90e8\u76e3\u67fb\u306e\u5b9f\u65bd\uff1a\u6587\u66f8\u7ba1\u7406\u306b\u7126\u70b9\u3092\u5f53\u3066\u305f\u76e3\u67fb\u3092\u884c\u3044\u3001\u767a\u898b\u4e8b\u9805\u3092CAPA\u3067\u662f\u6b63\u307e\u3067\u8ffd\u8de1\u3059\u308b<\/li>\n\n\n\n<li>\u8a18\u9332\u306e\u7167\u67fb\uff1a\u30ed\u30c3\u30c8\u3054\u3068\u306e\u8a18\u9332\u3067\u3001\u7f72\u540d\u30fb\u65e5\u4ed8\u306e\u8a18\u8f09\uff08\u5e30\u5c5e\u6027\uff09\u3084\u5373\u6642\u306e\u8a18\u9332\uff08\u540c\u6642\u6027\uff09\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u4e3b\u8981\u6587\u66f8\u306e\u6700\u65b0\u5316\uff1a\u30b5\u30a4\u30c8\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u3084\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30de\u30b9\u30bf\u30fc\u30d7\u30e9\u30f3\u306a\u3069\u3092\u6700\u65b0\u306b\u4fdd\u3061\u3001\u3059\u3050\u63d0\u793a\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>GMP\u7701\u4ee4\u7b2c18\u6761\u306f\u3001\u88fd\u9020\u30fb\u54c1\u8cea\u95a2\u9023\u696d\u52d9\u306b\u3064\u3044\u3066\u5b9a\u671f\u7684\u306b\u81ea\u5df1\u70b9\u691c\u3092\u884c\u3044\u3001\u7d50\u679c\u3092\u54c1\u8cea\u4fdd\u8a3c\u306b\u4fc2\u308b\u7d44\u7e54\u3068\u88fd\u9020\u7ba1\u7406\u8005\u306b\u6587\u66f8\u3067\u5831\u544a\u3057\u3001\u8a18\u9332\u3092\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b\u3088\u3046\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u6539\u5584\u304c\u5fc5\u8981\u306a\u5834\u5408\u306f\u3001\u63aa\u7f6e\u3092\u3068\u3063\u3066\u305d\u306e\u8a18\u9332\u3082\u6b8b\u3057\u307e\u3059\u3002\u67fb\u5bdf\u306e\u305f\u3081\u306e\u7279\u5225\u306a\u6e96\u5099\u306b\u983c\u3089\u305a\u3001\u3053\u306e\u4ed5\u7d44\u307f\u3092\u65e5\u5e38\u306e\u696d\u52d9\u3068\u3057\u3066\u56de\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-24\">GMP\u6587\u66f8\u7ba1\u7406\u306b\u304a\u3051\u308bAI\u6d3b\u7528<\/h2>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u3067\u306eAI\u6d3b\u7528\u306f\u3001<mark>\u898f\u5236\u5f53\u5c40\u304c\u8003\u3048\u65b9\u3092\u6574\u7406\u3057\u3066\u3044\u308b\u9014\u4e2d\u306e\u6bb5\u968e<\/mark>\u306b\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>EU\u3067\u306f\u3001\u533b\u85ac\u54c1\u88fd\u9020\u3067\u306eAI\u5229\u7528\u306b\u95a2\u3059\u308bGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300cAnnex 22\u300d\u306e\u6848\u306b\u3064\u3044\u3066\u30012025\u5e74\u306b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u304c\u884c\u308f\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u6848\u306f\u3001\u751f\u6210AI\u3084\u5927\u898f\u6a21\u8a00\u8a9e\u30e2\u30c7\u30eb\uff08LLM\uff09\u3092\u542b\u3080\u3001\u52d5\u7684\u30fb\u9069\u5fdc\u7684\u30fb\u78ba\u7387\u7684\u306a\u30e2\u30c7\u30eb\u3092\u3001\u91cd\u8981\u306aGMP\u7528\u9014\u306b\u4f7f\u3046\u3079\u304d\u3067\u306f\u306a\u3044\u3068\u3057\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u4e00\u65b9\u3067\u3001EMA\uff08European Medicines Agency\uff1a\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff09\u306b\u3088\u308b\u3068\u3001\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u3067\u306f\u751f\u6210AI\u3084LLM\u306e\u5229\u7528\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3078\u306e\u652f\u6301\u3082\u898b\u3089\u308c\u307e\u3057\u305f\u3002EMA\u306f\u7d50\u679c\u3092\u691c\u8a0e\u4e2d\u3067\u30012026\u5e746\u670830\u65e5\u304b\u30897\u67081\u65e5\u306b\u306f\u3001\u30ac\u30fc\u30c9\u30ec\u30fc\u30eb\u306a\u3069\u306e\u7ba1\u7406\u7b56\u306b\u3064\u3044\u3066\u5c02\u9580\u5bb6\u306e\u610f\u898b\u3092\u96c6\u3081\u308b\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u3092\u958b\u3044\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>FDA\u306f2025\u5e741\u6708\u306b\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u30fb\u54c1\u8cea\u306b\u95a2\u3059\u308b\u898f\u5236\u4e0a\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u3048\u308b\u60c5\u5831\u3084\u30c7\u30fc\u30bf\u3092AI\u3067\u4f5c\u6210\u3059\u308b\u5834\u5408\u306e\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u4f7f\u7528\u76ee\u7684\uff08COU\uff09\u306b\u5fdc\u3058\u3066AI\u30e2\u30c7\u30eb\u306e\u4fe1\u983c\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u67a0\u7d44\u307f\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3001\u8a66\u9a13\u7d50\u679c\u306e\u4fe1\u983c\u6027\u306b\u5f71\u97ff\u3057\u306a\u3044\u696d\u52d9\u52b9\u7387\u5316\u306e\u305f\u3081\u306eAI\u5229\u7528\uff08\u793e\u5185\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3084\u7533\u8acb\u66f8\u985e\u306e\u4e0b\u66f8\u304d\u306a\u3069\uff09\u306f\u3001\u5bfe\u8c61\u5916\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3069\u3061\u3089\u3082\u78ba\u5b9a\u3057\u305f\u898f\u5236\u3067\u306f\u306a\u3044\u305f\u3081\u3001AI\u3092\u4f7f\u3046\u696d\u52d9\u304c\u3069\u306e\u898f\u5236\u30fb\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u5bfe\u8c61\u306b\u306a\u308b\u304b\u3092\u78ba\u8a8d\u3057\u305f\u3046\u3048\u3067\u3001\u6d3b\u7528\u8a08\u753b\u3092\u7acb\u3066\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>AI\u306b\u4efb\u305b\u3089\u308c\u308b\u696d\u52d9\u3068\u4eba\u9593\u304c\u78ba\u8a8d\u3059\u3079\u304d\u696d\u52d9<\/li>\n\n\n\n<li>AI\u6d3b\u7528\u6642\u306e\u898f\u5236\u4e0a\u306e\u7559\u610f\u70b9<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.ema.europa.eu\/en\/events\/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22\" rel=\"nofollow\">EMA\u300cGood manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological\" rel=\"nofollow\">FDA\u300cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-25\">AI\u306b\u4efb\u305b\u3089\u308c\u308b\u696d\u52d9\u3068\u4eba\u9593\u304c\u78ba\u8a8d\u3059\u3079\u304d\u696d\u52d9<\/h3>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u3067AI\u304c\u529b\u3092\u767a\u63ee\u3059\u308b\u306e\u306f\u3001<mark>\u4eba\u304c\u6700\u7d42\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u524d\u63d0\u3068\u3057\u305f\u4e0b\u66f8\u304d\u3084\u78ba\u8a8d\u306e\u88dc\u52a9<\/mark>\u3067\u3059\u3002\u54c1\u8cea\u306b\u95a2\u3059\u308b\u5224\u65ad\u3068\u627f\u8a8d\u306f\u3001\u4eba\u304c\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002AI\u306b\u4efb\u305b\u3084\u3059\u3044\u696d\u52d9\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SOP\u6539\u8a02\u6848\u306e\u4e0b\u66f8\u304d\uff1a\u627f\u8a8d\u3055\u308c\u305f\u5909\u66f4\u8d77\u6848\u3092\u3082\u3068\u306b\u3001\u6539\u8a02\u304c\u5fc5\u8981\u306a\u7b87\u6240\u3068\u6587\u9762\u6848\u3092\u793a\u3059<\/li>\n\n\n\n<li>\u6587\u66f8\u306e\u6a2a\u65ad\u691c\u7d22\uff1a\u8907\u6570\u306e\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u307e\u305f\u304c\u308b\u6587\u66f8\u3092\u81ea\u7136\u8a00\u8a9e\u3067\u63a2\u3059<\/li>\n\n\n\n<li>\u6574\u5408\u6027\u30c1\u30a7\u30c3\u30af\uff1a\u6539\u8a02\u6587\u66f8\u5185\u306e\u77db\u76fe\u3084\u3001\u95a2\u9023\u6587\u66f8\u306e\u6539\u8a02\u6f0f\u308c\u3092\u691c\u51fa\u3059\u308b<\/li>\n\n\n\n<li>\u6821\u6b63\u30fb\u8868\u8a18\u7d71\u4e00\uff1a\u7528\u8a9e\u306e\u7d71\u4e00\u3084\u793e\u5185\u30eb\u30fc\u30eb\u3078\u306e\u6e96\u62e0\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u5b9a\u578b\u6587\u66f8\u306e\u4e0b\u66f8\u304d\uff1a\u88fd\u54c1\u54c1\u8cea\u306e\u7167\u67fb\u5831\u544a\u66f8\u306a\u3069\u306e\u30c9\u30e9\u30d5\u30c8\u3092\u4f5c\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u4e00\u65b9\u3001\u4eba\u304c\u5fc5\u305a\u62c5\u3046\u3079\u304d\u696d\u52d9\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u54c1\u8cea\u306b\u95a2\u3059\u308b\u6700\u7d42\u5224\u65ad\uff1a\u51fa\u8377\u5224\u5b9a\u3084\u9038\u8131\u306e\u5f71\u97ff\u8a55\u4fa1<\/li>\n\n\n\n<li>\u6587\u66f8\u306e\u627f\u8a8d\uff1a\u6a29\u9650\u3092\u6301\u3064\u8cac\u4efb\u8005\u306b\u3088\u308b\u627f\u8a8d\u884c\u70ba<\/li>\n\n\n\n<li>\u898f\u5236\u5bfe\u5fdc\u306e\u610f\u601d\u6c7a\u5b9a\uff1a\u898f\u5236\u306e\u89e3\u91c8\u3084\u5f53\u5c40\u3078\u306e\u5bfe\u5fdc\u65b9\u91dd\u306e\u6c7a\u5b9a<\/li>\n\n\n\n<li>AI\u51fa\u529b\u306e\u30ec\u30d3\u30e5\u30fc\uff1aAI\u304c\u4f5c\u6210\u3057\u305f\u30c9\u30e9\u30d5\u30c8\u306e\u6b63\u78ba\u6027\u30fb\u59a5\u5f53\u6027\u3092\u5c02\u9580\u5bb6\u304c\u78ba\u8a8d\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001\u8a66\u9a13\u7d50\u679c\u3092\u5165\u529b\u3059\u308b\u3068\u898f\u683c\u3068\u7167\u5408\u3057\u3066\u81ea\u52d5\u3067\u300c\u5408\u683c\u300d\u3068\u51fa\u529b\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306b\u3064\u3044\u3066\u3001\u51fa\u529b\u81ea\u4f53\u306f\u5dee\u3057\u652f\u3048\u306a\u3044\u3068\u3057\u3064\u3064\u3001\u54c1\u8cea\u90e8\u9580\u304c\u3042\u3089\u305f\u3081\u3066\u7d50\u679c\u3092\u691c\u8a0e\u3057\u3001\u9069\u5426\u3092\u5224\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u793a\u3057\u3066\u3044\u307e\u3059\u3002AI\u306e\u51fa\u529b\u306b\u3064\u3044\u3066\u3082\u3001\u540c\u3058\u8003\u3048\u65b9\u3067\u3001\u4eba\u306b\u3088\u308b\u5224\u5b9a\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u53c2\u8003\u3068\u3057\u3066\u3001\u533b\u85ac\u54c1\u958b\u767a\u306e\u9818\u57df\u3067\u306f\u3001\u5869\u91ce\u7fa9\u88fd\u85ac\u304c2026\u5e742\u670824\u65e5\u306b\u751f\u6210AI\u306b\u3088\u308b\u898f\u5236\u95a2\u9023\u6587\u66f8\u306e\u4f5c\u6210\u652f\u63f4\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u540c\u793e\u306ePoC\uff08\u6982\u5ff5\u5b9f\u8a3c\uff09\u3067\u306f\u3001\u6cbb\u9a13\u7dcf\u62ec\u5831\u544a\u66f8\u306e\u4f5c\u6210\u6642\u9593\u3092\u7d0450\uff05\u3001\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306e\u4f5c\u6210\u6642\u9593\u3092\u7d0420\uff05\u524a\u6e1b\u3059\u308b\u52b9\u679c\u3092\u78ba\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002GMP\u6587\u66f8\u3067\u306f\u306a\u304f\u6cbb\u9a13\u95a2\u9023\u6587\u66f8\u306e\u4e8b\u4f8b\u3067\u3059\u304c\u3001AI\u306b\u3088\u308b\u4e0b\u66f8\u304d\u304c\u6587\u66f8\u4f5c\u6210\u306e\u5de5\u6570\u524a\u6e1b\u306b\u3064\u306a\u304c\u308a\u3046\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.shionogi.com\/jp\/ja\/news\/2026\/02\/20260224.html\" rel=\"nofollow\">\u5869\u91ce\u7fa9\u88fd\u85ac\u300c\u5869\u91ce\u7fa9\u88fd\u85ac\u3068\u65e5\u7acb\u3001\u751f\u6210AI\u3092\u6d3b\u7528\u3057\u305f\u533b\u85ac\u54c1\u958b\u767a\u306e\u898f\u5236\u95a2\u9023\u6587\u66f8\u4f5c\u6210\u652f\u63f4\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u958b\u59cb\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-26\">AI\u6d3b\u7528\u6642\u306e\u898f\u5236\u4e0a\u306e\u7559\u610f\u70b9<\/h3>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u306bAI\u3092\u5c0e\u5165\u3059\u308b\u969b\u306f\u3001<mark>AI\u306e\u7528\u9014\u3068\u30ea\u30b9\u30af\u3092\u5b9a\u3081\u3001\u4eba\u306b\u3088\u308b\u78ba\u8a8d\u3068\u8a18\u9332\u3092\u7d44\u307f\u8fbc\u3080\u3053\u3068<\/mark>\u304c\u57fa\u672c\u3067\u3059\u3002<\/p>\n\n\n\n<p>EU GMP Annex 22\u306e\u6848\u3067\u306f\u3001\u78ba\u7387\u7684\u306b\u51fa\u529b\u304c\u5909\u308f\u308b\u751f\u6210AI\u3084LLM\u3092\u91cd\u8981\u306aGMP\u7528\u9014\u306b\u4f7f\u308f\u306a\u3044\u65b9\u5411\u6027\u304c\u793a\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u306e\u6271\u3044\u306f2026\u5e74\u6642\u70b9\u3067\u3082\u691c\u8a0e\u4e2d\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001AI\u306e\u7528\u9014\u306f\u5f53\u9762\u3001\u691c\u7d22\u88dc\u52a9\u3084\u30c9\u30e9\u30d5\u30c8\u4f5c\u6210\u306a\u3069\u4eba\u304c\u6700\u7d42\u78ba\u8a8d\u3059\u308b\u696d\u52d9\u3092\u4e2d\u5fc3\u306b\u8a2d\u8a08\u3059\u308b\u306e\u304c\u73fe\u5b9f\u7684\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002FDA\u306e\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001AI\u30e2\u30c7\u30eb\u306e\u4fe1\u983c\u6027\u3092\u8a55\u4fa1\u3059\u308b\u624b\u9806\u3068\u3057\u3066\u3001\u6b21\u306e\u6d41\u308c\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>AI\u3067\u7b54\u3048\u305f\u3044\u554f\u3044\u3092\u5b9a\u3081\u308b<\/li>\n\n\n\n<li>\u4f7f\u7528\u76ee\u7684\uff08COU\uff09\u3092\u5b9a\u3081\u308b<\/li>\n\n\n\n<li>\u30e2\u30c7\u30eb\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b<\/li>\n\n\n\n<li>\u4fe1\u983c\u6027\u8a55\u4fa1\u306e\u8a08\u753b\u3092\u7acb\u3066\u308b<\/li>\n\n\n\n<li>\u8a08\u753b\u3092\u5b9f\u884c\u3059\u308b<\/li>\n\n\n\n<li>\u7d50\u679c\u3092\u6587\u66f8\u5316\u3059\u308b<\/li>\n\n\n\n<li>\u4f7f\u7528\u76ee\u7684\u306b\u5bfe\u3057\u3066\u59a5\u5f53\u304b\u3092\u5224\u65ad\u3059\u308b<\/li>\n<\/ol>\n\n\n\n<p>\u3042\u308f\u305b\u3066\u3001\u7279\u5b9a\u306e\u4f7f\u7528\u76ee\u7684\u3067\u306f\u3001\u904b\u7528\u4e2d\u3082AI\u30e2\u30c7\u30eb\u306e\u51fa\u529b\u306e\u4fe1\u983c\u6027\u3092\u7dad\u6301\u7ba1\u7406\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3060\u3068\u3057\u3066\u3044\u307e\u3059\u3002GMP\u6587\u66f8\u7ba1\u7406\u306b\u7f6e\u304d\u63db\u3048\u308b\u3068\u3001\u6b21\u306e\u3088\u3046\u306a\u7ba1\u7406\u304c\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u3069\u306e\u696d\u52d9\u306bAI\u3092\u4f7f\u3046\u304b\u3092\u624b\u9806\u66f8\u3067\u5b9a\u3081\u308b<\/li>\n\n\n\n<li>\u8ab0\u304cAI\u306e\u51fa\u529b\u3092\u78ba\u8a8d\u30fb\u627f\u8a8d\u3057\u305f\u304b\u3092\u8a18\u9332\u306b\u6b8b\u3059<\/li>\n\n\n\n<li>AI\u30c4\u30fc\u30eb\u3084\u30e2\u30c7\u30eb\u306e\u5909\u66f4\u3092\u5909\u66f4\u7ba1\u7406\u306e\u5bfe\u8c61\u3068\u3059\u308b<\/li>\n\n\n\n<li>\u5229\u7528\u8005\u3078\u306e\u6559\u80b2\u8a13\u7df4\u3092\u884c\u3046<\/li>\n<\/ul>\n\n\n\n<p>\u898f\u5236\u52d5\u5411\u3092\u78ba\u8a8d\u3057\u306a\u304c\u3089\u3001\u4eba\u306e\u76e3\u7763\u3092\u7d44\u307f\u8fbc\u3093\u3060\u5f62\u3067AI\u6d3b\u7528\u3092\u6bb5\u968e\u7684\u306b\u9032\u3081\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.ema.europa.eu\/en\/events\/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22\" rel=\"nofollow\">EMA\u300cGood manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological\" rel=\"nofollow\">FDA\u300cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products\uff08Draft Guidance\uff09\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-27\">GMP\u6587\u66f8\u7ba1\u7406\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n<p>GMP\u6587\u66f8\u7ba1\u7406\u306b\u3064\u3044\u3066\u3001<mark>\u6c4e\u7528\u30b9\u30c8\u30ec\u30fc\u30b8\u306e\u5229\u7528\u3001\u96fb\u5b50\u7f72\u540d\u3068Part 11\u306e\u95a2\u4fc2\u3001\u7d19\u306e\u6587\u66f8\u30fb\u8a18\u9332\u306e\u5ec3\u6b62<\/mark>\u306b\u95a2\u3059\u308b\u7591\u554f\u306b\u304a\u7b54\u3048\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SharePoint\u306a\u3069\u306e\u6c4e\u7528\u30b9\u30c8\u30ec\u30fc\u30b8\u3060\u3051\u3067GMP\u6587\u66f8\u3092\u7ba1\u7406\u3067\u304d\u307e\u3059\u304b\uff1f<\/li>\n\n\n\n<li>\u96fb\u5b50\u7f72\u540d\u304c\u3042\u308c\u307021 CFR Part 11\u306b\u81ea\u52d5\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u304b\uff1f<\/li>\n\n\n\n<li>\u7d19\u306e\u6587\u66f8\u30fb\u8a18\u9332\u3092\u5b8c\u5168\u306b\u5ec3\u6b62\u3067\u304d\u307e\u3059\u304b\uff1f<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-28\">SharePoint\u306a\u3069\u306e\u6c4e\u7528\u30b9\u30c8\u30ec\u30fc\u30b8\u3060\u3051\u3067GMP\u6587\u66f8\u3092\u7ba1\u7406\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u6c4e\u7528\u30b9\u30c8\u30ec\u30fc\u30b8\u3067GMP\u6587\u66f8\u3092\u6271\u3046\u3053\u3068\u81ea\u4f53\u306f\u53ef\u80fd\u3067\u3059\u304c\u3001<mark>ER\/ES\u6307\u91dd\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u8a2d\u5b9a\u30fb\u904b\u7528\u3068CSV\u304c\u524d\u63d0<\/mark>\u3067\u3059\u3002GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001GMP\u6587\u66f8\u3092\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3067\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b\u6761\u4ef6\u3068\u3057\u3066\u3001ER\/ES\u6307\u91dd\u306e\u8981\u4ef6\u3092\u5099\u3048\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u57fa\u3065\u3044\u3066\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u6319\u3052\u3066\u3044\u307e\u3059\u3002\u6c4e\u7528\u30b9\u30c8\u30ec\u30fc\u30b8\u3067\u306f\u3001\u5c11\u306a\u304f\u3068\u3082\u4ee5\u4e0b\u306e\u70b9\u3092\u81ea\u793e\u306e\u8981\u4ef6\u306b\u7167\u3089\u3057\u3066\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u627f\u8a8d\u306e\u8a18\u9332\u304c\u6539\u3056\u3093\u3055\u308c\u306a\u3044\u5f62\u3067\u6b8b\u308b\u627f\u8a8d\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<\/li>\n\n\n\n<li>ER\/ES\u6307\u91dd\u3084Part 11\u306e\u8981\u4ef6\u306b\u6cbf\u3063\u305f\u96fb\u5b50\u7f72\u540d<\/li>\n\n\n\n<li>\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u524a\u9664\u3068\u305d\u306e\u7406\u7531\u3092\u8a18\u9332\u3059\u308b\u76e3\u67fb\u8a3c\u8de1<\/li>\n\n\n\n<li>\u6709\u52b9\u7248\u3068\u65e7\u7248\u3092\u533a\u5225\u3059\u308b\u30a2\u30af\u30bb\u30b9\u5236\u5fa1<\/li>\n\n\n\n<li>\u6587\u66f8\u6539\u8a02\u3068\u6559\u80b2\u8a13\u7df4\u8a18\u9332\u3068\u306e\u9023\u52d5<\/li>\n<\/ul>\n\n\n\n<p>\u4e0d\u8db3\u3059\u308b\u6a5f\u80fd\u306f\u30a2\u30c9\u30aa\u30f3\u3084\u904b\u7528\u30eb\u30fc\u30eb\u3067\u88dc\u3046\u304b\u3001GMP\u5bfe\u5fdc\u306eEDMS\u306e\u5c0e\u5165\u3092\u691c\u8a0e\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-29\">\u96fb\u5b50\u7f72\u540d\u304c\u3042\u308c\u307021 CFR Part 11\u306b\u81ea\u52d5\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p><mark>\u96fb\u5b50\u7f72\u540d\u3092\u5c0e\u5165\u3057\u305f\u3060\u3051\u3067\u306f\u300121 CFR Part 11\u3078\u306e\u5bfe\u5fdc\u3068\u3057\u3066\u4e0d\u5341\u5206<\/mark>\u3067\u3059\u3002Part 11\u306f\u3001\u96fb\u5b50\u7f72\u540d\u306b\u52a0\u3048\u3066\u3001\u96fb\u5b50\u8a18\u9332\u3092\u6271\u3046\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u306e\u7ba1\u7406\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u4e3b\u306a\u8981\u4ef6\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u6b63\u78ba\u6027\u30fb\u4fe1\u983c\u6027\u30fb\u4e00\u8cab\u3057\u305f\u6027\u80fd\u3092\u691c\u8a3c\u3059\u308b<\/li>\n\n\n\n<li>\u76e3\u67fb\u8a3c\u8de1\uff1a\u4f5c\u6210\u30fb\u5909\u66f4\u30fb\u524a\u9664\u3092\u3001\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u4ed8\u304d\u3067\u5b89\u5168\u306b\u8a18\u9332\u3059\u308b<\/li>\n\n\n\n<li>\u30a2\u30af\u30bb\u30b9\u5236\u9650\u3068\u6a29\u9650\u30c1\u30a7\u30c3\u30af\uff1a\u8a31\u53ef\u3055\u308c\u305f\u4eba\u3060\u3051\u304c\u64cd\u4f5c\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b<\/li>\n\n\n\n<li>ID\u30fb\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u7ba1\u7406\uff1a\u7d44\u307f\u5408\u308f\u305b\u306e\u4e00\u610f\u6027\u3001\u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u3001\u4e0d\u6b63\u4f7f\u7528\u306e\u8a66\u307f\u306e\u691c\u77e5\u3068\u5831\u544a<\/li>\n\n\n\n<li>\u6559\u80b2\u3068\u8cac\u4efb\uff1a\u5229\u7528\u8005\u306e\u6559\u80b2\u30fb\u8a13\u7df4\u3068\u3001\u96fb\u5b50\u7f72\u540d\u306b\u5bfe\u3059\u308b\u8cac\u4efb\u3092\u5b9a\u3081\u305f\u65b9\u91dd<\/li>\n\n\n\n<li>\u30b7\u30b9\u30c6\u30e0\u6587\u66f8\u306e\u7ba1\u7406\uff1a\u624b\u9806\u66f8\u306a\u3069\u306e\u914d\u4ed8\u30fb\u6539\u8a02\u306e\u7ba1\u7406<\/li>\n<\/ul>\n\n\n\n<p>\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u7d4c\u7531\u306a\u3069\u306e\u30aa\u30fc\u30d7\u30f3\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u6587\u66f8\u306e\u6697\u53f7\u5316\u306a\u3069\u306e\u8ffd\u52a0\u63aa\u7f6e\u3082\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u96fb\u5b50\u7f72\u540d\u306fPart 11\u5bfe\u5fdc\u306e\u4e00\u8981\u7d20\u306b\u3059\u304e\u306a\u3044\u305f\u3081\u3001\u5b9a\u671f\u7684\u306a\u81ea\u5df1\u70b9\u691c\u3067\u7ba1\u7406\u5168\u4f53\u304c\u6a5f\u80fd\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-11\" rel=\"nofollow\">eCFR\u300c21 CFR Part 11 \u2013 Electronic Records; Electronic Signatures\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-30\">\u7d19\u306e\u6587\u66f8\u30fb\u8a18\u9332\u3092\u5b8c\u5168\u306b\u5ec3\u6b62\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>GMP\u6587\u66f8\u3092\u96fb\u5b50\u7684\u306b\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b\u3053\u3068\u81ea\u4f53\u306f\u8a8d\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u304c\u3001<mark>\u624b\u66f8\u304d\u306e\u8a18\u9332\u3092\u5f8c\u304b\u3089\u96fb\u5b50\u5316\u3057\u305f\u5834\u5408\u306f\u3001\u5143\u306e\u624b\u66f8\u304d\u8a18\u9332\u3082\u4fdd\u7ba1\u3059\u308b\u5fc5\u8981<\/mark>\u304c\u3042\u308a\u307e\u3059\u3002GMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306f\u3001\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u306b\u4fdd\u7ba1\u3057\u305f\u5834\u5408\u3067\u3082\u3001\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u89b3\u70b9\u304b\u3089\u5143\u306e\u624b\u66f8\u304d\u306e\u8a18\u9332\u3092\u5225\u9014\u4fdd\u7ba1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u7d19\u3092\u3069\u3053\u307e\u3067\u6e1b\u3089\u305b\u308b\u304b\u306f\u3001\u4ee5\u4e0b\u306e\u89b3\u70b9\u3067\u5224\u65ad\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8a18\u9332\u306e\u767a\u751f\u6e90\uff1a\u6700\u521d\u304b\u3089\u96fb\u5b50\u3067\u8a18\u9332\u3067\u304d\u308b\u304b\u3001\u624b\u66f8\u304d\u306e\u539f\u8a18\u9332\u304c\u6b8b\u308b\u304b<\/li>\n\n\n\n<li>\u4f5c\u696d\u74b0\u5883\uff1a\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5185\u306a\u3069\u3001\u7aef\u672b\u306e\u6301\u3061\u8fbc\u307f\u3084\u64cd\u4f5c\u306b\u5236\u7d04\u304c\u306a\u3044\u304b<\/li>\n\n\n\n<li>\u969c\u5bb3\u6642\u306e\u904b\u7528\uff1a\u30b7\u30b9\u30c6\u30e0\u505c\u6b62\u6642\u306b\u696d\u52d9\u3092\u7d9a\u3051\u308b\u305f\u3081\u306e\u624b\u9806\u304c\u5fc5\u8981\u304b<\/li>\n\n\n\n<li>\u79fb\u884c\u306e\u8ca0\u62c5\uff1a\u904e\u53bb\u6587\u66f8\u306e\u96fb\u5b50\u5316\u306b\u304b\u304b\u308b\u8cbb\u7528\u3068\u671f\u9593<\/li>\n<\/ul>\n\n\n\n<p>\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u6587\u66f8\u304b\u3089\u6bb5\u968e\u7684\u306b\u96fb\u5b50\u5316\u3057\u3001\u79fb\u884c\u671f\u9593\u4e2d\u306e\u7d19\u6587\u66f8\u306e\u767a\u884c\u30fb\u56de\u53ce\u30d5\u30ed\u30fc\u3082\u3042\u308f\u305b\u3066\u5b9a\u3081\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000246306.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u30fb\u751f\u6d3b\u885b\u751f\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300cGMP\u4e8b\u4f8b\u96c6\uff082022\u5e74\u7248\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-31\">\u88fd\u85ac\u306eGMP\u6587\u66f8\u7ba1\u7406\u3092\u9069\u5207\u306b\u904b\u7528\u3059\u308b\u305f\u3081\u306b<\/h2>\n\n\n\n<p>\u88fd\u85ac\u306eGMP\u6587\u66f8\u7ba1\u7406\u3092\u9069\u5207\u306b\u904b\u7528\u3059\u308b\u306b\u306f\u3001<mark>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\u3001\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3001\u96fb\u5b50\u5316\u30fbAI\u306b\u3088\u308b\u52b9\u7387\u5316<\/mark>\u306e3\u3064\u3092\u4e26\u884c\u3057\u3066\u9032\u3081\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\uff1aALCOA+\u306b\u57fa\u3065\u304d\u3001\u7d19\u30fb\u96fb\u5b50\u3092\u554f\u308f\u305a\u30c7\u30fc\u30bf\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3067\u8a18\u9332\u306e\u4fe1\u983c\u6027\u3092\u4fdd\u3064<\/li>\n\n\n\n<li>\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\uff1a\u6539\u6b63GMP\u7701\u4ee4\u306e\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u30fb\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30fb\u6587\u66f8\u3068\u8a18\u9332\u306e\u4fe1\u983c\u6027\u78ba\u4fdd\u306b\u52a0\u3048\u3001ER\/ES\u6307\u91dd\u3001\u7c73\u56fd\u5411\u3051\u306b\u4f9b\u7d66\u3059\u308b\u5834\u5408\u306fPart 11\u3092\u81ea\u793e\u306e\u4f53\u5236\u306b\u53cd\u6620\u3059\u308b<\/li>\n\n\n\n<li>\u96fb\u5b50\u5316\u30fbAI\u306b\u3088\u308b\u52b9\u7387\u5316\uff1aEDMS\u306e\u5c0e\u5165\u3068CSV\u3092\u9032\u3081\u3001AI\u306f\u4eba\u306b\u3088\u308b\u78ba\u8a8d\u3092\u524d\u63d0\u306b\u691c\u7d22\u3084\u30c9\u30e9\u30d5\u30c8\u4f5c\u6210\u304b\u3089\u6d3b\u7528\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u6700\u521d\u306e\u4e00\u6b69\u3068\u3057\u3066\u3001\u3069\u306e\u6587\u66f8\u3092\u8ab0\u304c\u3069\u306e\u65b9\u6cd5\u3067\u7ba1\u7406\u3057\u3066\u3044\u308b\u304b\u3092\u6d17\u3044\u51fa\u3057\u3001\u73fe\u5728\u306e\u6587\u66f8\u7ba1\u7406\u4f53\u5236\u3092\u68da\u5378\u3057\u3057\u307e\u3057\u3087\u3046\u3002\u305d\u306e\u3046\u3048\u3067ALCOA+\u3084\u6539\u6b63GMP\u7701\u4ee4\u306e\u8981\u4ef6\u306b\u7167\u3089\u3057\u3066\u8ab2\u984c\u3092\u7279\u5b9a\u3059\u308c\u3070\u3001\u96fb\u5b50\u5316\u3084AI\u6d3b\u7528\u306e\u512a\u5148\u9806\u4f4d\u3092\u6839\u62e0\u3092\u3082\u3063\u3066\u6c7a\u3081\u3089\u308c\u307e\u3059\u3002\u898f\u5236\u306e\u8981\u6c42\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u3066\u8a08\u753b\u7684\u306b\u53d6\u308a\u7d44\u3080\u3053\u3068\u3067\u3001\u67fb\u5bdf\u3078\u306e\u5099\u3048\u3068\u696d\u52d9\u8ca0\u62c5\u306e\u8efd\u6e1b\u3092\u4e21\u7acb\u3067\u304d\u307e\u3059\u3002AI\u306b\u3088\u308b\u6587\u66f8\u6539\u8a02\u652f\u63f4\u306e\u5177\u4f53\u7684\u306a\u30a4\u30e1\u30fc\u30b8\u3092\u77e5\u308a\u305f\u3044\u65b9\u306f\u3001<a 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