{"id":11062,"date":"2026-11-07T01:31:46","date_gmt":"2026-11-06T16:31:46","guid":{"rendered":"https:\/\/japan-ai.geniee.co.jp\/media\/?p=11062"},"modified":"2026-11-07T01:31:46","modified_gmt":"2026-11-06T16:31:46","slug":"%e3%82%b3%e3%83%b3%e3%83%94%e3%83%a5%e3%83%bc%e3%82%bf%e5%8c%96%e3%82%b7%e3%82%b9%e3%83%86%e3%83%a0%e3%83%90%e3%83%aa%e3%83%87%e3%83%bc%e3%82%b7%e3%83%a7%e3%83%b3%ef%bc%88csv%ef%bc%89%e3%81%a8","status":"publish","type":"post","link":"https:\/\/japan-ai.co.jp\/media\/11062\/","title":{"rendered":"\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3068\u306f\uff1f\u88fd\u85ac\u696d\u754c\u306e\u54c1\u8cea\u7ba1\u7406\u306b\u5fc5\u9808\u306e\u57fa\u790e\u77e5\u8b58"},"content":{"rendered":"\n<p>\u88fd\u85ac\u696d\u754c\u3067\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u30fb\u904b\u7528\u3059\u308b\u969b\u306b\u907f\u3051\u3066\u901a\u308c\u306a\u3044\u306e\u304c\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3067\u3059\u3002\u65e5\u672c\u3067\u306f\u3001\u539a\u751f\u52b4\u50cd\u7701\u304c2010\u5e7410\u670821\u65e5\u306b\u767a\u51fa\u3057\u305f\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\uff08\u85ac\u98df\u76e3\u9ebb\u767a1021\u7b2c11\u53f7\uff09\u304c\u3001GQP\u7701\u4ee4\u30fbGMP\u7701\u4ee4\u306b\u57fa\u3065\u304f\u696d\u52d9\u3067\u4f7f\u3046\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u7ba1\u7406\u65b9\u6cd5\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u672c\u8a18\u4e8b\u3067\u306f\u3001CSV\u306e\u5b9a\u7fa9\u3084\u76ee\u7684\u304b\u3089\u3001\u95a2\u9023\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3001\u691c\u8a3c\u30d7\u30ed\u30bb\u30b9\u3068\u9069\u683c\u6027\u8a55\u4fa1\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u3001\u305d\u3057\u3066CSA\u3068\u306e\u9055\u3044\u3084\u5b9f\u52d9\u4e0a\u306e\u8ab2\u984c\u307e\u3067\u3001<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">\u88fd\u85ac\u696d\u754c\u5411\u3051AI\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u63d0\u4f9b\u3059\u308bJAPAN AI<\/a>\u304c\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"toc\">    <div id=\"toc_container\" class=\"toc_container toc-container sgb-toc--bullets js-smooth-scroll\" data-dialog-title=\"Table of Contents\">\n      <p class=\"toc_title\">\u76ee\u6b21 <\/p>\n      <ul class=\"toc_list\">  <li class=\"first\">    <a href=\"#i-0\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3068\u306f\uff1f<\/a>  <\/li>  <li>    <a href=\"#i-1\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u76ee\u7684<\/a>  <\/li>  <li>    <a href=\"#i-2\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u5bfe\u8c61\u3068\u306a\u308b\u30b7\u30b9\u30c6\u30e0<\/a>    <ul class=\"menu_level_1\">      <li class=\"first last\">        <a href=\"#i-3\">\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-4\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>  <\/li>  <li>    <a href=\"#i-5\">GAMP 5\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-6\">\u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5de5\u6570\u306e\u9055\u3044<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-7\">GAMP 5 \u7b2c2\u7248\u3067\u5f37\u5316\u3055\u308c\u305f\u70b9<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-8\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u30d7\u30ed\u30bb\u30b9<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-9\">\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\uff08URS\uff09<\/a>      <\/li>      <li>        <a href=\"#i-10\">\u8a2d\u8a08\u30fb\u69cb\u7bc9<\/a>      <\/li>      <li>        <a href=\"#i-11\">\u691c\u8a3c\uff08\u30c6\u30b9\u30c8\uff09<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-12\">\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5831\u544a\u30fb\u627f\u8a8d<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-13\">DQ\u30fbIQ\u30fbOQ\u30fbPQ\u3068\u306f<\/a>  <\/li>  <li>    <a href=\"#i-14\">\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1<\/a>  <\/li>  <li>    <a href=\"#i-15\">CSV\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-16\">\u904b\u7528\u30fb\u4fdd\u5b88<\/a>      <\/li>      <li>        <a href=\"#i-17\">\u5909\u66f4\u7ba1\u7406<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-18\">\u5ec3\u68c4<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-19\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3068\u306e\u95a2\u4fc2<\/a>  <\/li>  <li>    <a href=\"#i-20\">CSV\u3068CSA\u306e\u9055\u3044<\/a>  <\/li>  <li>    <a href=\"#i-21\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u8ab2\u984c\u3068\u5bfe\u5fdc\u7b56<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-22\">\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u5fb9\u5e95<\/a>      <\/li>      <li>        <a href=\"#i-23\">\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306e\u6d3b\u7528<\/a>      <\/li>      <li>        <a href=\"#i-24\">\u30d9\u30f3\u30c0\u30fc\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\u306e\u6d3b\u7528<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-25\">\u751f\u6210AI\u3092\u6d3b\u7528\u3057\u305fCSV\u696d\u52d9\u306e\u52b9\u7387\u5316<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-26\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-27\">CSV\u3067\u306f\u3069\u306e\u3088\u3046\u306a\u6587\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-28\">CSV\u3068CSA\u306f\u3069\u3061\u3089\u306b\u5bfe\u5fdc\u3059\u3079\u304d\u3067\u3059\u304b\uff1f<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-29\">CSV\u306f\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u5f8c\u3082\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/a>      <\/li>    <\/ul>  <\/li>  <li class=\"last\">    <a href=\"#i-30\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u3066\u54c1\u8cea\u7ba1\u7406\u306b\u6d3b\u304b\u305d\u3046<\/a>  <\/li><\/ul>\n      \n    <\/div><\/div><h2 class=\"wp-block-heading\" id=\"i-0\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u3068\u306f\uff1f<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff1aComputerized System Validation\uff09\u3068\u306f\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u305d\u306e\u8a18\u9332\u3092\u7dad\u6301\u3059\u308b\u6d3b\u52d5\u3067\u3059\u3002\u539a\u751f\u52b4\u50cd\u7701\u306e\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001GQP\u7701\u4ee4\u30fbGMP\u7701\u4ee4\u306b\u57fa\u3065\u304f\u696d\u52d9\u3092\u884c\u3046\u305f\u3081\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306b\u3064\u3044\u3066\u3001\u958b\u767a\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30fb\u904b\u7528\u7ba1\u7406\uff08\u30d0\u30ea\u30c7\u30fc\u30c8\u3055\u308c\u305f\u72b6\u614b\u306e\u7dad\u6301\u3084\u5ec3\u68c4\u3092\u542b\u3080\uff09\u306e\u9075\u5b88\u4e8b\u9805\u3092\u5b9a\u3081\u3001\u4e21\u7701\u4ee4\u306e\u9069\u6b63\u306a\u5b9f\u65bd\u306e\u78ba\u4fdd\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u540c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u5e73\u621022\u5e74\uff082010\u5e74\uff0910\u670821\u65e5\u306b\u767a\u51fa\u3055\u308c\u3001\u5e73\u621024\u5e74\uff082012\u5e74\uff094\u67081\u65e5\u304b\u3089\u9069\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u306a\u304a\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u793a\u3055\u308c\u305f\u7ba1\u7406\u65b9\u6cd5\u306f\u6a19\u6e96\u7684\u306a\u4f8b\u3067\u3042\u308a\u3001\u540c\u7b49\u307e\u305f\u306f\u305d\u308c\u4ee5\u4e0a\u306e\u76ee\u7684\u3092\u9054\u6210\u3067\u304d\u308b\u65b9\u6cd5\u3067\u3042\u308c\u3070\u3001\u4ee3\u308f\u308a\u306e\u65b9\u6cd5\u3092\u7528\u3044\u3066\u3082\u5dee\u3057\u652f\u3048\u306a\u3044\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>CSV\u304c\u6c42\u3081\u3089\u308c\u308b\u80cc\u666f\u306b\u306f\u3001\u88fd\u85ac\u696d\u754c\u7279\u6709\u306e\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\u306b\u4f7f\u7528\u3055\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u306b\u4e0d\u5177\u5408\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u4f4e\u4e0b\u3092\u62db\u304d\u3001\u6700\u7d42\u7684\u306b\u306f\u60a3\u8005\u306e\u5b89\u5168\u3092\u8105\u304b\u3057\u304b\u306d\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u305f\u3068\u3048\u3070\u3001\u54c1\u8cea\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u7ba1\u7406\u3059\u308bLIMS\uff08\u30e9\u30dc\u60c5\u5831\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff09\u3067\u8a08\u7b97\u30ed\u30b8\u30c3\u30af\u306b\u8aa4\u308a\u304c\u3042\u308b\u3068\u3001\u898f\u683c\u5916\u306e\u88fd\u54c1\u304c\u51fa\u8377\u3055\u308c\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u304c\u6b63\u3057\u304f\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001\u305d\u306e\u7d50\u679c\u3092\u8a18\u9332\u306b\u6b8b\u3059\u3053\u3068\u3067\u3001\u54c1\u8cea\u306b\u95a2\u308f\u308b\u5224\u65ad\u306e\u4fe1\u983c\u6027\u3092\u793e\u5185\u5916\u306b\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-1\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u76ee\u7684<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u76f4\u63a5\u306e\u76ee\u7684\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001GQP\u30fbGMP\u306e\u9069\u6b63\u306a\u5b9f\u65bd\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u305d\u306e\u3046\u3048\u3067\u5b9f\u52d9\u3067\u306f\u3001\u60a3\u8005\u5b89\u5168\u30fb\u88fd\u54c1\u54c1\u8cea\u30fb\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e3\u3064\u3092\u3001\u6d3b\u52d5\u306e\u512a\u5148\u9806\u4f4d\u3092\u6c7a\u3081\u308b\u8ef8\u3068\u3057\u3066\u6574\u7406\u3059\u308b\u306e\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u3053\u308c\u30893\u3064\u306e\u89b3\u70b9\u306f\u3001GAMP 5\u306a\u3069\u3067\u91cd\u8996\u3055\u308c\u308b\u54c1\u8cea\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5b9f\u52d9\u306b\u9069\u7528\u3059\u308b\u3046\u3048\u3067\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u60a3\u8005\u5b89\u5168\u306e\u78ba\u4fdd\uff1a\u30b7\u30b9\u30c6\u30e0\u306e\u4e0d\u5177\u5408\u306b\u3088\u308b\u54c1\u8cea\u4e8b\u6545\u3092\u672a\u7136\u306b\u9632\u6b62\u3057\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3092\u5b88\u308b<\/li>\n\n\n\n<li>\u88fd\u54c1\u54c1\u8cea\u306e\u4fdd\u8a3c\uff1a\u88fd\u9020\u30fb\u8a66\u9a13\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u30b7\u30b9\u30c6\u30e0\u304c\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u5ba2\u89b3\u7684\u306b\u793a\u3059<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\uff1a\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u30fb\u4e00\u8cab\u6027\u30fb\u6b63\u78ba\u6027\u3092\u7dad\u6301\u3057\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u8aac\u660e\u8cac\u4efb\u3092\u679c\u305f\u3059<\/li>\n<\/ul>\n\n\n\n<p>CSV\u306f\u5358\u306a\u308b\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u958b\u767a\u304b\u3089\u904b\u7528\u3001\u5ec3\u68c4\u307e\u3067\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u4f53\u7cfb\u7684\u306a\u53d6\u308a\u7d44\u307f\u3067\u3059\u3002\u7ba1\u7406\u898f\u5b9a\u306e\u6574\u5099\u3001\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3001\u9069\u683c\u6027\u8a55\u4fa1\u3001\u904b\u7528\u4e2d\u306e\u5909\u66f4\u7ba1\u7406\u3084\u81ea\u5df1\u70b9\u691c\u307e\u3067\u3092\u5305\u542b\u3059\u308b\u305f\u3081\u3001\u4e00\u5ea6\u5b9f\u65bd\u3057\u3066\u5b8c\u4e86\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u306b\u7dad\u6301\u30fb\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" rel=\"nofollow\">ISPE\u300cGAMP 5 Guide 2nd Edition\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-2\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u5bfe\u8c61\u3068\u306a\u308b\u30b7\u30b9\u30c6\u30e0<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u5bfe\u8c61\u306f\u3001\u539a\u52b4\u7701\u306e\u300c\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u304c\u5b9a\u3081\u308b\u3068\u304a\u308a\u3001GQP\u7701\u4ee4\u30fbGMP\u7701\u4ee4\u304c\u9069\u7528\u3055\u308c\u308b\u696d\u52d9\u306b\u4f7f\u308f\u308c\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002\u5bfe\u8c61\u30b7\u30b9\u30c6\u30e0\u306e\u4f8b\u3068\u3057\u3066\u3001\u5e02\u5834\u3078\u306e\u51fa\u8377\u5224\u5b9a\u3001\u88fd\u9020\u6307\u56f3\u66f8\u30fb\u88fd\u9020\u8a18\u9332\u306e\u4f5c\u6210\u30fb\u4fdd\u5b58\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u5236\u5fa1\u3001\u539f\u6750\u6599\u30fb\u88fd\u54c1\u306e\u5728\u5eab\u7ba1\u7406\u3001\u54c1\u8cea\u8a66\u9a13\u3001\u88fd\u9020\u652f\u63f4\u8a2d\u5099\u3001\u54c1\u8cea\u6587\u66f8\u306e\u7ba1\u7406\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u306a\u304a\u3001FDA\u306e2018\u5e74\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u307e\u305f\u306f\u95a2\u9023\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u3001\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u5468\u8fba\u6a5f\u5668\u3001\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3001\u30af\u30e9\u30a6\u30c9\u57fa\u76e4\u3001\u4eba\u54e1\u3001\u95a2\u9023\u6587\u66f8\u304c\u542b\u307e\u308c\u5f97\u308b\u3068\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u5358\u4f53\u3067\u306f\u306a\u304f\u3001\u904b\u7528\u3059\u308b\u4eba\u3084\u624b\u9806\u307e\u3067\u542b\u3081\u3066\u6349\u3048\u308b\u8996\u70b9\u306f\u3001\u5b9f\u52d9\u3067\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002\u4ee3\u8868\u7684\u306a\u30b7\u30b9\u30c6\u30e0\u306e\u4f8b\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MES\uff08\u88fd\u9020\u5b9f\u884c\u30b7\u30b9\u30c6\u30e0\uff09\uff1a\u88fd\u9020\u5de5\u7a0b\u306e\u7ba1\u7406\u30fb\u8a18\u9332\u3092\u62c5\u3044\u3001\u30d0\u30c3\u30c1\u3054\u3068\u306e\u88fd\u9020\u6761\u4ef6\u3084\u5b9f\u7e3e\u30c7\u30fc\u30bf\u3092\u96fb\u5b50\u7684\u306b\u7ba1\u7406\u3059\u308b<\/li>\n\n\n\n<li>LIMS\uff08\u30e9\u30dc\u60c5\u5831\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff09\uff1a\u54c1\u8cea\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u7ba1\u7406\u30fb\u96c6\u8a08\u3092\u884c\u3044\u3001\u8a66\u9a13\u7d50\u679c\u306e\u5224\u5b9a\u3084\u5831\u544a\u66f8\u4f5c\u6210\u3092\u652f\u63f4\u3059\u308b<\/li>\n\n\n\n<li>ERP\uff08\u57fa\u5e79\u696d\u52d9\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u3046\u3061GQP\u30fbGMP\u696d\u52d9\u306b\u4f7f\u308f\u308c\u308b\u6a5f\u80fd\uff1a\u51fa\u8377\u306e\u53ef\u5426\u3084\u8a18\u9332\u3001\u88fd\u9020\u6307\u56f3\u30fb\u88fd\u9020\u8a18\u9332\u3001\u539f\u6750\u6599\u30fb\u88fd\u54c1\u306e\u4fdd\u7ba1\u30fb\u51fa\u7d0d\u306a\u3069\u306b\u95a2\u308f\u308b\u6a5f\u80fd\u304c\u8a72\u5f53\u3057\u5f97\u308b\u3002\u4f1a\u8a08\u3084\u4eba\u4e8b\u306a\u3069\u5f53\u8a72\u696d\u52d9\u306b\u4f7f\u308f\u306a\u3044\u6a5f\u80fd\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3067\u5bfe\u8c61\u5916\u3068\u306a\u308a\u5f97\u308b<\/li>\n\n\n\n<li>\u5206\u6790\u88c5\u7f6e\u306e\u5236\u5fa1\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff1aHPLC\u3084\u8cea\u91cf\u5206\u6790\u8a08\u306a\u3069\u306e\u5206\u6790\u88c5\u7f6e\u3092\u5236\u5fa1\u3057\u3001\u6e2c\u5b9a\u30c7\u30fc\u30bf\u306e\u53d6\u5f97\u30fb\u51e6\u7406\u3092\u884c\u3046<\/li>\n\n\n\n<li>\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u30b7\u30b9\u30c6\u30e0\uff1a\u96fb\u5b50\u30d0\u30c3\u30c1\u8a18\u9332\u3084\u627f\u8a8d\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u7ba1\u7406\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306b\u5bfe\u5fdc\u3059\u308b<\/li>\n\n\n\n<li>\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08DMS\uff09\uff1aSOP\u3084\u54c1\u8cea\u6587\u66f8\u306e\u4f5c\u6210\u30fb\u627f\u8a8d\u30fb\u4fdd\u5b58\u3092\u7ba1\u7406\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/media\/119267\/download\" rel=\"nofollow\">FDA\u300cData Integrity and Compliance With Drug CGMP: Questions and Answers\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-3\">\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/h3>\n\n\n\n<p>\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u304a\u3051\u308b\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3068\u306f\u3001\u958b\u767a\u30fb\u691c\u8a3c\u30fb\u904b\u7528\u306e\u5404\u6bb5\u968e\u3067\u5b9f\u65bd\u3059\u3079\u304d\u5185\u5bb9\u3092\u6c7a\u3081\u308b\u305f\u3081\u306e\u8a55\u4fa1\u3067\u3059\u3002\u958b\u767a\u8cac\u4efb\u8005\u304c\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406\u898f\u5b9a\u306b\u57fa\u3065\u304d\u3001\u539f\u5247\u3068\u3057\u3066\u4ee5\u4e0b\u306e3\u3064\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e\uff1a\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u6210\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066\u3001\u3042\u3089\u304b\u3058\u3081\u30ab\u30c6\u30b4\u30ea\u3092\u6c7a\u5b9a\u3059\u308b<\/li>\n\n\n\n<li>\u88fd\u54c1\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\uff1a\u30b7\u30b9\u30c6\u30e0\u306e\u6a5f\u80fd\u304c\u88fd\u54c1\u54c1\u8cea\u306b\u4e0e\u3048\u308b\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b<\/li>\n\n\n\n<li>\u4f9b\u7d66\u8005\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\uff1a\u4f9b\u7d66\u8005\u306e\u9078\u5b9a\u3084\u59d4\u8a17\u306e\u7bc4\u56f2\u3001\u4f9b\u7d66\u8005\u76e3\u67fb\u306e\u8981\u5426\u3068\u5b9f\u65bd\u65b9\u6cd5\u3092\u6c7a\u3081\u308b\u305f\u3081\u306b\u4f9b\u7d66\u8005\u3092\u8a55\u4fa1\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e3\u3064\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u540c\u3058\u300c\u5e02\u8ca9\u30d1\u30c3\u30b1\u30fc\u30b8\u300d\u3067\u3082\u3001\u4f7f\u3044\u65b9\u3084\u4f9b\u7d66\u8005\u306e\u4f53\u5236\u306b\u5fdc\u3058\u3066\u691c\u8a3c\u306e\u6df1\u3055\u3092\u5909\u3048\u3089\u308c\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u88fd\u9020\u5de5\u7a0b\u3092\u76f4\u63a5\u5236\u5fa1\u3059\u308bMES\u3068\u3001\u54c1\u8cea\u5224\u65ad\u306b\u4f7f\u308f\u306a\u3044\u793e\u5185\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u6c42\u3081\u3089\u308c\u308b\u691c\u8a3c\u6d3b\u52d5\u304c\u307e\u3063\u305f\u304f\u7570\u306a\u308a\u307e\u3059\u3002\u3044\u305a\u308c\u304b1\u3064\u3001\u7279\u306b\u4f9b\u7d66\u8005\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u629c\u3044\u305f\u307e\u307e\u5b9f\u65bd\u5185\u5bb9\u3092\u6c7a\u3081\u308b\u3068\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u60f3\u5b9a\u3059\u308b\u5224\u65ad\u6750\u6599\u304c\u305d\u308d\u3044\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u306f\u6587\u66f8\u5316\u3057\u3001\u7ba1\u7406\u898f\u5b9a\u3067\u4f5c\u6210\u304c\u6c42\u3081\u3089\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u53f0\u5e33\u3068\u7d50\u3073\u3064\u3051\u3066\u7ba1\u7406\u3057\u307e\u3059\u3002\u65b0\u898f\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u6642\u3084\u65e2\u5b58\u30b7\u30b9\u30c6\u30e0\u306e\u5927\u5e45\u306a\u5909\u66f4\u6642\u306b\u306f\u3001\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u518d\u5b9f\u65bd\u3057\u3001\u5bfe\u8c61\u7bc4\u56f2\u3068\u5b9f\u65bd\u5185\u5bb9\u3092\u898b\u76f4\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-4\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306b\u95a2\u3059\u308b\u6587\u66f8\u306f\u3001\u56fd\u5185\u5916\u306e\u898f\u5236\u5f53\u5c40\u3084\u696d\u754c\u56e3\u4f53\u304b\u3089\u767a\u884c\u3055\u308c\u3066\u304a\u308a\u3001\u6cd5\u4ee4\u30fb\u884c\u653f\u901a\u77e5\u30fb\u67fb\u5bdf\u30ac\u30a4\u30c0\u30f3\u30b9\u30fb\u696d\u754c\u30ac\u30a4\u30c9\u306e\u4f4d\u7f6e\u3065\u3051\u306e\u9055\u3044\u3092\u62bc\u3055\u3048\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n<div id=\"id-16133537-2ff8-484f-914f-f982f51f7637\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/th><th>\u767a\u884c\u5143<\/th><th>\u6982\u8981<\/th><\/tr><tr><td>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/td><td>\u539a\u751f\u52b4\u50cd\u7701<\/td><td>GQP\u7701\u4ee4\u30fbGMP\u7701\u4ee4\u306b\u57fa\u3065\u304f\u696d\u52d9\u306b\u4f7f\u3046\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u958b\u767a\u30fb\u691c\u8a3c\u30fb\u904b\u7528\u7ba1\u7406\u3092\u898f\u5b9a\u30022010\u5e7410\u6708\u767a\u51fa\u30012012\u5e744\u67081\u65e5\u9069\u7528<\/td><\/tr><tr><td>\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\uff08ER\/ES\u6307\u91dd\uff09<\/td><td>\u539a\u751f\u52b4\u50cd\u7701<\/td><td>2005\u5e744\u67081\u65e5\u767a\u51fa\uff08\u85ac\u98df\u767a\u7b2c0401022\u53f7\uff09\u3002\u7533\u8acb\u7b49\u306b\u95a2\u308f\u308b\u8cc7\u6599\u3067\u96fb\u78c1\u7684\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u3092\u4f7f\u3046\u5834\u5408\u306e\u8981\u4ef6\u3002\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u5bfe\u8c61\u30b7\u30b9\u30c6\u30e0\u304c\u3053\u306e\u6307\u91dd\u306e\u9069\u7528\u3092\u53d7\u3051\u308b\u5834\u5408\u306f\u3001\u4f75\u305b\u3066\u8981\u4ef6\u3092\u5099\u3048\u308b\u5fc5\u8981\u304c\u3042\u308b<\/td><\/tr><tr><td>GAMP 5<\/td><td>ISPE<\/td><td>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u57fa\u3065\u304f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406\u306e\u696d\u754c\u30ac\u30a4\u30c9\uff08\u6cd5\u898f\u5236\u3067\u306f\u306a\u3044\uff09\u30022022\u5e747\u6708\u306b\u7b2c2\u7248\u3092\u767a\u884c<\/td><\/tr><tr><td>EU GMP Annex 11<\/td><td>\u6b27\u5dde\u59d4\u54e1\u4f1a<\/td><td>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308bEU GMP\u306e\u9644\u5c5e\u66f8\u30022025\u5e747\u6708\u306bChapter 4\u3068\u3068\u3082\u306b\u6539\u8a02\u6848\u3068AI\u306b\u95a2\u3059\u308b\u65b0Annex 22\u6848\u304c\u516c\u8868\u3055\u308c\u3001\u610f\u898b\u52df\u96c6\u306f2025\u5e7410\u67087\u65e5\u306b\u7d42\u4e86\u30022026\u5e7410\u6708\u6642\u70b9\u3067\u3001\u610f\u898b\u52df\u96c6\u30da\u30fc\u30b8\u306b\u6700\u7d42\u63a1\u629e\u306e\u8a18\u8f09\u306f\u306a\u3044<\/td><\/tr><tr><td>21 CFR Part 11<\/td><td>FDA<\/td><td>FDA\u898f\u5236\u306e\u5bfe\u8c61\u3068\u306a\u308b\u4e00\u5b9a\u306e\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u306b\u3064\u3044\u3066\u3001\u4fe1\u983c\u3067\u304d\u308b\u3082\u306e\u3068\u307f\u306a\u3059\u305f\u3081\u306e\u57fa\u6e96\u3092\u5b9a\u3081\u308b\u9023\u90a6\u898f\u5247<\/td><\/tr><tr><td>PIC\/S PI 041-1<\/td><td>PIC\/S<\/td><td>GMP\/GDP\u74b0\u5883\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u7ba1\u7406\u3068\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u67fb\u5bdf\u30ac\u30a4\u30c0\u30f3\u30b9\u30022021\u5e746\u67081\u65e5\u63a1\u629e\u30012021\u5e747\u67081\u65e5\u767a\u52b9\u3002\u6cd5\u7684\u306a\u5f37\u5236\u529b\u306f\u306a\u3044<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>\u65e5\u672c\u56fd\u5185\u3067\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u696d\u3084\u88fd\u9020\u696d\u3092\u55b6\u3080\u5834\u5408\u3001\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3078\u306e\u9069\u5408\u304c\u57fa\u672c\u3067\u3059\u3002\u6d77\u5916\u5e02\u5834\u306b\u95a2\u308f\u308b\u5834\u5408\u3001\u8f38\u51fa\u3059\u308b\u3068\u3044\u3046\u4e8b\u5b9f\u3060\u3051\u3067Annex 11\u3084Part 11\u306e\u9069\u7528\u304c\u6c7a\u307e\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u76f8\u624b\u56fd\u3067\u88fd\u9020\u6240\u304c\u67fb\u5bdf\u30fb\u627f\u8a8d\u306e\u5bfe\u8c61\u3068\u306a\u308b\u5834\u5408\u3084\u3001FDA\u898f\u5236\u306e\u5bfe\u8c61\u3068\u306a\u308b\u96fb\u5b50\u8a18\u9332\u3092\u6271\u3046\u5834\u5408\u306b\u3001\u305d\u306e\u5f53\u5c40\u306eGMP\u3084\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u306e\u8981\u4ef6\u3092\u500b\u5225\u306b\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\" rel=\"nofollow\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u300cStakeholders\u2019 Consultation on EudraLex Volume 4 \u2013 Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/docview\/4234\" rel=\"nofollow\">PIC\/S\u300cPI 041-1 Good Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-5\">GAMP 5\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u5206\u985e<\/h2>\n\n\n\n<p>GAMP 5\uff08Good Automated Manufacturing Practice 5\uff09\u306f\u3001ISPE\u304c\u767a\u884c\u3059\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u3067GxP\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u696d\u754c\u30ac\u30a4\u30c9\u3067\u3042\u308a\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u30ab\u30c6\u30b4\u30ea\u306b\u5206\u985e\u3057\u3066\u691c\u8a3c\u306e\u8003\u3048\u65b9\u3092\u6574\u7406\u3059\u308b\u67a0\u7d44\u307f\u3067\u5e83\u304f\u77e5\u3089\u308c\u3066\u3044\u307e\u3059\u30022022\u5e747\u6708\u767a\u884c\u306e\u7b2c2\u7248\u306f\u3001\u521d\u7248\u306e\u539f\u5247\u3068\u67a0\u7d44\u307f\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u77e5\u8b58\u3068\u7d4c\u9a13\u306e\u3042\u308b\u5c02\u9580\u5bb6\uff08SME\uff09\u306b\u3088\u308b\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306e\u91cd\u8981\u6027\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-6\">\u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5de5\u6570\u306e\u9055\u3044<\/h3>\n\n\n\n<p>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ab\u30c6\u30b4\u30ea\u306f\u4e00\u822c\u306b1\u30fb3\u30fb4\u30fb5\u306e4\u3064\u3067\u8aac\u660e\u3055\u308c\u3001\u30ab\u30c6\u30b4\u30ea2\uff08\u30d5\u30a1\u30fc\u30e0\u30a6\u30a7\u30a2\uff09\u306fGAMP 5\u306e\u521d\u7248\uff082008\u5e74\uff09\u3067\u5ec3\u6b62\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3082\u540c\u69d8\u306e4\u30ab\u30c6\u30b4\u30ea\u306b\u3088\u308b\u5206\u985e\u3092\u6c42\u3081\u3066\u304a\u308a\u3001\u5225\u7d192\u300c\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u8868\u3068\u5bfe\u5fdc\u4f8b\u300d\u3067\u3001\u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306eDQ\u30fbIQ\u30fbOQ\u30fbPQ\u306e\u6a19\u6e96\u7684\u306a\u8981\u5426\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n<div id=\"id-a964fcdf-b68e-43b6-9b41-b3feb1c9a46f\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u30ab\u30c6\u30b4\u30ea<\/th><th>\u5225\u7d192\u306e\u540d\u79f0\u3068\u5185\u5bb9<\/th><th>DQ<\/th><th>IQ<\/th><th>OQ<\/th><th>PQ<\/th><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea1<\/td><td>\u57fa\u76e4\u30bd\u30d5\u30c8\uff1a\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u69cb\u7bc9\u3055\u308c\u308b\u57fa\u76e4\uff08\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\uff09\u3084\u3001\u904b\u7528\u74b0\u5883\u3092\u7ba1\u7406\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/td><td>\u2015<\/td><td>\u25ce<\/td><td>\u25cb<\/td><td>\u25cb<\/td><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea3<\/td><td>\u69cb\u6210\u8a2d\u5b9a\u3057\u3066\u3044\u306a\u3044\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff1a\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u306b\u5408\u308f\u305b\u3066\u69cb\u6210\u8a2d\u5b9a\u3057\u3066\u3044\u306a\u3044\u65e2\u88fd\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08\u8868\u306f\u300c\u5358\u72ec\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u300d\u306e\u4f8b\u3002\u88fd\u9020\u8a2d\u5099\u30fb\u5206\u6790\u6a5f\u5668\u7b49\u306b\u642d\u8f09\u3055\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u3067\u306fOQ\u304c\u25b3\uff09<\/td><td>\u2015<\/td><td>\u25ce<\/td><td>\u2015<\/td><td>\u25ce<\/td><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea4<\/td><td>\u69cb\u6210\u8a2d\u5b9a\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff1a\u30e6\u30fc\u30b6\u30fc\u306e\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u306b\u5408\u308f\u305b\u3066\u69cb\u6210\u8a2d\u5b9a\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u5909\u66f4\u3057\u305f\u5834\u5408\u306f\u30ab\u30c6\u30b4\u30ea5\uff09<\/td><td>\u25b3<\/td><td>\u25ce<\/td><td>\u25cb<\/td><td>\u25ce<\/td><\/tr><tr><td>\u30ab\u30c6\u30b4\u30ea5<\/td><td>\u30ab\u30b9\u30bf\u30e0\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff1a\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u306b\u5408\u308f\u305b\u3066\u8a2d\u8a08\u3055\u308c\u3001\u30d7\u30ed\u30b0\u30e9\u30e0\u3055\u308c\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/td><td>\u25ce<\/td><td>\u25ce<\/td><td>\u25ce<\/td><td>\u25ce<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>\u51e1\u4f8b\u306f\u300c\u25ce\uff1a\u5fc5\u9808\u300d\u300c\u25cb\uff1a\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u306b\u3088\u308b\uff08\u57fa\u672c\u7684\u306b\u306f\u5fc5\u8981\uff09\u300d\u300c\u25b3\uff1a\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u306b\u3088\u308b\uff08\u57fa\u672c\u7684\u306b\u306f\u7701\u7565\uff09\u300d\u300c\u2015\uff1a\u7701\u7565\u53ef\u80fd\u300d\u3067\u3059\u3002\u306a\u304a\u3001\u5225\u7d192\u3067\u306f\u4e00\u90e8\u306e\u8a18\u53f7\u306b\u6ce8\u8a18\u304c\u4ed8\u3044\u3066\u3044\u308b\u305f\u3081\u3001\u904b\u7528\u306b\u843d\u3068\u3057\u8fbc\u3080\u969b\u306f\u539f\u6587\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u8868\u306e\u3068\u304a\u308a\u3001\u81ea\u793e\u56fa\u6709\u306e\u8a2d\u5b9a\u30fb\u958b\u767a\u304c\u5897\u3048\u308b\u30ab\u30c6\u30b4\u30ea\u307b\u3069\u5fc5\u9808\u306e\u8a55\u4fa1\u304c\u591a\u304f\u3001\u5de5\u6570\u3082\u5927\u304d\u304f\u306a\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u25cb\u3068\u25b3\u306f\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u306b\u3088\u3063\u3066\u5224\u65ad\u3059\u308b\u3068\u3055\u308c\u3066\u304a\u308a\u3001\u30ab\u30c6\u30b4\u30ea\u3060\u3051\u3067\u6a5f\u68b0\u7684\u306b\u6c7a\u307e\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305f\u3068\u3048\u3070\u3001\u540c\u3058\u30ab\u30c6\u30b4\u30ea4\u3067\u3082\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u76f4\u63a5\u5236\u5fa1\u306b\u7528\u3044\u308b\u3082\u306e\u3068\u9593\u63a5\u7684\u306a\u4e8b\u52d9\u51e6\u7406\u306b\u7528\u3044\u308b\u3082\u306e\u3067\u306f\u3001\u6c42\u3081\u3089\u308c\u308b\u691c\u8a3c\u306e\u6df1\u3055\u304c\u7570\u306a\u308a\u307e\u3059\u3002\u5225\u7d192\u306e\u5bfe\u5fdc\u4f8b\u3092\u51fa\u767a\u70b9\u306b\u3001\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u5de5\u6570\u3092\u914d\u5206\u3059\u308b\u3053\u3068\u3067\u3001\u91cd\u8981\u306a\u6a5f\u80fd\u306b\u4eba\u54e1\u3092\u96c6\u4e2d\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=2\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d\uff08\u5225\u7d192\uff09<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-7\">GAMP 5 \u7b2c2\u7248\u3067\u5f37\u5316\u3055\u308c\u305f\u70b9<\/h3>\n\n\n\n<p>GAMP 5\u7b2c2\u7248\u306f\u3001\u521d\u7248\u306e\u539f\u5247\u3068\u67a0\u7d44\u307f\u3092\u7dad\u6301\u3057\u3064\u3064\u3001\u73fe\u4ee3\u306e\u958b\u767a\u30fb\u904b\u7528\u74b0\u5883\u3078\u306e\u9069\u7528\u65b9\u6cd5\u3092\u66f4\u65b0\u3057\u305f\u6539\u8a02\u3067\u3059\u3002ISPE\u306e\u516c\u958b\u8aac\u660e\u306b\u3088\u308c\u3070\u3001\u4e3b\u306a\u5909\u66f4\u70b9\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30b7\u30f3\u30ad\u30f3\u30b0\u306e\u5f37\u8abf\uff1a\u72b6\u6cc1\u306b\u5fdc\u3058\u305f\u9069\u5207\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3001\u77e5\u8b58\u3068\u7d4c\u9a13\u306e\u3042\u308b\u5c02\u9580\u5bb6\u306e\u5224\u65ad\u3067\u5b9a\u3081\u308b\u3053\u3068\u3092\u91cd\u8996\u3057\u305f<\/li>\n\n\n\n<li>\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u306e\u91cd\u8981\u6027\u306e\u53cd\u6620\uff1a\u5916\u90e8\u306e\u4f9b\u7d66\u8005\u3084\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u8005\u306e\u6d3b\u7528\u304c\u5897\u3048\u305f\u5b9f\u614b\u3092\u8e0f\u307e\u3048\u305f<\/li>\n\n\n\n<li>\u53cd\u5fa9\u30fb\u5897\u5206\u578b\u306e\u958b\u767a\u3078\u306e\u5bfe\u5fdc\uff1a\u30a6\u30a9\u30fc\u30bf\u30fc\u30d5\u30a9\u30fc\u30eb\u578b\u306b\u9650\u3089\u306a\u3044\u3001\u53cd\u5fa9\u30fb\u5897\u5206\u578b\u306e\u958b\u767a\u624b\u6cd5\u3078\u306e\u9069\u7528\u3092\u6574\u7406\u3057\u305f<\/li>\n\n\n\n<li>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30c4\u30fc\u30eb\u3068\u81ea\u52d5\u5316\u306e\u6d3b\u7528\uff1a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3067\u306e\u30c4\u30fc\u30eb\u5229\u7528\u306e\u62e1\u5927\u3092\u53cd\u6620\u3057\u305f<\/li>\n\n\n\n<li>CSA\u3068\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3078\u306e\u8a00\u53ca\uff1aFDA\u306eCSA\u3092\u3081\u3050\u308b\u52d5\u5411\u306e\u8b70\u8ad6\u3068\u3001ISPE\/GAMP\u306e\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30ac\u30a4\u30c0\u30f3\u30b9\u3078\u306e\u30ea\u30f3\u30af\u3092\u8ffd\u52a0\u3057\u305f<\/li>\n\n\n\n<li>\u65b0\u3057\u3044\u6280\u8853\u30c8\u30d4\u30c3\u30af\u306e\u4ed8\u9332\uff1a\u30d6\u30ed\u30c3\u30af\u30c1\u30a7\u30fc\u30f3\u3001AI\/\u6a5f\u68b0\u5b66\u7fd2\u3001\u30af\u30e9\u30a6\u30c9\u30b3\u30f3\u30d4\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0\u3001\u30aa\u30fc\u30d7\u30f3\u30bd\u30fc\u30b9\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u4ed8\u9332\u3067\u6271\u3046<\/li>\n<\/ul>\n\n\n\n<p>\u7b2c2\u7248\u306f\u5f93\u6765\u306e\u67a0\u7d44\u307f\u3092\u6839\u672c\u304b\u3089\u5909\u3048\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3088\u308a\u5b9f\u8df5\u7684\u306b\u6d3b\u7528\u3059\u308b\u305f\u3081\u306e\u6307\u91dd\u3067\u3059\u3002\u5f62\u5f0f\u3088\u308a\u3082\u5b9f\u8cea\u3092\u91cd\u8996\u3057\u3001\u9650\u3089\u308c\u305f\u30ea\u30bd\u30fc\u30b9\u3092\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u9818\u57df\u306b\u96c6\u4e2d\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u54c1\u8cea\u306e\u7dad\u6301\u3068\u696d\u52d9\u52b9\u7387\u306e\u4e21\u7acb\u3092\u56f3\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" rel=\"nofollow\">ISPE\u300cGAMP 5 Guide 2nd Edition\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-8\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u30d7\u30ed\u30bb\u30b9<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u958b\u767a\u30fb\u691c\u8a3c\u306e\u5404\u6bb5\u968e\u3067\u6210\u679c\u7269\u3092\u6587\u66f8\u5316\u3057\u306a\u304c\u3089\u3001\u8981\u6c42\u4e8b\u9805\u304c\u6e80\u305f\u3055\u308c\u305f\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u3044\u304f\u6d41\u308c\u3067\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u958b\u767a\u8a08\u753b\u3001\u8981\u6c42\u4ed5\u69d8\u3001\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3001\u6a5f\u80fd\u4ed5\u69d8\u3001\u8a2d\u8a08\u4ed5\u69d8\u3001\u30d7\u30ed\u30b0\u30e9\u30e0\u30c6\u30b9\u30c8\u3001\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u3001\u53d7\u5165\u8a66\u9a13\u3092\u7d4c\u3066\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u306b\u57fa\u3065\u304fDQ\u30fbIQ\u30fbOQ\u30fbPQ\u3068\u5168\u4f53\u5831\u544a\u3092\u884c\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4ed5\u69d8\u3068\u691c\u8a3c\u306e\u5bfe\u5fdc\u95a2\u4fc2\u306f\u3001V\u30e2\u30c7\u30eb\u3067\u8aac\u660e\u3055\u308c\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u305f\u3060\u3057V\u30e2\u30c7\u30eb\u306f\u5bfe\u5fdc\u95a2\u4fc2\u3092\u793a\u3059\u4e00\u4f8b\u3067\u3042\u308a\u3001GAMP 5\u7b2c2\u7248\u306f\u53cd\u5fa9\u30fb\u5897\u5206\u578b\u306e\u958b\u767a\u306b\u3082\u9069\u7528\u3067\u304d\u308b\u8003\u3048\u65b9\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002CSV\u30d7\u30ed\u30bb\u30b9\u306e\u4e3b\u8981\u306a\u30d5\u30a7\u30fc\u30ba\u306f\u6b21\u306e4\u3064\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\uff08URS\uff09\u306e\u4f5c\u6210<\/li>\n\n\n\n<li>\u8a2d\u8a08\u30fb\u69cb\u7bc9<\/li>\n\n\n\n<li>\u691c\u8a3c\uff08\u30c6\u30b9\u30c8\uff09<\/li>\n\n\n\n<li>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5831\u544a\u30fb\u627f\u8a8d<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-9\">\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\uff08URS\uff09<\/h3>\n\n\n\n<p>CSV\u30d7\u30ed\u30bb\u30b9\u306e\u8d77\u70b9\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306b\u6c42\u3081\u308b\u696d\u52d9\u8981\u4ef6\u30fb\u6a5f\u80fd\u8981\u4ef6\u30fb\u898f\u5236\u8981\u4ef6\u3092\u6587\u66f8\u5316\u3059\u308bURS\uff08User Requirement Specification\uff1a\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff09\u306e\u4f5c\u6210\u3067\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u958b\u767a\u8a08\u753b\u306b\u95a2\u3059\u308b\u6587\u66f8\u306e\u4f5c\u6210\u306b\u7d9a\u3044\u3066\u8981\u6c42\u4ed5\u69d8\u306b\u95a2\u3059\u308b\u6587\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>URS\u306e\u54c1\u8cea\u304cCSV\u5168\u4f53\u306e\u6210\u5426\u3092\u5de6\u53f3\u3059\u308b\u305f\u3081\u3001\u5229\u7528\u90e8\u9580\u30fb\u54c1\u8cea\u90e8\u9580\u30fbIT\u90e8\u9580\u304c\u9023\u643a\u3057\u3066\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u5229\u7528\u90e8\u9580\u304c\u300c\u4f55\u3092\u30b7\u30b9\u30c6\u30e0\u306b\u6c42\u3081\u308b\u304b\u300d\u3092\u3001\u54c1\u8cea\u90e8\u9580\u304c\u300c\u3069\u306eGQP\u30fbGMP\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3079\u304d\u304b\u300d\u3092\u3001IT\u90e8\u9580\u304c\u300c\u6280\u8853\u7684\u306a\u5b9f\u73fe\u53ef\u80fd\u6027\u3068\u5236\u7d04\u300d\u3092\u305d\u308c\u305e\u308c\u6301\u3061\u5bc4\u308a\u3001\u4e09\u8005\u306e\u8996\u70b9\u3092\u7d71\u5408\u3057\u307e\u3059\u3002URS\u306f\u5f8c\u5de5\u7a0b\u306eDQ\u3067\u6a5f\u80fd\u4ed5\u69d8\u66f8\u30fb\u8a2d\u8a08\u4ed5\u69d8\u66f8\u3068\u306e\u7a81\u5408\u306b\u4f7f\u308f\u308c\u3001PQ\u3067\u306f\u8981\u6c42\u4ed5\u69d8\u3069\u304a\u308a\u306b\u7a3c\u50cd\u3059\u308b\u304b\u306e\u5224\u5b9a\u57fa\u6e96\u306b\u3082\u306a\u308a\u307e\u3059\u3002\u66d6\u6627\u306a\u8a18\u8ff0\u3092\u6b8b\u3059\u3068\u8a2d\u8a08\u30fb\u691c\u8a3c\u30d5\u30a7\u30fc\u30ba\u3067\u624b\u623b\u308a\u304c\u767a\u751f\u3059\u308b\u305f\u3081\u3001\u5b9a\u91cf\u7684\u3067\u691c\u8a3c\u53ef\u80fd\u306a\u8a18\u8ff0\u3092\u5fc3\u304c\u3051\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-10\">\u8a2d\u8a08\u30fb\u69cb\u7bc9<\/h3>\n\n\n\n<p>\u8a2d\u8a08\u30fb\u69cb\u7bc9\u30d5\u30a7\u30fc\u30ba\u3067\u306f\u3001URS\u306b\u57fa\u3065\u3044\u3066\u6a5f\u80fd\u4ed5\u69d8\u66f8\uff08FS\uff09\u3068\u8a2d\u8a08\u4ed5\u69d8\u66f8\uff08DS\uff09\u3092\u4f5c\u6210\u3057\u3001\u4ed5\u69d8\u306b\u5f93\u3063\u3066\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002FS\u3067\u306f\u30b7\u30b9\u30c6\u30e0\u304c\u300c\u4f55\u3092\u3059\u308b\u304b\u300d\u3092\u3001DS\u3067\u306f\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4e21\u9762\u304b\u3089\u300c\u3069\u3046\u5b9f\u73fe\u3059\u308b\u304b\u300d\u3092\u6587\u66f8\u5316\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u8a2d\u8a08\u4ed5\u69d8\u306b\u7d9a\u3044\u3066\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u4f5c\u6210\u3068\u30d7\u30ed\u30b0\u30e9\u30e0\u30c6\u30b9\u30c8\u3001\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u3001\u53d7\u5165\u8a66\u9a13\u3092\u884c\u3044\u307e\u3059\u3002\u30d1\u30c3\u30b1\u30fc\u30b8\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u3059\u308b\u5834\u5408\u3001\u3053\u308c\u3089\u306e\u591a\u304f\u306f\u4f9b\u7d66\u8005\u5074\u3067\u5b9f\u65bd\u3055\u308c\u308b\u305f\u3081\u3001\u4f9b\u7d66\u8005\u306e\u8a2d\u8a08\u6587\u66f8\u3084\u8a66\u9a13\u8a18\u9332\u304cURS\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002URS\u306e\u5404\u8981\u4ef6\u304c\u3001FS\u3084DS\u306e\u3069\u306e\u9805\u76ee\u306b\u5bfe\u5fdc\u3057\u3001\u3069\u306e\u8a66\u9a13\u3067\u691c\u8a3c\u3055\u308c\u308b\u304b\u3092\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30af\u30b9\u3067\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u8981\u4ef6\u306e\u629c\u3051\u6f0f\u308c\u3092\u9632\u3052\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-11\">\u691c\u8a3c\uff08\u30c6\u30b9\u30c8\uff09<\/h3>\n\n\n\n<p>\u691c\u8a3c\u30d5\u30a7\u30fc\u30ba\u3067\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u306b\u57fa\u3065\u304d\u3001DQ\u30fbIQ\u30fbOQ\u30fbPQ\u306e\u9069\u683c\u6027\u8a55\u4fa1\u3092\u901a\u3058\u3066\u30b7\u30b9\u30c6\u30e0\u304c\u8981\u6c42\u3069\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u691c\u8a3c\u8cac\u4efb\u8005\u304c\u5404\u8a55\u4fa1\u306e\u8a08\u753b\u66f8\u3092\u4f5c\u6210\u3057\u3001\u691c\u8a3c\u62c5\u5f53\u8005\u304c\u8a08\u753b\u66f8\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3092\u5b9f\u65bd\u30fb\u8a18\u9332\u3057\u305f\u3046\u3048\u3067\u3001\u691c\u8a3c\u8cac\u4efb\u8005\u304c\u7d50\u679c\u306e\u9069\u5426\u3092\u5224\u5b9a\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u691c\u8a3c\u3067\u306f\u3001\u8a55\u4fa1\u3054\u3068\u306e\u8a08\u753b\u7b56\u5b9a\u3001\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u306e\u4f5c\u6210\u3001\u30c6\u30b9\u30c8\u5b9f\u884c\u3001\u7d50\u679c\u306e\u8a18\u9332\u3068\u9038\u8131\u5bfe\u5fdc\u3068\u3044\u3046\u6d41\u308c\u3067\u9032\u3081\u307e\u3059\u3002\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u306fURS\u3084FS\u304b\u3089\u5c0e\u51fa\u3057\u3001\u5404\u8981\u4ef6\u306b\u5bfe\u3057\u3066\u5408\u683c\u57fa\u6e96\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u5de5\u5834\u51fa\u8377\u8a66\u9a13\uff08FAT\uff09\u3084\u73fe\u5730\u53d7\u5165\u8a66\u9a13\uff08SAT\uff09\u3092\u884c\u3063\u305f\u5834\u5408\u306f\u3001\u305d\u306e\u78ba\u8a8d\u65b9\u6cd5\u3068\u8a18\u9332\u304c\u691c\u8a3c\u8cac\u4efb\u8005\u306b\u3088\u3063\u3066\u9069\u5207\u3068\u8a8d\u3081\u3089\u308c\u308c\u3070\u3001\u9069\u683c\u6027\u8a55\u4fa1\u306b\u7d50\u679c\u3092\u5f15\u7528\u3067\u304d\u307e\u3059\u3002\u9038\u8131\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306f\u539f\u56e0\u3092\u8abf\u67fb\u3057\u3001\u662f\u6b63\u63aa\u7f6e\u3092\u5b9f\u65bd\u3057\u305f\u3046\u3048\u3067\u518d\u30c6\u30b9\u30c8\u3092\u884c\u3044\u3001\u3059\u3079\u3066\u306e\u7d50\u679c\u3092\u8a18\u9332\u3068\u3057\u3066\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-12\">\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5831\u544a\u30fb\u627f\u8a8d<\/h3>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u691c\u8a3c\u6d3b\u52d5\u304c\u5b8c\u4e86\u3057\u305f\u3089\u3001\u691c\u8a3c\u8cac\u4efb\u8005\u304c\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5404\u6bb5\u968e\u306e\u7d50\u679c\u3068\u7dcf\u5408\u8a55\u4fa1\u3092\u307e\u3068\u3081\u305f\u5168\u4f53\u5831\u544a\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u5831\u544a\u66f8\u306b\u306f\u3001\u30c6\u30b9\u30c8\u7d50\u679c\u306e\u7dcf\u62ec\u3001\u9038\u8131\u4e8b\u9805\u3068\u305d\u306e\u662f\u6b63\u5185\u5bb9\u3001\u6b8b\u5b58\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u3092\u307e\u3068\u3081\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u627f\u8a8d\u306e\u4f53\u5236\u306f\u3001GMP\u3068GQP\u3067\u7570\u306a\u308a\u307e\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001GMP\u7701\u4ee4\u3067\u306f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3084\u5909\u66f4\u30fb\u9038\u8131\u306e\u7ba1\u7406\u306b\u54c1\u8cea\u90e8\u9580\u7b49\u306e\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001GQP\u7701\u4ee4\u3067\u306f\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u306b\u3088\u308b\u7ba1\u7406\u4f53\u5236\u306e\u4e2d\u3067\u9032\u3081\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3057\u3066\u3044\u307e\u3059\u3002GMP\u306b\u3064\u3044\u3066\u306f\u30012021\u5e748\u67081\u65e5\u65bd\u884c\u306e\u6539\u6b63GMP\u7701\u4ee4\u3067\u54c1\u8cea\u4fdd\u8a3c\u306b\u4fc2\u308b\u696d\u52d9\u3092\u62c5\u5f53\u3059\u308b\u7d44\u7e54\u304c\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3001\u5909\u66f4\u306e\u7ba1\u7406\u3067\u306f\u3053\u306e\u7d44\u7e54\u306e\u627f\u8a8d\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u73fe\u884c\u306e\u7701\u4ee4\u6761\u6587\u3068\u7167\u3089\u3057\u5408\u308f\u305b\u305f\u3046\u3048\u3067\u3001\u7d44\u7e54\u5f62\u614b\u3068\u30b7\u30b9\u30c6\u30e0\u306e\u7bc4\u56f2\u306b\u5fdc\u3058\u305f\u8cac\u4efb\u3068\u6a29\u9650\u3092\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406\u898f\u5b9a\u306b\u660e\u78ba\u306b\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002\u5168\u4f53\u5831\u544a\u306f\u67fb\u5bdf\u6642\u306b\u63d0\u793a\u3092\u6c42\u3081\u3089\u308c\u308b\u91cd\u8981\u6587\u66f8\u306e\u305f\u3081\u3001\u4fdd\u7ba1\u671f\u9593\u3068\u7ba1\u7406\u65b9\u6cd5\u3082\u3042\u3089\u304b\u3058\u3081\u5b9a\u3081\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><br>\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-13\">DQ\u30fbIQ\u30fbOQ\u30fbPQ\u3068\u306f<\/h2>\n\n\n\n<p>DQ\u30fbIQ\u30fbOQ\u30fbPQ\u3068\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u4ed5\u69d8\u3069\u304a\u308a\u306b\u8a2d\u8a08\u30fb\u636e\u4ed8\u3055\u308c\u3001\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u7a3c\u50cd\u3059\u308b\u3053\u3068\u3092\u6bb5\u968e\u7684\u306b\u78ba\u8a8d\u3059\u308b4\u3064\u306e\u9069\u683c\u6027\u8a55\u4fa1\u3067\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u76ee\u7684\u3092\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n<div id=\"id-eec03f81-7336-4b60-9145-a2b4b5ce4deb\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u8a55\u4fa1<\/th><th>\u6b63\u5f0f\u540d\u79f0<\/th><th>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u4e0a\u306e\u78ba\u8a8d\u5185\u5bb9<\/th><\/tr><tr><td>DQ<\/td><td>\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08Design Qualification\uff09<\/td><td>\u8981\u6c42\u4ed5\u69d8\u66f8\u306e\u8981\u6c42\u4e8b\u9805\u304c\u3001\u6a5f\u80fd\u4ed5\u69d8\u66f8\u30fb\u8a2d\u8a08\u4ed5\u69d8\u66f8\u7b49\u306b\u6b63\u3057\u304f\u53cd\u6620\u3055\u308c\u3066\u3044\u308b\u3053\u3068<\/td><\/tr><tr><td>IQ<\/td><td>\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08Installation Qualification\uff09<\/td><td>\u8a2d\u8a08\u4ed5\u69d8\u7b49\u306b\u8a18\u8f09\u3055\u308c\u305f\u3068\u304a\u308a\u306b\u636e\u3048\u4ed8\u3051\u3089\u308c\u3001\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u3055\u308c\u305f\u3053\u3068<\/td><\/tr><tr><td>OQ<\/td><td>\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08Operational Qualification\uff09<\/td><td>\u904b\u8ee2\u6642\u306b\u3001\u6a5f\u80fd\u4ed5\u69d8\u7b49\u306b\u793a\u3055\u308c\u305f\u6a5f\u80fd\u30fb\u6027\u80fd\u3092\u767a\u63ee\u3059\u308b\u3053\u3068<\/td><\/tr><tr><td>PQ<\/td><td>\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff08Performance Qualification\uff09<\/td><td>\u7a3c\u50cd\u6642\u306b\u3001\u8981\u6c42\u4ed5\u69d8\u7b49\u3069\u304a\u308a\u306b\u6a5f\u80fd\u3057\u3001\u6027\u80fd\u3092\u767a\u63ee\u3057\u3066\u904b\u8ee2\u3067\u304d\u308b\u3053\u3068<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>4\u3064\u306e\u8a55\u4fa1\u306e\u4f7f\u3044\u5206\u3051\u3067\u62bc\u3055\u3048\u3066\u304a\u304d\u305f\u3044\u306e\u304c\u3001\u7701\u7565\u3068\u5f15\u7528\u306e\u8003\u3048\u65b9\u3067\u3059\u3002\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u5225\u7d192\u300c\u30ab\u30c6\u30b4\u30ea\u5206\u985e\u8868\u3068\u5bfe\u5fdc\u4f8b\u300d\u306f\u3001\u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306bDQ\u30fbIQ\u30fbOQ\u30fbPQ\u306e\u6a19\u6e96\u7684\u306a\u8981\u5426\u3092\u793a\u3057\u3066\u304a\u308a\u3001\u305f\u3068\u3048\u3070\u30ab\u30c6\u30b4\u30ea3\u306e\u5358\u72ec\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001DQ\u3068OQ\u304c\u300c\u7701\u7565\u53ef\u80fd\u300d\u3068\u3055\u308c\u3066\u3044\u307e\u3059\uff08\u88fd\u9020\u8a2d\u5099\u3084\u5206\u6790\u6a5f\u5668\u7b49\u306b\u642d\u8f09\u3055\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001OQ\u306f\u300c\u25b3\uff1a\u57fa\u672c\u7684\u306b\u306f\u7701\u7565\u300d\uff09\u3002<\/p>\n\n\n\n<p>\u307e\u305f\u672c\u6587\u3067\u306f\u3001OQ\u306e\u691c\u8a3c\u5185\u5bb9\u3084\u74b0\u5883\u3001\u6761\u4ef6\u304cPQ\u3068\u5dee\u304c\u306a\u3044\u5834\u5408\u306fOQ\u3092\u7701\u7565\u3067\u304d\u3001\u305d\u306e\u5834\u5408\u306f\u7701\u7565\u306e\u65e8\u3092\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u66f8\u306a\u3069\u306b\u660e\u8a18\u3059\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002FAT\u3084SAT\u306e\u7d50\u679c\u3082\u3001\u691c\u8a3c\u8cac\u4efb\u8005\u304c\u9069\u5207\u3068\u8a8d\u3081\u308c\u3070\u9069\u683c\u6027\u8a55\u4fa1\u306b\u5f15\u7528\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305f\u3060\u3057\u3001\u5225\u7d192\u306f\u3042\u304f\u307e\u3067\u6a19\u6e96\u7684\u306a\u4f8b\u3067\u3059\u3002\u3069\u306e\u8a55\u4fa1\u3092\u7701\u7565\u30fb\u7c21\u7565\u5316\u3057\u3001\u4f55\u3092\u4f9b\u7d66\u8005\u306e\u8a18\u9332\u3067\u4ee3\u66ff\u3059\u308b\u304b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u3092\u8e0f\u307e\u3048\u3001\u6839\u62e0\u3068\u3068\u3082\u306b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u66f8\u306b\u5b9a\u3081\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-14\">\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1<\/h2>\n\n\n\n<p>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u306f\u3001\u3059\u3079\u3066\u306e\u30b7\u30b9\u30c6\u30e0\u30fb\u6a5f\u80fd\u306b\u4e00\u5f8b\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u5b9f\u65bd\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u30ea\u30b9\u30af\u306e\u5927\u304d\u3055\u306b\u5fdc\u3058\u3066\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6d3b\u52d5\u306e\u7bc4\u56f2\u3068\u6df1\u3055\u3092\u8abf\u6574\u3059\u308b\u8003\u3048\u65b9\u3067\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u300c\u88fd\u54c1\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u300d\u3068\u3057\u3066\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u304a\u308a\u3001GAMP 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class=\"wp-block-heading\" id=\"i-15\">CSV\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306f\u300c\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u6642\u306b\u4e00\u5ea6\u5b9f\u65bd\u3059\u308c\u3070\u7d42\u308f\u308a\u300d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u958b\u767a\u30fb\u691c\u8a3c\u306b\u52a0\u3048\u3001\u904b\u7528\u7ba1\u7406\u3001\u81ea\u5df1\u70b9\u691c\u3001\u5ec3\u68c4\u307e\u3067\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3067\u306e\u7ba1\u7406\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002CSV\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u3067\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30c8\u3055\u308c\u305f\u72b6\u614b\u3092\u7dad\u6301\u3057\u3001\u5909\u66f4\u3084\u5ec3\u68c4\u306e\u969b\u306b\u3082\u8a18\u9332\u306e\u4fe1\u983c\u6027\u3092\u4fdd\u3064\u3053\u3068\u304c\u76ee\u7684\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-16\">\u904b\u7528\u30fb\u4fdd\u5b88<\/h3>\n\n\n\n<p>\u672c\u7a3c\u50cd\u5f8c\u306eCSV\u3067\u306f\u3001\u904b\u7528\u7ba1\u7406\u57fa\u6e96\u66f8\u3068\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u66f8\u306b\u5f93\u3063\u3066\u30d0\u30ea\u30c7\u30fc\u30c8\u3055\u308c\u305f\u72b6\u614b\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u904b\u7528\u7ba1\u7406\u696d\u52d9\u3068\u3057\u3066\u6319\u3052\u308b\u9805\u76ee\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u904b\u7528\u7ba1\u7406\u306b\u95a2\u3059\u308b\u6587\u66f8\u3068\u64cd\u4f5c\u624b\u9806\u306b\u95a2\u3059\u308b\u6587\u66f8\u306e\u4f5c\u6210<\/li>\n\n\n\n<li>\u4fdd\u5b88\u70b9\u691c\u306e\u5b9f\u65bd<\/li>\n\n\n\n<li>\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u7ba1\u7406\u306e\u5b9f\u65bd<\/li>\n\n\n\n<li>\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u304a\u3088\u3073\u30ea\u30b9\u30c8\u30a2<\/li>\n\n\n\n<li>\u5909\u66f4\u306e\u7ba1\u7406<\/li>\n\n\n\n<li>\u9038\u8131\uff08\u30b7\u30b9\u30c6\u30e0\u30c8\u30e9\u30d6\u30eb\uff09\u306e\u7ba1\u7406<\/li>\n\n\n\n<li>\u6559\u80b2\u8a13\u7df4\uff08\u8a08\u753b\u306e\u4f5c\u6210\u3001\u5b9f\u65bd\u3001\u8a18\u9332\u306e\u4fdd\u7ba1\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u306b\u52a0\u3048\u3066\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u5b9a\u671f\u7684\u306a\u81ea\u5df1\u70b9\u691c\u306e\u5b9f\u65bd\u3068\u6539\u5584\u63aa\u7f6e\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u81ea\u5df1\u70b9\u691c\u306e\u983b\u5ea6\u306f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u672c\u6587\u3067\u5e74\u6b21\u306a\u3069\u3068\u6307\u5b9a\u3055\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u81ea\u793e\u306e\u624b\u9806\u3067\u5b9a\u3081\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u307e\u305f\u3001\u76e3\u67fb\u8a3c\u8de1\uff08\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\u30c8\u30ec\u30a4\u30eb\uff09\u306e\u78ba\u8a8d\u306f\u3001PIC\/S\u306e\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30ac\u30a4\u30c0\u30f3\u30b9\u3084Part 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id=\"i-17\">\u5909\u66f4\u7ba1\u7406<\/h3>\n\n\n\n<p>\u5909\u66f4\u7ba1\u7406\u3068\u306f\u3001\u5909\u66f4\u304c\u30d0\u30ea\u30c7\u30fc\u30c8\u3055\u308c\u305f\u72b6\u614b\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u4e8b\u524d\u306b\u8a55\u4fa1\u3057\u3001\u627f\u8a8d\u3092\u53d7\u3051\u3066\u304b\u3089\u5909\u66f4\u3092\u5b9f\u65bd\u3059\u308b\u4ed5\u7d44\u307f\u3067\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u884c\u3044\u3001\u305d\u306e\u7d50\u679c\u3092\u78ba\u8a8d\u30fb\u8a18\u9332\u3057\u305f\u3046\u3048\u3067\u904b\u7528\u3092\u518d\u958b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5909\u66f4\u7ba1\u7406\u306e\u6d41\u308c\u306f\u3001GMP\u7701\u4ee4\u7b2c14\u6761\uff08\u5909\u66f4\u306e\u7ba1\u7406\uff09\u306b\u6cbf\u3063\u3066\u6574\u7406\u3059\u308b\u3068\u660e\u78ba\u3067\u3059\u3002\u540c\u6761\u306f\u3001\u5909\u66f4\u306b\u3088\u308b\u88fd\u54c1\u54c1\u8cea\u3068\u627f\u8a8d\u4e8b\u9805\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u305d\u306e\u7d50\u679c\u306b\u57fa\u3065\u3044\u3066\u54c1\u8cea\u4fdd\u8a3c\u306b\u4fc2\u308b\u696d\u52d9\u3092\u62c5\u5f53\u3059\u308b\u7d44\u7e54\u306e\u627f\u8a8d\u3092\u53d7\u3051\u3001\u627f\u8a8d\u3092\u53d7\u3051\u3066\u5909\u66f4\u3092\u884c\u3046\u969b\u306b\u95a2\u9023\u6587\u66f8\u306e\u6539\u8a02\u3084\u6559\u80b2\u8a13\u7df4\u306a\u3069\u306e\u63aa\u7f6e\u3092\u3068\u308b\u3068\u3044\u3046\u9806\u5e8f\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\u3084\u8a2d\u5b9a\u5909\u66f4\u3067\u3082\u3001\u3053\u306e\u9806\u5e8f\u3092\u5b88\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4e00\u3064\u306e\u8a2d\u5b9a\u5909\u66f4\u304c\u4ed6\u306e\u6a5f\u80fd\u3084\u30c7\u30fc\u30bf\u30d5\u30ed\u30fc\u306b\u6ce2\u53ca\u3059\u308b\u53ef\u80fd\u6027\u3092\u8003\u616e\u3057\u3066\u5f71\u97ff\u8a55\u4fa1\u3092\u884c\u3044\u3001\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u8981\u5426\u3068\u7bc4\u56f2\u3092\u4e8b\u524d\u306b\u6c7a\u3081\u307e\u3059\u3002\u5909\u66f4\u5185\u5bb9\u30fb\u5f71\u97ff\u8a55\u4fa1\u7d50\u679c\u30fb\u627f\u8a8d\u8a18\u9332\u30fb\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7d50\u679c\u3092\u3059\u3079\u3066\u6587\u66f8\u5316\u3057\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3057\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\" 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class=\"wp-block-list\">\n<li>\u5ec3\u68c4\u306e\u8a08\u753b\u306b\u95a2\u3059\u308b\u6587\u66f8\u306e\u4f5c\u6210<\/li>\n\n\n\n<li>\u5ec3\u68c4\u8a18\u9332\u306e\u4f5c\u6210<\/li>\n<\/ul>\n\n\n\n<p>\u6b8b\u3059\u3079\u304d\u8a18\u9332\u306e\u4fdd\u5b58\u671f\u9593\u3068\u5a92\u4f53\u306f\u3001GQP\u7701\u4ee4\u30fbGMP\u7701\u4ee4\u306e\u6587\u66f8\u30fb\u8a18\u9332\u7ba1\u7406\u306e\u898f\u5b9a\u306b\u5408\u308f\u305b\u3066\u6c7a\u3081\u307e\u3059\u3002\u5b9f\u52d9\u4e0a\u306f\u3001\u30c7\u30fc\u30bf\u3092\u79fb\u884c\u30fb\u30a2\u30fc\u30ab\u30a4\u30d6\u3057\u305f\u5f8c\u306b\u8aad\u307f\u51fa\u305b\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001\u4fdd\u5b58\u671f\u9593\u304c\u6e80\u4e86\u3059\u308b\u307e\u3067\u53c2\u7167\u3067\u304d\u308b\u624b\u6bb5\u3092\u78ba\u4fdd\u3057\u3066\u304a\u304f\u3068\u3001\u67fb\u5bdf\u3067\u30c7\u30fc\u30bf\u306e\u63d0\u793a\u3092\u6c42\u3081\u3089\u308c\u305f\u969b\u306b\u3082\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u53f0\u5e33\u3084SOP\u306a\u3069\u306e\u95a2\u9023\u6587\u66f8\u304b\u3089\u3082\u3001\u5ec3\u68c4\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u306e\u60c5\u5831\u3092\u5fd8\u308c\u305a\u306b\u66f4\u65b0\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-19\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3068\u306e\u95a2\u4fc2<\/h2>\n\n\n\n<p>\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3068\u306f\u3001\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u30fb\u4e00\u8cab\u6027\u30fb\u6b63\u78ba\u6027\u3092\u6307\u3057\u3001CSV\u3068\u5bc6\u63a5\u306b\u95a2\u9023\u3059\u308b\u6982\u5ff5\u3067\u3059\u3002\u56fd\u5185\u3067\u306f\u30012021\u5e748\u67081\u65e5\u65bd\u884c\u306e\u6539\u6b63GMP\u7701\u4ee4\u7b2c20\u6761\uff08\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u7ba1\u7406\uff09\u3067\u3001\u624b\u9806\u66f8\u7b49\u3068\u8a18\u9332\u306b\u6b20\u843d\u304c\u306a\u3044\u3088\u3046\u3001\u307e\u305f\u4ed6\u306e\u624b\u9806\u66f8\u7b49\u3084\u8a18\u9332\u3068\u306e\u4e0d\u6574\u5408\u304c\u306a\u3044\u3088\u3046\u3001\u7d99\u7d9a\u7684\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6d77\u5916\u3067\u306f\u3001FDA\u306e2018\u5e74\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u3092\u5b8c\u5168\u6027\u30fb\u4e00\u8cab\u6027\u30fb\u6b63\u78ba\u6027\u3068\u5b9a\u7fa9\u3057\u3001\u3053\u3046\u3057\u305f\u30c7\u30fc\u30bf\u304c\u5099\u3048\u308b\u3079\u304d\u7279\u6027\u3092ALCOA\u3068\u547c\u3093\u3067\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u5b8c\u5168\u6027\u30fb\u4e00\u8cab\u6027\u30fb\u6c38\u7d9a\u6027\u30fb\u5165\u624b\u53ef\u80fd\u6027\u3092\u52a0\u3048\u305fALCOA+\u306f\u3001FDA\u306e\u540c\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u306f\u306a\u304f\u3001PIC\/S PI 041-1\u304c\u6574\u7406\u3057\u3066\u3044\u307e\u3059\u3002\u5404\u8981\u7d20\u306e\u610f\u5473\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n<div id=\"id-ccc183e1-c912-4e5d-8873-8c84bedbe2bb\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u539f\u5247<\/th><th>\u82f1\u8a9e<\/th><th>\u610f\u5473<\/th><\/tr><tr><td>\u5e30\u5c5e\u6027<\/td><td>Attributable<\/td><td>\u8ab0\u304c\u30fb\u3044\u3064\u8a18\u9332\u3057\u305f\u304b\u3092\u7279\u5b9a\u3067\u304d\u308b\u3002\u4fee\u6b63\u30fb\u524a\u9664\u306a\u3069\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u3082\u3001\u8ab0\u304c\u30fb\u3044\u3064\u30fb\u306a\u305c\u884c\u3063\u305f\u304b\u3092\u7279\u5b9a\u3067\u304d\u308b<\/td><\/tr><tr><td>\u5224\u8aad\u6027<\/td><td>Legible<\/td><td>\u8a18\u9332\u304c\u8aad\u307f\u53d6\u308a\u53ef\u80fd\u3067\u3001\u66d6\u6627\u3055\u304c\u306a\u304f\u7406\u89e3\u3067\u304d\u308b<\/td><\/tr><tr><td>\u540c\u6642\u6027<\/td><td>Contemporaneous<\/td><td>\u884c\u70ba\u30fb\u4e8b\u8c61\u30fb\u5224\u65ad\u304c\u8d77\u304d\u305f\u6642\u70b9\u3067\u8a18\u9332\u3055\u308c\u3066\u3044\u308b<\/td><\/tr><tr><td>\u539f\u672c\u6027<\/td><td>Original<\/td><td>\u6700\u521d\u306b\u53d6\u5f97\u3055\u308c\u305f\u60c5\u5831\u3067\u3042\u308b\u3002FDA\u306eALCOA\u3067\u306f\u300c\u539f\u672c\u307e\u305f\u306f\u771f\u6b63\u306a\u30b3\u30d4\u30fc\u300d\u3068\u8868\u73fe\u3055\u308c\u308b<\/td><\/tr><tr><td>\u6b63\u78ba\u6027<\/td><td>Accurate<\/td><td>\u8a18\u9332\u304c\u4e8b\u5b9f\u3092\u6b63\u3057\u304f\u8868\u3057\u3066\u3044\u308b<\/td><\/tr><tr><td>\u5b8c\u5168\u6027<\/td><td>Complete<\/td><td>\u4e8b\u8c61\u3092\u518d\u73fe\u3059\u308b\u305f\u3081\u306b\u91cd\u8981\u306a\u60c5\u5831\u304c\u5931\u308f\u308c\u3066\u3044\u306a\u3044<\/td><\/tr><tr><td>\u4e00\u8cab\u6027<\/td><td>Consistent<\/td><td>\u5b9a\u3081\u3089\u308c\u305f\u4e00\u8cab\u3057\u305f\u65b9\u6cd5\u3067\u4f5c\u6210\u30fb\u51e6\u7406\u30fb\u4fdd\u5b58\u3055\u308c\u3066\u3044\u308b<\/td><\/tr><tr><td>\u6c38\u7d9a\u6027<\/td><td>Enduring<\/td><td>\u4fdd\u5b58\u671f\u9593\u3092\u901a\u3058\u3066\u3001\u640d\u306a\u308f\u308c\u305a\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u72b6\u614b\u3067\u4fdd\u6301\u3055\u308c\u308b<\/td><\/tr><tr><td>\u5165\u624b\u53ef\u80fd\u6027<\/td><td>Available<\/td><td>\u4fdd\u5b58\u671f\u9593\u4e2d\u3001\u30ec\u30d3\u30e5\u30fc\u306b\u5fc5\u8981\u306a\u3068\u304d\u306b\u8aad\u3081\u308b\u5f62\u5f0f\u3067\u5229\u7528\u3067\u304d\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>CSV\u306b\u3088\u3063\u3066\u30b7\u30b9\u30c6\u30e0\u306e\u4fe1\u983c\u6027\u3092\u62c5\u4fdd\u3059\u308b\u3053\u3068\u306f\u3001\u305d\u306e\u30b7\u30b9\u30c6\u30e0\u304c\u751f\u6210\u30fb\u7ba1\u7406\u3059\u308b\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u793a\u3059\u305f\u3081\u306e\u524d\u63d0\u3067\u3059\u3002CSV\u3092\u9069\u5207\u306b\u5b9f\u65bd\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u76e3\u67fb\u8a3c\u8de1\u306e\u81ea\u52d5\u8a18\u9332\u3084\u96fb\u5b50\u7f72\u540d\u306b\u3088\u308b\u5e30\u5c5e\u306e\u660e\u78ba\u5316\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u306b\u3088\u308b\u6c38\u7d9a\u6027\u306e\u78ba\u4fdd\u306a\u3069\u3001ALCOA+\u306e\u5404\u8981\u7d20\u3092\u6280\u8853\u7684\u306b\u652f\u3048\u307e\u3059\u3002<\/p>\n\n\n\n<p>CSV\u6d3b\u52d5\u306e\u4e2d\u3067\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u8981\u4ef6\u3092\u610f\u8b58\u3057\u305f\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3092\u8a2d\u8a08\u3059\u308b\u3053\u3068\u3067\u3001\u6539\u6b63GMP\u7701\u4ee4\u304c\u6c42\u3081\u308b\u8a18\u9332\u306e\u4fe1\u983c\u6027\u78ba\u4fdd\u306b\u3082\u3001\u30b7\u30b9\u30c6\u30e0\u3068\u30c7\u30fc\u30bf\u306e\u4e21\u9762\u304b\u3089\u5bfe\u5fdc\u3067\u304d\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.fda.gov\/media\/119267\/download\" 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\u300cPI 041-1 Good Practices for Data Management and Integrity in Regulated GMP\/GDP Environments\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-20\">CSV\u3068CSA\u306e\u9055\u3044<\/h2>\n\n\n\n<p>CSA\uff08Computer Software Assurance\uff09\u306f\u3001CSV\u3092\u7f6e\u304d\u63db\u3048\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u30ea\u30b9\u30af\u306b\u898b\u5408\u3063\u305f\u4fdd\u8a3c\u6d3b\u52d5\u306b\u6ce8\u529b\u3059\u308b\u305f\u3081\u306e\u8003\u3048\u65b9\u3067\u3059\u3002FDA\u304c\u533b\u7642\u6a5f\u5668\u5206\u91ce\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u3057\u3066\u793a\u3057\u3066\u304a\u308a\u3001\u5f62\u5f0f\u7684\u306a\u6587\u66f8\u5316\u304b\u3089\u306e\u8131\u5374\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n<div id=\"id-d7aebb1e-b79a-45ea-ac5b-86acaca9171d\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>\u9805\u76ee<\/th><th>CSV\uff08\u5f93\u6765\u306e\u5b9f\u52d9\u3067\u898b\u3089\u308c\u308b\u50be\u5411\uff09<\/th><th>CSA<\/th><\/tr><tr><td>\u4f4d\u7f6e\u3065\u3051<\/td><td>GQP\u30fbGMP\u306a\u3069\u306e\u898f\u5236\u306b\u57fa\u3065\u304f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u7ba1\u7406\u6d3b\u52d5\u3002\u672c\u6765\u306f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u304c\u524d\u63d0<\/td><td>FDA\u306e\u533b\u7642\u6a5f\u5668\u5411\u3051\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u793a\u3055\u308c\u305f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u4fdd\u8a3c\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u8003\u3048\u65b9<\/td><\/tr><tr><td>\u4fdd\u8a3c\u6d3b\u52d5\u306e\u7d5e\u308a\u8fbc\u307f<\/td><td>\u5168\u6a5f\u80fd\u3092\u540c\u3058\u6df1\u3055\u3067\u691c\u8a3c\u3059\u308b\u904b\u7528\u306b\u504f\u308a\u3084\u3059\u3044<\/td><td>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u610f\u56f3\u3057\u305f\u7528\u9014\u3068\u3001\u5de5\u7a0b\u30ea\u30b9\u30af\u304c\u9ad8\u3044\u304b\u3069\u3046\u304b\u3092\u8ef8\u306b\u4fdd\u8a3c\u6d3b\u52d5\u3092\u7d5e\u308a\u8fbc\u3080<\/td><\/tr><tr><td>\u30c6\u30b9\u30c8\u65b9\u91dd<\/td><td>\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\u3092\u4e00\u5f8b\u306b\u9069\u7528\u3057\u304c\u3061<\/td><td>\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u3001\u30a2\u30c9\u30db\u30c3\u30af\u30c6\u30b9\u30c8\u3084\u63a2\u7d22\u7684\u30c6\u30b9\u30c8\u306a\u3069\u306e\u975e\u30b9\u30af\u30ea\u30d7\u30c8\u30c6\u30b9\u30c8\u3082\u6d3b\u7528\u3059\u308b<\/td><\/tr><tr><td>\u8a18\u9332<\/td><td>\u7db2\u7f85\u7684\u306a\u6587\u66f8\u5316\u306b\u504f\u308a\u3084\u3059\u3044<\/td><td>\u4fdd\u8a3c\u306e\u6839\u62e0\u3068\u3057\u3066\u5fc5\u8981\u5341\u5206\u306a\u8a18\u9332\u3068\u3057\u3001\u4f4e\u30ea\u30b9\u30af\u9818\u57df\u3067\u306f\u7c21\u6f54\u306a\u8a18\u9332\u3067\u8db3\u308a\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>FDA\u306e\u73fe\u884c\u30ac\u30a4\u30c0\u30f3\u30b9\u300cComputer Software Assurance for Production and Quality Management System Software\u300d\u306f2026\u5e742\u67083\u65e5\u306b\u767a\u884c\u3055\u308c\u30012025\u5e749\u670824\u65e5\u306b\u767a\u884c\u3055\u308c\u305f\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u300cComputer Software Assurance for Production and Quality System Software\u300d\u3092\u7f6e\u304d\u63db\u3048\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u524d\u65e5\u306e2026\u5e742\u67082\u65e5\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u5247\u3067\u3042\u308bQMSR\uff08\u6539\u6b6321 CFR Part 820\uff09\u304c\u65bd\u884c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u540c\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u307e\u305f\u306f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u4e00\u90e8\u3068\u3057\u3066\u4f7f\u308f\u308c\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30fb\u81ea\u52d5\u30c7\u30fc\u30bf\u51e6\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u5bfe\u8c61\u3068\u3057\u3066\u304a\u308a\u3001\u533b\u85ac\u54c1\u306eGMP\u624b\u7d9a\u304d\u306b\u305d\u306e\u307e\u307e\u9069\u7528\u3055\u308c\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u4e00\u65b9\u3001\u65e5\u672c\u306e\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u6a19\u6e96\u4f8b\u3068\u540c\u7b49\u307e\u305f\u306f\u305d\u308c\u4ee5\u4e0a\u306e\u76ee\u7684\u3092\u9054\u6210\u3067\u304d\u308b\u65b9\u6cd5\u3067\u3042\u308c\u3070\u3001\u4ee3\u308f\u308a\u306e\u65b9\u6cd5\u3092\u7528\u3044\u3066\u3082\u5dee\u3057\u652f\u3048\u306a\u3044\u3068\u3057\u3066\u3044\u307e\u3059\u3002CSA\u306b\u898b\u3089\u308c\u308b\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u305f\u30c6\u30b9\u30c8\u624b\u6cd5\u306e\u9078\u629e\u3092\u53d6\u308a\u5165\u308c\u308b\u5834\u5408\u3082\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u76ee\u7684\u3092\u540c\u7b49\u4ee5\u4e0a\u306b\u9054\u6210\u3067\u304d\u308b\u3053\u3068\u3092\u3001\u81ea\u793e\u306e\u7ba1\u7406\u898f\u5b9a\u3084\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u3067\u8aac\u660e\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/computer-software-assurance-production-and-quality-management-system-software\" rel=\"nofollow\">FDA\u300cComputer Software Assurance for Production and Quality Management System Software\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/quality-management-system-regulation-qmsr\" rel=\"nofollow\">FDA\u300cQuality Management System Regulation\uff08QMSR\uff09\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-21\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u8ab2\u984c\u3068\u5bfe\u5fdc\u7b56<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306e\u5b9f\u52d9\u3067\u306f\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u5171\u901a\u306e\u8ab2\u984c\u3092\u62b1\u3048\u3066\u3044\u307e\u3059\u3002\u8ab2\u984c\u306e\u672c\u8cea\u306f\u30ea\u30bd\u30fc\u30b9\u914d\u5206\u306e\u6700\u9069\u5316\u3068\u6587\u66f8\u4f5c\u6210\u8ca0\u8377\u306e\u8efd\u6e1b\u306b\u3042\u308a\u3001\u4ee3\u8868\u7684\u306a\u5bfe\u5fdc\u7b56\u3068\u3057\u3066\u6b21\u306e4\u3064\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u5fb9\u5e95<\/li>\n\n\n\n<li>\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306e\u6d3b\u7528<\/li>\n\n\n\n<li>\u30d9\u30f3\u30c0\u30fc\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\u306e\u6d3b\u7528<\/li>\n\n\n\n<li>\u751f\u6210AI\u3092\u6d3b\u7528\u3057\u305fCSV\u696d\u52d9\u306e\u52b9\u7387\u5316<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-22\">\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u5fb9\u5e95<\/h3>\n\n\n\n<p>\u300c\u3059\u3079\u3066\u306e\u30b7\u30b9\u30c6\u30e0\u30fb\u6a5f\u80fd\u3092\u540c\u3058\u30ec\u30d9\u30eb\u3067\u691c\u8a3c\u3057\u3088\u3046\u3068\u3057\u3066\u5de5\u6570\u304c\u81a8\u3089\u3080\u300d\u3068\u3044\u3046\u8ab2\u984c\u306b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u306b\u57fa\u3065\u304f\u691c\u8a3c\u7bc4\u56f2\u306e\u30e1\u30ea\u30cf\u30ea\u4ed8\u3051\u304c\u6709\u52b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u6bb5\u968e\u3067GQP\u30fbGMP\u696d\u52d9\u3078\u306e\u5f71\u97ff\u3092\u660e\u78ba\u306b\u533a\u5206\u3057\u3001\u5f71\u97ff\u306e\u5c0f\u3055\u3044\u6a5f\u80fd\u306b\u307e\u3067\u8a73\u7d30\u306a\u30c6\u30b9\u30c8\u30b9\u30af\u30ea\u30d7\u30c8\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3092\u907f\u3051\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305f\u3068\u3048\u3070\u3001GQP\u30fbGMP\u306e\u8a18\u9332\u306b\u8a72\u5f53\u3057\u306a\u3044\u753b\u9762\u306e\u914d\u8272\u3084\u8868\u793a\u9806\u5e8f\u306a\u3069\u3001\u60a3\u8005\u5b89\u5168\u30fb\u88fd\u54c1\u54c1\u8cea\u30fb\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u5f71\u97ff\u3057\u306a\u3044\u6a5f\u80fd\u306b\u3064\u3044\u3066\u306f\u3001\u7c21\u6613\u306a\u52d5\u4f5c\u78ba\u8a8d\u306b\u3068\u3069\u3081\u308b\u5224\u65ad\u304c\u5408\u7406\u7684\u3067\u3059\u3002\u9006\u306b\u3001\u88fd\u9020\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5236\u5fa1\u3084\u54c1\u8cea\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u8a08\u7b97\u30ed\u30b8\u30c3\u30af\u3001\u8a66\u9a13\u6210\u7e3e\u66f8\u306a\u3069\u306e\u8a18\u9332\u3092\u51fa\u529b\u3059\u308b\u6a5f\u80fd\u306b\u306f\u3001\u5341\u5206\u306a\u30c6\u30b9\u30c8\u5de5\u6570\u3092\u78ba\u4fdd\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-23\">\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306e\u6d3b\u7528<\/h3>\n\n\n\n<p>CSV\u6587\u66f8\u306e\u4f5c\u6210\u8ca0\u8377\u3092\u4e0b\u3052\u308b\u306b\u306f\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u6587\u66f8\u4f53\u7cfb\u306b\u6cbf\u3063\u305f\u6a19\u6e96\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306e\u6574\u5099\u304c\u52b9\u679c\u7684\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u66f8\u3084\u8981\u6c42\u4ed5\u69d8\u66f8\u3001\u5404\u9069\u683c\u6027\u8a55\u4fa1\u306e\u8a08\u753b\u66f8\u30fb\u5831\u544a\u66f8\u306a\u3069\u306e\u6a19\u6e96\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u793e\u5185\u3067\u6574\u5099\u3057\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3054\u3068\u306b\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3057\u3066\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u6587\u66f8\u4f5c\u6210\u306e\u52b9\u7387\u3092\u9ad8\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306f\u3001\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u539f\u5247\u3068\u3057\u3066\u6c42\u3081\u3089\u308c\u308b\u8a18\u8f09\u4e8b\u9805\u3092\u62bc\u3055\u3048\u3064\u3064\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u56fa\u6709\u306e\u8a18\u8f09\u7b87\u6240\u3092\u660e\u78ba\u306b\u3059\u308b\u69cb\u6210\u304c\u5b9f\u7528\u7684\u3067\u3059\u3002GAMP 5\u306f\u6cd5\u7684\u8981\u6c42\u3067\u306f\u306a\u3044\u305f\u3081\u3001\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u53d6\u308a\u5165\u308c\u308b\u5834\u5408\u306f\u81ea\u793e\u306e\u7ba1\u7406\u898f\u5b9a\u3068\u306e\u5bfe\u5fdc\u95a2\u4fc2\u3092\u6574\u7406\u3057\u3066\u304a\u304f\u3068\u3001\u67fb\u5bdf\u6642\u306b\u3082\u8aac\u660e\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-24\">\u30d9\u30f3\u30c0\u30fc\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\u306e\u6d3b\u7528<\/h3>\n\n\n\n<p>\u5e02\u8ca9\u30d1\u30c3\u30b1\u30fc\u30b8\u3084\u30af\u30e9\u30a6\u30c9\u30b5\u30fc\u30d3\u30b9\u3001\u53d7\u8a17\u958b\u767a\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u3059\u308b\u5834\u5408\u3001\u4f9b\u7d66\u8005\u306e\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u3092\u8a55\u4fa1\u3059\u308b\u30d9\u30f3\u30c0\u30fc\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\uff08\u4f9b\u7d66\u8005\u76e3\u67fb\uff09\u304c\u6709\u52b9\u3067\u3059\u3002\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3082\u3001\u4f9b\u7d66\u8005\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306f\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u4e00\u90e8\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30d9\u30f3\u30c0\u30fc\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\u3067\u306f\u3001\u4f9b\u7d66\u8005\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3001\u30c6\u30b9\u30c8\u4f53\u5236\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3001\u5909\u66f4\u7ba1\u7406\u624b\u9806\u306a\u3069\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002\u5de5\u5834\u51fa\u8377\u8a66\u9a13\u3084\u73fe\u5730\u53d7\u5165\u8a66\u9a13\u306e\u8a18\u9332\u306f\u3001\u78ba\u8a8d\u65b9\u6cd5\u3068\u8a18\u9332\u3092\u691c\u8a3c\u8cac\u4efb\u8005\u304c\u9069\u5207\u3068\u8a8d\u3081\u305f\u5834\u5408\u306b\u3001\u9069\u683c\u6027\u8a55\u4fa1\u3078\u5f15\u7528\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305f\u3060\u3057\u3001\u5f15\u7528\u306b\u3088\u3063\u3066\u30e6\u30fc\u30b6\u30fc\u5074\u306e\u691c\u8a3c\u8cac\u4efb\u304c\u306a\u304f\u306a\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u4f55\u3092\u4f9b\u7d66\u8005\u306e\u8a18\u9332\u3067\u4ee3\u66ff\u3057\u3001\u4f55\u3092\u81ea\u793e\u3067\u78ba\u8a8d\u3059\u308b\u304b\u3092\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u306b\u660e\u8a18\u3057\u3001\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8\u306e\u7d50\u679c\u306f\u4f9b\u7d66\u8005\u8a55\u4fa1\u306e\u8a18\u9332\u3068\u3057\u3066\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb6573&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-25\">\u751f\u6210AI\u3092\u6d3b\u7528\u3057\u305fCSV\u696d\u52d9\u306e\u52b9\u7387\u5316<\/h3>\n\n\n\n<p>\u751f\u6210AI\u3092CSV\u95a2\u9023\u306e\u6587\u66f8\u696d\u52d9\u306b\u6d3b\u7528\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3059\u308b\u4f01\u696d\u3082\u51fa\u3066\u304d\u3066\u3044\u307e\u3059\u3002GxP\u9818\u57df\u306eAI\u6d3b\u7528\u306b\u3064\u3044\u3066\u306f\u3001ISPE\u304c2025\u5e747\u6708\u306b\u3001GAMP 5\u7b2c2\u7248\u306e\u8003\u3048\u65b9\u3092AI\u306e\u7279\u6027\u306b\u6a4b\u6e21\u3057\u3059\u308b\u300cISPE GAMP Guide: Artificial Intelligence\u300d\u3092\u767a\u884c\u3057\u3066\u3044\u307e\u3059\u3002\u60f3\u5b9a\u3055\u308c\u308b\u4e3b\u306a\u6d3b\u7528\u306e\u65b9\u5411\u6027\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CSV\u6587\u66f8\u306e\u30c9\u30e9\u30d5\u30c8\u4f5c\u6210\uff1a\u8981\u6c42\u4ed5\u69d8\u66f8\u3084\u30c6\u30b9\u30c8\u8a08\u753b\u66f8\u306e\u30c9\u30e9\u30d5\u30c8\u3092AI\u304c\u4f5c\u6210\u3057\u3001\u62c5\u5f53\u8005\u304c\u30ec\u30d3\u30e5\u30fc\u30fb\u4fee\u6b63\u3059\u308b<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u652f\u63f4\uff1a\u904e\u53bb\u306e\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u3082\u3068\u306b\u3001\u30ea\u30b9\u30af\u9805\u76ee\u306e\u6d17\u3044\u51fa\u3057\u3092\u88dc\u52a9\u3059\u308b<\/li>\n\n\n\n<li>\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u306e\u7d20\u6848\u4f5c\u6210\uff1a\u8981\u6c42\u4ed5\u69d8\u66f8\u306e\u8a18\u8ff0\u304b\u3089\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u306e\u7d20\u6848\u3092\u5c0e\u51fa\u3059\u308b<\/li>\n\n\n\n<li>\u6587\u66f8\u9593\u306e\u6574\u5408\u6027\u30c1\u30a7\u30c3\u30af\uff1a\u8981\u6c42\u4ed5\u69d8\u66f8\u30fb\u6a5f\u80fd\u4ed5\u69d8\u66f8\u30fb\u30c6\u30b9\u30c8\u8a08\u753b\u66f8\u9593\u306e\u4e0d\u6574\u5408\u3092\u691c\u51fa\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u305f\u3060\u3057\u3001AI\u306e\u51fa\u529b\u306f\u3042\u304f\u307e\u3067\u30c9\u30e9\u30d5\u30c8\u3067\u3059\u3002\u6700\u7d42\u7684\u306a\u5185\u5bb9\u306e\u78ba\u8a8d\u3001\u30ea\u30b9\u30af\u5224\u65ad\u3001\u627f\u8a8d\u306f\u4eba\u304c\u884c\u3046\u3001Human-in-the-Loop\uff08\u4eba\u304c\u4ecb\u5728\u3059\u308b\u8a2d\u8a08\u601d\u60f3\uff09\u304c\u524d\u63d0\u3067\u3059\u3002\u53c2\u8003\u3068\u3057\u3066\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c2025\u5e747\u6708\u306b\u610f\u898b\u52df\u96c6\u3092\u958b\u59cb\u3057\u305fEU GMP Annex 22\u6848\u306f\u3001\u751f\u6210AI\u3068\u5927\u898f\u6a21\u8a00\u8a9e\u30e2\u30c7\u30eb\uff08LLM\uff09\u3092\u540c\u6848\u306e\u9069\u7528\u5bfe\u8c61\u5916\u3068\u3057\u305f\u3046\u3048\u3067\u3001\u60a3\u8005\u5b89\u5168\u30fb\u88fd\u54c1\u54c1\u8cea\u30fb\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u91cd\u8981\u306aGMP\u7528\u9014\u306b\u306f\u4f7f\u7528\u3059\u3079\u304d\u3067\u306a\u3044\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u76f4\u63a5\u5f71\u97ff\u306e\u306a\u3044\u7528\u9014\u3067\u4f7f\u3046\u5834\u5408\u306f\u3001\u9069\u5207\u306a\u8cc7\u683c\u3068\u8a13\u7df4\u3092\u6301\u3064\u62c5\u5f53\u8005\u304c\u3001\u51fa\u529b\u304c\u610f\u56f3\u3057\u305f\u7528\u9014\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5e38\u306b\u78ba\u8a8d\u3059\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u540c\u6848\u306e\u610f\u898b\u52df\u96c6\u306f2025\u5e7410\u67087\u65e5\u306b\u7d42\u4e86\u3057\u3066\u304a\u308a\u30012026\u5e7410\u6708\u6642\u70b9\u3067\u610f\u898b\u52df\u96c6\u30da\u30fc\u30b8\u306b\u6700\u7d42\u63a1\u629e\u306e\u8a18\u8f09\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001AI\u306e\u4f7f\u3044\u3069\u3053\u308d\u3092\u6c7a\u3081\u308b\u969b\u306e\u53c2\u8003\u306b\u306a\u308a\u307e\u3059\u3002AI\u306e\u51fa\u529b\u304cGQP\u30fbGMP\u306e\u8a18\u9332\u3084\u5224\u65ad\u306b\u95a2\u308f\u308b\u5834\u5408\u306f\u3001\u305d\u306e\u30c4\u30fc\u30eb\u81ea\u4f53\u3092\u30b7\u30b9\u30c6\u30e0\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u5bfe\u8c61\u3068\u3057\u3066\u6271\u3044\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/ispe.org\/pharmaceutical-engineering\/ispeak\/new-gampr-guide-addresses-challenges-posed-ai-enabled\" rel=\"nofollow\">ISPE\u300cNew GAMP Guide Addresses Challenges Posed by AI-Enabled Systems\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf\" rel=\"nofollow\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u300cAnnex 22: Artificial Intelligence\uff08consultation draft\uff09\u300d<\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\">\n\n\n\n<p><b>CSV\u95a2\u9023\u306e\u6587\u66f8\u696d\u52d9\u3092\u52b9\u7387\u5316\u3059\u308b\u306a\u3089\u300cJAPAN AI \u88fd\u85ac\u300d<\/b><br>SOP\u3084\u54c1\u8cea\u6587\u66f8\u306e\u6539\u8a02\u306f\u3001\u95a2\u9023\u6587\u66f8\u306e\u7279\u5b9a\u304b\u3089\u6539\u8a02\u6848\u306e\u4f5c\u6210\u3001\u6574\u5408\u78ba\u8a8d\u307e\u3067\u591a\u304f\u306e\u624b\u4f5c\u696d\u3092\u4f34\u3044\u307e\u3059\u3002<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">JAPAN AI \u88fd\u85ac<\/a>\u306f\u3001\u88fd\u85ac\u696d\u754c\u306e\u6587\u66f8\u6539\u8a02\u306b\u7279\u5316\u3057\u305fAI\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u793e\u5185\u6587\u66f8\u306e\u81ea\u7136\u8a00\u8a9e\u691c\u7d22\u3001\u627f\u8a8d\u3055\u308c\u305f\u5909\u66f4\u8d77\u6848\u3092\u3082\u3068\u306b\u3057\u305f\u6539\u8a02\u6848\u306e\u30c9\u30e9\u30d5\u30c8\u4f5c\u6210\u3001\u6539\u8a02\u6587\u66f8\u5185\u306e\u77db\u76fe\u30fb\u9f5f\u9f6c\u306e\u691c\u51fa\u307e\u3067\u3092\u652f\u63f4\u3057\u307e\u3059\u3002AI\u306f\u63d0\u6848\u307e\u3067\u3092\u62c5\u3044\u3001\u6700\u7d42\u5224\u65ad\u30fb\u627f\u8a8d\u30fb\u5b9f\u884c\u306f\u4eba\u304c\u884c\u3046Human-in-the-Loop\u8a2d\u8a08\u3067\u3059\u3002GAMP 5\u306b\u57fa\u3065\u304f\u958b\u767a\u30fb\u30c6\u30b9\u30c8\u8a18\u9332\u3092\u3001\u53ef\u80fd\u306a\u7bc4\u56f2\u3067\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u6599\u3068\u3057\u3066\u63d0\u4f9b\u3057\u3001\u5c0e\u5165\u4f01\u696d\u304c\u5b9f\u65bd\u3059\u308b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\u30fbOQ\u30fbPQ\uff09\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u5165\u529b\u3055\u308c\u305f\u6a5f\u5bc6\u30c7\u30fc\u30bf\u3084\u6587\u66f8\u304cAI\u306e\u30d1\u30d6\u30ea\u30c3\u30af\u30e2\u30c7\u30eb\u306e\u518d\u5b66\u7fd2\u306b\u5229\u7528\u3055\u308c\u308b\u3053\u3068\u306f\u306a\u304f\u3001ISO\/IEC 27001\u3092\u53d6\u5f97\u3057\u305f\u4f53\u5236\u3067\u904b\u7528\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-26\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-27\">CSV\u3067\u306f\u3069\u306e\u3088\u3046\u306a\u6587\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u539a\u52b4\u7701\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u539f\u5247\u3068\u3057\u3066\u6319\u3052\u308b\u4e3b\u306a\u6587\u66f8\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul 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