{"id":11467,"date":"2026-11-11T19:58:59","date_gmt":"2026-11-11T10:58:59","guid":{"rendered":"https:\/\/japan-ai.geniee.co.jp\/media\/?p=11467"},"modified":"2026-11-11T19:59:03","modified_gmt":"2026-11-11T10:59:03","slug":"gmp%e3%81%a8%e3%81%af%ef%bc%9f%e6%84%8f%e5%91%b3%e3%83%bb%e4%b8%89%e5%8e%9f%e5%89%87%e3%83%bb%e7%a8%ae%e9%a1%9e%e3%81%8b%e3%82%89%e8%aa%8d%e8%a8%bc%e5%88%b6%e5%ba%a6%e3%81%be%e3%81%a7%e3%82%8f","status":"publish","type":"post","link":"https:\/\/japan-ai.co.jp\/media\/11467\/","title":{"rendered":"GMP\u3068\u306f\uff1f\u610f\u5473\u30fb\u4e09\u539f\u5247\u30fb\u7a2e\u985e\u304b\u3089\u8a8d\u8a3c\u5236\u5ea6\u307e\u3067\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac"},"content":{"rendered":"\n<p>GMP\uff08Good Manufacturing Practice\uff1a\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09\u3068\u306f\u3001\u539f\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u6700\u7d42\u88fd\u54c1\u306e\u51fa\u8377\u306b\u81f3\u308b\u307e\u3067\u306e\u5168\u5de5\u7a0b\u3067\u3001\u9069\u6b63\u306a\u88fd\u9020\u7ba1\u7406\u3068\u54c1\u8cea\u7ba1\u7406\u3092\u6c42\u3081\u308b\u8003\u3048\u65b9\u30fb\u57fa\u6e96\u306e\u7dcf\u79f0\u3067\u3059\u3002\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u3067\u306fGMP\u7701\u4ee4\u306b\u57fa\u3065\u304f\u6cd5\u7684\u306a\u57fa\u6e96\u3068\u3057\u3066\u904b\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u307e\u305f\u3001\u7d4c\u904e\u63aa\u7f6e\u671f\u9593\u3092\u7d4c\u3066\u30012026\u5e749\u67081\u65e5\u304b\u3089\u306f\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\uff08\u9320\u5264\u30fb\u30ab\u30d7\u30bb\u30eb\u5264\u306a\u3069\uff09\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306b\u3082GMP\u57fa\u6e96\u304c\u5168\u9762\u7684\u306b\u9069\u7528\u3055\u308c\u307e\u3057\u305f\u30022027\u5e745\u670820\u65e5\u306b\u306f\u3001\u5b9a\u671f\u9069\u5408\u6027\u8abf\u67fb\u306e\u983b\u5ea6\u30925\u5e74\u306b1\u5ea6\u304b\u30893\u5e74\u306b1\u5ea6\u3068\u3059\u308b\u306a\u3069\u3001\u533b\u85ac\u54c1\u7b49\u306eGMP\u9069\u5408\u6027\u8abf\u67fb\u5236\u5ea6\u306e\u898b\u76f4\u3057\u3082\u65bd\u884c\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001GMP\u3068\u306f\u305d\u3082\u305d\u3082\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u304b\u3001GMP\u7701\u4ee4\u3084ISO 9001\u3001PIC\/S\u3068\u306f\u3069\u3046\u9055\u3046\u306e\u304b\u3001\u81ea\u793e\u88fd\u54c1\u306b\u306f\u3069\u306e\u57fa\u6e96\u304c\u9069\u7528\u3055\u308c\u308b\u306e\u304b\u3001\u3068\u3044\u3063\u305f\u7591\u554f\u3092\u6301\u3064\u65b9\u3082\u591a\u3044\u306e\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u304b\u3002<\/p>\n\n\n\n<p>\u672c\u8a18\u4e8b\u3067\u306f\u3001<mark>GMP\u306e\u610f\u5473\u3084\u4e09\u539f\u5247\u304b\u3089\u3001\u533b\u85ac\u54c1\u30fb\u5065\u5eb7\u98df\u54c1\u30fb\u5316\u7ca7\u54c1\u3068\u3044\u3063\u305f\u5206\u91ce\u3054\u3068\u306e\u9055\u3044\u3001\u305d\u3057\u3066GMP\u7701\u4ee4\u3084\u8a8d\u8a3c\u5236\u5ea6\u306e\u4ed5\u7d44\u307f<\/mark>\u307e\u3067\u3001<a href=\"https:\/\/japan-ai.co.jp\/pharma\/?uqid=p2056i86409db80a&amp;bid=6683I86d2e24f378\">\u88fd\u85ac\u696d\u754c\u5411\u3051AI\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u63d0\u4f9b\u3059\u308bJAPAN AI<\/a>\u304c\u7db2\u7f85\u7684\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/notice\/entry\/039209\/\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306e\u3046\u3061\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u9320\u5264\u3001\u30ab\u30d7\u30bb\u30eb\u5264\u7b49\u98df\u54c1\u306e\u88fd\u9020\u53c8\u306f\u52a0\u5de5\u306e\u57fa\u6e96\u306e\u5236\u5b9a\u53ca\u3073\u98df\u54c1\u8868\u793a\u57fa\u6e96\u306b\u3064\u3044\u3066\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/427M60000002010\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u98df\u54c1\u8868\u793a\u57fa\u6e96\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/stf\/r7_gmptyousa_minaoshi.html\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u4ee4\u548c\uff17\u5e74\u85ac\u6a5f\u6cd5\u6539\u6b63\u306b\u304a\u3051\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u5236\u5ea6\u306e\u898b\u76f4\u3057\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<div class=\"toc\">    <div id=\"toc_container\" class=\"toc_container toc-container sgb-toc--bullets js-smooth-scroll\" data-dialog-title=\"Table of Contents\">\n      <p class=\"toc_title\">\u76ee\u6b21 <\/p>\n      <ul class=\"toc_list\">  <li class=\"first\">    <a href=\"#i-0\">GMP\u3068\u306f\uff1f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-1\">GMP\u306e\u76ee\u7684<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-2\">GMP\u7701\u4ee4\u5236\u5b9a\u306e\u7d4c\u7def<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-3\">GMP\u4e09\u539f\u5247\u3068\u306f\uff1f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-4\">\u4eba\u70ba\u7684\u306a\u30df\u30b9\u3092\u6700\u5c0f\u9650\u306b\u3059\u308b\u3053\u3068<\/a>      <\/li>      <li>        <a href=\"#i-5\">\u6c5a\u67d3\u53ca\u3073\u54c1\u8cea\u4f4e\u4e0b\u306e\u9632\u6b62<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-6\">\u9ad8\u3044\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u8a08<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-7\">GMP\u306e\u7a2e\u985e<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-8\">\u533b\u85ac\u54c1GMP<\/a>      <\/li>      <li>        <a href=\"#i-9\">\u5065\u5eb7\u98df\u54c1GMP<\/a>      <\/li>      <li>        <a href=\"#i-10\">\u5316\u7ca7\u54c1GMP<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-11\">\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306eGMP\u7fa9\u52d9\u5316<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-12\">GMP\u7701\u4ee4\u3068\u306f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-13\">GMP\u3068ISO 9001\u306e\u9055\u3044<\/a>      <\/li>      <li>        <a href=\"#i-14\">GMP\u3068PIC\/S\u3068\u306e\u9055\u3044<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-15\">\u4ee4\u548c7\u5e74\u85ac\u6a5f\u6cd5\u6539\u6b63\u3068GMP\u9069\u5408\u6027\u8abf\u67fb\u306e\u898b\u76f4\u3057<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-16\">\u5065\u5eb7\u98df\u54c1\u306b\u304a\u3051\u308bGMP\u8a8d\u8a3c\u30fbGMP\u8a8d\u5b9a\u5de5\u5834\u3068\u306f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-17\">GMP\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u307e\u3067\u306e\u6d41\u308c<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-18\">GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u30e1\u30ea\u30c3\u30c8<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-19\">GMP\u3067\u7ba1\u7406\u3059\u308b\u5bfe\u8c61<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-20\">\u30cf\u30fc\u30c9\u9762\uff08\u69cb\u9020\u8a2d\u5099\uff09<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-21\">\u30bd\u30d5\u30c8\u9762\uff08\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\uff09<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-22\">GMP\u306e\u904b\u7528\u65b9\u6cd5<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-23\">\u81ea\u793e\u88fd\u54c1\u3068\u88fd\u9020\u5de5\u7a0b\u306e\u30ea\u30b9\u30af\u306e\u6d17\u3044\u51fa\u3057<\/a>      <\/li>      <li>        <a href=\"#i-24\">\u624b\u9806\u66f8\u306e\u4f5c\u6210<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-25\">GMP\u9069\u5408\u6027\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc<\/a>      <\/li>    <\/ul>  <\/li>  <li>    <a href=\"#i-26\">GMP\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/a>    <ul class=\"menu_level_1\">      <li class=\"first\">        <a href=\"#i-27\">GMP\u8a8d\u8a3c\u304c\u306a\u3044\u5de5\u5834\u3067\u88fd\u9020\u3055\u308c\u305f\u88fd\u54c1\u306f\u8ca9\u58f2\u3067\u304d\u307e\u3059\u304b\uff1f<\/a>      <\/li>      <li>        <a href=\"#i-28\">GMP\u3068HACCP\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/a>      <\/li>      <li class=\"last\">        <a href=\"#i-29\">GMP\u8a8d\u8a3c\u306e\u53d6\u5f97\u306b\u304b\u304b\u308b\u671f\u9593\u3068\u8cbb\u7528\u306e\u76ee\u5b89\u306f\u3069\u306e\u304f\u3089\u3044\u3067\u3059\u304b\uff1f<\/a>      <\/li>    <\/ul>  <\/li>  <li class=\"last\">    <a href=\"#i-30\">GMP\u3092\u7406\u89e3\u3057\u3066\u5b89\u5fc3\u611f\u306e\u3042\u308b\u88fd\u54c1\u3065\u304f\u308a\u3092<\/a>  <\/li><\/ul>\n      \n    <\/div><\/div><h2 class=\"wp-block-heading\" id=\"i-0\">GMP\u3068\u306f\uff1f<\/h2>\n\n\n\n<p>GMP\uff08Good Manufacturing Practice\uff09\u306f\u3001\u65e5\u672c\u8a9e\u3067\u300c\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u300d\u3068\u8a33\u3055\u308c\u307e\u3059\u3002\u539f\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u6700\u7d42\u88fd\u54c1\u306e\u51fa\u8377\u306b\u81f3\u308b\u307e\u3067\u306e\u5168\u5de5\u7a0b\u3067\u3001\u9069\u6b63\u306a\u88fd\u9020\u7ba1\u7406\u3068\u54c1\u8cea\u7ba1\u7406\u3092\u6c42\u3081\u308b\u8003\u3048\u65b9\u30fb\u57fa\u6e96\u306e\u7dcf\u79f0\u3067\u3059\u3002WHO\uff08\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff09\u306f\u3001GMP\u3092\u54c1\u8cea\u4fdd\u8a3c\u306e\u4e00\u5074\u9762\u3068\u4f4d\u7f6e\u3065\u3051\u3066\u3044\u307e\u3059\u3002\u533b\u85ac\u54c1\u304c\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u3075\u3055\u308f\u3057\u3044\u54c1\u8cea\u57fa\u6e96\u306b\u5f93\u3063\u3066\u6052\u5e38\u7684\u306b\u88fd\u9020\u30fb\u7ba1\u7406\u3055\u308c\u308b\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p>GMP\u306e\u8d77\u6e90\u306b\u3064\u3044\u3066\u3001\u539a\u751f\u52b4\u50cd\u7701\u306e\u8cc7\u6599\u306f\u30011962\u5e74\u306b\u7c73\u56fd\u304c\u300c\u9023\u90a6\u98df\u54c1\u30fb\u533b\u85ac\u54c1\u30fb\u5316\u7ca7\u54c1\u6cd5\u300d\u306e\u4e2d\u3067\u533b\u85ac\u54c1\u306e\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09\u306b\u95a2\u3059\u308b\u4e8b\u9805\u3092\u5b9a\u3081\u305f\u3053\u3068\u3092\u59cb\u307e\u308a\u3068\u3057\u3066\u3044\u307e\u3059\u3002WHO\u3067\u306fGMP\u306e\u521d\u7a3f\u304c1968\u5e74\u306b\u63a1\u629e\u3055\u308c\u307e\u3057\u305f\u30021969\u5e74\u306b\u306f\u3001\u56fd\u969b\u7684\u306b\u6d41\u901a\u3059\u308b\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u306b\u95a2\u3059\u308bWHO\u8a8d\u8a3c\u5236\u5ea6\u306e\u4e0d\u53ef\u6b20\u306a\u4e00\u90e8\u3068\u3057\u3066\u53d7\u3051\u5165\u308c\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u73fe\u5728\u3067\u306f\u3001\u533b\u85ac\u54c1\u306b\u3068\u3069\u307e\u3089\u305a\u3001\u98df\u54c1\u3084\u5316\u7ca7\u54c1\u306e\u5206\u91ce\u3067\u3082\u305d\u308c\u305e\u308c\u306eGMP\u57fa\u6e96\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.who.int\/teams\/health-product-policy-and-standards\/standards-and-specifications\/norms-and-standards\/gmp\" rel=\"nofollow\">WHO\u300cGood Manufacturing Practices\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/shingi\/2009\/03\/dl\/s0330-12c_0113.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c5\uff09GMP\u67fb\u5bdf\u306e\u5b9f\u614b\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/notice\/assets\/food_labeling_cms201_240823_01.pdf\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306e\u4eca\u5f8c\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-1\">GMP\u306e\u76ee\u7684<\/h3>\n\n\n\n<p>GMP\u306e\u76ee\u7684\u306f\u3001\u3059\u3079\u3066\u306e\u88fd\u54c1\u3092\u5b9a\u3081\u3089\u308c\u305f\u54c1\u8cea\u3067\u6052\u5e38\u7684\u306b\u88fd\u9020\u3067\u304d\u308b\u4f53\u5236\u3092\u3064\u304f\u308a\u3001\u54c1\u8cea\u306e\u3070\u3089\u3064\u304d\u3084\u4e0d\u826f\u54c1\u306e\u51fa\u8377\u3092\u9632\u3050\u3053\u3068\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6700\u7d42\u88fd\u54c1\u306e\u629c\u304d\u53d6\u308a\u691c\u67fb\u3067\u78ba\u8a8d\u3067\u304d\u308b\u306e\u306f\u3001\u30ed\u30c3\u30c8\u306e\u4e00\u90e8\u3060\u3051\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u691c\u67fb\u3055\u308c\u306a\u304b\u3063\u305f\u88fd\u54c1\u306b\u54c1\u8cea\u4e0a\u306e\u554f\u984c\u304c\u6f5c\u3093\u3067\u3044\u308b\u53ef\u80fd\u6027\u306f\u6392\u9664\u3067\u304d\u307e\u305b\u3093\u3002\u305f\u3068\u3048\u3070\u9320\u5264\u306e\u6709\u52b9\u6210\u5206\u306e\u542b\u91cf\u304c\u5de5\u7a0b\u306e\u9014\u4e2d\u3067\u3070\u3089\u3064\u3044\u305f\u5834\u5408\u3001\u629c\u304d\u53d6\u3063\u305f\u6570\u9320\u304c\u898f\u683c\u5185\u3067\u3082\u3001\u30ed\u30c3\u30c8\u5168\u4f53\u306e\u5747\u4e00\u6027\u307e\u3067\u306f\u4fdd\u8a3c\u3067\u304d\u307e\u305b\u3093\u3002\u305d\u3053\u3067GMP\u3067\u306f\u3001\u5de5\u7a0b\u305d\u306e\u3082\u306e\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002\u539f\u6599\u306e\u53d7\u5165\u308c\u3084\u88fd\u9020\u6761\u4ef6\u3001\u8a2d\u5099\u3001\u4f5c\u696d\u8005\u3001\u8a18\u9332\u306a\u3069\u3092\u7ba1\u7406\u3057\u3001\u3069\u306e\u88fd\u54c1\u3082\u540c\u3058\u6761\u4ef6\u3067\u4f5c\u3089\u308c\u305f\u3053\u3068\u3092\u8a18\u9332\u3067\u793a\u305b\u308b\u72b6\u614b\u3092\u6c42\u3081\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u306f\u300c\u54c1\u8cea\u306f\u691c\u67fb\u3067\u306f\u306a\u304f\u3001\u5de5\u7a0b\u306e\u4e2d\u3067\u3064\u304f\u308a\u8fbc\u3080\u300d\u3068\u3044\u3046\u8003\u3048\u65b9\u306b\u7acb\u3063\u3066\u3044\u307e\u3059\u3002\u5de5\u7a0b\u7ba1\u7406\u3067\u54c1\u8cea\u3092\u4fdd\u8a3c\u3057\u3066\u304a\u3051\u3070\u3001\u554f\u984c\u304c\u8d77\u304d\u305f\u3068\u304d\u3082\u8a18\u9332\u304b\u3089\u539f\u56e0\u3092\u305f\u3069\u308a\u3001\u5f71\u97ff\u7bc4\u56f2\u3092\u7279\u5b9a\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-2\">GMP\u7701\u4ee4\u5236\u5b9a\u306e\u7d4c\u7def<\/h3>\n\n\n\n<p>\u65e5\u672c\u306e\u533b\u85ac\u54c1GMP\u306f\u3001\u884c\u653f\u6307\u5c0e\u304b\u3089\u7701\u4ee4\u306b\u3088\u308b\u6cd5\u5236\u5316\u3078\u3001\u3055\u3089\u306b\u8a31\u53ef\u30fb\u627f\u8a8d\u306e\u8981\u4ef6\u3078\u3068\u3001\u6bb5\u968e\u7684\u306b\u5f37\u5316\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u3002\u539a\u751f\u52b4\u50cd\u7701\u306e\u8cc7\u6599\u306b\u3088\u308b\u4e3b\u306a\u7d4c\u7def\u306f\u3001\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>1974\u5e74\uff1a\u300c\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u3059\u308b\u57fa\u6e96\u300d\u304c\u5c40\u9577\u901a\u77e5\u3068\u3057\u3066\u516c\u8868\u3055\u308c\u308b\uff081976\u5e744\u6708\u304b\u3089\u884c\u653f\u6307\u5c0e\u3068\u3057\u3066\u5b9f\u65bd\uff09<\/li>\n\n\n\n<li>1980\u5e74\uff1a1979\u5e74\u306e\u85ac\u4e8b\u6cd5\u6539\u6b63\u306b\u57fa\u3065\u304d\u300c\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u898f\u5247\u300d\u304c\u5b9a\u3081\u3089\u308c\u3001GMP\u304c\u88fd\u9020\u696d\u8005\u306e\u9075\u5b88\u4e8b\u9805\u3068\u3057\u3066\u6cd5\u5236\u5316\u3055\u308c\u308b<\/li>\n\n\n\n<li>1994\u5e74\uff1aGMP\u7701\u4ee4\u3078\u306e\u9069\u5408\u304c\u88fd\u9020\u696d\u306e\u8a31\u53ef\u8981\u4ef6\u3068\u306a\u308b<\/li>\n\n\n\n<li>2005\u5e74\uff1a2002\u5e74\u306e\u85ac\u4e8b\u6cd5\u6539\u6b63\u3092\u7d4c\u3066\u3001GMP\u304c\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u306e\u8981\u4ef6\u3068\u306a\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u540c\u3058\u8cc7\u6599\u306f\u3001\u65e5\u672c\u304cGMP\u3092\u5c0e\u5165\u3057\u305f\u80cc\u666f\u3068\u3057\u3066\u30011969\u5e74\u306bWHO\u304c\u52a0\u76df\u56fd\u3078GMP\u306b\u57fa\u3065\u304f\u8a3c\u660e\u5236\u5ea6\u306e\u63a1\u7528\u3092\u52e7\u544a\u3057\u305f\u3053\u3068\u3092\u6319\u3052\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305d\u306e\u5f8c\u3082GMP\u7701\u4ee4\u306f\u6539\u6b63\u304c\u91cd\u306d\u3089\u308c\u3066\u3044\u307e\u3059\u30022021\u5e748\u67081\u65e5\u65bd\u884c\u306e\u6539\u6b63\u3067\u306f\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3068\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u95a2\u3059\u308b\u898f\u5b9a\u304c\u65b0\u305f\u306b\u76db\u308a\u8fbc\u307e\u308c\u307e\u3057\u305f\u3002\u88fd\u9020\u696d\u8005\u7b49\u306b\u306f\u3001\u54c1\u8cea\u65b9\u91dd\u3084\u54c1\u8cea\u76ee\u6a19\u306e\u8a2d\u5b9a\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u5b9a\u671f\u7684\u306a\u7167\u67fb\u306a\u3069\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306fICH Q10\uff08\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff09\u3084ICH Q9\uff08\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff09\u3068\u95a2\u308f\u308a\u306e\u6df1\u3044\u8003\u3048\u65b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/file\/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka\/iryouyouiyakuhinngiouhinnryuutuubousi3-1sannkou.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300cGMP\u7701\u4ee4\u306e\u6cbf\u9769\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/shingi\/2009\/03\/dl\/s0330-12c_0113.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c5\uff09GMP\u67fb\u5bdf\u306e\u5b9f\u614b\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-3\">GMP\u4e09\u539f\u5247\u3068\u306f\uff1f<\/h2>\n\n\n\n<p>GMP\u4e09\u539f\u5247\u3068\u306f\u3001GMP\u306e\u57fa\u672c\u7684\u306a\u8003\u3048\u65b9\u30923\u3064\u306b\u6574\u7406\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u6cd5\u4ee4\u306e\u6761\u6587\u3067\u5b9a\u3081\u3089\u308c\u305f\u7528\u8a9e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u3067\u3082\u3001\u533b\u85ac\u54c1\u3084\u5065\u5eb7\u98df\u54c1\u306a\u3069\u306e\u5206\u91ce\u3092\u554f\u308f\u305a\u3001GMP\u306e\u76ee\u7684\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306e\u67a0\u7d44\u307f\u3068\u3057\u3066\u6559\u80b2\u3084\u89e3\u8aac\u306e\u5834\u3067\u7528\u3044\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u4e09\u539f\u5247\u306f\u6b21\u306e3\u3064\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4eba\u70ba\u7684\u306a\u30df\u30b9\u3092\u6700\u5c0f\u9650\u306b\u3059\u308b\u3053\u3068<\/li>\n\n\n\n<li>\u6c5a\u67d3\u53ca\u3073\u54c1\u8cea\u4f4e\u4e0b\u306e\u9632\u6b62<\/li>\n\n\n\n<li>\u9ad8\u3044\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u8a08<\/li>\n<\/ul>\n\n\n\n<p>3\u3064\u306e\u539f\u5247\u306f\u4e92\u3044\u306b\u88dc\u3044\u5408\u3046\u95a2\u4fc2\u306b\u3042\u308a\u307e\u3059\u3002\u30df\u30b9\u3068\u6c5a\u67d3\u3092\u500b\u5225\u306b\u9632\u3050\u3060\u3051\u3067\u306a\u304f\u3001\u305d\u308c\u3092\u7d99\u7d9a\u7684\u306b\u4fdd\u8a3c\u3059\u308b\u4ed5\u7d44\u307f\u307e\u3067\u6574\u3048\u308b\u3053\u3068\u3067\u3001\u6052\u5e38\u7684\u306a\u54c1\u8cea\u78ba\u4fdd\u3068\u3044\u3046GMP\u306e\u76ee\u7684\u3092\u9054\u6210\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-4\">\u4eba\u70ba\u7684\u306a\u30df\u30b9\u3092\u6700\u5c0f\u9650\u306b\u3059\u308b\u3053\u3068<\/h3>\n\n\n\n<p>\u4eba\u70ba\u7684\u306a\u30df\u30b9\u3092\u6700\u5c0f\u9650\u306b\u3059\u308b\u306b\u306f\u3001\u4f5c\u696d\u8005\u500b\u4eba\u306e\u6ce8\u610f\u529b\u306b\u983c\u3089\u305a\u3001\u8ab0\u304c\u4f5c\u696d\u3057\u3066\u3082\u540c\u3058\u7d50\u679c\u306b\u306a\u308b\u4ed5\u7d44\u307f\u3092\u6574\u3048\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u88fd\u9020\u73fe\u5834\u3067\u306f\u3001\u79e4\u91cf\u306e\u8aa4\u308a\u3084\u539f\u6599\u306e\u53d6\u308a\u9055\u3048\u3001\u8868\u793a\u30e9\u30d9\u30eb\u306e\u8cbc\u308a\u9593\u9055\u3044\u306a\u3069\u306e\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u304c\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u76f4\u7d50\u3057\u307e\u3059\u3002GMP\u3067\u306f\u3001\u3053\u3046\u3057\u305f\u30df\u30b9\u3092\u9632\u3050\u305f\u3081\u306b\u6b21\u306e\u3088\u3046\u306a\u4ed5\u7d44\u307f\u3092\u6574\u5099\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u624b\u9806\u66f8\u306e\u6574\u5099\uff1aSOP\uff08Standard Operating Procedure\uff1a\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u3068\u3057\u3066\u3001\u8ab0\u304c\u4f5c\u696d\u3057\u3066\u3082\u540c\u3058\u7d50\u679c\u304c\u5f97\u3089\u308c\u308b\u3088\u3046\u624b\u9806\u3092\u6587\u66f8\u5316\u3059\u308b<\/li>\n\n\n\n<li>\u6559\u80b2\u8a13\u7df4\u306e\u5b9f\u65bd\uff1a\u4f5c\u696d\u8005\u304c\u624b\u9806\u66f8\u306e\u5185\u5bb9\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u3001\u5b9f\u884c\u3067\u304d\u308b\u3088\u3046\u8a08\u753b\u7684\u306b\u8a13\u7df4\u3059\u308b<\/li>\n\n\n\n<li>\u30c0\u30d6\u30eb\u30c1\u30a7\u30c3\u30af\u4f53\u5236\uff1a\u91cd\u8981\u306a\u5de5\u7a0b\u3067\u306f\u8907\u6570\u4eba\u3067\u78ba\u8a8d\u3057\u3001\u898b\u843d\u3068\u3057\u3092\u9632\u3050<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u4ed5\u7d44\u307f\u306b\u3088\u308a\u3001\u4f5c\u696d\u8005\u306e\u7d4c\u9a13\u3084\u30b9\u30ad\u30eb\u306e\u5dee\u306b\u5de6\u53f3\u3055\u308c\u306b\u304f\u3044\u3001\u5b89\u5b9a\u3057\u305f\u88fd\u9020\u4f53\u5236\u3092\u69cb\u7bc9\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-5\">\u6c5a\u67d3\u53ca\u3073\u54c1\u8cea\u4f4e\u4e0b\u306e\u9632\u6b62<\/h3>\n\n\n\n<p>\u88fd\u54c1\u306e\u6c5a\u67d3\u3084\u54c1\u8cea\u4f4e\u4e0b\u306f\u3001\u6d88\u8cbb\u8005\u306e\u5065\u5eb7\u88ab\u5bb3\u306b\u76f4\u7d50\u3059\u308b\u304a\u305d\u308c\u304c\u3042\u308b\u305f\u3081\u3001GMP\u3067\u306f\u88fd\u9020\u74b0\u5883\u3068\u4fdd\u7ba1\u6761\u4ef6\u306e\u4e21\u9762\u304b\u3089\u9632\u6b62\u7b56\u3092\u8b1b\u3058\u307e\u3059\u3002\u4e3b\u306a\u89b3\u70b9\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4ea4\u5dee\u6c5a\u67d3\u306e\u9632\u6b62\uff1a\u7570\u306a\u308b\u88fd\u54c1\u540c\u58eb\u304c\u6df7\u3056\u308a\u5408\u308f\u306a\u3044\u3088\u3046\u3001\u88fd\u9020\u533a\u57df\u306e\u5206\u96e2\u3084\u30e9\u30a4\u30f3\u306e\u6d17\u6d44\u624b\u9806\u3092\u5b9a\u3081\u308b<\/li>\n\n\n\n<li>\u6e29\u6e7f\u5ea6\u7ba1\u7406\uff1a\u539f\u6750\u6599\u3084\u4e2d\u9593\u88fd\u54c1\u3001\u6700\u7d42\u88fd\u54c1\u306e\u4fdd\u7ba1\u6761\u4ef6\u3092\u9069\u5207\u306b\u7ba1\u7406\u3057\u3001\u52a3\u5316\u3092\u9632\u3050<\/li>\n\n\n\n<li>\u7570\u7269\u6df7\u5165\u9632\u6b62\uff1a\u88fd\u9020\u74b0\u5883\u306e\u6e05\u6d44\u5ea6\u7ba1\u7406\u3084\u9632\u866b\u5bfe\u7b56\u3001\u4f5c\u696d\u8005\u306e\u885b\u751f\u7ba1\u7406\u3092\u5fb9\u5e95\u3059\u308b<\/li>\n\n\n\n<li>\u5fae\u751f\u7269\u6c5a\u67d3\u5bfe\u7b56\uff1a\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3092\u8a2d\u7f6e\u3057\u3001\u7121\u83cc\u64cd\u4f5c\u3092\u884c\u3046<\/li>\n<\/ul>\n\n\n\n<p>\u3069\u306e\u5bfe\u7b56\u3092\u3069\u3053\u307e\u3067\u884c\u3046\u304b\u306f\u3001\u88fd\u54c1\u306e\u7a2e\u985e\u3084\u7279\u6027\u306b\u5fdc\u3058\u305f\u30ea\u30b9\u30af\u306e\u5927\u304d\u3055\u3092\u8e0f\u307e\u3048\u3066\u6c7a\u3081\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u6ce8\u5c04\u5264\u306e\u3088\u3046\u306a\u7121\u83cc\u88fd\u5264\u3067\u306f\u5fae\u751f\u7269\u6c5a\u67d3\u5bfe\u7b56\u306e\u6bd4\u91cd\u304c\u9ad8\u304f\u3001\u5438\u6e7f\u3057\u3084\u3059\u3044\u9320\u5264\u3067\u306f\u6e29\u6e7f\u5ea6\u7ba1\u7406\u306e\u6bd4\u91cd\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002\u30ea\u30b9\u30af\u306b\u898b\u5408\u3063\u305f\u5bfe\u7b56\u3092\u9078\u3076\u3053\u3068\u3067\u3001\u904e\u5270\u306a\u8a2d\u5099\u6295\u8cc7\u3092\u907f\u3051\u306a\u304c\u3089\u5fc5\u8981\u306a\u54c1\u8cea\u3092\u78ba\u4fdd\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-6\">\u9ad8\u3044\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u8a08<\/h3>\n\n\n\n<p>GMP\u4e09\u539f\u5247\u306e3\u3064\u76ee\u306f\u3001\u500b\u3005\u306e\u7ba1\u7406\u7b56\u3092\u5b9f\u65bd\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u54c1\u8cea\u3092\u7d99\u7d9a\u7684\u306b\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u3092\u8a2d\u8a08\u30fb\u904b\u7528\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u4ed5\u7d44\u307f\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u9020\u5de5\u7a0b\u306e\u6a19\u6e96\u5316\uff1a\u88fd\u54c1\u3054\u3068\u306b\u88fd\u9020\u624b\u9806\u3084\u7ba1\u7406\u57fa\u6e96\u3092\u660e\u78ba\u306b\u3057\u3001\u518d\u73fe\u6027\u3092\u78ba\u4fdd\u3059\u308b<\/li>\n\n\n\n<li>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u88fd\u9020\u6240\u306e\u69cb\u9020\u8a2d\u5099\u3084\u624b\u9806\u3001\u5de5\u7a0b\u306a\u3069\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u65b9\u6cd5\u304c\u3001\u671f\u5f85\u3055\u308c\u308b\u7d50\u679c\u3092\u4e0e\u3048\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u3001\u6587\u66f8\u5316\u3059\u308b<\/li>\n\n\n\n<li>\u8a18\u9332\u7ba1\u7406\uff1a\u88fd\u9020\u5de5\u7a0b\u3084\u54c1\u8cea\u8a66\u9a13\u306e\u7d50\u679c\u3092\u8a18\u9332\u3057\u3001\u8ffd\u8de1\u53ef\u80fd\u6027\uff08\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff09\u3092\u78ba\u4fdd\u3059\u308b<\/li>\n\n\n\n<li>\u9038\u8131\u7ba1\u7406\u30fb\u5909\u66f4\u7ba1\u7406\uff1a\u624b\u9806\u304b\u3089\u306e\u9038\u8131\u304c\u751f\u3058\u305f\u969b\u306e\u5bfe\u5fdc\u3084\u3001\u624b\u9806\u306a\u3069\u3092\u5909\u66f4\u3059\u308b\u524d\u306b\u54c1\u8cea\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3066\u627f\u8a8d\u3092\u53d7\u3051\u308b\u624b\u9806\u3092\u5b9a\u3081\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u3088\u3046\u306b\u3001GMP\u3067\u306f\u62c5\u5f53\u8005\u306e\u52aa\u529b\u3067\u306f\u306a\u304f\u300c\u4ed5\u7d44\u307f\uff08\u30b7\u30b9\u30c6\u30e0\uff09\u3067\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u300d\u3068\u3044\u3046\u8003\u3048\u65b9\u304c\u8cab\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u62c5\u5f53\u8005\u304c\u5165\u308c\u66ff\u308f\u3063\u3066\u3082\u54c1\u8cea\u6c34\u6e96\u3092\u7dad\u6301\u3067\u304d\u308b\u70b9\u304c\u3001\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066\u8a2d\u8a08\u3059\u308b\u5229\u70b9\u306e\u4e00\u3064\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" 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rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u300e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u306e\u8868\u793a\u8a31\u53ef\u7b49\u306b\u3064\u3044\u3066\u300f\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-10\">\u5316\u7ca7\u54c1GMP<\/h3>\n\n\n\n<p>\u5316\u7ca7\u54c1GMP\u306f\u3001\u65e5\u672c\u3067\u306f\u6cd5\u4ee4\u4e0a\u306e\u7fa9\u52d9\u3067\u306f\u306a\u304f\u3001\u56fd\u969b\u898f\u683c\u3067\u3042\u308bISO 22716\uff08\u5316\u7ca7\u54c1GMP\uff09\u306a\u3069\u3092\u7528\u3044\u305f\u81ea\u4e3b\u7684\u306a\u53d6\u308a\u7d44\u307f\u3068\u3057\u3066\u904b\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u7701\u4ee4\u306e\u9069\u7528\u7bc4\u56f2\u3092\u5b9a\u3081\u308b\u85ac\u6a5f\u6cd5\u65bd\u884c\u4ee4\u7b2c20\u6761\u306f\u3001\u533b\u85ac\u54c1\u3068\u533b\u85ac\u90e8\u5916\u54c1\u3092\u5bfe\u8c61\u3068\u3057\u3066\u304a\u308a\u3001\u5316\u7ca7\u54c1\u306e\u88fd\u9020\u306bGMP\u7701\u4ee4\u306f\u9069\u7528\u3055\u308c\u307e\u305b\u3093\u3002\u4e00\u65b9\u3067\u3001\u5316\u7ca7\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u696d\u30fb\u88fd\u9020\u696d\u306b\u306f\u85ac\u6a5f\u6cd5\u4e0a\u306e\u8a31\u53ef\u304c\u5fc5\u8981\u3067\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306b\u306fGQP\u7701\u4ee4\uff08\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\uff09\u3082\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6d77\u5916\u306b\u306fGMP\u3092\u6cd5\u4ee4\u3067\u6c42\u3081\u308b\u5730\u57df\u3082\u3042\u308a\u307e\u3059\u3002EU\u306e\u5316\u7ca7\u54c1\u898f\u5247\u7b2c8\u6761\u306f\u3001\u5316\u7ca7\u54c1\u306e\u88fd\u9020\u304cGMP\u306b\u9069\u5408\u3059\u308b\u3053\u3068\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u3042\u308f\u305b\u3066\u3001EU\u5b98\u5831\u3067\u516c\u8868\u3055\u308c\u305f\u6574\u5408\u898f\u683c\u306b\u5f93\u3063\u3066\u88fd\u9020\u3057\u305f\u5834\u5408\u306fGMP\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3068\u63a8\u5b9a\u3059\u308b\u3001\u3068\u3082\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002ISO 22716\u306f\u3001\u3053\u3046\u3057\u305f\u9069\u5408\u3092\u793a\u3059\u969b\u306b\u7528\u3044\u3089\u308c\u308b\u5316\u7ca7\u54c1GMP\u306e\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6c42\u3081\u3089\u308c\u308b\u5bfe\u5fdc\u306f\u3001\u8f38\u51fa\u5148\u306e\u898f\u5236\u3084\u53d6\u5f15\u5148\u306e\u8981\u4ef6\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u6d77\u5916\u5c55\u958b\u3092\u691c\u8a0e\u3059\u308b\u5834\u5408\u306f\u3001\u5bfe\u8c61\u5e02\u5834\u306e\u898f\u5236\u3068\u53d6\u5f15\u6761\u4ef6\u3092\u500b\u5225\u306b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2009\/1223\/oj\" rel=\"nofollow\">EUR-Lex\u300cRegulation\uff08EC\uff09No 1223\/2009 on cosmetic products\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-11\">\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306eGMP\u7fa9\u52d9\u5316<\/h3>\n\n\n\n<p>\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u3067\u306f\u30012026\u5e749\u67081\u65e5\u304b\u3089\u3001GMP\u306b\u57fa\u3065\u304f\u88fd\u9020\u7ba1\u7406\u304c\u98df\u54c1\u8868\u793a\u57fa\u6e96\u4e0a\u306e\u5c4a\u51fa\u8005\u306e\u9075\u5b88\u4e8b\u9805\u3068\u3057\u3066\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u304d\u3063\u304b\u3051\u306f\u30012024\u5e74\u306b\u8d77\u304d\u305f\u5065\u5eb7\u88ab\u5bb3\u306e\u4e8b\u6848\u3067\u3059\u3002\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u3068\u3057\u3066\u5c4a\u3051\u51fa\u3089\u308c\u305f\u3001\u7d05\u9eb9\u3092\u539f\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u88fd\u54c1\u3092\u6442\u53d6\u3057\u305f\u6d88\u8cbb\u8005\u306b\u5065\u5eb7\u88ab\u5bb3\u304c\u767a\u751f\u3057\u307e\u3057\u305f\u3002\u6d88\u8cbb\u8005\u5e81\u306f\u3053\u306e\u4e8b\u6848\u3092\u8e0f\u307e\u3048\u3066\u5236\u5ea6\u3092\u898b\u76f4\u3057\u30012024\u5e748\u670823\u65e5\u306b\u98df\u54c1\u8868\u793a\u57fa\u6e96\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u5185\u95a3\u5e9c\u4ee4\u3092\u516c\u5e03\u3001\u540c\u5e749\u67081\u65e5\u306b\u65bd\u884c\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u3046\u3061\u300c\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u9320\u5264\u3001\u30ab\u30d7\u30bb\u30eb\u5264\u7b49\u98df\u54c1\u300d\u3078\u306eGMP\u57fa\u6e96\u306e\u9069\u7528\u306f\u30012026\u5e749\u67081\u65e5\u304b\u3089\u5b9f\u65bd\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u6d88\u8cbb\u8005\u5e81\u306e\u8cc7\u6599\u3067\u306f\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\u306e\u52a0\u5de5\u98df\u54c1\u3092\u6b21\u306e\u3088\u3046\u306b\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u5929\u7136\u7531\u6765\u306e\u62bd\u51fa\u7269\u306e\u3046\u3061\u6210\u5206\u5272\u5408\u304c\u672c\u6765\u3068\u7570\u306a\u308b\u3082\u306e\u3084\u5316\u5b66\u7684\u5408\u6210\u54c1\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u3001\u9320\u5264\u30fb\u30ab\u30d7\u30bb\u30eb\u5264\u30fb\u7c89\u672b\u5264\u30fb\u6db2\u5264\u7b49\u306e\u5f62\u72b6\u306e\u98df\u54c1\u3067\u3059\u3002<\/p>\n\n\n\n<p>GMP\u57fa\u6e96\u306e\u9075\u5b88\u306f\u5c4a\u51fa\u8005\u306e\u8cac\u4efb\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5c4a\u51fa\u8005\u306b\u3088\u308b\u81ea\u4e3b\u70b9\u691c\u306b\u52a0\u3048\u3001\u6d88\u8cbb\u8005\u5e81\u304c\u98df\u54c1\u8868\u793a\u6cd5\u306b\u57fa\u3065\u304f\u7acb\u5165\u691c\u67fb\u7b49\u3092\u884c\u3046\u65b9\u91dd\u3082\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u88fd\u9020\u3092\u5916\u90e8\u306b\u59d4\u8a17\u3057\u3066\u3044\u308b\u5834\u5408\u3082\u9075\u5b88\u4e8b\u9805\u306f\u5c4a\u51fa\u8005\u306b\u8ab2\u3055\u308c\u308b\u305f\u3081\u3001\u59d4\u8a17\u5148\u306e\u88fd\u9020\u6240\u304cGMP\u57fa\u6e96\u306b\u6cbf\u3063\u3066\u88fd\u9020\u3057\u3066\u3044\u308b\u304b\u3092\u3001\u81ea\u4e3b\u70b9\u691c\u306e\u4ed5\u7d44\u307f\u3092\u901a\u3058\u3066\u78ba\u8a8d\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/notice\/assets\/food_labeling_cms201_240823_01.pdf\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306e\u4eca\u5f8c\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.cao.go.jp\/consumer\/iinkai\/2024\/438\/doc\/20240627_shiryou2-3.pdf\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u59d4\u54e1\u4f1a\u300c\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u5236\u5ea6\u306e\u898b\u76f4\u3057\u5185\u5bb9\u3068\u65bd\u884c\u671f\u65e5\u7b49\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-12\">GMP\u7701\u4ee4\u3068\u306f<\/h2>\n\n\n\n<p>GMP\u7701\u4ee4\u3068\u306f\u3001\u6b63\u5f0f\u540d\u79f0\u3092\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\uff08\u5e73\u621016\u5e74\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c179\u53f7\uff09\u3068\u3044\u3046\u6cd5\u4ee4\u3067\u3059\u3002\u85ac\u6a5f\u6cd5\u306b\u57fa\u3065\u304d\u3001\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u6240\u306b\u6c42\u3081\u3089\u308c\u308b\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u306f\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u3059\u308b\u8003\u3048\u65b9\u3092\u5e83\u304f\u6307\u3059\u7528\u8a9e\u3067\u3059\u3002\u3053\u308c\u306b\u5bfe\u3057\u3001GMP\u7701\u4ee4\u306f\u65e5\u672c\u306e\u85ac\u6a5f\u6cd5\u306e\u4e0b\u3067\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u7701\u4ee4\u3068\u3044\u3046\u70b9\u304c\u5927\u304d\u306a\u9055\u3044\u3067\u3059\u3002GMP\u7701\u4ee4\u3067\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u304c\u88fd\u9020\u696d\u8005\u7b49\u306b\u88fd\u9020\u6240\u3067\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u3092\u884c\u308f\u305b\u308b\u3053\u3068\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u88fd\u9020\u696d\u8005\u7b49\u306b\u306f\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3057\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u6d3b\u7528\u3057\u3066\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u3092\u884c\u3046\u3053\u3068\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u7701\u4ee4\u3092\u6b63\u3057\u304f\u7406\u89e3\u3059\u308b\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u898f\u683c\u3084\u56fd\u969b\u7684\u306a\u67a0\u7d44\u307f\u3001\u6700\u65b0\u306e\u5236\u5ea6\u6539\u6b63\u3068\u306e\u95a2\u4fc2\u3082\u62bc\u3055\u3048\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002GMP\u7701\u4ee4\u3068\u95a2\u308f\u308a\u306e\u6df1\u3044\u4e3b\u306a\u30c6\u30fc\u30de\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GMP\u3068ISO 9001\u306e\u9055\u3044<\/li>\n\n\n\n<li>GMP\u3068PIC\/S\u3068\u306e\u9055\u3044<\/li>\n\n\n\n<li>\u4ee4\u548c7\u5e74\u85ac\u6a5f\u6cd5\u6539\u6b63\u3068GMP\u9069\u5408\u6027\u8abf\u67fb\u306e\u898b\u76f4\u3057<\/li>\n<\/ul>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-13\">GMP\u3068ISO 9001\u306e\u9055\u3044<\/h3>\n\n\n\n<p>GMP\u3068ISO 9001\u306e\u6700\u3082\u5927\u304d\u306a\u9055\u3044\u306f\u3001\u6cd5\u7684\u306a\u4f4d\u7f6e\u3065\u3051\u3067\u3059\u3002GMP\u306f\u533b\u85ac\u54c1\u306a\u3069\u3067\u306f\u6cd5\u4ee4\u306b\u57fa\u3065\u304f\u898f\u5236\u3067\u3042\u308b\u306e\u306b\u5bfe\u3057\u3001ISO 9001\u306f\u696d\u7a2e\u3092\u554f\u308f\u305a\u4efb\u610f\u3067\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<\/p>\n\n\n<div id=\"id-701d56c5-2182-409e-ba7b-486412beb3e2\">\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u6bd4\u8f03\u9805\u76ee<\/th><th>GMP<\/th><th>ISO 9001<\/th><\/tr><\/thead><tbody><tr><td>\u6027\u8cea<\/td><td>\u533b\u85ac\u54c1\u7b49\u3067\u306f\u6cd5\u4ee4\u306b\u57fa\u3065\u304f\u898f\u5236\u3002\u5206\u91ce\u306b\u3088\u3063\u3066\u306f\u4efb\u610f\u57fa\u6e96\u3084\u56fd\u969b\u898f\u683c\u306e\u5834\u5408\u3082\u3042\u308b<\/td><td>\u56fd\u969b\u7684\u306a\u4efb\u610f\u898f\u683c<\/td><\/tr><tr><td>\u5bfe\u8c61<\/td><td>\u533b\u85ac\u54c1\u30fb\u98df\u54c1\u30fb\u5316\u7ca7\u54c1\u7b49\u306e\u88fd\u9020\u5de5\u7a0b\u3002\u5206\u91ce\u3054\u3068\u306b\u9069\u7528\u7bc4\u56f2\u304c\u7570\u306a\u308b<\/td><td>\u696d\u7a2e\u3092\u554f\u308f\u306a\u3044\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u5168\u822c<\/td><\/tr><tr><td>\u6e96\u62e0\u306e\u7fa9\u52d9<\/td><td>\u533b\u85ac\u54c1\uff08\u65bd\u884c\u4ee4\u3067\u9664\u5916\u3055\u308c\u308b\u54c1\u76ee\u3092\u9664\u304f\uff09\u3068\u539a\u751f\u52b4\u50cd\u5927\u81e3\u304c\u6307\u5b9a\u3059\u308b\u533b\u85ac\u90e8\u5916\u54c1\u306f\u6cd5\u7684\u7fa9\u52d9\u3002\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306f\u98df\u54c1\u8868\u793a\u57fa\u6e96\u4e0a\u306e\u9075\u5b88\u4e8b\u9805\u3001\u540c\u3058\u5f62\u72b6\u306e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u306f\u8a31\u53ef\u306e\u8981\u4ef6\u3002\u305d\u306e\u4ed6\u306e\u5065\u5eb7\u98df\u54c1\u30fb\u5316\u7ca7\u54c1\u306f\u4efb\u610f<\/td><td>\u4efb\u610f\uff08\u53d6\u5f15\u8981\u4ef6\u3068\u3057\u3066\u6c42\u3081\u3089\u308c\u308b\u3053\u3068\u304c\u3042\u308b\uff09<\/td><\/tr><tr><td>\u5be9\u67fb\u30fb\u8abf\u67fb<\/td><td>\u533b\u85ac\u54c1\u7b49\uff1aPMDA\u30fb\u90fd\u9053\u5e9c\u770c\u306b\u3088\u308b\u6cd5\u5b9a\u306e\u9069\u5408\u6027\u8abf\u67fb\uff0f\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\uff1a\u5c4a\u51fa\u8005\u306e\u81ea\u4e3b\u70b9\u691c\u3068\u6d88\u8cbb\u8005\u5e81\u306e\u7acb\u5165\u691c\u67fb\u7b49\uff0f\u540c\u3058\u5f62\u72b6\u306e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\uff1a\u8a31\u53ef\u7533\u8acb\u6642\u306e\u8cc7\u6599\u5be9\u67fb\u3068\u3001\u6d88\u8cbb\u8005\u5e81\u306b\u3088\u308b\u88fd\u9020\u6240\u3067\u306e\u57fa\u6e96\u9075\u5b88\u306e\u78ba\u8a8d\uff0f\u305d\u306e\u4ed6\u306e\u5065\u5eb7\u98df\u54c1\u30fb\u5316\u7ca7\u54c1\uff1a\u6c11\u9593\u56e3\u4f53\u30fb\u8a8d\u8a3c\u6a5f\u95a2\u306b\u3088\u308b\u4efb\u610f\u306e\u7b2c\u4e09\u8005\u8a8d\u8a3c\u7b49<\/td><td>\u6c11\u9593\u306e\u8a8d\u8a3c\u6a5f\u95a2\u306b\u3088\u308b\u8a8d\u8a3c\u5be9\u67fb<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n<p>ISO 9001\u306f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u5168\u822c\u306e\u56fd\u969b\u898f\u683c\u3067\u3042\u308a\u3001ISO 22716\u306f\u5316\u7ca7\u54c1GMP\u306b\u7279\u5316\u3057\u305f\u898f\u683c\u3067\u3059\u3002ISO 9001\u8a8d\u8a3c\u3068GMP\u306b\u57fa\u3065\u304f\u7ba1\u7406\u306f\u4f75\u7528\u3067\u304d\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u533b\u85ac\u54c1GMP\u306f\u6cd5\u4ee4\u4e0a\u306e\u57fa\u6e96\u3067\u3042\u308a\u3001ISO\u898f\u683c\u306e\u8a8d\u8a3c\u53d6\u5f97\u3068\u306f\u5236\u5ea6\u306e\u6027\u8cea\u304c\u7570\u306a\u308b\u70b9\u306b\u7559\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.iso.org\/insights\/iso-9001-explained\" rel=\"nofollow\">ISO\u300cISO 9001 explained\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.iso.org\/standard\/36437.html\" rel=\"nofollow\">ISO\u300cISO 22716:2007 Cosmetics \u2014 Good Manufacturing Practices\uff08GMP\uff09\u2014 Guidelines on Good Manufacturing Practices\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/policies\/policy\/food_labeling\/foods_for_specified_health_uses\/notice\/assets\/food_labeling_cms206_20250423_06.pdf\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u300e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u306e\u8868\u793a\u8a31\u53ef\u7b49\u306b\u3064\u3044\u3066\u300f\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-14\">GMP\u3068PIC\/S\u3068\u306e\u9055\u3044<\/h3>\n\n\n\n<p>PIC\/S\uff08Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme\uff1a\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u5b9a\u53ca\u3073\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u540c\u30b9\u30ad\u30fc\u30e0\uff09\u306f\u3001GMP\u305d\u306e\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5404\u56fd\u306e\u898f\u5236\u5f53\u5c40\u304c\u3001GMP\u67fb\u5bdf\u306e\u57fa\u6e96\u3084\u624b\u6cd5\u3092\u56fd\u969b\u7684\u306b\u8abf\u548c\u3055\u305b\u308b\u305f\u3081\u306e\u67a0\u7d44\u307f\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u306f2014\u5e747\u6708\u306bPIC\/S\u306b\u52a0\u76df\u3057\u3001\u539a\u751f\u52b4\u50cd\u7701\u3068PMDA\u304c1\u3064\u306e\u52a0\u76df\u5f53\u5c40\u3068\u3057\u3066\u53c2\u52a0\u3057\u3066\u304a\u308a\u3001\u90fd\u9053\u5e9c\u770c\u306f\u539a\u751f\u52b4\u50cd\u7701\u304c\u4ee3\u8868\u3057\u3066\u3044\u307e\u3059\u3002PIC\/S\u306fGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u7b56\u5b9a\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u65e5\u672c\u3067\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064GMP\u306e\u57fa\u6e96\u306fGMP\u7701\u4ee4\u3067\u3059\u3002\u539a\u751f\u52b4\u50cd\u7701\u306f\u3001PIC\/S\u306eGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u300cGMP\u7701\u4ee4\u3092\u8e0f\u307e\u3048\u305f\u4e0a\u3067\u53c2\u8003\u3068\u306a\u308b\u54c1\u8cea\u4fdd\u8a3c\u306e\u624b\u6cd5\u3092\u793a\u3057\u305f\u3082\u306e\u300d\u3068\u4f4d\u7f6e\u3065\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u306e\u88fd\u9020\u6240\u306b\u6c42\u3081\u3089\u308c\u308b\u306e\u306f\u3001\u3042\u304f\u307e\u3067GMP\u7701\u4ee4\u3078\u306e\u9069\u5408\u3067\u3059\u3002PIC\/S\u306eGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u305d\u306e\u8981\u4ef6\u3092\u3069\u3046\u6e80\u305f\u3059\u304b\u3092\u691c\u8a0e\u3059\u308b\u969b\u306e\u53c2\u8003\u8cc7\u6599\u3068\u3057\u3066\u6d3b\u7528\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/picscheme.org\/en\/members\" rel=\"nofollow\">PIC\/S\u300cMembers\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tb8021&amp;dataType=1&amp;pageNo=1\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u300ePIC\/S\u306eGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u6d3b\u7528\u3059\u308b\u969b\u306e\u8003\u3048\u65b9\u306b\u3064\u3044\u3066\u300f\u306e\u8cea\u7591\u5fdc\u7b54\u96c6\uff08Q&amp;A\uff09\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-15\">\u4ee4\u548c7\u5e74\u85ac\u6a5f\u6cd5\u6539\u6b63\u3068GMP\u9069\u5408\u6027\u8abf\u67fb\u306e\u898b\u76f4\u3057<\/h3>\n\n\n\n<p>2025\u5e745\u670821\u65e5\u306b\u516c\u5e03\u3055\u308c\u305f\u6539\u6b63\u85ac\u6a5f\u6cd5\uff08\u4ee4\u548c7\u5e74\u6cd5\u5f8b\u7b2c37\u53f7\uff09\u306b\u3088\u308a\u3001GMP\u9069\u5408\u6027\u8abf\u67fb\u5236\u5ea6\u304c\u898b\u76f4\u3055\u308c\u307e\u3059\u3002\u898b\u76f4\u3057\u306b\u95a2\u3059\u308b\u898f\u5b9a\u306f\u30012027\u5e745\u670820\u65e5\u306b\u65bd\u884c\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e3b\u306a\u6539\u6b63\u5185\u5bb9\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u533b\u85ac\u54c1\u7b49\u306e\u5b9a\u671f\u9069\u5408\u6027\u8abf\u67fb\u306e\u983b\u5ea6\u3092\u3001\u73fe\u884c\u306e5\u5e74\u306b1\u5ea6\u304b\u30893\u5e74\u306b1\u5ea6\u306b\u77ed\u7e2e\u3059\u308b\uff08\u7d4c\u904e\u63aa\u7f6e\u306b\u3088\u308a\u3001\u79fb\u884c\u306e\u30bf\u30a4\u30df\u30f3\u30b0\u306f\u54c1\u76ee\u3054\u3068\u306b\u7570\u306a\u308b\uff09<\/li>\n\n\n\n<li>\u5b9a\u671f\u9069\u5408\u6027\u8abf\u67fb\u306b\u5148\u7acb\u3063\u3066\u88fd\u9020\u6240\u306eGMP\u4e0d\u9069\u5408\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3057\u3001\u30ea\u30b9\u30af\u304c\u5c11\u306a\u3044\u3068\u8a55\u4fa1\u3055\u308c\u305f\u5834\u5408\u306f\u305d\u306e\u56de\u306e\u8abf\u67fb\u3092\u884c\u308f\u306a\u3044\uff08\u4e8b\u524d\u8a55\u4fa1\u306f\u65bd\u884c\u65e5\u4ee5\u5f8c\u306e\u7533\u8acb\u304b\u3089\u5fc5\u8981\uff09<\/li>\n\n\n\n<li>\u7279\u5b9a\u533a\u5206\u9069\u5408\u6027\u8abf\u67fb\u306e\u5c0e\u5165\u3084\u3001\u5f8c\u767a\u533b\u85ac\u54c1\u306e\u8abf\u67fb\u4e3b\u4f53\u306e\u79fb\u7ba1\u306a\u3069\u3082\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\uff08\u5177\u4f53\u7684\u306a\u904b\u7528\u306f\u539a\u751f\u52b4\u50cd\u7701\u304c\u8ffd\u3063\u3066\u516c\u8868\u3059\u308b\u3068\u3057\u3066\u3044\u308b\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u7d4c\u904e\u63aa\u7f6e\u306e\u904b\u7528\u306f\u30012026\u5e7410\u670822\u65e5\u4ed8\u306e\u901a\u77e5\uff08\u533b\u85ac\u76e3\u9ebb\u767a1022\u7b2c21\u53f7\uff09\u3067\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u65bd\u884c\u524d\u306b\u8abf\u67fb\u3092\u53d7\u3051\u305f\u54c1\u76ee\u304c\u65bd\u884c\u5f8c\u306b\u983b\u56de\u306e\u8abf\u67fb\u3092\u53d7\u3051\u306a\u3044\u3088\u3046\u8a2d\u3051\u3089\u308c\u305f\u63aa\u7f6e\u3067\u3059\u3002\u81ea\u793e\u54c1\u76ee\u306e\u6b21\u56de\u8abf\u67fb\u306e\u6642\u671f\u3084\u4e8b\u524d\u8a55\u4fa1\u3078\u306e\u5bfe\u5fdc\u3092\u3001\u65e9\u3081\u306b\u78ba\u8a8d\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/stf\/r7_gmptyousa_minaoshi.html\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u4ee4\u548c\uff17\u5e74\u85ac\u6a5f\u6cd5\u6539\u6b63\u306b\u304a\u3051\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u5236\u5ea6\u306e\u898b\u76f4\u3057\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-16\">\u5065\u5eb7\u98df\u54c1\u306b\u304a\u3051\u308bGMP\u8a8d\u8a3c\u30fbGMP\u8a8d\u5b9a\u5de5\u5834\u3068\u306f<\/h2>\n\n\n\n<p>\u5065\u5eb7\u98df\u54c1\u306b\u304a\u3051\u308bGMP\u8a8d\u8a3c\u3068\u306f\u3001\u7b2c\u4e09\u8005\u6a5f\u95a2\u306e\u5be9\u67fb\u3092\u53d7\u3051\u3066\u3001\u88fd\u9020\u6240\u306e\u7ba1\u7406\u4f53\u5236\u304cGMP\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3068\u8a8d\u3081\u3089\u308c\u308b\u5236\u5ea6\u3067\u3059\u3002GMP\u8a8d\u5b9a\u5de5\u5834\u3068\u306f\u3001\u3053\u306e\u5be9\u67fb\u306b\u5408\u683c\u3057\u3066\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u88fd\u9020\u6240\u3092\u6307\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u85ac\u54c1\u306e\u5834\u5408\u306f\u3001PMDA\u3084\u90fd\u9053\u5e9c\u770c\u306b\u3088\u308b\u6cd5\u5b9a\u306eGMP\u9069\u5408\u6027\u8abf\u67fb\u304c\u884c\u308f\u308c\u3001\u6c11\u9593\u306e\u7b2c\u4e09\u8005\u6a5f\u95a2\u306b\u3088\u308b\u300cGMP\u8a8d\u8a3c\u300d\u3068\u306f\u5236\u5ea6\u306e\u6027\u8cea\u304c\u7570\u306a\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u3067\u306f\u3001GMP\u57fa\u6e96\u306e\u9075\u5b88\u304c\u98df\u54c1\u8868\u793a\u57fa\u6e96\u4e0a\u306e\u5c4a\u51fa\u8005\u306e\u9075\u5b88\u4e8b\u9805\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u306f\u6c11\u9593\u306e\u8a8d\u8a3c\u53d6\u5f97\u3068\u306f\u5225\u306e\u6cd5\u4ee4\u4e0a\u306e\u7fa9\u52d9\u3067\u3042\u308a\u3001\u540c\u3058\u5f62\u72b6\u306e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u3067\u3082GMP\u306e\u57fa\u6e96\u306b\u5373\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u8a31\u53ef\u306e\u8981\u4ef6\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7b2c\u4e09\u8005\u8a8d\u8a3c\u304c\u793a\u3059\u306e\u306f\u3001\u5be9\u67fb\u6642\u70b9\u3067\u88fd\u9020\u6240\u306e\u7ba1\u7406\u4f53\u5236\u304c\u5f53\u8a72\u5236\u5ea6\u306e\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002\u500b\u3005\u306e\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u5065\u5eb7\u98df\u54c1\u306eGMP\u8a8d\u8a3c\u306b\u3064\u3044\u3066\u62bc\u3055\u3048\u3066\u304a\u304d\u305f\u3044\u306e\u306f\u3001\u8a8d\u5b9a\u307e\u3067\u306e\u6d41\u308c\u3068\u53d6\u5f97\u306e\u30e1\u30ea\u30c3\u30c8\u306e2\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GMP\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u307e\u3067\u306e\u6d41\u308c<\/li>\n\n\n\n<li>GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u30e1\u30ea\u30c3\u30c8<\/li>\n<\/ul>\n\n\n\n<p>\u8a8d\u8a3c\u306e\u610f\u5473\u3068\u9650\u754c\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u305f\u3046\u3048\u3067\u3001\u53d6\u5f97\u306e\u8981\u5426\u3084\u6642\u671f\u3092\u691c\u8a0e\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-17\">GMP\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u307e\u3067\u306e\u6d41\u308c<\/h3>\n\n\n\n<p>GMP\u8a8d\u5b9a\u306f\u3001\u4e00\u822c\u7684\u306b\u7533\u8acb\u304b\u3089\u66f8\u985e\u8abf\u67fb\u3001\u5b9f\u5730\u8abf\u67fb\u3092\u7d4c\u3066\u4ed8\u4e0e\u3055\u308c\u3001\u305d\u306e\u5f8c\u3082\u5b9a\u671f\u7684\u306a\u78ba\u8a8d\u3084\u66f4\u65b0\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u5177\u4f53\u7684\u306a\u624b\u7d9a\u304d\u3084\u6709\u52b9\u671f\u9593\u306f\u8a8d\u8a3c\u6a5f\u95a2\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u304a\u304a\u3080\u306d\u6b21\u306e\u6d41\u308c\u3067\u9032\u307f\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u7533\u8acb\uff1a\u8a8d\u5b9a\u3092\u5e0c\u671b\u3059\u308b\u88fd\u9020\u6240\u304c\u3001\u5be9\u67fb\u6a5f\u95a2\u306b\u7533\u8acb\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b<\/li>\n\n\n\n<li>\u66f8\u985e\u8abf\u67fb\uff1a\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u306e\u6587\u66f8\u3084\u624b\u9806\u66f8\u306a\u3069\u304c\u5be9\u67fb\u3055\u308c\u308b<\/li>\n\n\n\n<li>\u5b9f\u5730\u8abf\u67fb\uff1a\u5be9\u67fb\u54e1\u304c\u88fd\u9020\u6240\u3092\u8a2a\u554f\u3057\u3001\u8a2d\u5099\u3084\u904b\u7528\u72b6\u6cc1\u3092\u73fe\u5730\u3067\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u8a8d\u5b9a\uff1a\u66f8\u985e\u8abf\u67fb\u3068\u5b9f\u5730\u8abf\u67fb\u306e\u7d50\u679c\u3092\u3082\u3068\u306b\u5be9\u67fb\u4f1a\u3067\u5be9\u8b70\u3055\u308c\u3001GMP\u57fa\u6e96\u3078\u306e\u9069\u5408\u304c\u8a8d\u3081\u3089\u308c\u308c\u3070\u8a8d\u5b9a\u304c\u4ed8\u4e0e\u3055\u308c\u308b<\/li>\n\n\n\n<li>\u4e2d\u9593\u8abf\u67fb\uff1a\u8a8d\u5b9a\u671f\u9593\u4e2d\u306b\u3001\u4e2d\u9593\u7684\u306a\u8abf\u67fb\u304c\u5b9f\u65bd\u3055\u308c\u308b\uff08\u4e3b\u306a2\u56e3\u4f53\u3067\u306f\u5e741\u56de\uff09<\/li>\n\n\n\n<li>\u66f4\u65b0\uff1a\u8a8d\u8a3c\u6a5f\u95a2\u304c\u5b9a\u3081\u308b\u6709\u52b9\u671f\u9593\uff08\u4e3b\u306a2\u56e3\u4f53\u3067\u306f3\u5e74\uff09\u3054\u3068\u306b\u66f4\u65b0\u5be9\u67fb\u304c\u884c\u308f\u308c\u308b<\/li>\n<\/ol>\n\n\n\n<p>\u5be9\u67fb\u3067\u306f\u3001\u624b\u9806\u66f8\u306a\u3069\u306e\u6587\u66f8\u304c\u6574\u3063\u3066\u3044\u308b\u304b\u3060\u3051\u3067\u306a\u304f\u3001\u305d\u306e\u624b\u9806\u3069\u304a\u308a\u306b\u4f5c\u696d\u304c\u884c\u308f\u308c\u3001\u8a18\u9332\u304c\u6b8b\u3055\u308c\u3066\u3044\u308b\u304b\u3082\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002\u8a8d\u5b9a\u53d6\u5f97\u307e\u3067\u306e\u671f\u9593\u306f\u3001\u88fd\u9020\u6240\u306e\u898f\u6a21\u3084\u65e2\u5b58\u306e\u7ba1\u7406\u4f53\u5236\u306e\u6574\u5099\u72b6\u6cc1\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002\u4e8b\u524d\u306b\u8a8d\u8a3c\u6a5f\u95a2\u3078\u76f8\u8ac7\u3057\u3001\u81ea\u793e\u306e\u4f53\u5236\u3068\u306e\u30ae\u30e3\u30c3\u30d7\u3084\u6240\u8981\u671f\u9593\u306e\u76ee\u5b89\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.jhnfa.org\/gmp1.html\" rel=\"nofollow\">\u516c\u76ca\u8ca1\u56e3\u6cd5\u4eba\u65e5\u672c\u5065\u5eb7\u30fb\u6804\u990a\u98df\u54c1\u5354\u4f1a\u300cGMP\u5de5\u5834\u8a8d\u5b9a\uff5e\u7533\u8acb\u306e\u8981\u4ef6\u30fb\u8a8d\u5b9a\u307e\u3067\u306e\u6d41\u308c\u30fb\u8a8d\u5b9a\u5f8c\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.jihfs.jp\/jihfs-cs\/cs_02.html\" rel=\"nofollow\">\u4e00\u822c\u793e\u56e3\u6cd5\u4eba\u65e5\u672c\u5065\u5eb7\u98df\u54c1\u898f\u683c\u5354\u4f1a\u300c\u5065\u5eb7\u98df\u54c1GMP\u8a8d\u8a3c\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-18\">GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u30e1\u30ea\u30c3\u30c8<\/h3>\n\n\n\n<p>GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3068\u3001\u7ba1\u7406\u4f53\u5236\u3092\u5bfe\u5916\u7684\u306b\u793a\u305b\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u9020\u6240\u81ea\u8eab\u306e\u54c1\u8cea\u7ba1\u7406\u3092\u5e95\u4e0a\u3052\u3059\u308b\u52b9\u679c\u3082\u671f\u5f85\u3067\u304d\u307e\u3059\u3002\u4e3b\u306a\u30e1\u30ea\u30c3\u30c8\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4fe1\u983c\u6027\u306e\u5411\u4e0a\uff1a\u53d6\u5f15\u5148\u3084\u6d88\u8cbb\u8005\u306b\u5bfe\u3057\u3066\u3001\u7ba1\u7406\u4f53\u5236\u304c\u7b2c\u4e09\u8005\u306e\u5be9\u67fb\u3092\u7d4c\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u305b\u308b<\/li>\n\n\n\n<li>\u88fd\u54c1\u54c1\u8cea\u306e\u5b89\u5b9a\u5316\uff1aGMP\u57fa\u6e96\u306b\u6cbf\u3063\u305f\u7ba1\u7406\u4f53\u5236\u3092\u69cb\u7bc9\u30fb\u7dad\u6301\u3059\u308b\u3053\u3068\u3067\u3001\u54c1\u8cea\u306e\u3070\u3089\u3064\u304d\u3092\u6291\u3048\u3084\u3059\u304f\u306a\u308b<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u4f4e\u6e1b\uff1a\u54c1\u8cea\u30c8\u30e9\u30d6\u30eb\u3084\u56de\u53ce\u306b\u3064\u306a\u304c\u308b\u554f\u984c\u3092\u3001\u65e9\u3044\u6bb5\u968e\u3067\u767a\u898b\u3057\u3084\u3059\u304f\u306a\u308b<\/li>\n\n\n\n<li>\u53d6\u5f15\u6a5f\u4f1a\u306e\u62e1\u5927\uff1a\u53d6\u5f15\u5148\u304cGMP\u8a8d\u8a3c\u3092\u53d6\u5f15\u6761\u4ef6\u3068\u3057\u3066\u3044\u308b\u5834\u5408\u306b\u3082\u5bfe\u5fdc\u3067\u304d\u308b<\/li>\n\n\n\n<li>\u6d77\u5916\u5c55\u958b\u3078\u306e\u5099\u3048\uff1aGMP\u3078\u306e\u9069\u5408\u3092\u6c42\u3081\u308b\u5e02\u5834\u3084\u53d6\u5f15\u5148\u3078\u306e\u5bfe\u5fdc\u3092\u9032\u3081\u3084\u3059\u304f\u306a\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u305f\u3060\u3057\u3001\u8a8d\u8a3c\u306e\u53d6\u5f97\u81ea\u4f53\u304c\u76ee\u7684\u306b\u306a\u308b\u3068\u3001\u5be9\u67fb\u5f8c\u306b\u904b\u7528\u304c\u5f62\u9ab8\u5316\u3059\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002\u65e5\u3005\u306e\u88fd\u9020\u3067GMP\u3092\u5b9f\u8df5\u3057\u7d9a\u3051\u308b\u3053\u3068\u3067\u3001\u3053\u308c\u3089\u306e\u30e1\u30ea\u30c3\u30c8\u3092\u7d99\u7d9a\u7684\u306b\u5f97\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-19\">GMP\u3067\u7ba1\u7406\u3059\u308b\u5bfe\u8c61<\/h2>\n\n\n\n<p>GMP\u3067\u7ba1\u7406\u3059\u308b\u5bfe\u8c61\u306f\u3001\u5927\u304d\u304f\u300c\u30cf\u30fc\u30c9\u9762\uff08\u69cb\u9020\u8a2d\u5099\uff09\u300d\u3068\u300c\u30bd\u30d5\u30c8\u9762\uff08\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\uff09\u300d\u306e2\u3064\u306b\u5206\u3051\u3066\u6574\u7406\u3067\u304d\u307e\u3059\u3002\u539f\u6750\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u6700\u7d42\u88fd\u54c1\u306e\u51fa\u8377\u307e\u3067\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u3042\u3089\u3086\u308b\u6bb5\u968e\u304c\u7ba1\u7406\u306e\u5bfe\u8c61\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30cf\u30fc\u30c9\u9762\uff08\u69cb\u9020\u8a2d\u5099\uff09<\/li>\n\n\n\n<li>\u30bd\u30d5\u30c8\u9762\uff08\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u3069\u308c\u307b\u3069\u512a\u308c\u305f\u8a2d\u5099\u3092\u5099\u3048\u3066\u3082\u3001\u904b\u7528\u3059\u308b\u624b\u9806\u3084\u8a18\u9332\u304c\u4e0d\u5341\u5206\u3067\u3042\u308c\u3070\u54c1\u8cea\u306f\u4fdd\u8a3c\u3067\u304d\u307e\u305b\u3093\u3002\u53cd\u5bfe\u306b\u3001\u624b\u9806\u304c\u6574\u3063\u3066\u3044\u3066\u3082\u8a2d\u5099\u304c\u6c5a\u67d3\u3092\u9632\u3052\u306a\u3044\u69cb\u9020\u3067\u306f\u610f\u5473\u304c\u3042\u308a\u307e\u305b\u3093\u3002GMP\u306e\u7ba1\u7406\u5bfe\u8c61\u3092\u691c\u8a0e\u3059\u308b\u969b\u306f\u3001\u30cf\u30fc\u30c9\u3068\u30bd\u30d5\u30c8\u3092\u4e00\u4f53\u3067\u8a2d\u8a08\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-20\">\u30cf\u30fc\u30c9\u9762\uff08\u69cb\u9020\u8a2d\u5099\uff09<\/h3>\n\n\n\n<p>GMP\u306b\u304a\u3051\u308b\u30cf\u30fc\u30c9\u9762\u306e\u7ba1\u7406\u3068\u306f\u3001\u88fd\u9020\u6240\u306e\u69cb\u9020\u3084\u8a2d\u5099\u305d\u306e\u3082\u306e\u3092\u3001\u6c5a\u67d3\u3084\u53d6\u308a\u9055\u3048\u304c\u8d77\u304d\u306b\u304f\u3044\u72b6\u614b\u306b\u6574\u3048\u308b\u3053\u3068\u3067\u3059\u3002\u533b\u85ac\u54c1\u306e\u5834\u5408\u3001\u88fd\u9020\u6240\u306e\u69cb\u9020\u8a2d\u5099\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306f\u3001\u88fd\u9020\u696d\u306e\u8a31\u53ef\u8981\u4ef6\u3067\u3042\u308b\u300c\u85ac\u5c40\u7b49\u69cb\u9020\u8a2d\u5099\u898f\u5247\u300d\u3067\u3082\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u4e3b\u306a\u8981\u4ef6\u306e\u4f8b\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u9020\u533a\u57df\u306e\u8a2d\u8a08\u30fb\u914d\u7f6e\uff1a\u88fd\u54c1\u306e\u7a2e\u985e\u3084\u88fd\u9020\u5de5\u7a0b\u306b\u5fdc\u3058\u3066\u533a\u57df\u3092\u5206\u3051\u3001\u4ea4\u5dee\u6c5a\u67d3\u3092\u9632\u3050\u52d5\u7dda\u3092\u78ba\u4fdd\u3059\u308b<\/li>\n\n\n\n<li>\u7a7a\u8abf\u30fb\u6e29\u6e7f\u5ea6\u7ba1\u7406\uff1a\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u74b0\u5883\u56e0\u5b50\u3092\u3001\u88fd\u54c1\u306e\u533a\u5206\u306b\u5fdc\u3058\u3066\u9069\u5207\u306b\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3067\u304d\u308b\u8a2d\u5099\u3092\u5099\u3048\u308b<\/li>\n\n\n\n<li>\u7d66\u6392\u6c34\u8a2d\u5099\uff1a\u88fd\u9020\u306b\u4f7f\u7528\u3059\u308b\u6c34\u306e\u54c1\u8cea\u3092\u78ba\u4fdd\u3057\u3001\u6392\u6c34\u306b\u3088\u308b\u6c5a\u67d3\u3092\u9632\u3050<\/li>\n\n\n\n<li>\u6e05\u6383\u3057\u3084\u3059\u3044\u69cb\u9020\uff1a\u88fd\u9020\u6240\u306e\u8a2d\u5099\u3084\u4f5c\u696d\u5ba4\u306f\u3001\u6e05\u6383\u3084\u4fdd\u5b88\u304c\u5bb9\u6613\u306a\u3082\u306e\u3068\u3057\u3001\u7121\u83cc\u533b\u85ac\u54c1\u306a\u3069\u3067\u306f\u3001\u5929\u4e95\u30fb\u58c1\u30fb\u5e8a\u306e\u8868\u9762\u3092\u6d88\u6bd2\u6db2\u7b49\u306b\u3088\u308b\u6d17\u6d44\u306b\u8010\u3048\u308b\u3082\u306e\u3068\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u30cf\u30fc\u30c9\u9762\u306e\u8981\u4ef6\u306f\u3001\u7a3c\u50cd\u5f8c\u306b\u6539\u4fee\u3059\u308b\u3068\u3001\u5de5\u4e8b\u8cbb\u7528\u3060\u3051\u3067\u306a\u304f\u88fd\u9020\u505c\u6b62\u3082\u4f34\u3046\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u9020\u6240\u306e\u65b0\u8a2d\u3084\u6539\u4fee\u306e\u969b\u306f\u3001\u8a08\u753b\u6bb5\u968e\u304b\u3089\u7d44\u307f\u8fbc\u3093\u3067\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/file\/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka\/iryouyouiyakuhinngiouhinnryuutuubousi3-1sannkou.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300cGMP\u7701\u4ee4\u306e\u6cbf\u9769\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><br>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/336M50000100002\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u85ac\u5c40\u7b49\u69cb\u9020\u8a2d\u5099\u898f\u5247\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-21\">\u30bd\u30d5\u30c8\u9762\uff08\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\uff09<\/h3>\n\n\n\n<p>GMP\u306b\u304a\u3051\u308b\u30bd\u30d5\u30c8\u9762\u306e\u7ba1\u7406\u3068\u306f\u3001\u65e5\u5e38\u306e\u88fd\u9020\u30fb\u54c1\u8cea\u7ba1\u7406\u6d3b\u52d5\u3092\u624b\u9806\u3068\u8a18\u9332\u3067\u7d71\u5236\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u8a2d\u5099\u304c\u6574\u3063\u3066\u3044\u3066\u3082\u904b\u7528\u304c\u5c5e\u4eba\u7684\u3067\u306f\u54c1\u8cea\u3092\u4fdd\u8a3c\u3067\u304d\u306a\u3044\u305f\u3081\u3001\u30cf\u30fc\u30c9\u9762\u3068\u4e26\u3093\u3067\u91cd\u8981\u3067\u3059\u3002\u4e3b\u306a\u7ba1\u7406\u9805\u76ee\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u624b\u9806\u66f8\u306e\u6574\u5099\uff1a\u88fd\u54c1\u6a19\u6e96\u66f8\u3084\u3001\u885b\u751f\u7ba1\u7406\u30fb\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306a\u3069\u306e\u624b\u9806\u3092\u5b9a\u3081\u305f\u624b\u9806\u66f8\u306a\u3069\u306e\u6587\u66f8\u4f53\u7cfb\u3092\u69cb\u7bc9\u3059\u308b<\/li>\n\n\n\n<li>\u8a18\u9332\u7ba1\u7406\uff1a\u88fd\u9020\u8a18\u9332\u3084\u8a66\u9a13\u8a18\u9332\u3001\u9038\u8131\u8a18\u9332\u306a\u3069\u3001\u5404\u5de5\u7a0b\u306e\u8a18\u9332\u3092\u4f5c\u6210\u30fb\u4fdd\u7ba1\u3059\u308b<\/li>\n\n\n\n<li>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u88fd\u9020\u6240\u306e\u69cb\u9020\u8a2d\u5099\u3084\u624b\u9806\u3001\u5de5\u7a0b\u306a\u3069\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u65b9\u6cd5\u304c\u3001\u671f\u5f85\u3055\u308c\u308b\u7d50\u679c\u3092\u4e0e\u3048\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u3001\u6587\u66f8\u5316\u3059\u308b<\/li>\n\n\n\n<li>\u9038\u8131\u7ba1\u7406\uff1a\u624b\u9806\u66f8\u304b\u3089\u306e\u9038\u8131\u304c\u767a\u751f\u3057\u305f\u969b\u306b\u3001\u5185\u5bb9\u3092\u8a18\u9332\u3057\u3066\u54c1\u8cea\u3078\u306e\u5f71\u97ff\u3092\u8abf\u67fb\u3057\u3001\u91cd\u5927\u306a\u9038\u8131\u3067\u306f\u539f\u56e0\u306e\u7a76\u660e\u3068\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\u3092\u884c\u3046\u4f53\u5236\u3092\u6574\u3048\u308b<\/li>\n\n\n\n<li>\u5909\u66f4\u7ba1\u7406\uff1a\u8a2d\u5099\u30fb\u624b\u9806\u30fb\u539f\u6750\u6599\u306e\u5909\u66f4\u304c\u54c1\u8cea\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u4e8b\u524d\u306b\u8a55\u4fa1\u3057\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u7d4c\u3066\u5b9f\u65bd\u3059\u308b<\/li>\n\n\n\n<li>\u81ea\u5df1\u70b9\u691c\uff1a\u81ea\u793e\u306e\u7ba1\u7406\u4f53\u5236\u304c\u9069\u5207\u306b\u6a5f\u80fd\u3057\u3066\u3044\u308b\u304b\u3092\u5b9a\u671f\u7684\u306b\u70b9\u691c\u3059\u308b<\/li>\n\n\n\n<li>\u6559\u80b2\u8a13\u7df4\uff1a\u88fd\u9020\u3084\u54c1\u8cea\u7ba1\u7406\u306e\u696d\u52d9\u306b\u5f93\u4e8b\u3059\u308b\u8077\u54e1\u306b\u5bfe\u3057\u3001GMP\u6559\u80b2\u3092\u8a08\u753b\u7684\u306b\u5b9f\u65bd\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u7ba1\u7406\u9805\u76ee\u306f\u4e92\u3044\u306b\u9023\u52d5\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u9038\u8131\u306e\u539f\u56e0\u304c\u624b\u9806\u306e\u4e0d\u5099\u3067\u3042\u308c\u3070\u3001\u5909\u66f4\u7ba1\u7406\u3092\u901a\u3058\u3066\u624b\u9806\u66f8\u3092\u6539\u8a02\u3057\u3001\u6559\u80b2\u8a13\u7df4\u3067\u5468\u77e5\u3059\u308b\u3068\u3044\u3046\u6d41\u308c\u3067\u6539\u5584\u304c\u9032\u307f\u307e\u3059\u3002\u4e00\u9023\u306e\u6d3b\u52d5\u3092\u8a18\u9332\u3067\u7d50\u3073\u3064\u3051\u3066\u304a\u3051\u3070\u3001\u54c1\u8cea\u554f\u984c\u306e\u518d\u767a\u9632\u6b62\u3068\u8abf\u67fb\u6642\u306e\u8aac\u660e\u3092\u540c\u6642\u306b\u5b9f\u73fe\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><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-22\">GMP\u306e\u904b\u7528\u65b9\u6cd5<\/h2>\n\n\n\n<p>GMP\u306e\u904b\u7528\u306f\u3001\u307e\u305a\u81ea\u793e\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u5236\u5ea6\u3092\u78ba\u8a8d\u3057\u3001\u305d\u306e\u3046\u3048\u3067\u30ea\u30b9\u30af\u306e\u6d17\u3044\u51fa\u3057\u3084\u624b\u9806\u66f8\u306e\u4f5c\u6210\u3001\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc\u3068\u3044\u3046\u9806\u306b\u884c\u308f\u308c\u307e\u3059\u3002\u9069\u7528\u3055\u308c\u308b\u6cd5\u4ee4\u30fb\u57fa\u6e96\u3084\u3001\u8abf\u67fb\u30fb\u8a8d\u8a3c\u306e\u8981\u5426\u306f\u3001\u533b\u85ac\u54c1\u3001\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u306a\u3069\u306e\u5206\u91ce\u3068\u88fd\u54c1\u533a\u5206\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>GMP\u306e\u904b\u7528\u3067\u62bc\u3055\u3048\u3066\u304a\u304d\u305f\u3044\u30b9\u30c6\u30c3\u30d7\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u81ea\u793e\u88fd\u54c1\u3068\u88fd\u9020\u5de5\u7a0b\u306e\u30ea\u30b9\u30af\u306e\u6d17\u3044\u51fa\u3057<\/li>\n\n\n\n<li>\u624b\u9806\u66f8\u306e\u4f5c\u6210<\/li>\n\n\n\n<li>GMP\u9069\u5408\u6027\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc<\/li>\n<\/ol>\n\n\n\n<p>\u7279\u306b\u533b\u85ac\u54c1\u3067\u306f\u3001\u6cd5\u5b9a\u306eGMP\u9069\u5408\u6027\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc\u307e\u3067\u898b\u636e\u3048\u3066\u4f53\u5236\u3092\u6574\u3048\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-23\">\u81ea\u793e\u88fd\u54c1\u3068\u88fd\u9020\u5de5\u7a0b\u306e\u30ea\u30b9\u30af\u306e\u6d17\u3044\u51fa\u3057<\/h3>\n\n\n\n<p>GMP\u306e\u904b\u7528\u3092\u59cb\u3081\u308b\u969b\u306f\u3001\u307e\u305a\u81ea\u793e\u306e\u88fd\u54c1\u7279\u6027\u3068\u88fd\u9020\u5de5\u7a0b\u306b\u6f5c\u3080\u54c1\u8cea\u30ea\u30b9\u30af\u3092\u4f53\u7cfb\u7684\u306b\u6d17\u3044\u51fa\u3057\u3001\u512a\u5148\u9806\u4f4d\u3092\u3064\u3051\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u85ac\u54c1\u306eGMP\u7701\u4ee4\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u7b49\u306b\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u6d3b\u7528\u3057\u3066\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u3092\u884c\u3046\u3053\u3068\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3067\u306f\u3001ICH Q9\uff08R1\uff09\u306e\u8003\u3048\u65b9\u306b\u6cbf\u3063\u3066\u3001\u6b21\u306e\u624b\u9806\u3067\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3057\u3001\u7ba1\u7406\u7b56\u3092\u691c\u8a0e\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u8981\u56e0\uff08\u539f\u6750\u6599\u3001\u5de5\u7a0b\u6761\u4ef6\u3001\u8a2d\u5099\u3001\u4f5c\u696d\u8005\u3001\u74b0\u5883\u306a\u3069\uff09\u3092\u7279\u5b9a\u3059\u308b<\/li>\n\n\n\n<li>\u5404\u8981\u56e0\u306e\u30ea\u30b9\u30af\u306e\u5927\u304d\u3055\u3092\u3001\u767a\u751f\u306e\u53ef\u80fd\u6027\u3068\u91cd\u5927\u6027\uff08\u5f71\u97ff\u5ea6\uff09\u306e\u89b3\u70b9\u304b\u3089\u8a55\u4fa1\u3059\u308b\uff08\u624b\u6cd5\u306b\u3088\u3063\u3066\u306f\u691c\u51fa\u6027\u3082\u52a0\u5473\u3059\u308b\uff09<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u8981\u56e0\u304b\u3089\u512a\u5148\u7684\u306b\u7ba1\u7406\u7b56\u3092\u8a2d\u8a08\u3059\u308b<\/li>\n<\/ol>\n\n\n\n<p>\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u5de5\u7a0b\u306b\u7ba1\u7406\u3092\u96c6\u4e2d\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u9650\u3089\u308c\u305f\u4eba\u54e1\u3084\u8a2d\u5099\u6295\u8cc7\u3092\u914d\u5206\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002\u5f8c\u7d9a\u306e\u624b\u9806\u66f8\u4f5c\u6210\u3084\u7ba1\u7406\u4f53\u5236\u306e\u8a2d\u8a08\u306b\u3082\u3001\u4e00\u8cab\u3057\u305f\u6839\u62e0\u3092\u6301\u305f\u305b\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0049.html\" rel=\"nofollow\">\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u300cICH-Q9 \u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-24\">\u624b\u9806\u66f8\u306e\u4f5c\u6210<\/h3>\n\n\n\n<p>\u624b\u9806\u66f8\u306e\u4f5c\u6210\u3068\u306f\u3001\u30ea\u30b9\u30af\u306e\u6d17\u3044\u51fa\u3057\u306e\u7d50\u679c\u3092\u8e0f\u307e\u3048\u3001\u8ab0\u304c\u30fb\u3044\u3064\u30fb\u4f55\u3092\u30fb\u3069\u306e\u3088\u3046\u306b\u884c\u3046\u304b\u3092\u6587\u66f8\u3067\u5b9a\u3081\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u4e3b\u8981\u306a\u6587\u66f8\u306b\u306f\u3001\u88fd\u54c1\u3054\u3068\u306e\u898f\u683c\u3084\u88fd\u9020\u65b9\u6cd5\u3092\u5b9a\u3081\u305f\u88fd\u54c1\u6a19\u6e96\u66f8\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u307b\u304b\u3001\u885b\u751f\u7ba1\u7406\u30fb\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306a\u3069\u306e\u624b\u9806\u3092\u5b9a\u3081\u305f\u624b\u9806\u66f8\u3084\u3001\u5404\u4f5c\u696d\u306e\u5177\u4f53\u7684\u306a\u624b\u9806\u3092\u5b9a\u3081\u305fSOP\u306a\u3069\u3067\u3059\u3002\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3059\u308b\u969b\u306f\u3001\u6b21\u306e\u70b9\u306b\u7559\u610f\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4f5c\u696d\u8005\u304c\u8ff7\u308f\u305a\u5b9f\u884c\u3067\u304d\u308b\u3001\u5177\u4f53\u7684\u304b\u3064\u660e\u78ba\u306a\u8a18\u8ff0\u306b\u3059\u308b<\/li>\n\n\n\n<li>\u8a18\u9332\u69d8\u5f0f\uff08\u30ed\u30b0\u30b7\u30fc\u30c8\u7b49\uff09\u3092\u624b\u9806\u66f8\u3068\u30bb\u30c3\u30c8\u3067\u6574\u5099\u3059\u308b<\/li>\n\n\n\n<li>\u5b9a\u671f\u7684\u306b\u898b\u76f4\u3057\u30fb\u6539\u8a02\u3092\u884c\u3044\u3001\u5e38\u306b\u6700\u65b0\u306e\u72b6\u614b\u3092\u7dad\u6301\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u624b\u9806\u66f8\u3068\u8a18\u9332\u69d8\u5f0f\u3092\u4e00\u4f53\u3067\u6574\u5099\u3057\u3066\u304a\u304f\u3068\u3001\u65e5\u3005\u306e\u8a18\u9332\u304c\u305d\u306e\u307e\u307e\u8abf\u67fb\u3084\u76e3\u67fb\u3067\u306e\u6839\u62e0\u8cc7\u6599\u3068\u3057\u3066\u4f7f\u3044\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002\u4f5c\u696d\u8005\u306e\u8ca0\u62c5\u3092\u6291\u3048\u306a\u304c\u3089\u3001\u9069\u5408\u72b6\u6cc1\u3092\u793a\u3057\u3084\u3059\u304f\u306a\u308b\u70b9\u304c\u5229\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100179\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-25\">GMP\u9069\u5408\u6027\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc<\/h3>\n\n\n\n<p>\u533b\u85ac\u54c1\u3067\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u306e\u7533\u8acb\u6642\u306b\u52a0\u3048\u3001\u627f\u8a8d\u5f8c\u3082\u5b9a\u671f\u7684\u306bPMDA\u307e\u305f\u306f\u90fd\u9053\u5e9c\u770c\u306b\u3088\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u304c\u884c\u308f\u308c\u307e\u3059\uff08\u5bfe\u8c61\u306f\u653f\u4ee4\u3067\u5b9a\u3081\u308b\u54c1\u76ee\u3067\u3059\uff09\u3002\u5b9a\u671f\u9069\u5408\u6027\u8abf\u67fb\u306e\u983b\u5ea6\u306f\u30012027\u5e745\u670820\u65e5\u306e\u65bd\u884c\u306b\u3088\u308a\u73fe\u884c\u306e5\u5e74\u306b1\u5ea6\u304b\u30893\u5e74\u306b1\u5ea6\u3078\u898b\u76f4\u3055\u308c\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u7d4c\u904e\u63aa\u7f6e\u306b\u3088\u308a\u3001\u79fb\u884c\u306e\u30bf\u30a4\u30df\u30f3\u30b0\u306f\u54c1\u76ee\u3054\u3068\u306b\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>PMDA\u306f\u3001\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u533b\u85ac\u54c1\u3092\u88fd\u9020\u3059\u308b\u56fd\u5185\u5916\u306e\u88fd\u9020\u6240\u306e\u88fd\u9020\u8a2d\u5099\u3084\u88fd\u9020\u7ba1\u7406\u624b\u6cd5\u304cGMP\u306b\u9069\u5408\u3057\u3001\u9069\u5207\u306a\u54c1\u8cea\u306e\u88fd\u54c1\u3092\u88fd\u9020\u3067\u304d\u308b\u4f53\u5236\u3067\u3042\u308b\u304b\u3092\u3001\u5b9f\u5730\u3084\u66f8\u9762\u3067\u8abf\u67fb\u3057\u3066\u3044\u307e\u3059\u3002\u8abf\u67fb\u3067\u306fGMP\u7701\u4ee4\u306e\u8981\u6c42\u4e8b\u9805\u3078\u306e\u9069\u5408\u72b6\u6cc1\u304c\u78ba\u8a8d\u3055\u308c\u3001\u4e0d\u5099\u304c\u898b\u3064\u304b\u3063\u305f\u5834\u5408\u306f\u6539\u5584\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u8abf\u67fb\u3092\u5186\u6ed1\u306b\u53d7\u3051\u308b\u305f\u3081\u306b\u306f\u3001\u65e5\u9803\u304b\u3089\u306e\u7a4d\u307f\u91cd\u306d\u304c\u91cd\u8981\u3067\u3059\u3002\u8a18\u9332\u7ba1\u7406\u3092\u5fb9\u5e95\u3057\u3001\u9038\u8131\u3084\u5909\u66f4\u3092\u624b\u9806\u3069\u304a\u308a\u306b\u51e6\u7406\u3057\u3001\u6559\u80b2\u8a13\u7df4\u306e\u5b9f\u65bd\u8a18\u9332\u3092\u4fdd\u7ba1\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002\u8abf\u67fb\u306e\u305f\u3081\u306b\u66f8\u985e\u3092\u6574\u3048\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u65e5\u5e38\u306e\u904b\u7528\u8a18\u9332\u3092\u305d\u306e\u307e\u307e\u8abf\u67fb\u8cc7\u6599\u3068\u3057\u3066\u4f7f\u3048\u308b\u72b6\u614b\u3092\u76ee\u6307\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/stf\/r7_gmptyousa_minaoshi.html\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300c\u4ee4\u548c\uff17\u5e74\u85ac\u6a5f\u6cd5\u6539\u6b63\u306b\u304a\u3051\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u5236\u5ea6\u306e\u898b\u76f4\u3057\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/review-services\/gmp-qms-gctp\/gmp\/0001.html\" rel=\"nofollow\">\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u300cGMP\u9069\u5408\u6027\u8abf\u67fb\u696d\u52d9\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.pmda.go.jp\/files\/000279918.pdf\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300cGMP\u8abf\u67fb\u8981\u9818\u306e\u5236\u5b9a\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c6\u5e743\u670829\u65e5\u4ed8\u3051\u533b\u85ac\u76e3\u9ebb\u767a0329\u7b2c9\u53f7\uff09<\/a><br>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/335AC0000000145\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/336CO0000000011\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u65bd\u884c\u4ee4\u300d<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-26\">GMP\u306b\u95a2\u3057\u3066\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-27\">GMP\u8a8d\u8a3c\u304c\u306a\u3044\u5de5\u5834\u3067\u88fd\u9020\u3055\u308c\u305f\u88fd\u54c1\u306f\u8ca9\u58f2\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u88fd\u54c1\u5206\u91ce\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002GMP\u7701\u4ee4\u306e\u9069\u7528\u5bfe\u8c61\u3068\u306a\u308b\u533b\u85ac\u54c1\uff08\u304a\u3088\u3073\u539a\u751f\u52b4\u50cd\u5927\u81e3\u304c\u6307\u5b9a\u3059\u308b\u533b\u85ac\u90e8\u5916\u54c1\uff09\u3067\u306f\u3001GMP\u9069\u5408\u6027\u8abf\u67fb\u3078\u306e\u9069\u5408\u304c\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u306e\u8981\u4ef6\u306e\u4e00\u3064\u3068\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001GMP\u306b\u9069\u5408\u3057\u306a\u3044\u88fd\u9020\u6240\u3067\u306f\u627f\u8a8d\u3092\u5f97\u3089\u308c\u307e\u305b\u3093\u3002\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\uff08\u9320\u5264\u30fb\u30ab\u30d7\u30bb\u30eb\u5264\u306a\u3069\uff09\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306f\u3001\u7d4c\u904e\u63aa\u7f6e\u671f\u9593\u3092\u7d4c\u3066\u30012026\u5e749\u67081\u65e5\u304b\u3089GMP\u57fa\u6e96\u306e\u9075\u5b88\u304c\u5c4a\u51fa\u8005\u306e\u9075\u5b88\u4e8b\u9805\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u540c\u3058\u5f62\u72b6\u306e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u3067\u306f\u3001GMP\u306e\u57fa\u6e96\u306b\u5373\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u8a31\u53ef\u306e\u8981\u4ef6\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u4e00\u65b9\u3001\u305d\u308c\u4ee5\u5916\u306e\u5065\u5eb7\u98df\u54c1\u3084\u5316\u7ca7\u54c1\u306f\u3001\u6c11\u9593\u306eGMP\u8a8d\u8a3c\u304c\u306a\u304f\u3066\u3082\u8ca9\u58f2\u3067\u304d\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u5316\u7ca7\u54c1\u306b\u306f\u88fd\u9020\u696d\u8a31\u53ef\u3084GQP\u7701\u4ee4\u306a\u3069\u306e\u85ac\u6a5f\u6cd5\u4e0a\u306e\u898f\u5236\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u53d6\u5f15\u5148\u304cGMP\u8a8d\u8a3c\u3092\u53d6\u5f15\u6761\u4ef6\u3068\u3057\u3066\u3044\u308b\u30b1\u30fc\u30b9\u3082\u3042\u308b\u305f\u3081\u3001\u81ea\u793e\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u5236\u5ea6\u3068\u53d6\u5f15\u6761\u4ef6\u3092\u3042\u308f\u305b\u3066\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/335AC0000000145\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/336CO0000000011\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u65bd\u884c\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/laws.e-gov.go.jp\/law\/416M60000100136\" rel=\"nofollow\">e-Gov\u6cd5\u4ee4\u691c\u7d22\u300c\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/notice\/entry\/039209\/\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306e\u3046\u3061\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u9320\u5264\u3001\u30ab\u30d7\u30bb\u30eb\u5264\u7b49\u98df\u54c1\u306e\u88fd\u9020\u53c8\u306f\u52a0\u5de5\u306e\u57fa\u6e96\u306e\u5236\u5b9a\u53ca\u3073\u98df\u54c1\u8868\u793a\u57fa\u6e96\u306b\u3064\u3044\u3066\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/policies\/policy\/food_labeling\/foods_for_specified_health_uses\/notice\/assets\/food_labeling_cms206_20250423_06.pdf\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u300e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u306e\u8868\u793a\u8a31\u53ef\u7b49\u306b\u3064\u3044\u3066\u300f\u306e\u4e00\u90e8\u6539\u6b63\u306b\u3064\u3044\u3066\u300d<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-28\">GMP\u3068HACCP\u306e\u9055\u3044\u306f\u306a\u3093\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>GMP\u306f\u3001\u539f\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u51fa\u8377\u307e\u3067\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u5168\u822c\u3092\u5bfe\u8c61\u3068\u3059\u308b\u57fa\u6e96\u3067\u3059\u3002HACCP\uff08Hazard Analysis and Critical Control Point\uff09\u306f\u3001\u98df\u54c1\u306e\u88fd\u9020\u5de5\u7a0b\u3067\u5371\u5bb3\u8981\u56e0\u3092\u5206\u6790\u3057\u3001\u7279\u306b\u91cd\u8981\u306a\u5de5\u7a0b\u3092\u91cd\u70b9\u7684\u306b\u7ba1\u7406\u3059\u308b\u885b\u751f\u7ba1\u7406\u306e\u624b\u6cd5\u3067\u3059\u3002\u65e5\u672c\u3067\u306f2021\u5e746\u67081\u65e5\u304b\u3089\u3001\u539f\u5247\u3068\u3057\u3066\u3059\u3079\u3066\u306e\u98df\u54c1\u7b49\u4e8b\u696d\u8005\u306b\u3001\u4e00\u822c\u7684\u306a\u885b\u751f\u7ba1\u7406\u306b\u52a0\u3048\u3066HACCP\u306b\u6cbf\u3063\u305f\u885b\u751f\u7ba1\u7406\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\uff08\u9320\u5264\u30fb\u30ab\u30d7\u30bb\u30eb\u5264\u306a\u3069\uff09\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306e\u88fd\u9020\u6240\u3067\u306f\u3001HACCP\u306b\u6cbf\u3063\u305f\u885b\u751f\u7ba1\u7406\u3068GMP\u57fa\u6e96\u3078\u306e\u5bfe\u5fdc\u306e\u4e21\u65b9\u304c\u5fc5\u8981\u3067\u3059\u3002\u4e21\u8005\u306e\u5f79\u5272\u3092\u6574\u7406\u3057\u305f\u3046\u3048\u3067\u3001\u7ba1\u7406\u4f53\u7cfb\u3092\u8a2d\u8a08\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<p>\u51fa\u5178:<a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/kenkou_iryou\/shokuhin\/haccp\/index.html\" rel=\"nofollow\">\u539a\u751f\u52b4\u50cd\u7701\u300cHACCP\uff08\u30cf\u30b5\u30c3\u30d7\uff09\u300d<\/a><br>\u51fa\u5178:<a href=\"https:\/\/www.caa.go.jp\/policies\/policy\/food_labeling\/foods_with_function_claims\/notice\/assets\/food_labeling_cms205_261002_01.pdf\" rel=\"nofollow\">\u6d88\u8cbb\u8005\u5e81\u300c\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306e\u3046\u3061\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u9320\u5264\u3001\u30ab\u30d7\u30bb\u30eb\u5264\u7b49\u98df\u54c1\u306e\u88fd\u9020\u53c8\u306f\u52a0\u5de5\u306e\u57fa\u6e96\u306b\u4fc2\u308b\u5c4a\u51fa\u8005\u5411\u3051\u70b9\u691c\u6307\u91dd\u306b\u3064\u3044\u3066\u300d\uff08\u6d88\u98df\u8868\u7b2c773\u53f7\uff09<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"i-29\">GMP\u8a8d\u8a3c\u306e\u53d6\u5f97\u306b\u304b\u304b\u308b\u671f\u9593\u3068\u8cbb\u7528\u306e\u76ee\u5b89\u306f\u3069\u306e\u304f\u3089\u3044\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>GMP\u8a8d\u8a3c\u306e\u53d6\u5f97\u306b\u304b\u304b\u308b\u671f\u9593\u306f\u3001\u88fd\u9020\u6240\u306e\u898f\u6a21\u3084\u696d\u7a2e\u3001\u65e2\u5b58\u306e\u7ba1\u7406\u4f53\u5236\u306e\u6574\u5099\u72b6\u6cc1\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002\u8cbb\u7528\u306f\u3001\u5be9\u67fb\u8cbb\u7528\u3084\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u8cbb\u7528\u3001\u8a2d\u5099\u6539\u4fee\u8cbb\u7528\u3060\u3051\u3067\u8003\u3048\u306a\u3044\u3088\u3046\u306b\u3057\u307e\u3057\u3087\u3046\u3002\u6587\u66f8\u6574\u5099\u3084\u6559\u80b2\u8a13\u7df4\u306b\u304b\u304b\u308b\u793e\u5185\u5de5\u6570\u3001\u8a8d\u8a3c\u53d6\u5f97\u5f8c\u306e\u7dad\u6301\u30fb\u66f4\u65b0\u8cbb\u7528\u3082\u542b\u3081\u3066\u898b\u7a4d\u3082\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u6761\u4ef6\u306b\u3088\u3063\u3066\u5e45\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305a\u306f\u8a8d\u8a3c\u6a5f\u95a2\u306b\u4e8b\u524d\u76f8\u8ac7\u3057\u3001\u81ea\u793e\u306b\u5fc5\u8981\u306a\u5bfe\u5fdc\u306e\u7bc4\u56f2\u3068\u6982\u7b97\u8cbb\u7528\u3092\u628a\u63e1\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"i-30\">GMP\u3092\u7406\u89e3\u3057\u3066\u5b89\u5fc3\u611f\u306e\u3042\u308b\u88fd\u54c1\u3065\u304f\u308a\u3092<\/h2>\n\n\n\n<p>GMP\u306f\u3001\u539f\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u51fa\u8377\u307e\u3067\u306e\u5168\u5de5\u7a0b\u3067\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u3092\u5fb9\u5e95\u3057\u3001\u54c1\u8cea\u3092\u5de5\u7a0b\u306e\u4e2d\u3067\u3064\u304f\u308a\u8fbc\u3080\u305f\u3081\u306e\u8003\u3048\u65b9\u3067\u3059\u3002\u305d\u306e\u4e2d\u5fc3\u306b\u306f\u3001\u300c\u4eba\u70ba\u7684\u306a\u30df\u30b9\u306e\u6700\u5c0f\u5316\u300d\u300c\u6c5a\u67d3\u53ca\u3073\u54c1\u8cea\u4f4e\u4e0b\u306e\u9632\u6b62\u300d\u300c\u9ad8\u3044\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u8a08\u300d\u3068\u3044\u3046\u4e09\u539f\u5247\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e00\u65b9\u3067\u3001GMP\u306e\u6cd5\u7684\u306a\u4f4d\u7f6e\u3065\u3051\u306f\u5206\u91ce\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u533b\u85ac\u54c1\uff08\u304a\u3088\u3073\u539a\u751f\u52b4\u50cd\u5927\u81e3\u304c\u6307\u5b9a\u3059\u308b\u533b\u85ac\u90e8\u5916\u54c1\uff09\u3067\u306fGMP\u7701\u4ee4\u306b\u57fa\u3065\u304f\u6cd5\u7684\u7fa9\u52d9\u3067\u3059\u3002\u5065\u5eb7\u98df\u54c1\u3067\u306f\u3001\u4efb\u610f\u306e\u7b2c\u4e09\u8005\u8a8d\u8a3c\u306b\u52a0\u3048\u3066\u3001\u5929\u7136\u62bd\u51fa\u7269\u7b49\u3092\u539f\u6750\u6599\u3068\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u5f62\u72b6\u306e\u6a5f\u80fd\u6027\u8868\u793a\u98df\u54c1\u306b\u306f\u98df\u54c1\u8868\u793a\u57fa\u6e96\u4e0a\u306e\u9075\u5b88\u4e8b\u9805\u304c\u3001\u540c\u3058\u5f62\u72b6\u306e\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u306b\u306f\u8a31\u53ef\u306e\u8981\u4ef6\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u5316\u7ca7\u54c1\u3067\u306f\u3001ISO 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Manufacturing Practice\uff1a\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09\u3068\u306f\u3001\u539f\u6599\u306e\u53d7\u5165\u308c\u304b\u3089\u6700\u7d42\u88fd\u54c1\u306e\u51fa\u8377\u306b\u81f3\u308b\u307e\u3067\u306e\u5168\u5de5\u7a0b\u3067\u3001\u9069\u6b63\u306a\u88fd\u9020\u7ba1\u7406\u3068\u54c1\u8cea\u7ba1\u7406\u3092\u6c42\u3081\u308b\u8003\u3048\u65b9\u30fb\u57fa\u6e96\u306e\u7dcf\u79f0\u3067\u3059\u3002\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u3067\u306fGMP &#8230; <\/p>\n","protected":false},"author":20,"featured_media":11495,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":{"0":"post-11467","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-basic","8":"entry"},"_links":{"self":[{"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/posts\/11467","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/users\/20"}],"replies":[{"embeddable":true,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/comments?post=11467"}],"version-history":[{"count":5,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/posts\/11467\/revisions"}],"predecessor-version":[{"id":11497,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/posts\/11467\/revisions\/11497"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/media\/11495"}],"wp:attachment":[{"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/media?parent=11467"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/categories?post=11467"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/japan-ai.co.jp\/media\/wp-json\/wp\/v2\/tags?post=11467"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}