{"id":35219,"date":"2025-08-21T11:25:35","date_gmt":"2025-08-21T02:25:35","guid":{"rendered":"https:\/\/tech-d.jp\/column\/?p=35219"},"modified":"2025-08-21T11:35:04","modified_gmt":"2025-08-21T02:35:04","slug":"tdo2025073101","status":"publish","type":"post","link":"https:\/\/ondemand-wp.tech-d.jp\/column\/tdo2025073101\/","title":{"rendered":"\u3010\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\uff1atdo2025073101\u3011\u5316\u7ca7\u54c1GMP\u306e\u5b9f\u8df5\u3068\u54c1\u8cea\u4fdd\u8a3c"},"content":{"rendered":"<head>\r\n  <meta name=\"viewport\" content=\"width=device-width, initial-scale=1\"> <\/head>\r\n<div class=\"main wrapper\">\r\n  <div class=\"movie\">\r\n    <div class=\"youtube-wrap\">\r\n      <!-- \u52d5\u753b\u304c\u30a2\u30c3\u30d7\u3055\u308c\u305f\u3089\u3053\u3061\u3089\u3078 -->\r\n<iframe src=\"https:\/\/player.vimeo.com\/video\/1111133391?badge=0&amp;autopause=0&amp;player_id=0&amp;app_id=58479\" frameborder=\"0\" allow=\"autoplay; fullscreen; picture-in-picture; clipboard-write; encrypted-media; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" style=\"position:absolute;top:0;left:0;width:100%;height:100%;\" title=\"Teaser \u5316\u7ca7\u54c1GMP\u306e\u5b9f\u8df5\u3068\u54c1\u8cea\u4fdd\u8a3c\"><\/iframe>\r\n <\/div>\r\n    <div class=\"catch wrapper\">\r\n      <!-- \u8b1b\u5e2b\u7d39\u4ecb\u6b04\u3067\u3059 -->\r\n      <div class=\"inst-info\">\r\n        <div class=\"name\">\r\n          <!-- \u8b1b\u5e2b\u540d\u3092\u5165\u529b -->\u5143\u682a\u5f0f\u4f1a\u793e\u8cc7\u751f\u5802 \u639b\u5ddd\u5de5\u5834 \u5927\u962a\u5de5\u5834 \u6280\u8853\u90e8\u9577 \u9234\u6728\u6b3d\u4e5f\u3000\u6c0f<\/div>\r\n        <!-- name -->\r\n        <div class=\"career\">\r\n          <!-- \u8b1b\u5e2b\u7d39\u4ecb\u3092\u5165\u529b -->1980\u5e74\u65e9\u7a32\u7530\u5927\u5b66\u7406\u5de5\u5b66\u90e8\u5352\u696d\u5f8c\u3001\u3231\u8cc7\u751f\u5802\u306b\u5165\u793e\u3002\u639b\u5ddd\u5de5\u5834\u3067\u691c\u67fb\u3001\u51e6\u65b9\u958b\u767a\u30fb\u751f\u7523\u6280\u8853\u958b\u767a\u3092\u62c5\u5f53\uff08\u7d0411\u5e74\u9593\uff09\u3002\u305d\u306e\u5f8c\u3001\u672c\u793e\u751f\u7523\u6280\u8853\u90e8\u3067\u6d77\u5916\u4e8b\u696d\u6226\u7565\u3001\u6d77\u5916\u5de5\u5834\u5efa\u8a2d\u3001\u751f\u7523\u6280\u8853\u79fb\u8ee2\u3001\u6d77\u5916\u85ac\u4e8b\u5bfe\u5fdc\u3001\u6d77\u5916\u539f\u6599\u30fb\u8cc7\u6750\u30fb\u88fd\u54c1\u8abf\u9054\u306e\u696d\u52d9\u3092\u62c5\u5f53\uff08\u7d0410\u5e74\u9593\uff09\u3002\u4e2d\u56fd\u5317\u4eac\u5de5\u5834\u306e\u53d6\u7de0\u5f79\u5de5\u5834\u9577\uff08\u7d043.5\u5e74\u9593\uff09\u3001\u639b\u5ddd\u5de5\u5834\u6280\u8853\u90e8\u9577\u3001\u5927\u962a\u5de5\u5834\u6280\u8853\u90e8\u9577\u3092\u62c5\u5f53\uff08\u5408\u8a087\u5e74\u9593\uff09\u3001\u3231\u30b3\u30b9\u30e2\u30d3\u30e5\u30c6\u30a3\u30fc\u57f7\u884c\u5f79\u54e1\u3000\u54c1\u8cea\u7ba1\u7406\u90e8\u9577\u3068\u3057\u3066\u30d9\u30c8\u30ca\u30e0\u5de5\u5834\u3001\u4e2d\u56fd\u5de5\u5834\u3092\u5efa\u8a2d\u3002\u904e\u53bb\u306b\u306f\u3001\u7c73\u56fd\uff2f\uff34\uff23\u88fd\u54c1\u306e\u5316\u7ca7\u54c1\u696d\u754c\u3067\u65e5\u672c\u56fd\u5185\u521d\u306e\uff26\uff24\uff21\u67fb\u5bdf\u3092\u53d7\u3051\u5165\u308c\u3001\u6307\u6458\u4e8b\u9805\u30bc\u30ed\u4ef6\u3067\u306e\u5bfe\u5fdc\u3084\u30d2\u30a2\u30eb\u30ed\u30f3\u9178\u306e\u30e8\u30fc\u30ed\u30c3\u30d1\u539f\u85ac\u767b\u9332\u30fb\u7c73\u56fd\uff26\uff24\uff21\u767b\u9332\u3001\u30d2\u30a2\u30eb\u30ed\u30f3\u9178\u306e\u539f\u85ac\u5de5\u5834\u68df\u306e\u5897\u8a2d\u3092\u8cac\u4efb\u8005\u3068\u3057\u3066\u63a8\u9032\u3057\u305f\u7d4c\u9a13\u3092\u6301\u3064\u3002\u516c\u5bb3\u9632\u6b62\u7ba1\u7406\u8005\uff08\u6c34\u8cea1\u7a2e\u3001\u5927\u6c171\u7a2e\uff09\u3001\u4e2d\u5c0f\u4f01\u696d\u8a3a\u65ad\u58eb\uff08\u57fc\u7389\u770c\u6b63\u4f1a\u54e1\uff09\u3001\uff26\uff32\u6280\u80fd\u58eb\u3001\u30bf\u30fc\u30f3\u30a2\u30e9\u30a6\u30f3\u30c9\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\uff08\u4e8b\u696d\u518d\u751f\u3001\uff08\u4e00\u793e\uff09\u91d1\u878d\u691c\u5b9a\u5354\u4f1a\u8a8d\u5b9a\uff09ISO9001\u5be9\u67fb\u54e1\u88dc\u3001\u5065\u5eb7\u7d4c\u55b6EX\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u3002<br><br>\r\n          <div class=\"kome\"><strong><\/strong><\/div>\r\n        <\/div>\r\n        <!-- career -->\r\n      <\/div>\r\n      <!-- inst-info -->\r\n      <!-- \u30a2\u30b3\u30fc\u30c7\u30a3\u30aa\u30f3\u90e8\u5206\u3067\u3059 -->\r\n       <!--\u30e9\u30d9\u30eb1-->\r\n<div class=\"accbox\"><input type=\"checkbox\" id=\"label1\" class=\"cssacc\" checked\/><label for=\"label1\">\u5bfe\u8c61<\/label>\r\n        <div class=\"accshow\">\r\n          <!-- \u4e0b\u8a18p\u306b\u8996\u8074\u6599\u3092\u5165\u529b\u3057\u3066\u304f\u3060\u3055\u3044 -->\r\n          <ul>\r\n            <li>\u54c1\u8cea\u7ba1\u7406\u30fb\u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005<\/li>\r\n            <li>\u5316\u7ca7\u54c1\u696d\u754c\u306e\u6280\u8853\u8005<\/li>\r\n            <li>\u6559\u80b2\u30fb\u7814\u4fee\u62c5\u5f53\u8005<\/li>\r\n            \r\n            <\/ul>\r\n        <\/div>\r\n        <!--\/\/\u30e9\u30d9\u30eb1-->\r\n       <input type=\"checkbox\" id=\"label0\" class=\"cssacc\" checked\/> <label for=\"label0\">\u30d7\u30ed\u30b0\u30e9\u30e0<\/label>\r\n        <div class=\"accshow\">\r\n          <li class=\"title\">1. GMP\u306e\u57fa\u672c\u3068\u5316\u7ca7\u54c1GMP\u306e\u4f4d\u7f6e\u3065\u3051<\/li>\r\n    <ul>\r\n      <li>1\uff09GMP\u3068\u306f\u4f55\u304b\uff1f\uff08\u5b9a\u7fa9\u3068\u76ee\u7684\uff09<\/li>\r\n      <li>2\uff09\u533b\u85ac\u54c1GMP\u3068\u306e\u9055\u3044<\/li>\r\n      <li>3\uff09\u5316\u7ca7\u54c1GMP\u306e\u80cc\u666f\u3068\u91cd\u8981\u6027<\/li>\r\n      <li>4\uff09\u5316\u7ca7\u54c1GMP\u306e\u6cd5\u7684\u6839\u62e0\uff08\u85ac\u6a5f\u6cd5\u7b2c56\u6761\u3001\u653f\u4ee4\u30fb\u7701\u4ee4\uff09<\/li>\r\n      <li>5\uff09ISO 22716\u306e\u6982\u8981\u3068\u69cb\u9020<\/li>\r\n      <li>6\uff09\u5316\u7ca7\u54c1GMP\u3068QMS\u306e\u95a2\u4fc2<\/li>\r\n    <\/ul>\r\n \r\n  <li class=\"title\">2. ISO 22716\u306b\u57fa\u3065\u304fGMP\u8981\u6c42\u4e8b\u9805<\/li>\r\n    <ul>\r\n      <li>1\uff09ISO 22716\u306e\u5168\u4f53\u69cb\u6210<\/li>\r\n      <li>2\uff09\u7d44\u7e54\u3068\u4eba\u54e1\uff08\u8cac\u4efb\u8005\u306e\u4efb\u547d\u3001\u6559\u80b2\u8a13\u7df4\uff09<\/li>\r\n      <li>3\uff09\u5efa\u7269\u3068\u65bd\u8a2d\uff08\u30be\u30fc\u30cb\u30f3\u30b0\u3001\u4ea4\u5dee\u6c5a\u67d3\u9632\u6b62\uff09<\/li>\r\n      <li>4\uff09\u8a2d\u5099\uff08\u4fdd\u5b88\u30fb\u70b9\u691c\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u8003\u3048\u65b9\uff09<\/li>\r\n      <li>5\uff09\u539f\u6599\u3068\u8cc7\u6750\u306e\u7ba1\u7406\uff08\u53d7\u5165\u3001\u4fdd\u7ba1\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff09<\/li>\r\n      <li>6\uff09\u88fd\u9020\u7ba1\u7406\uff08\u8a18\u9332\u3001\u30ed\u30c3\u30c8\u7ba1\u7406\u3001\u624b\u9806\u66f8\uff09<\/li>\r\n      <li>7\uff09\u5305\u88c5\u30fb\u8868\u793a\uff08\u6b63\u78ba\u6027\u3001\u5370\u5237\u30e9\u30d9\u30eb\u7ba1\u7406\uff09<\/li>\r\n      <li>8\uff09\u54c1\u8cea\u7ba1\u7406\uff08\u629c\u53d6\u691c\u67fb\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u3001\u4fdd\u7ba1\u30b5\u30f3\u30d7\u30eb\uff09<\/li>\r\n      <li>9\uff09\u82e6\u60c5\u30fb\u30ea\u30b3\u30fc\u30eb\u5bfe\u5fdc\uff08\u4e8b\u4f8b\u3001\u5bfe\u5fdc\u30d5\u30ed\u30fc\uff09<\/li>\r\n      <li>10\uff09\u5185\u90e8\u76e3\u67fb\uff08\u983b\u5ea6\u3001\u5831\u544a\u3001\u662f\u6b63\u51e6\u7f6e\uff09<\/li>\r\n      <li>11\uff09\u6587\u66f8\u7ba1\u7406\uff08\u8a18\u9332\u4fdd\u5b58\u3001\u6539\u8a02\u7ba1\u7406\u3001\u96fb\u5b50\u8a18\u9332\uff09<\/li>\r\n    <\/ul>\r\n\r\n  <li class=\"title\">3. GMP\u306e\u5b9f\u52d9\u7684\u904b\u7528\u3068\u6539\u5584\u6d3b\u52d5<\/li>\r\n    <ul>\r\n      <li>1\uff09GMP\u6587\u66f8\u4f53\u7cfb\uff08SOP\u30fb\u8a18\u9332\u30fb\u30de\u30cb\u30e5\u30a2\u30eb\uff09<\/li>\r\n      <li>2\uff09\u6559\u80b2\u8a13\u7df4\u30d7\u30ed\u30b0\u30e9\u30e0\uff08OJT\u3068\u96c6\u5408\u6559\u80b2\uff09<\/li>\r\n      <li>3\uff09\u65e5\u5e38\u70b9\u691c\u3068GMP\u9075\u5b88\u78ba\u8a8d\uff085S\u3001\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\uff09<\/li>\r\n      <li>4\uff09\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08ICH Q9\u306e\u8003\u3048\u65b9\u306e\u5fdc\u7528\uff09<\/li>\r\n      <li>5\uff09\u5909\u66f4\u7ba1\u7406\u3068\u9038\u8131\u7ba1\u7406\uff08CAPA\u3068\u306e\u95a2\u4fc2\uff09<\/li>\r\n      <li>6\uff09GMP\u6587\u5316\u306e\u91b8\u6210\uff08\u5f93\u696d\u54e1\u306e\u610f\u8b58\u6539\u9769\uff09<\/li>\r\n      <li>7\uff09\u6d77\u5916\u5411\u3051\u5316\u7ca7\u54c1\u306eGMP\u5bfe\u5fdc\uff08EU\u3001\u30a2\u30b8\u30a2\u8af8\u56fd\uff09<\/li>\r\n      <li>8\uff09GQP\u3068\u306e\u9023\u643a\uff08GQP\u8cac\u4efb\u8005\u306e\u95a2\u4e0e\uff09<\/li>\r\n      <li>9\uff09\u5916\u90e8\u59d4\u8a17\u5148\u306eGMP\u8a55\u4fa1\u3068\u7ba1\u7406<\/li>\r\n    <\/ul>\r\n  \r\n  <li class=\"title\">4. \u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/li>\r\n    <ul>\r\n      <li>1\uff09\u539f\u6599\u306e\u53d7\u5165\u30df\u30b9<\/li>\r\n      <li>2\uff09\u88fd\u9020\u30a8\u30e9\u30fc\u306b\u3088\u308b\u56de\u53ce<\/li>\r\n      <li>3\uff09\u76e3\u67fb\u6307\u6458\u3078\u306e\u662f\u6b63\u5bfe\u5fdc<\/li>\r\n      <li>4\uff09\u4e0d\u9069\u5207\u306a\u6559\u80b2\u8a18\u9332<\/li>\r\n      <li>5\uff09\u8868\u793a\u30df\u30b9\u306b\u3088\u308b\u82e6\u60c5\u5bfe\u5fdc<\/li>\r\n    <\/ul>\r\n           \r\n<p>\u3000\u3000\u672c\u30bb\u30df\u30ca\u30fc\u3067\u306f\u3001\u5316\u7ca7\u54c1\u88fd\u9020\u73fe\u5834\u306e\u54c1\u8cea\u4fdd\u8a3c\u3092\u5f37\u5316\u3059\u308b\u305f\u3081\u3001ISO22716\u306b\u57fa\u3065\u304fGMP\u306e\u57fa\u672c\u304b\u3089\u5b9f\u52d9\u904b\u7528\u3001\u6539\u5584\u6d3b\u52d5\u307e\u3067\u4f53\u7cfb\u7684\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002\u4e00\u822c\u7684\u306a\u8981\u6c42\u4e8b\u9805\u306e\u89e3\u8aac\u3067\u306f\u306a\u304f\u5b9f\u8df5\u7684\u306a\u8996\u70b9\u304b\u3089\u3001GMP\u306e\u76ee\u7684\u3084\u533b\u85ac\u54c1GMP\u3068\u306e\u9055\u3044\u3001\u6cd5\u7684\u6839\u62e0\u3001\u56fd\u969b\u52d5\u5411\u3092\u62bc\u3055\u3048\u3064\u3064\u3001\u7d44\u7e54\u30fb\u4eba\u54e1\u3001\u65bd\u8a2d\u30fb\u8a2d\u5099\u3001\u539f\u6599\u30fb\u8cc7\u6750\u3001\u88fd\u9020\u3001\u5305\u88c5\u30fb\u8868\u793a\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u82e6\u60c5\u30fb\u30ea\u30b3\u30fc\u30eb\u3001\u5185\u90e8\u76e3\u67fb\u3001\u6587\u66f8\u7ba1\u7406\u306a\u306917\u306e\u8981\u6c42\u4e8b\u9805\u3092\u5177\u4f53\u4f8b\u3068\u5171\u306b\u7559\u610f\u70b9\u3092\u4e2d\u5fc3\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u6559\u80b2\u8a13\u7df4\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u65e5\u5e38\u70b9\u691c\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001\u5909\u66f4\u30fb\u9038\u8131\u7ba1\u7406\u3068CAPA\u306e\u9023\u643a\u3084\u3001GMP\u6587\u5316\u306e\u91b8\u6210\u3001\u6d77\u5916\u898f\u5236\u5bfe\u5fdc\u306a\u3069\u5b9f\u8df5\u7684\u306a\u904b\u7528\u30dd\u30a4\u30f3\u30c8\u3092\u63d0\u793a\u3057\u307e\u3059\u3002\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u901a\u3058\u3001\u5de5\u7a0b\u3067\u54c1\u8cea\u3092\u4f5c\u308a\u8fbc\u3080\u8003\u3048\u65b9\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u56fd\u969b\u7684\u306a\u30d3\u30b8\u30cd\u30b9\u306b\u3082\u901a\u3058\u308b\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u3092\u76ee\u6307\u3057\u307e\u3059\u3002<\/p>\r\n        <\/div>\r\n        <!--\/\/\u30e9\u30d9\u30eb0-->\r\n        <!--\u30e9\u30d9\u30eb1-->\r\n<input type=\"checkbox\" id=\"label1\" class=\"cssacc\" checked\/><label for=\"label1\">\u8b1b\u5ea7\u306e\u30b4\u30fc\u30eb<\/label>\r\n        <div class=\"accshow\">\r\n          <!-- \u4e0b\u8a18p\u306b\u8996\u8074\u6599\u3092\u5165\u529b\u3057\u3066\u304f\u3060\u3055\u3044 -->\r\n          <ul>\r\n            <li>ISO22716\u306b\u57fa\u3065\u304fGMP\u306e\u57fa\u672c\u69cb\u9020\u3068\u76ee\u7684<\/li>\r\n            <li>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068CAPA\u306e\u9023\u643a<\/li>\r\n<li>GMP\u306e17\u8981\u4ef6\u306e\u5177\u4f53\u7684\u306a\u904b\u7528\u65b9\u6cd5<\/li>\r\n            <\/ul>\r\n        <\/div>\r\n        <!--\/\/\u30e9\u30d9\u30eb1-->\r\n        <!--\u30e9\u30d9\u30eb2-->\r\n        <!--\/\/\u30e9\u30d9\u30eb2-->\r\n        <!--\u30e9\u30d9\u30eb3--><input type=\"checkbox\" id=\"label3\" class=\"cssacc\" checked\/><label 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