{"id":14,"date":"2016-05-24T09:32:56","date_gmt":"2016-05-24T00:32:56","guid":{"rendered":"http:\/\/52.196.95.92\/wordpress\/?page_id=14"},"modified":"2025-05-12T14:49:25","modified_gmt":"2025-05-12T05:49:25","slug":"consultant","status":"publish","type":"page","link":"https:\/\/www.fsz.co.jp\/?page_id=14","title":{"rendered":"\u533b\u85ac \u88fd\u85ac\uff5cGMP GDP CSV\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">\u533b\u85ac \u88fd\u85ac\uff5cGMP GDP CSV\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0<\/h2>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong>\u673a\u4e0a\u306e\u7a7a\u8ad6\u306f\u7533\u3057\u307e\u305b\u3093\u3002<\/strong><br><strong>\u5fa1\u793e\u306b\u30b8\u30e3\u30b9\u30c8\u30d5\u30a3\u30c3\u30c8\u306a\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u3002\u3082\u3061\u308d\u3093\u3001\u5b9f\u8df5\u6d3e\u3067\u3059\u3002<\/strong><\/p>\n<\/blockquote>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"762\" data-id=\"4111\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2017\/11\/csvcon001-1024x762.png\" alt=\"\" class=\"wp-image-4111\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2017\/11\/csvcon001-1024x762.png 1024w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2017\/11\/csvcon001-300x223.png 300w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/figure>\n\n\n\n<p>\u533b\u85ac\u30fb\u88fd\u85ac\u4f01\u696d\u3092\u4e2d\u5fc3\u306b\u539f\u6599\u30fb\u533b\u85ac\u4e2d\u9593\u4f53\u3001\u539f\u85ac\u3001\u533b\u7642\u6a5f\u5668\u3001\u5065\u5eb7\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u7b49\u306e\u4f01\u696d\u306b\u7279\u5316\u3057\u3066\u3001\u304a\u5ba2\u69d8\u306e\u696d\u52d9\u3092\u63a8\u9032\u3059\u308b\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u3092\u5fa1\u63d0\u4f9b\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30fb\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u85ac\u6a5f\u6cd5\u3078\u306e\u5bfe\u5fdc<br>\u30fb\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\uff08GQP)\u69cb\u7bc9<br>\u30fbGMP\u3001FDA\u67fb\u5bdf\u5bfe\u5fdc\uff08\u30ea\u30cf\u30fc\u30b5\u30eb\u306a\u3069\uff09<br>\u30fbISO13485\u66f4\u65b0\u5bfe\u5fdc<br>\u30fb\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08CSV\uff08Computerized System Validation\uff09\uff09\u306e\u5bfe\u5fdc<\/p>\n\n\n\n<p>\u521d\u56de\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u7121\u6599\u3067\u3059\u3002\u304a\u6c17\u8efd\u306b\u3053\u3061\u3089\u304b\u3089\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6240\u5c5e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/h2>\n\n\n\n<p>FBCN\uff08Feeler Bussiness Consulting Network\uff09\u306f\u3001\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u696d\u52d9\u3084\u7814\u4fee\u696d\u52d9\u3092\u884c\u306a\u3046\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u96c6\u308a\u3067\u3059\u3002\u533b\u85ac\u30fb\u88fd\u85ac\u4f01\u696d\u3092\u4e2d\u5fc3\u306b\u539f\u6599\u30fb\u533b\u85ac\u4e2d\u9593\u4f53\u3001\u539f\u85ac\u3001\u533b\u7642\u6a5f\u5668\u3001\u5065\u5eb7\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u7b49\u306e\u4f01\u696d\u306b\u7279\u5316\u3057\u3001\u533b\u85ac\u30fb\u88fd\u85ac\u4f01\u696d\u3067\u9577\u5e74\u57f9\u3063\u3066\u304d\u305f\u30ce\u30a6\u30cf\u30a6\u3001\u77e5\u898b\u3001\u6280\u8853\u306a\u3069\u3092\u751f\u304b\u3057\u3001\u672c\u5f53\u306e\u5b9f\u52d9\u306b\u6cbf\u3063\u305f\u5177\u4f53\u7684\u306a\u89e3\u6c7a\u7b56\u3092\u5fa1\u63d0\u4f9b\u3044\u305f\u3057\u307e\u3059<\/p>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"100\" height=\"130\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/yoshida.jpg\" alt=\"\" class=\"wp-image-112 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u5409\u7530 \u7693\u4e00\u3000-Koichi Yoshida-<br>\u6b66\u7530\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fb\u5c0e\u5165\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u4e3b\u773c\u306b\u304a\u3044\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406<br>\u30fb\u533b\u85ac\u3001\u98df\u54c1\u3001\u5316\u5b66\u696d\u754c\u306eIT\u5316\u6226\u7565\u8a08\u753b\uff08EA\uff09\u7acb\u6848<br>\u30fbERP\u30d1\u30c3\u30b1\u30fc\u30b8\uff08\u533b\u85ac\u3001\u98df\u54c1\u3001\u5316\u5b66\u696d\u754c\u5411\u3051\uff09\u5c0e\u5165\u3001\u6559\u80b2\uff08\u30e6\u30fc\u30b6\u4f01\u696d\u5411\u3051\uff09<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u6b66\u7530\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e \u60c5\u5831\u30b7\u30b9\u30c6\u30e0\u90e8\u9580\u306b\u52e4\u52d9\u3002\u4e00\u8cab\u3057\u3066\u6b66\u7530\u85ac\u54c1\uff29\uff34\u5316\u3092\u5148\u5c0e\u3002<br>\u5728\u52e4\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<br>\u4eba\u4e8b\u3001\u7d4c\u7406\u3001\u8ca9\u58f2\u3001\u751f\u7523\u3001\u7269\u6d41\u3001\uff2d\uff32\u652f\u63f4\u3001\u5e02\u5834\u7ba1\u7406\u306e\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3001\u4f01\u753b\u3001\u7acb\u6848<br>\u6b66\u7530\u85ac\u54c1\u4e2d\u671fIT\u6226\u7565\u8a08\u753b\u7acb\u6848\u306e\u691c\u8a0e\u3001\u7acb\u6848\u3001\u5b9f\u73fe\u5316<br>\u6b66\u7530\u85ac\u54c1ERP\u7dcf\u62ec\u8cac\u4efb\u8005\uff08\u62c5\u5f53\u90e8\u9577\uff09\u3068\u3057\u3066\uff32\uff0f\uff13\u5c0e\u5165\u306e\u73fe\u5834\u3067\u6307\u63ee\u3002<br>\u5143\u533b\u85ac\u696d\u754c\u60c5\u5831\u90e8\u9580\u9577\u4f1a\u8b70\u30e1\u30f3\u30d0\u30fc<br>\u5143\uff33\uff21\uff30\u30e6\u30fc\u30b6\u30fc\u4f1a\u533b\u85ac\u54c1\u90e8\u4f1a\u9577\u3001\u5143\uff33\uff21\uff30\u30e6\u30fc\u30b6\u30fc\u4f1a\u5e79\u4e8b\uff08\uff24\uff32\uff31\u62c5\u5f53\uff09<br>\u540d\u53e4\u5c4b\u5546\u79d1\u5927\u5b66 \u5927\u5b66\u9662\u975e\u5e38\u52e4\u8b1b\u5e2b\uff08ERP\uff09\u306b\u5f93\u4e8b\u3059\u308b\u3002<br>\u57f7\u7b46\u30fb\u8457\u66f8<br>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u304a\u3088\u3073\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5b9f\u65bd\u3068\u5177\u4f53\u7684\u5bfe\u5fdc\uff08\u5171\u8457\u3000\u6280\u8853\u60c5\u5831\u5354\u4f1a\uff09<br>\u652f\u63f4\u5185\u5bb9<br>\u5c0e\u5165\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u4e3b\u773c\u306b\u304a\u3044\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406<br>\u533b\u85ac\u3001\u98df\u54c1\u3001\u5316\u5b66\u696d\u754c\u306eIT\u5316\u6226\u7565\u8a08\u753b\uff08EA\uff09\u7acb\u6848<br>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<br>\u30d9\u30f3\u30c0\u30fc\u30aa\u30fc\u30c7\u30a3\u30c3\u30c8<br>SE\u306e\u305f\u3081\u306e\u533b\u85ac\u696d\u754c\u306e\u6559\u80b2<br>\u958b\u767a\u65b9\u6cd5\u8ad6\u306e\u958b\u767a\u3001\u8ca9\u58f2<br>BPR\u5c0e\u5165\u8a08\u753b\u3001\u4f01\u753b\u30fb\u7acb\u6848<br>ERP\u30d1\u30c3\u30b1\u30fc\u30b8\uff08\u533b\u85ac\u3001\u98df\u54c1\u3001\u5316\u5b66\u696d\u754c\u5411\u3051\uff09\u5c0e\u5165\u3001\u6559\u80b2\uff08\u30e6\u30fc\u30b6\u4f01\u696d\u5411\u3051\uff09<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"99\" height=\"130\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/tabegai.png\" alt=\"\" class=\"wp-image-114 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u7530\u90e8\u4e95\u667a\u4e09\u3000- Tomozo Tamegai &#8211;<br>\u30a8\u30fc\u30b6\u30a4\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fbFDA\u67fb\u5bdf\u5bfe\u5fdc\u3001\u56fd\u5185\u5916\u306e\u67fb\u5bdf\u30fb\u76e3\u67fb\u5bfe\u5fdc<br>\u30fbCorporate GMP\u76e3\u67fb<br>\u30fbGMP\u4f53\u5236\u69cb\u7bc9<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u85ac\u4e8b\u30fbGMP\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8(\u7406\u5b66\u535a\u58eb)<br>\u56fd\u5185\u5916\u306e\u88fd\u85ac\u4f01\u696d\u3001\u5316\u5b66\u4f01\u696d\u3001\u5546\u793e\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u5b9f\u65bd\u4e2d<br>\u7279\u5b9a\u975e\u55b6\u5229\u6d3b\u52d5\u6cd5\u4eba \u533b\u85ac\u54c1\uff65\u98df\u54c1\u54c1\u8cea\u4fdd\u8a3c\u652f\u63f4\u30bb\u30f3\u30bf\u30fc(\u7565\u79f0\uff1b\uff2e\uff30\uff2f\uff0d\uff31\uff21\u30bb\u30f3\u30bf\u30fc)\u9867\u554f<br>\u57f7\u7b46\u30fb\u8457\u66f8<br>\u533b\u85ac\u54c1\u306e\u591a\u5f62\u73fe\u8c61\u3068\u6676\u6790\u79d1\u5b66\u3000\u5171\u540c\u57f7\u7b46\u3000\u6280\u8853\u60c5\u5831\u5354\u4f1a\u30fb\u4e38\u5584<br>FDA\/EMEA\u306b\u304a\u3051\u308bGMP\u67fb\u5bdf\u3068FDA483\/Warning Letters\u3000\u5bfe\u7b56\u3000\u5171\u540c\u57f7\u7b46\u3000\u6280\u8853\u60c5\u5831\u5354\u4f1a<br>FDA\u306e\u67fb\u5bdf\u3092\u53d7\u3051\u308b\u306b\u3042\u305f\u3063\u3066\u3000PHARMSTAGE, 55(4)2002<br>\u539f\u85ac\u306e\u59d4\u8a17\u88fd\u9020\u306b\u304a\u3051\u308b\u6280\u8853\u79fb\u7ba1\u3068\u6cd5\u7684\u5bfe\u5fdc\uff1b\u88fd\u5264\u6a5f\u68b0\u6280\u8853\u7814\u7a76\u4f1a\u8a8c, 39 (2)2003<br>FDA\u306e21st A Risk-Based Approach\u306e\u8003\u3048\u65b9\u3068\u30b7\u30b9\u30c6\u30e0\u67fb\u5bdf\u3078\u306e\u5bfe\u5fdc\uff1b\u88fd\u5264\u6a5f\u68b0\u6280\u8853\u7814\u7a76\u4f1a\u8a8c, 39(4)2003<br>GMP\u6559\u80b2\u8a13\u7df4\u30b7\u30b9\u30c6\u30e0\u3000\u5171\u540c\u57f7\u7b46\u30002003\u5e748\u6708\uff5e2004\u5e748\u6708<br>\u533b\u85ac\u54c1\u306e\u56fd\u969b\u5316\u3068GMP\u3000Co-authoring; CMC, 2009\u5e741\u6708<br>Points of FDA Application and FDA Inspection; Co-writing, \u60c5\u5831\u6a5f\u69cb Feb.2011<br>\u652f\u63f4\u3001\u6307\u5c0e\u5185\u5bb9<br>GMP\/GQP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<br>Corporate GMP\u76e3\u67fb<br>FDA\u67fb\u5bdf\u5bfe\u5fdc\u3001\u56fd\u5185\u5916\u306e\u67fb\u5bdf\u30fb\u76e3\u67fb\u5bfe\u5fdc<br>GMP\u4f53\u5236\u69cb\u7bc9<br>\u5909\u66f4\u7ba1\u7406\u3001\u9038\u8131\u3042\u308b\u3044\u306fOOS\u306a\u3069\u54c1\u8cea\u7570\u5e38\u306b\u95a2\u3059\u308b\u5bfe\u5fdc<br>\u85ac\u4e8b\u898f\u5236\u3078\u306e\u5bfe\u5fdc<br>GMP\u6559\u80b2\u8a13\u7df4<br>\u5168\u9762\u59d4\u53d7\u8a17\u88fd\u9020<br>\u54c1\u8cea\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30fc\u30b8\u30e1\u30f3\u30c8\u306e\u8003\u3048\u65b9<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"100\" height=\"128\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/Takeuchi.png\" alt=\"\" class=\"wp-image-115 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u7af9\u5185 \u7965\u96c4\u3000-Yoshio Takeuchi-<br>\u85e4\u6ca2\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fbCSV\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u5bfe\u5fdc\u6559\u80b2<br>\u30fbGMP\u5b9f\u8df5\u6307\u5c0e\uff08GMP\u4f53\u5236\u8a3a\u65ad\u3001\u6539\u5584\u3001\u904b\u55b6\u6307\u5c0e\u3001\u6559\u80b2\u8a08\u753b\uff09<br>\u30fb\u539a\u751f\u52b4\u50cd\u7701ERES\u3001FDA 21CFR Part11\uff08\u96fb\u78c1\u7684\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\uff09\u6307\u91dd\u5bfe\u5fdc\u6307\u5c0e<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u85ac\u5264\u5e2b<br>\u5143\u30fb\u5927\u85ac\u5354\uff08\u5927\u962a\u533b\u85ac\u54c1\u5354\u4f1a\uff09GMP\u59d4\u54e1\u4f1a\u5e38\u4efb\u59d4\u54e1<br>\u5143\u30fb\u65e5\u85ac\u9023\uff08\u65e5\u672c\u88fd\u85ac\u56e3\u4f53\u9023\u5408\u4f1a\uff09GMP\u59d4\u54e1\u4f1a\u5e38\u4efb\u59d4\u54e1<br>\u5143\u30fb\u65e5\u85ac\u9023GMP\u59d4\u54e1\u4f1a\u3000\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\u30d7\u30ed\u30b8\u30a7\u30af\u30c8<br>\u5143\u30fb\u85ac\u4e8b\u6cd5\u6539\u6b63\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\uff08\u65e5\u85ac\u9023\u59d4\u54e1\uff09<br>\u7279\u5b9a\u975e\u55b6\u5229\u6d3b\u52d5\u6cd5\u4eba \u533b\u85ac\u54c1\uff65\u98df\u54c1\u54c1\u8cea\u4fdd\u8a3c\u652f\u63f4\u30bb\u30f3\u30bf\u30fc\u3000\u7406\u4e8b\u3000(\u7565\u79f0\uff1aNPO-QA\u30bb\u30f3\u30bf\u30fc)<br>\u652f\u63f4\u3001\u6307\u5c0e\u5185\u5bb9<br>GMP\u5bfe\u5fdc\u6307\u5c0e<br>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u6307\u5c0e<br>\u533b\u85ac\u54c1\u5de5\u5834\u306e\u54c1\u8cea\u7ba1\u7406\u6307\u5c0e<br>\u95a2\u9023\u6cd5\u4ee4\u3001\u898f\u5247\u89e3\u8aac<br>GMP\u5b9f\u8df5\u6307\u5c0e\u3000\uff08GMP\u4f53\u5236\u8a3a\u65ad\u3001\u6539\u5584\u3001\u904b\u55b6\u6307\u5c0e\u3001\u6559\u80b2\u8a08\u753b\uff09<br>GMP\u4f53\u5236\u69cb\u7bc9\u652f\u63f4\u3000\uff08\u7d44\u7e54\u7de8\u5236\u3001\u7ba1\u7406\u57fa\u6e96\u30fb\u624b\u9806\u4f5c\u6210\uff09<br>GMP\u95a2\u9023\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0 (\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2) \u958b\u767a\u7ba1\u7406\u6307\u5c0e<br>CSV \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u958b\u8a2d\u3001\u6559\u80b2<br>CSV \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff09\u95a2\u9023\u6559\u80b2\u3001\u5b9f\u65bd\u6307\u5c0e\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u7ba1\u7406\u306e\u6307\u5c0e<br>\u539a\u751f\u52b4\u50cd\u7701ERES\uff08\u96fb\u78c1\u7684\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\uff09\u6307\u91dd\u5bfe\u5fdc\u6307\u5c0e<br>FDA 21CFR Part11\u3001\u539a\u751f\u52b4\u50cd\u7701ERES\u6307\u91dd\u306e\u5bfe\u5fdc\u5b9f\u884c\u8a08\u753b\u4f5c\u6210\u307e\u3067\u3001\u5404\u30b9\u30c6\u30c3\u30d7\u6307\u5c0e\u53ca\u3073\u9032\u6357\u7ba1\u7406\u306e\u6307\u5c0e\u3001<br>\u96fb\u5b50\u60c5\u5831\u7ba1\u7406\u306e\u89e3\u8aac\u3001\u8aac\u660e\u000b\u30ef\u30fc\u30ad\u30f3\u30b0\u30c1\u30fc\u30e0\u904b\u55b6\u306e\u652f\u63f4\u7ba1\u7406<br>\u57fa\u6e96\u66f8\u30fb\u8981\u9818\u985e\u306e\u518d\u6574\u5099\u30fb\u4f5c\u6210\u904e\u7a0b\u306e\u6307\u5c0e<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"973\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/takashima-1024x973.jpg\" alt=\"\" class=\"wp-image-3394 size-full\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/takashima-1024x973.jpg 1024w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/takashima-300x285.jpg 300w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/takashima.jpg 1584w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u9ad8\u5cf6 \u5e73\u5e78\u3000- Hirayuki Takashima\u2013<br>\u30a2\u30fc\u30af\u30ec\u30a4\u682a\u5f0f\u4f1a\u793e\u3001\u30a2\u30b9\u30c6\u30e9\u30b9\u88fd\u85ac\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fbFDA\u67fb\u5bdf\u5bfe\u5fdc\u3001\u56fd\u5185\u5916\u306e\u67fb\u5bdf\u30fb\u76e3\u67fb\u5bfe\u5fdc\u3001\u82f1\u8a9e\u582a\u80fd<br>\u30fbGMP\u4e26\u3073\u306bISO13485\u306b\u95a2\u308f\u308b\u4f53\u5236\u69cb\u7bc9<br>\u30fb\u7121\u83cc\u88fd\u5264\u306b\u3064\u3044\u3066\u306eGMP\u5bfe\u5fdc\u3001\u507d\u85ac\u5bfe\u7b56<\/p>\n\n\n\n<p>\u57f7\u7b46<br>\u6d77\u5916\u67fb\u5bdf\u5bfe\u5fdc\u306e\u30d7\u30ed\u304c\u6559\u3048\u308b\u30cd\u30a4\u30c6\u30a3\u30d6\u304c\u4f7f\u3046\u73fe\u5834\u306e\u82f1\u8a9e\u8868\u73fe2500<br>\u301c\u8077\u5834\u306e\u4f1a\u8a71\u30fb\u4f1a\u8b70\u3001email\uff0f\u5831\u544a\u66f8\u301c<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u25a0\u30a2\u30fc\u30af\u30ec\u30a4\u682a\u5f0f\u4f1a\u793e<br>\u3000QSR\u5ba4\u9577\u3001\u54c1\u8cea\u672c\u90e8\u9577<br>\u25a0\u30a2\u30b9\u30c6\u30e9\u30b9\u88fd\u85ac\u682a\u5f0f\u4f1a\u793e<br>\u3000\u4fe1\u983c\u6027\u4fdd\u8a3c\u672c\u90e8\u3000\u30a8\u30b0\u30bc\u30af\u30c6\u30a3\u30d6\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc<br>\u3000\u5728\u8077\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<\/p>\n\n\n\n<p>Management Representative (ISO13485\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406\u8cac\u4efb\u8005)<br>\u30fb\u30b0\u30ed\u30fc\u30d0\u30eb\u306b\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u518d\u69cb\u7bc9\u3092\u884c\u3044\u3001\u7d44\u7e54\u30fb\u624b\u9806\u306e\u6574\u5099\u3001\u57fa\u5e79\u8981\u54e1\u306e\u000b\u5145\u8db3\u30fb\u80b2\u6210\u3092\u56f3\u308b\u3002\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u3001\u56de\u53ce\u5be9\u67fb\u59d4\u54e1\u9577\u3001CAPA\u59d4\u54e1\u9577\u3092\u52d9\u3081\u305f<br>\u30fb\u4e8b\u696d\u6240(\u5de5\u5834\u3068\u958b\u767a\u90e8\u9580)\u306e\u6539\u5584\u3092\u30ea\u30fc\u30c9\u3057\u3001\u7c73\u56fdFDA\u67fb\u5bdf\u3092\u30af\u30ea\u30a2\u3002\u305d\u306e\u4ed6\u306e\u884c\u653f\u4e26\u3073\u306b\u8a8d\u8a3c\u6a5f\u95a2\u5bfe\u5fdc\u3082\u5b9f\u65bd\u3002<br>\u30fb\u7c73\u56fd\u3001\u82f1\u56fd(EU)\u3068\u5171\u306b\u3001\u30d5\u30a3\u30ea\u30d4\u30f3\u3001\u4e2d\u56fd\u3001\u97d3\u56fd\u7b49\u306e\u54c1\u8cea\u30fb\u85ac\u4e8b\u306b\u95a2\u308f\u308b\u696d\u52d9\u306e\u000b\u3000\u6d41\u308c\u30fb\u9023\u643a\u4f53\u5236\u3092\u69cb\u7bc9\u3001\u30ea\u30fc\u30b8\u30e7\u30ca\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u65b9\u5f0f\u3092\u63a1\u7528\u3002<\/p>\n\n\n\n<p>GQP\u30b7\u30b9\u30c6\u30e0\u306e\u78ba\u7acb\u3068\u904b\u55b6\u3001FDA,EMEA\u7b49\u306e\u67fb\u5bdf\u5bfe\u5fdc<br>\uff1c\u6539\u6b63\u85ac\u4e8b\u6cd5\u5bfe\u5fdc\uff1e<br>\u30fb\u7b2c\u4e00\u7a2e\u3001\u7b2c\u4e8c\u7a2e\u533b\u85ac\u54c1 \u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005<br>\u30fb\u533b\u7642\u6a5f\u5668 \u7dcf\u62ec\u88fd\u9020\u8ca9\u58f2\u8cac\u4efb\u8005<br>\u30fb\u533b\u7642\u6a5f\u5668 \u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"100\" height=\"130\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/Kimura.png\" alt=\"\" class=\"wp-image-105 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u6728\u6751 \u8cc7\u6b63\u3000-Motomasa Kimura-<br>\u6b66\u7530\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fb\u55b6\u696d\u90e8\u9580\u306b\u5bfe\u3059\u308b\u696d\u52d9\u6539\u5584\u63d0\u6848<br>\u30fb\u55b6\u696d\u90e8\u9580\u306e\u5468\u8fba\u30b7\u30b9\u30c6\u30e0\u306b\u84c4\u7a4d\u3055\u308c\u305f\u60c5\u5831\u6d3b\u7528\u8853\u63d0\u6848<br>\u30fb\u88fd\u85ac\u696d\u754c\u306b\u95a2\u9023\u3059\u308bIT\u30b5\u30fc\u30d3\u30b9\uff08IMS\u3001\u30a2\u30eb\u30c8\u30de\u30fc\u30af\u306a\u3069\uff09\u306e\u5c0e\u5165\u30fb\u6d3b\u7528\u652f\u63f4<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u6b66\u7530\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e \u60c5\u5831\u30b7\u30b9\u30c6\u30e0\u90e8\u9580\u3001\u55b6\u696d\u90e8\u9580\u306b\u52e4\u52d9\u3002\u6b66\u7530\u85ac\u54c1\u306e\u55b6\u696d\u90e8\u9580\uff29\uff34\u5316\u3092\u63a8\u9032\u3059\u308b<br>\u682a\u5f0f\u4f1a\u793e\u65e5\u7acb\u30a4\u30f3\u30b9\u30d5\u30a1\u30fc\u30de\u3000\u55b6\u696d\u63a8\u9032\u5ba4\u306b\u52e4\u52d9\u3002\u88fd\u85ac\u4f1a\u793e\u306b\u4f01\u753b\u63d0\u6848\u3092\u884c\u3046<br>\u5728\u52e4\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<br>\u85ac\u4fa1\u3068\u85ac\u4fa1\u6539\u5b9a\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\u533b\u7642\u7528\u533b\u85ac\u54c1\u306e\u4fa1\u683c\u7ba1\u7406\uff09<br>iPhone\u6d3b\u52d5\u5165\u529b\uff2d\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\uff2d\uff32\u306e\u6d3b\u52d5\u5831\u544a\u3092iPhone\u3067\u7c21\u6613\u306b\u884c\u3046\uff09<br>\u5b9f\u6d88\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\u5378\u8ca9\u58f2\u30c7\u30fc\u30bf\u3092\u30af\u30ec\u30f3\u30b8\u30f3\u30b0\u3059\u308b\uff09<br>\u5378\u30c7\u30dd\u5225\uff2d\uff33\u5225\u5b9f\u7e3e\u7ba1\u7406\u306e\u69cb\u7bc9\uff08\u5378\u306e\u7d44\u7e54\u304a\u3088\u3073\uff2d\uff33\u5225\u306b\u5b9f\u6d88\u5316\u3092\u7ba1\u7406\uff09<br>\uff2d\uff33\u5225\u7a4d\u4e0a\u3052\u8a08\u753b\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\u5378\uff2d\uff33\u3068\u6708\u5225\u8a08\u753b\u3092\u7acb\u6848\uff09<br>\u5378\u5225\u5272\u623b\u91d1\uff08\u30ea\u30d9\u30fc\u30c8\uff09\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\u5378\u3078\u306e\u5272\u623b\u91d1\u3092\u7ba1\u7406\uff09<br>\u5378\u5225\u8ca9\u58f2\u8377\u96e2\u5728\u5eab\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\u5378\u306e\u696d\u7e3e\u3092\u7ba1\u7406\uff09<br>\uff33\uff21\uff30\u55b6\u696d\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\uff32\uff13\u306b\u3088\u308b\u55b6\u696d\u7ba1\u7406\uff09<br>\uff2d\uff32\u8a08\u753b\u7acb\u6848\u652f\u63f4\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\uff2d\uff32\u306e\u671f\u5225\u8a08\u753b\u3092\u7acb\u6848\uff09<br>\u751f\u7269\u7531\u6765\u88fd\u54c1\u30ed\u30c3\u30c8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\u751f\u7269\u7531\u6765\u88fd\u54c1\u306e\u30ed\u30c3\u30c8\u5225\u5b9f\u6d88\u5316\u7ba1\u7406\uff09<br>\uff2d\uff32\uff0f\u55b6\u696d\u5185\u52e4\u8005\u306e\u30ca\u30ec\u30c3\u30b8\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\uff08\uff2d\uff32\u3068\u5185\u52e4\u8005\u3092\u5225\u3005\u306b\u30ca\u30ec\u30c3\u30b8\u7ba1\u7406\uff09<br>\uff2d\uff32\uff0f\u5185\u52e4\u8005\u7528\u306e\u30dd\u30fc\u30bf\u30eb\u30b5\u30a4\u30c8\u69cb\u7bc9\uff08\u793e\u5185\u30a4\u30f3\u30c8\u30e9\u30cd\u30c3\u30c8\u306e\uff28\uff30\uff09<br>\u55b6\u696d\u652f\u63f4\u30b7\u30b9\u30c6\u30e0\uff32\uff26\uff30\u4f5c\u6210\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<br>\u5b9f\u6d88\u5316\u5171\u540c\u30b5\u30fc\u30d3\u30b9\u7acb\u3061\u4e0a\u3052\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<br>\u652f\u63f4\u3001\u6307\u5c0e\u5185\u5bb9<br>\u55b6\u696d\u90e8\u9580\u306b\u5bfe\u3059\u308b\u696d\u52d9\u6539\u5584\u63d0\u6848<br>\u55b6\u696d\u90e8\u9580\u306e\u696d\u52d9\u5185\u5bb9\u304b\u3089\u5c0e\u5165\u3059\u3079\u304d\u30b7\u30b9\u30c6\u30e0\u306e\u63d0\u6848\u30fb\u53d6\u6368\u9078\u629e<br>\u55b6\u696d\u90e8\u9580\u306e\u5468\u8fba\u30b7\u30b9\u30c6\u30e0\u306b\u84c4\u7a4d\u3055\u308c\u305f\u60c5\u5831\u6d3b\u7528\u8853\u63d0\u6848<br>\u88fd\u85ac\u696d\u754c\u306b\u95a2\u9023\u3059\u308bIT\u30b5\u30fc\u30d3\u30b9\uff08IMS\u3001\u30a2\u30eb\u30c8\u30de\u30fc\u30af\u306a\u3069\uff09\u306e\u5c0e\u5165\u30fb\u6d3b\u7528\u652f\u63f4<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"101\" height=\"144\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/furuzawa.jpg\" alt=\"\" class=\"wp-image-116 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u53e4\u6fa4 \u4e45\u4ec1\u5f66\u3000-Kunihiko Furuzawa-<br>\u7b2c\u4e00\u4e09\u5171\u682a\u5f0f\u4f1a\u793e\uff0c\u30c6\u30d0\u88fd\u85ac\u682a\u5f0f\u4f1a\u793e \u4e09\u4e95\u8fb2\u6797\u682a\u5f0f\u4f1a\u793e\uff0c\u4f4f\u53cb\u5316\u5b66\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fb\u533b\u85ac\u54c1\u88fd\u9020\u306b\u95a2\u3059\u308bGMP\/GQP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6307\u5c0e\uff08PIC\/S\u3001FDA\/EMA\uff09<br>\u30fb\u88fd\u9020\u6240\u306eGxP\u76e3\u67fb\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3001GMP\u7ba1\u7406\u306e\u5b9f\u8df5\u7684\u5bfe\u5fdc<br>\u30fbCAPA\/\u6839\u672c\u539f\u56e0\u8abf\u67fb\u3001Risk\u5206\u6790\u3001PMDA\/FDA\u67fb\u5bdf\u306e\u5b9f\u8df5\u7684\u5bfe\u5fdc<\/p>\n\n\n\n<p>\u57f7\u7b46\u30fb\u8457\u66f8<br>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306b\u3088\u308bGMP\u76e3\u67fb\u5b9f\u65bd\u30ce\u30a6\u30cf\u30a6 \u7b2c2\u7248<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u98df\u54c1\u8868\u793a\u7ba1\u7406\u58eb<br>\u5728\u8077\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<br>\u8fb2\u85ac\u306e\u5275\u85ac\u3001\u5b89\u5168\u6027\u8a55\u4fa1\u7814\u7a76\u306b\u5f93\u4e8b<br>\u6d77\u5916\u90e8\u9580\u306b\u3066\u3001\u767b\u9332\u3001\u59d4\u8a17\u88fd\u9020\u3001\u7814\u7a76\u306eCoordination QC\u306b\u5f93\u4e8b<br>US\u5411\u3051\u533b\u85ac\u539f\u85acQMS \u306e\u69cb\u7bc9\u3002FDA\u5411\u3051\u539f\u85acDMF\u306e\u7de8\u7e82\u30fb\u767b\u9332\u3001NDA\u306b\u57fa\u3065\u304fFDA\u67fb\u5bdf\u5bfe\u5fdc\u3002<br>\u56fd\u969b\u57fa\u6e96\uff08CFR\u3001EMA\u3001PIC\/S\uff09\u306b\u57fa\u3065\u304f\u30fb\u59d4\u8a17\u30fb\u539f\u6599\u88fd\u9020\u5148\u306eRisk Based\u76e3\u67fb\uff08\u56fd\u5185\u5916\u306e\u3079150\u88fd\u9020\u6240\u306e\u7d4c\u9a13\uff09\u306a\u3089\u3073\u306b\u88ab\u76e3\u67fb\u88fd\u9020\u6240\u306eCAPA\u306e\u6307\u5c0e<br>\u793e\u5185GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u95a2\u9023\u306e\u76e3\u67fb\u30fb\u6307\u5c0e\u3001\u4e26\u3073\u306bGMP\u30fbCAPA\u6559\u80b2\u8a13\u7df4\u30fb\u5b9f\u52d9\u6307\u5c0e\u3001FDA PAI\u5bfe\u5fdc\u30fb\u6e96\u5099\u6307\u5c0e<br>GMP\u6559\u80b2\u3001Risk\u5206\u6790\u30fb\u8a55\u4fa1\u3001Root Cause\u8abf\u67fb\u306e\u624b\u6cd5\u7b49\u306e\u6559\u80b2\u8a13\u7df4<br>\u76e3\u67fb\u54e1\u80b2\u6210\u306e\u6559\u80b2\u8a13\u7df4\u3001\u56fd\u969b\u57fa\u6e96GMP\u30ac\u30a4\u30c9\u306e\u5c0e\u5165\u30fb\u8a13\u7df4<br>\u57f7\u7b46\u30fb\u8457\u66f8<br>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306b\u3088\u308bGMP\u76e3\u67fb\u5b9f\u65bd\u30ce\u30a6\u30cf\u30a6 \u7b2c2\u7248<br>\u539f\u85ac\u306e\u54c1\u8cea\u7ba1\u7406\u3068\u4e0d\u7d14\u7269\u7ba1\u7406<br>GMP\u5909\u66f4\u7ba1\u7406\u30fb\u6280\u8853\u79fb\u8ee2 \u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u8a55\u4fa1\u3068\u7533\u8acb\u306e\u8003\u3048\u65b9<br>\u7d9a \u4e8b\u4f8b\u306b\u5b66\u3076CAPA\u3068\u305d\u306e\u5b9f\u8df5 #483\u304b\u3089Warning Letter\u767a\u51fa\u307e\u3067\u306e\u7d4c\u904e\u3092\u8aad\u307f\u89e3\u304f<br>\u6b63\u3057\u3044\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\u306e\u305f\u3081\u306e \u4e8b\u4f8b\u306b\u5b66\u3076 CAPA\u3068\u305d\u306e\u5b9f\u8df5<br>\u88fd\u9020\u5de5\u7a0b\u5225GMP\u30ea\u30b9\u30af\u5206\u6790\u30fb\u8a55\u4fa1\u4e8b\u4f8b\u96c6<br>\u226a3\u6975\u30fbPIC\/S\u67fb\u5bdf\u6307\u6458\u4e8b\u4f8b\u226b \u6d17\u6d44\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5b9f\u65bd\u30fb\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u59a5\u5f53\u6027\u3068 DHT\u30fbCHT\/\u6b8b\u7559\u8a31\u5bb9\u5024\u306e\u8a2d\u5b9a<br>GMP\u57fa\u790e\u6559\u80b2: \u521d\u3081\u3066GMP\u306b\u304b\u304b\u308f\u308b\u65b9\u3078<br>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306b\u3088\u308bGMP\u76e3\u67fb\u5b9f\u65bd\u30ce\u30a6\u30cf\u30a6<br>\u8b1b\u6f14<br>2012\u5e7410\u670819\u65e5\u3000\u660e\u65e5\u304b\u3089\u59cb\u3081\u308b\u30b0\u30ed\u30fc\u30d0\u30ebGMP\u5165\u9580\u7814\u4fee<br>2012\u5e7411\u670822\u65e5\u3000GMP\u5de5\u5834\u306e\u7dad\u6301\u7ba1\u7406\u3001\u7b2c4\u90e8\u3000PIC\/S\u3000GMP\u67fb\u5bdf\u306e\u50be\u5411\u3092\u3075\u307e\u3048\u305f\u5bfe\u5fdc\u306e\u30dd\u30a4\u30f3\u30c8<br>2014\u5e741\u670822\u65e5\u3000\u54c1\u8cea\u7ba1\u7406\u5ba4<br>\u652f\u63f4\u3001\u6307\u5c0e\u5185\u5bb9<br>\u533b\u85ac\u54c1\u88fd\u9020\uff08\u4f4e\u5206\u5b50\u306e\u307f\u306a\u3089\u305a\u3001\u57f9\u990a\u30fb\u751f\u7269\u7531\u6765\u533b\u85ac\u54c1\uff09\u306b\u95a2\u3059\u308bGMP\/GQP\u3000\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6307\u5c0e\uff08PIC\/S\u3001FDA\/EMA\u5bfe\u5fdc\u3092\u4e2d\u5fc3\uff09<br>\u88fd\u9020\u6240\u306eGM(x)P\u76e3\u67fb\/Risk\u8a55\u4fa1<br>GMP\u7ba1\u7406\uff08\u88fd\u9020\u7ba1\u7406\u3001\u54c1\u8cea\u4fdd\u8a3c\u30fb\u7ba1\u7406\u3001\u6587\u66f8\u7ba1\u7406\uff09\u306e\u5b9f\u8df5\u7684\u5bfe\u5fdc<br>CAPA\/\u6839\u672c\u539f\u56e0\u8abf\u67fb\u3001Risk\u5206\u6790\u3001PMDA\/FDA\u67fb\u5bdf\u306e\u5b9f\u8df5\u7684\u5bfe\u5fdc<br>\u751f\u7269\u533b\u85ac\u30fb\u57f9\u990a\u7b49\u306e\u5c01\u3058\u8fbc\u3081\u304c\u5fc5\u8981\u306a\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u30ea\u30b9\u30af\u8a55\u4fa1<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"99\" height=\"130\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2016\/05\/ito.png\" alt=\"\" class=\"wp-image-117 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u4f0a\u6771 \u7167\u8d77\u3000-Teruki Ito-<br>\u30a2\u30b9\u30c6\u30e9\u30b9\u88fd\u85ac\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fb\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u5065\u5eb7\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u5316\u5b66\u306a\u3069\u306e\u5c02\u9580\u7528\u8a9e\u304c\u4f7f\u308f\u308c\u308b\u6587\u732e\u7ffb\u8a33<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u9000\u8077\u5f8c\u3001\u7d4c\u9a13\u3092\u751f\u304b\u3057\u305f\u7ffb\u8a33\u4f5c\u696d\u3067\u4f55\u3089\u304b\u306e\u8ca2\u732e\u3092\u3057\u305f\u3044\u610f\u6b32\u304c\u3042\u308a\u3001\u7ffb\u8a33\u6280\u8853\u3092\u78e8\u304f\u305f\u3081\u7ffb\u8a33\u5b66\u6821\u306e<br>\u901a\u5b66\u30b3\u30fc\u30b9\u3001\u901a\u4fe1\u30b3\u30fc\u30b9\u4fee\u4e86\u3002<br>2009\u5e74\u3088\u308a\u533b\u7642\u6a5f\u5668\u53d6\u8aac\u3001\u6a5f\u68b0\u95a2\u4fc2\u7c73\u56fd\u7279\u8a31\u6284\u8a33\u7b49\u306e\u7d4c\u9a13\u3042\u308a(5\u5e74\u95931,000\u4ef6\u4ee5\u4e0a\uff09<br>\u6a5f\u68b0\u95a2\u4fc2\u4ed5\u69d8\u66f8\u65e5\u82f1\u7ffb\u8a3310\u4ef6\u4ee5\u4e0a\u7d4c\u9a13\u3042\u308a<br>\u5b66\u6b74<br>\u5927\u962a\u5927\u5b66\u5927\u5b66\u9662\u57fa\u790e\u5de5\u5b66\u90e8\u6a5f\u68b0<br>\u30d5\u30a7\u30ed\u30fc\u30a2\u30ab\u30c7\u30df\u30fc\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30b3\u30fc\u30b9<br>\u5728\u52e4\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<br>\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u88fd\u5264\u88fd\u85ac\u8a2d\u5099\u57fa\u672c\u8a2d\u8a08<br>\u5de5\u5834\u5de5\u52d9\u90e8\u3001\u751f\u7523\u30e9\u30a4\u30f3<br>\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5de5\u5834\u5efa\u8a2d<br>\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8Eng\u696d\u52d9\u306eIT\u5316<br>IT\u4f01\u753b\u3001\u751f\u7523\u4f01\u753b\u751f\u7523\u90e8\u9580SAP,MES\u5c0e\u5165\u696d\u52d9<br>IT\u4f01\u753b\u3001\u54c1\u8cea\u4fdd\u8a3c\u517c\u52d9IT\u95a2\u9023regulation\u5bfe\u5fdc<br>\u54c1\u8cea\u4fdd\u8a3c\u90e8\u3000\u54c1\u8cea\u30dd\u30ea\u30b7\u30fc\u3001CSV\/ERES\u30dd\u30ea\u30b7\u30fc\u4f5c\u6210\u3001GMP\u76e3\u67fb\u696d\u52d9<br>\u652f\u63f4\u3001\u6307\u5c0e\u5185\u5bb9<br>\u85ac\u6a5f\u6cd5\u4f01\u696d\u5411\u3051\u7ffb\u8a33<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"108\" height=\"144\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2017\/01\/Murata-e1487036347649.jpg\" alt=\"\" class=\"wp-image-2299 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u6751\u7530 \u517c\u4e00\u3000-Kenichi Murata-<br>\u85e4\u6ca2\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e\uff0c\u30a2\u30b9\u30c6\u30e9\u30b9\u88fd\u85ac\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fb\u533b\u85ac\u54c1\u5de5\u5834\u8a08\u6570\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<br>\u30fb\u539f\u4fa1\u8a08\u7b97\u304a\u3088\u3073\u5de5\u5834\u8a08\u6570\u8a08\u753b\u3001\u5b9f\u7e3e\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u304a\u3088\u3073\u904b\u7528\u7ba1\u7406\u652f\u63f4<br>\u30fb\u30d0\u30e9\u30f3\u30b9\u30c9\u30b9\u30b3\u30a2\u30ab\u30fc\u30c9\u3001KPI\u306b\u3088\u308b\u696d\u7e3e\u8a55\u4fa1\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u652f\u63f4<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p><br>\u5927\u962a\u5927\u5b66\u85ac\u5b66\u90e8\u85ac\u5b66\u79d1\u5352\u696d\u3000\u85ac\u5264\u5e2b\u85e4\u6ca2\u85ac\u54c1\u5de5\u696d\u682a\u5f0f\u4f1a\u793e\u304b\u3089\u5408\u4f75\u5f8c\u30a2\u30b9\u30c6\u30e9\u30b9\u88fd\u85ac\u682a\u5f0f\u4f1a\u793e\u306b\u52e4\u52d9<br>\u9000\u793e\u5f8c\u6751\u7530\u517c\u4e00\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u682a\u5f0f\u4f1a\u793e\u8a2d\u7acb\u3057\u4ee3\u8868\u53d6\u7de0\u5f79\u3068\u306a\u308a\u73fe\u5728\u306b\u81f3\u308b<br>\u5728\u8077\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<br>\u30fb\u751f\u7523\u6280\u8853\u95a2\u9023<br>\u6ce8\u5c04\u5264(\u51cd\u7d50\u4e7e\u71e5\u30fb\u7c89\u672b\u5145\u586b)\u88fd\u9020\u306b\u5f93\u4e8b<br>\u7121\u83cc\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6280\u8853\u958b\u767a\u53ca\u3073\u5b9f\u65bd<br>\u88fd\u5264\u6280\u8853\u6539\u5584\u304a\u3088\u3073IE\/VE\/\u65b0\u898f\u6280\u8853\u306b\u3088\u308b\u5de5\u7a0b\u6539\u5584<br>\u5de5\u5834\u7ba1\u7406\u90e8\u9580\u306b\u3066\u65b0\u88fd\u54c1\u751f\u7523\u5c0e\u5165\u3001\u5909\u66f4\uff65\u9038\u8131\u7ba1\u7406\u3001FDA\u5bfe\u5fdc\u7b49<br>\u88fd\u9020\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306b\u3088\u308a\u30b0\u30eb\u30fc\u30d7\u5185\u5de5\u5834\u3001\u751f\u7523\u54c1\u76ee\u518d\u7de8\u3092\u4f01\u753b\u30fb\u63a8\u9032(\u7d0470\u54c1\u76ee200\u898f\u683c\u306e\u54c1\u76ee\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3092\u5b9f\u65bd)<br>\u30fb\u751f\u7523\u6226\u7565\u4f01\u753b<br>Activity Based Costing\u306e\u8003\u3048\u65b9\u3067\u306e\u65b0\u539f\u4fa1\u8a08\u7b97\u5236\u5ea6\u3001\u7ba1\u7406\u4f53\u7cfb\u3092\u63d0\u6848\u3001\u30b7\u30b9\u30c6\u30e0\u5316<br>\u85e4\u6ca2\u85ac\u54c1\u5de5\u696d\u751f\u7523\u672c\u90e8\u4e2d\u671f\u6226\u7565\u8a08\u753b\u3092\u62c5\u5f53\u3057\u56fd\u5185\u751f\u7523\u5de5\u5834\u306e\u5206\u793e\u5316\u3092\u4f01\u753b\u3001\u63a8\u9032<br>\u5408\u4f75\u6e96\u5099\u59d4\u54e1\u4f1a\u306b\u3066CMC\u30fb\u751f\u7523\u30fb\u7269\u6d41\u5206\u91ce\u306e\u5408\u4f75\u65b0\u793e\u4e2d\u671f\u8a08\u753b\u3001\u7d44\u7e54\u6a5f\u80fd\u8a2d\u8a08\u3092\u62c5\u5f53<br>\u30a2\u30b9\u30c6\u30e9\u30b9\u88fd\u85ac\u6280\u8853\u672c\u90e8\u4e2d\u671f\u8a08\u753b\u3001\u5e74\u5ea6\u8a08\u753b\u306e\u6226\u7565\u4f01\u753b\u7acb\u6848<br>\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3001\u4f53\u5236\u306e\u6574\u5099<br>\u30fbIT(SAP)\u95a2\u9023<br>SCM\u30fb\u30b3\u30b9\u30c8\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u95a2\u9023\u5404\u7a2eBPR\u304a\u3088\u3073SAP\u5c0e\u5165\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6b74\u4efb<br>SAP\u30e6\u30fc\u30b6\u30fc\u4f1a\u533b\u85ac\u54c1\u90e8\u4f1a\u306b\u3066QM\u6a19\u6e96\u30d7\u30ed\u30bb\u30b9\u5b9a\u7fa9\u3092\u4e3b\u5c0e<br>\u30b0\u30ed\u30fc\u30d0\u30ebIT\u30b7\u30b9\u30c6\u30e0(SAP)\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u4f01\u753b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u63a8\u9032<br>SAP\u304a\u3088\u3073\u30af\u30e9\u30a6\u30c9\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u308b\u59d4\u8a17\u54c1\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u958b\u767a\u30fb\u5c0e\u5165<br>\u8b1b\u6f14\u30fb\u30bb\u30df\u30ca\u30fc\u7b49<br>\u533b\u85ac\u54c1\u5de5\u5834\u306e\u539f\u4fa1\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u539f\u4fa1\u8a08\u7b97\u3068\u88fd\u9020\u30b3\u30b9\u30c8\u4f4e\u6e1b\u3078\u306e\u53d6\u308a\u7d44\u307f<br>\u5f8c\u767a\u533b\u85ac\u54c180\uff05\u6642\u4ee3\u306eCDMO\u306e\u5f79\u5272\u3068\u6226\u7565<br>\u533b\u85ac\u54c1\u5de5\u5834\u3000\u52dd\u3061\u30d1\u30bf\u30fc\u30f3\u306e\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb<br>\u533b\u85ac\u54c1CMO\u306e\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb<br>\u57f7\u7b46<br>\u696d\u754c\u96d1\u611f\u3000GMP\u30dd\u30fc\u30bf\u30eb\u30b5\u30a4\u30c8\u300cGMP Platform\u300d\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000&lt;2016.10-&gt;<br>\uff1cPHARM TECH JAPAN\uff1e<br>\u30d3\u30b8\u30cd\u30b9\u3092\u6210\u529f\u306b\u5c0e\u304f\u3053\u308c\u304b\u3089\u306e\u533b\u85ac\u54c1\u88fd\u9020\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u6226\u7565\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000&lt;2016 &gt;<br>\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u9078\u5b9a\u306e\u30dd\u30a4\u30f3\u30c8\u3000\u88fd\u85ac\u4f01\u696d\u306e\u8996\u70b9\u53ca\u3073\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u8996\u70b9\u304b\u3089<br>&lt;2015 &gt;\u533b\u85ac\u54c1\u5de5\u5834\u306b\u304a\u3051\u308b\u539f\u4fa1\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068\u88fd\u9020\u30b3\u30b9\u30c8\u4f4e\u6e1b\u3078\u306e\u53d6\u308a\u7d44\u307f\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000&lt;2014&gt;\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u6226\u7565\u3068CMO\u306e\u9078\u5b9a\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 &lt;2012&gt;<br>\u8b1b\u6f14\u30fb\u30bb\u30df\u30ca\u30fc\u7b49<br>\u533b\u85ac\u54c1\u5de5\u5834\u306e\u539f\u4fa1\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u539f\u4fa1\u8a08\u7b97\u3068\u88fd\u9020\u30b3\u30b9\u30c8\u4f4e\u6e1b\u3078\u306e\u53d6\u308a\u7d44\u307f<br>\u5f8c\u767a\u533b\u85ac\u54c180\uff05\u6642\u4ee3\u306eCDMO\u306e\u5f79\u5272\u3068\u6226\u7565<br>\u533b\u85ac\u54c1\u5de5\u5834\u3000\u52dd\u3061\u30d1\u30bf\u30fc\u30f3\u306e\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb<br>\u533b\u85ac\u54c1CMO\u306e\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb<br>\u9078\u3070\u308c\u308bCMO\u306e\u8a2d\u5099\u65bd\u8a2d\u4e8b\u4f8b<br>\u52dd\u3061\u30d1\u30bf\u30fc\u30f3\u306eCMO\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb<br>\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3068\u751f\u7523\u6226\u7565<br>\u533b\u85ac\u54c1\u306e\u88fd\u9020\u59d4\u53d7\u8a17\u5951\u7d04\/GQP\u53d6\u6c7a\u3081\u3068\u6280\u8853\u79fb\u8ee2\u53ca\u3073\u59d4\u8a17\u88fd\u9020\u6642\u306e\u5909\u66f4\/\u9038\u8131\u7ba1\u7406<br>\u5b9f\u52d9\u7d4c\u9a13\u306b\u5b66\u3076\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0<br>\u59d4\u53d7\u8a17\u5951\u7d04\u7de0\u7d50\u6642\u306e\u6ce8\u610f\u70b9<br>\u88fd\u5264\u5de5\u5834\u306e\u8a08\u6570\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<br>\u652f\u63f4\u3001\u6307\u5c0e\u5185\u5bb9<br>\u751f\u7523\u6226\u7565\u4f01\u753b(\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u6226\u7565\u4f01\u753b)<br>\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb\u8a2d\u8a08\u4e2d\u671f\u6226\u7565\u8a08\u753b\u30fb\u5e74\u5ea6\u5b9f\u884c\u8a08\u753b\u7b49\u7acb\u6848\u652f\u63f4<br>\u30d0\u30e9\u30f3\u30b9\u30c9\u30b9\u30b3\u30a2\u30ab\u30fc\u30c9\u3001KPI\u306b\u3088\u308b\u696d\u7e3e\u8a55\u4fa1\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u652f\u63f4<br>\u533b\u85ac\u54c1\u5de5\u5834\u8a08\u6570\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<br>KPI\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a2d\u8a08\u304a\u3088\u3073\u904b\u7528\u7ba1\u7406\u652f\u63f4<br>\u539f\u4fa1\u8a08\u7b97\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u30b3\u30b9\u30c8\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u4f53\u5236\u518d\u69cb\u7bc9\u652f\u63f4<br>\u5de5\u5834\u8a08\u6570\u8a08\u753b\u304a\u3088\u3073\u5b9f\u7e3e\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u304a\u3088\u3073\u904b\u7528\u7ba1\u7406\u652f\u63f4<br>\u751f\u7523\u6226\u7565\u4f01\u753b(\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u6226\u7565\u4f01\u753b)<br>\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb\u8a2d\u8a08\u4e2d\u671f\u6226\u7565\u8a08\u753b\u30fb\u5e74\u5ea6\u5b9f\u884c\u8a08\u753b\u7b49\u7acb\u6848\u652f\u63f4<br>\u30d0\u30e9\u30f3\u30b9\u30c9\u30b9\u30b3\u30a2\u30ab\u30fc\u30c9\u3001KPI\u306b\u3088\u308b\u696d\u7e3e\u8a55\u4fa1\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u652f\u63f4<br>\u533b\u7642\u7528\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<br>\u4ed5\u5165\u308c\u5148\u7ba1\u7406\u3001\u5909\u66f4\u30fb\u9038\u8131\u7ba1\u7406\u7b49GQP\u7ba1\u7406\u306e\u652f\u63f4<br>\u65b0\u88fd\u54c1\u30fb\u65b0\u898f\u53d7\u8a17\u54c1\u5c0e\u5165\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u63a8\u9032\u652f\u63f4<br>IT\u57fa\u5e79\u696d\u52d9\u30b7\u30b9\u30c6\u30e0(SAP)\u5c0e\u5165\u6642\u306e\u696d\u52d9\u4f01\u753b<br>\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u8a2d\u8a08\u3001\u696d\u52d9\u6a5f\u80fd\u5b9a\u7fa9\u652f\u63f4<br>BPR(Business Process Reengineering)\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u63a8\u9032\u652f\u63f4<br>\u6559\u80b2\u7814\u4fee\u4f01\u753b\u53ca\u3073\u5b9f\u65bd<br>\u539f\u4fa1\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u7814\u4fee<br>\u7121\u83cc\u88fd\u5264Validation\u3001GMP\u7ba1\u7406\u6559\u80b2<br>\u751f\u7523\u6280\u8853\u6539\u5584\u3001\u54c1\u8cea\u6539\u5584\u7b49\u306e\u5c0f\u96c6\u56e3\u6d3b\u52d5\u63a8\u9032\u652f\u63f4<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"480\" height=\"581\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2022\/05\/IMG_6157.jpeg\" alt=\"\" class=\"wp-image-17647 size-full\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2022\/05\/IMG_6157.jpeg 480w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2022\/05\/IMG_6157-248x300.jpeg 248w\" sizes=\"auto, (max-width: 480px) 100vw, 480px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p>\u592a\u7530 \u9032\u3000-Susum Ota-<br>\u65e5\u672cBBN\u682a\u5f0f\u4f1a\u793e\uff0cSAP\u30b8\u30e3\u30d1\u30f3\u682a\u5f0f\u4f1a\u793e\u51fa\u8eab<\/p>\n\n\n\n<p>\u30fb\u533b\u85ac\u30fb\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u7b49\u306eERP\u30d1\u30c3\u30b1\u30fc\u30b8\u5c0e\u5165\u652f\u63f4\uff08\u751f\u7523\u7ba1\u7406\uff0c\u54c1\u8cea\u7ba1\u7406\uff0c\u8ca9\u58f2\u7ba1\u7406\uff09<br>\u30fb\u533b\u85ac\u55b6\u696d\u652f\u63f4\uff0c\u8ca9\u58f2\u5b9f\u7e3e\u5206\u6790\u306e\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u652f\u63f4<br>\u30fb\u82f1\u8a9e\u5bfe\u5fdc\u53ef<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u7565\u6b74<\/summary>\n<p>\u6771\u4eac\u5927\u5b66\u6587\u5b66\u90e8\u6587\u5316\u5b66\u79d1\u5352\u696d\uff08\u5b66\u58eb\uff09<br>\u65e5\u672cBBN(\u682a)\uff0cSAP\u30b8\u30e3\u30d1\u30f3(\u682a)\u3092\u7d4c\u3066\uff0c\u30c6\u30ce\u30f3\u30fb\u30b7\u30b9\u30c6\u30e0\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0(\u682a)\u3092\u5275\u7acb<br>\u540c\u793e\u53d6\u7de0\u5f79\u9000\u4efb\u5f8c\uff0c\u30d5\u30ea\u30fc\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<br>NPO\u6cd5\u4eba\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u5354\u8b70\u4f1a\u5c02\u52d9\u7406\u4e8b<br>\u5728\u8077\u4e2d\u306e\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<br>\u30fb\u30d7\u30ea\u30f3\u30b7\u30d1\u30eb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\uff08\u54c1\u8cea\u7ba1\u7406\uff09<br>\u30fb\u88fd\u85ac\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u62c5\u5f53\u30b7\u30cb\u30a2\u30de\u30cd\u30b8\u30e3\u30fc<br>\u30fb\u65e5\u672c\u306e\u88fd\u85ac\u4f01\u696d\u5411\u3051\u306b\u751f\u7523\u7ba1\u7406\uff08GMP\u5bfe\u5fdc\uff09\u3068\u8ca9\u58f2\u7ba1\u7406\uff08JD-NET\u5bfe\u5fdc\uff09\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u958b\u767a\u3002\u305d\u308c\u3089\u3092\u6838\u3068\u3057\u3066\u65e5\u672c\u306e\u88fd\u85ac\u4f01\u696d\u5411\u3051SAP\u88fd\u85ac\u57fa\u672c\u30e2\u30c7\u30eb\u3092\u958b\u767a\u3002<br>\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u5206\u91ce<br>\u30fb\u696d\u754c\uff1a\u88fd\u85ac\uff08\u65b0\u85ac\u30fb\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u30fbOTC\uff09\uff0c\u533b\u85ac\u5378\uff0c\u98df\u54c1\u306a\u3069<br>\u30fb\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u306e\u5f79\u5272\uff1a\u3000\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u8005\uff0c\u30c1\u30fc\u30e0\u30ea\u30fc\u30c0\uff0c\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\uff0c\u30a2\u30c9\u30d0\u30a4\u30b6<br>\u30fb\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30b9\u30b3\u30fc\u30d7\uff1a\u3000\u4e8b\u524d\u691c\u8a0e\uff5e\u69cb\u7bc9\uff5e\u5b9a\u7740<br>\u30fbSAP\u306a\u3069ERP\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5c0e\u5165\u3068\u696d\u52d9\u6539\u9769<br>SCM\uff0cPLM\uff08\u751f\u7523\u7ba1\u7406\uff0c\u54c1\u8cea\u7ba1\u7406\uff0c\u8ca9\u58f2\u7269\u6d41\uff0c\u533b\u85acG\uff58P\uff0cCSV\uff09<br>\u30fbERP\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u5468\u8fba\u30b7\u30b9\u30c6\u30e0\u306e\u30a4\u30f3\u30bf\u30d5\u30a7\u30a4\u30b9\u69cb\u7bc9<br>JD-NET\uff0c\u5b9f\u6d88\u5316\uff0c\uff13PL<br>\u30fb\u88fd\u85ac\u696d\u306eCRM\uff0c\u55b6\u696d\u652f\u63f4\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u3068\u55b6\u696d\u751f\u7523\u6027\u5411\u4e0a<br>\u884c\u52d5\u7ba1\u7406\uff0cPDCA\u30b5\u30a4\u30af\u30eb\uff0c\u30d3\u30b8\u30cd\u30b9\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\uff0c\u30b3\u30f3\u30c6\u30f3\u30c4\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<br>\u30fb\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u30e1\u30fc\u30ab\u306e\u696d\u52d9\u6539\u9769<br>\u4e8b\u696d\u6226\u7565\u7acb\u6848\uff0c\u55b6\u696d\u6d3b\u52d5\u6539\u5584\uff0cIT\u6226\u7565\u7acb\u6848\uff0c\u60c5\u5831\u30b7\u30b9\u30c6\u30e0\u6539\u5584<br><br>\u57f7\u7b46\u30fb\u8b1b\u6f14<br>\u30fb\u5730\u57df\u5305\u62ec\u30b1\u30a2\u306b\u5bfe\u5fdc\u3059\u308b\u30a8\u30ea\u30a2\u8ca9\u58f2\u30fb\u55b6\u696d\u6226\u7565<br>\u3000\uff082015\u5e745\u6708\uff0c\u300c\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u30fb\u30d0\u30a4\u30aa\u5f8c\u7d9a\u54c1\u306e\u958b\u767a\u3068\u8ca9\u58f2<br>\u3000\u30fb\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565\u300d\u30bb\u30df\u30ca\u30fc\uff0c\u6280\u8853\u60c5\u5831\u5354\u4f1a\uff09<br>\u30fbSAP\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u5c0e\u5165<br>\u3000\uff082002\u5e7410\u6708\uff0c\u300cSAP\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u5b8c\u5168\u89e3\u8aac\u300d\uff0c\u65e5\u7d4cBP\u793e\uff09<br>\u30fb\u533b\u7642SCM\u65b0\u30e2\u30c7\u30eb\u69cb\u60f3\u66f8\uff082007\u5e746\u6708\uff0c\u533b\u7642SCM\u7814\u7a76\u4f1a\uff09<br>\u30fb\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u666e\u53ca\u306e\u610f\u5473\uff082009\u5e7410\u6708\uff0c\u30b8\u30a7\u30cd\u30d9\u30eb\uff09<br>\u30fb\u5730\u57df\u3067\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u4f7f\u7528\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b<br>\u3000\u3000\uff082012\u5e745\u6708\uff0c\u300c\u672a\u75c5\u3068\u6297\u8001\u5316\u300d\u7b2c21\u5dfb\uff0c\u535a\u6148\u4f1a\u8001\u4eba\u75c5\u7814\u7a76\u6240\uff09<\/p>\n<\/details>\n<\/div><\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u8cbb\u7528\u306e\u76ee\u5b89<\/h2>\n\n\n\n<p>\u6848\u4ef6\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u5834\u5408\u304c\u3054\u3056\u3044\u307e\u3059\u3002<br>\u6848\u4ef6\u304c\u78ba\u5b9a\u3059\u308b\u307e\u3067\u306e\u3054\u76f8\u8ac7\u306f\u7121\u6599\u3067\u3054\u3056\u3044\u307e\u3059\u3002\u304a\u6c17\u8efd\u306b\u3001\u304a\u58f0\u304c\u3051\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u4f5c\u696d\u5185\u5bb9 \u4f5c\u696d\u5834\u6240 \u5358\u4f4d \u91d1\u984d \u5099\u8003<br>\u30fb\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u8cbb\u7528 \u3054\u6307\u5b9a\u306e\u5834\u6240 1\u65e5 \uffe5200,000<br>\u30fb\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u8cbb\u7528 \u3054\u6307\u5b9a\u306e\u5834\u6240 \u534a\u65e5\uff08\uff14\u6642\u9593\u4ee5\u5185\uff09 \uffe5100,000<br>\u30fb\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u5185\u5bb9\u306b\u95a2\u308f\u308b\u8abf\u67fb\u3001\u8cc7\u6599\u4f5c\u6210 \u5f0a\u793e 1\u6642\u9593 \uffe520,000<br>\u30fbSOP\u3001GMP\u3001CSV\u306a\u3069\u306e\u8cc7\u6599\u4f5c\u6210\u5b9f\u52d9 \u5f0a\u793e 1\u65e5 \uffe525,000\u301c<\/p>\n\n\n\n<p>\u30fb\u548c\u6587&#8211;&gt;\u82f1\u8a33 \u5f0a\u793e \u8a33\u6587\uff11\u30ef\u30fc\u30c9 \uffe530<br>\u30fb\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u8cbb\u7528\u306b\u5831\u544a\u66f8\u4f5c\u6210\u306f\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<br>\u30fb\u65c5\u8cbb\u4ea4\u901a\u8cbb\u306f\u5b9f\u8cbb\u3067\u5225\u9014\u8acb\u6c42\u3044\u305f\u3057\u307e\u3059\u3002<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u5185\u5bb9\u8a73\u7d30<\/h2>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>GQP\u3001GMP\u3001FDA<\/summary>\n<p>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u6307\u5c0e\u3001\u54c1\u8cea\u7ba1\u7406\u6307\u5c0e<br>\u95a2\u9023\u6cd5\u4ee4\u3001\u898f\u5247\u89e3\u8aac<br>GMP\u5b9f\u8df5\u6307\u5c0e\uff08Corporate GMP\u3001\u4f53\u5236\u69cb\u7bc9\u8a3a\u65ad\u3001\u6539\u5584\u3001\u904b\u55b6\u6307\u5c0e\u3001\u6559\u80b2\u8a08\u753b\u3001\u88fd\u9020\u7ba1\u7406\u3001\u54c1\u8cea\u4fdd\u8a3c\u30fb\u7ba1\u7406\u3001\u6587\u66f8\u7ba1\u7406\uff09<br>\u88fd\u9020\u6240\u306eGQP\u3001GMP\u76e3\u67fb\u3001\u30ea\u30b9\u30af\u8a55\u4fa1<br>\u533b\u85ac\u54c1\u88fd\u9020\uff08\u4f4e\u5206\u5b50\u306e\u307f\u306a\u3089\u305a\u3001\u57f9\u990a\u30fb\u751f\u7269\u7531\u6765\u533b\u85ac\u54c1\uff09\u306b\u95a2\u3059\u308bGMP\/GQP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6307\u5c0e\uff08PIC\/S\u3001FDA\/EMA\u5bfe\u5fdc\u3092\u4e2d\u5fc3\uff09<br>\u54c1\u8cea\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30fc\u30b8\u30e1\u30f3\u30c8\u306e\u8003\u3048\u65b9<br>\u751f\u7269\u533b\u85ac\u30fb\u57f9\u990a\u7b49\u306e\u5c01\u3058\u8fbc\u3081\u304c\u5fc5\u8981\u306a\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u30ea\u30b9\u30af\u8a55\u4fa1<br>PMDA\/FDA\u67fb\u5bdf\u5bfe\u5fdc\u3001\u56fd\u5185\u5916\u306e\u67fb\u5bdf\u30fb\u76e3\u67fb\u5bfe\u5fdc<br>CAPA\/\u6839\u672c\u539f\u56e0\u8abf\u67fb\u3001\u30ea\u30b9\u30af\u5206\u6790\u3001\u5b9f\u8df5\u7684\u5bfe\u5fdc<br>\u5909\u66f4\u7ba1\u7406\u3001\u9038\u8131\u3042\u308b\u3044\u306fOOS\u306a\u3069\u54c1\u8cea\u7570\u5e38\u306b\u95a2\u3059\u308b\u5bfe\u5fdc<br>\u85ac\u4e8b\u898f\u5236\u3078\u306e\u5bfe\u5fdc<br>\u5168\u9762\u59d4\u53d7\u8a17\u88fd\u9020<\/p>\n<\/details>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u96fb\u5b50\u8a8d\u8a3c\u3001\u96fb\u78c1\u7684\u4fdd\u5b58<\/summary>\n<p>FDA\u300021CFR\u3000Part11\u3000\u89e3\u8aac\u3001\u6307\u5c0e\u3001\u5bfe\u5fdc<br>\u539a\u751f\u52b4\u50cd\u7701\u3000ERES\uff08\u96fb\u78c1\u7684\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\uff09\u89e3\u8aac\u3001\u6307\u5c0e\u3001\u5bfe\u5fdc<\/p>\n<\/details>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u533b\u85ac\u30fb\u88fd\u85ac\u55b6\u696d<\/summary>\n<p>\u85ac\u4fa1\u6539\u5b9a\u3001\u5b9f\u6d88\u5316\u7ba1\u7406\u30fb\u30c7\u30fc\u30bf\u30af\u30ec\u30f3\u30b8\u30f3\u30b0\u3001\u751f\u7269\u7531\u6765\u30ed\u30c3\u30c8\u7ba1\u7406\u3001<br>\u5378\u30c7\u30dd\u5225\uff2d\uff33\u5225\u5b9f\u7e3e\u7ba1\u7406\u3001\u7a4d\u4e0a\u3052\u8a08\u753b\u3001\u5378\u5225\u5272\u623b\u91d1\u7ba1\u7406\uff08\u30ea\u30d9\u30fc\u30c8\uff09\u3001\u000b\u5378\u5225\u8ca9\u58f2\u8377\u96e2\u5728\u5eab\u3001<br>\uff2d\uff32\u30e2\u30d0\u30a4\u30eb\u6d3b\u7528\u3001\u6d3b\u52d5\u8a08\u753b\u7acb\u6848\u652f\u63f4<\/p>\n<\/details>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>\u533b\u85ac\u30fb\u88fd\u85ac\u696d\u754c\u306a\u3069\u306e\u65e5\u82f1\u30fb\u82f1\u65e5\u7ffb\u8a33<\/summary>\n<p>PIC\/S\u52a0\u76df\u306a\u3069\u306b\u3088\u308a\u3001\u6b27\u7c73\u304b\u3089\u306e\u60c5\u5831\u3092\u53ce\u96c6\u3059\u308b\u3053\u3068\u304c\u5fc5\u8981\u306a\u533b\u85ac\u54c1\u958b\u767a\u30fb\u88fd\u9020\u30fb\u8ca9\u58f2\u3067\u306f\u3001\u9069\u5207\u306a\u5c02\u9580\u7528\u8a9e\u3092\u7528\u3044\u305f\u6b63\u78ba\u306a\u7ffb\u8a33\u304c\u5fc5\u8981\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u305d\u306e\u6587\u66f8\u3084\u898f\u5236\u8981\u4ef6\u306b\u306f\u696d\u754c\u306a\u3089\u3067\u306f\u306e\u72ec\u7279\u306e\u5c02\u9580\u7528\u8a9e\u304c\u3042\u308a\u307e\u3059\u306e\u3067\u3001\u7ffb\u8a33\u306b\u306f\u5c02\u9580\u7684\u306a\u77e5\u8b58\u304c\u5fc5\u8981\u3067\u3059\u3002\u5f0a\u793e\u306f\u3053\u306e\u533b\u85ac\u30fb\u88fd\u85ac\u696d\u754c\u306b\u7cbe\u901a\u3057\u305f\u7ffb\u8a33\u8005\u306b\u3088\u308b\u30b5\u30fc\u30d3\u30b9\u3092\u3054\u63d0\u4f9b\u3044\u305f\u3057\u307e\u3059\u3002\u82f1\u8a9e\u2192\u65e5\u672c\u8a9e\u3001\u65e5\u672c\u8a9e\u2192\u82f1\u8a9e<\/p>\n<\/details>\n\n\n\n<div 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