{"id":2946,"date":"2016-06-16T16:18:11","date_gmt":"2016-06-16T07:18:11","guid":{"rendered":"http:\/\/ec2-52-196-95-92.ap-northeast-1.compute.amazonaws.com\/wordpress\/?p=2946"},"modified":"2025-11-12T20:19:28","modified_gmt":"2025-11-12T11:19:28","slug":"pharmaceutical02","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=pharmaceutical02","title":{"rendered":"\u5404\u56fd\u306eCSV,ER\/ES"},"content":{"rendered":"

\u3053\u3093\u306b\u3061\u306f\u3001FSZ\u9d3b\u6c60\u3067\u3059\u3002
\n\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08\u4ee5\u4e0b\u3001CSV\uff09\u8d85\u5165\u9580\u3001\u5404\u56fd\u306eCSV,ER\/ES\u306b\u3064\u3044\u3066\u66f8\u304d\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002\u307e\u305a\u306f\u3001\u5404\u56fd\u306e\u4f53\u7cfb\u304b\u3089\u3001\u305d\u3057\u3066\u5185\u5bb9\u3092\u3002
\n[table id=25 \/]
\n 
\n 
\n\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09<\/strong>
\nCSV\u3068\u306f\u3001\u201dComputerized System Validation\u201d\u306e\u7565\u3067\u3001\u65e5\u672c\u8a9e\u3067\u306f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u3002\u539a\u751f\u52b4\u50cd\u7701\u306e\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\uff08\u4ee5\u4e0b\u3001\u85ac\u6a5f\u6cd5\uff09\u306b\u95a2\u308f\u308b\u4f01\u696d\u3001\u88fd\u85ac\uff08\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u518d\u751f\u533b\u7642\uff09\u3001\u533b\u7642\u6a5f\u5668\u3001\u5065\u5eb7\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u306a\u3069\u304c\u3001\u958b\u767a\uff08GLP\uff1a\u975e\u81e8\u5e8a\u3001GCP\uff1a\u81e8\u5e8a\uff09\u3001\u88fd\u54c1\uff08GQP\u3001GMP\u3001QMS\u3001GCTP\uff09\u3001\u7269\u6d41\uff08GDP\uff09\u3001\u5e02\u8ca9\u5f8c\uff08GVP\u3001GPSP\uff09\u306a\u3069\u306e\u696d\u52d9\u306b\u5229\u7528\u3059\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u958b\u767a\u3068\u904b\u7528\u3092\u9069\u6b63\u306b\u7ba1\u7406\u3057\u3001\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3057\u3066\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n

\u30fb\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b
\n\u30fb\u898f\u5236\u306b\u9069\u5408\u3057\u3066\u3044\u308b<\/p>\n

\u4f46\u3057\u3001CSV\u3068\u3044\u3046\u8868\u73fe\u306fGAMP\u3067\u306f\u5229\u7528\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u306e\u3001\u539a\u751f\u52b4\u50cd\u7701\u306a\u3069\u306e\u65e5\u672c\u306e\u7701\u4ee4\u3067\u306f\u4e00\u5207\u5229\u7528\u3055\u308c\u3066\u304a\u3089\u305a\u3001\u65e5\u672c\u306e\u696d\u754c\u6a19\u6e96\u3067\u306e\u901a\u79f0\u3067\u5229\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002
\n 
\n 
\n\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u5e73\u621022\u5e7410\u670821\u65e5\uff09<\/strong>
\n\u539a\u751f\u52b4\u50cd\u7701\u304b\u3089\u51fa\u3066\u3044\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u4ee5\u4e0b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u306e\u6587\u982d\u306e\u8aac\u660e\u306f\u96e3\u3057\u3044\u3067\u3059\u3002<\/p>\n

\uff1c\u539f\u6587\uff1e
\n\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(\u5e73\u6210 16 \u5e74 12 \u670824 \u65e5\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c 179 \u53f7) (\u4ee5\u4e0b\uff62\uff27\uff2d\uff30\u7701\u4ee4\uff63\u3068\u3044\u3046\u3002) \u304c\u9069\u7528\u3055\u308c\u308b\u533b\u85ac\u54c1\u53c8\u306f\u533b\u85ac\u90e8\u5916\u54c1\u3092\u88fd\u9020\u8ca9\u58f2\u3059\u308b\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u53c8\u306f\u88fd\u9020\u3059\u308b\u88fd\u9020\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u3001\u300c\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d(\u5e73\u6210 16 \u5e74 9 \u6708 22 \u65e5\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c 136 \u53f7)\u53ca\u3073\uff27\uff2d\uff30\u7701\u4ee4\u306b\u57fa\u3065\u304f\u696d\u52d9\u306b\u4f7f\u7528\u3055\u308c\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306b\u4fc2\u308b\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5225\u6dfb\u306e\u3068\u304a\u308a\u5b9a\u3081\u3001\u5e73\u6210\uff12\uff14\u5e74\uff14\u6708\uff11\u65e5\u3088\u308a\u9069\u7528\u3059\u308b\u3053\u3068\u306b\u3057\u305f\u306e\u3067\u3001\u8cb4\u7ba1\u4e0b\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u5bfe\u3057\u3066\u5468\u77e5\u5fb9\u5e95\u3092\u56f3\u3089\u308c\u308b\u3088\u3046\u304a\u9858\u3044\u3057\u307e\u3059\u3002<\/p>\n

\u539a\u751f\u52b4\u50cd\u7701\u767a\u4ee4\u85ac\u98df\u76e3\u9ebb\u767a1021\u7b2c11\u53f7\u3088\u308a\u629c\u7c8b
\n<\/h5>\n

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\n\u300c\u5e73\u621016\u5e7412\u670824\u65e5\u306b\u3067\u305f\uff27\uff2d\uff30\u7701\u4ee4\u3068\u5e73\u621016\u5e749\u670822\u65e5\u306b\u3067\u305fGQP\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306b\u95a2\u308f\u308b\u696d\u52d9\u3067\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3092\u5229\u7528\u3059\u308b\u5834\u5408\u306f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u57fa\u6e96\u3068\u3057\u307e\u3057\u3087\u3046\u300d<\/strong>\u3068\u3044\u3046\u3053\u3068\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002
\n\u3053\u3053\u3067\u3084\u3084\u3053\u3057\u3044\u306e\u306f\u305d\u306e\u30b9\u30b3\u30fc\u30d7\u3002\u5e73\u621016\u5e7412\u670824\u65e5\u306b\u3067\u305f\uff27\uff2d\uff30\u7701\u4ee4\u306e\u5bfe\u8c61\u306f\u300c\u533b\u85ac\u54c1\u53c8\u306f\u533b\u85ac\u90e8\u5916\u54c1\u3092\u88fd\u9020\u8ca9\u58f2\u3059\u308b\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u53c8\u306f\u88fd\u9020\u3059\u308b\u88fd\u9020\u696d\u8005\u7b49\u300d\u3067\u3059\u304c\u3001\u5e73\u621016\u5e749\u670822\u65e5\u306b\u3067\u305fGQP\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306e\u5bfe\u8c61\u306f\u300c\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u300d\u3068\u306a\u308a\u307e\u3059\u3002
\n\u6587\u9762\u3060\u3051\u3067\u306f\u3061\u3087\u3063\u3068\u308f\u304b\u3089\u306a\u3044\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u7d50\u5c40\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306a\u306e\u3067\u6cd5\u7684\u62d8\u675f\u529b\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u88fd\u85ac\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u518d\u751f\u533b\u7642\u306a\u3069\u306e\u5206\u91ce\u3067\u306f\u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u76f8\u5f53\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u54c1\u8cea\u7ba1\u7406\u3092\u3059\u308b\u3079\u304d\u3068\u3044\u3046\u898b\u89e3\u3067\u3001\u533b\u7642\u6a5f\u5668\u3001\u5316\u7ca7\u54c1\u3001\u5065\u5eb7\u98df\u54c1\u306e\u5206\u91ce\u3067\u306f\u3001\u662f\u975e\u53c2\u8003\u3059\u308b\u3079\u304d\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002
\n 
\n 
\nGAMP\uff08Good Automated Manufacturing Practice\uff09\u3068\u306f<\/strong>
\n\u30fb\u4efb\u610f\u56e3\u4f53ISPE\uff08\u56fd\u969b\u88fd\u85ac\u6280\u8853\u5354\u4f1a\uff09\u304c\u516c\u8868\u3057\u3066\u3044\u308bCSV\u5b9f\u8df5\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u9075\u5b88\u306e\u5fc5\u8981\u306f\u306a\u3044\u3002\u6700\u65b0\u7248\u306fGAMP5\u3002
\n\u30fb2000\u5e74\u306bISPE\u306e\u5098\u4e0b\u3068\u306a\u308a\u3001GAMP4\u306f\u7c73\u56fdFDA\u306e\u30ec\u30d3\u30e5\u30fc\u53d7\u3051\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u3068\u306a\u3063\u305f\u3002\u65e5\u7c73\u6b27\u3067\u3053\u306e\u8003\u3048\u65b9\u3092\u5c0e\u5165\u3057\u3066\u3044\u308b\u4f01\u696d\u304c\u591a\u6570\u306a\u306e\u3067\u3001\u5b9f\u8cea\u7684\u306a\u4e16\u754c\u6a19\u6e96\u306eCSV\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3002
\n\u30fb\u5404\u898f\u5236\u5f53\u5c40\u304cCSV\u5b9f\u65bd\u306b\u304a\u3051\u308b\u53c2\u8003\u6587\u66f8\u3068\u3057\u3066\u3042\u3052\u3089\u308c\u3066\u304a\u308a\u3001\u65e5\u672c\u306e\u65b0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u8cea\u7591\u5fdc\u7b54\u96c6\u3067\u3082\u300c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u4ee3\u308f\u308b\u9069\u5207\u306a\u65b9\u6cd5\u300d\u3068\u3055\u308c\u3066\u3044\u308b\u3002
\n 
\n 
\nPIC\/S\uff08Pharmaceutical Inspection Convention\/Scheme\uff1a\u533b\u85ac\u54c1\u67fb\u5bdf\u5354\u5b9a\u304a\u3088\u3073\u533b\u85ac\u54c1\u67fb\u5bdf\u30b9\u30ad\u30fc\u30e0\uff09\u3068\u306f<\/strong>
\n\u30fb\u539f\u6587\u3001PIC\/S\u306e\u516c\u5f0f\u30b5\u30a4\u30c8<\/a>\u3088\u308a
\n\u30fbFDA\u3001\u65e5\u672c\u3082\u52a0\u76df
\n2004\u5e747\u6708\u306b\u767a\u884c\u3055\u308c\u305f\u300cGOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED \u201cGXP\u201d ENVIRONMENTS\u300d\u306f\u3001\u8981\u6c42\u4e8b\u9805\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u2192EU GMP Annex11\u3067 \u8981\u6c42\u3055\u308c\u3066\u3044\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u898f\u5236\u306b\u5bfe\u3059\u308b\u89e3\u91c8\u3068\u67fb\u5bdf\u5b98 \u306b\u5bfe\u3059\u308b\u6559\u80b2\u7684\u306a\u8cc7\u6599\u3068\u306a\u3063\u3066\u3044\u308b\u3002
\n\u30fb\u65e5\u672c\u306e\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u65bd\u884c\u524d\u306b\u5c0e\u5165\u6e08\u307f\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u9069\u683c\u6027\u78ba\u8a8d\u65b9\u6cd5\u3068\u3055\u308c\u3066\u3044\u308b\u3002<\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-2946","news","type-news","status-publish","hentry","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/2946","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2946"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=2946"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}