{"id":11490,"date":"2019-06-19T16:35:26","date_gmt":"2019-06-19T07:35:26","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=knowledge&#038;p=11490"},"modified":"2025-04-04T10:53:49","modified_gmt":"2025-04-04T01:53:49","slug":"11490","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=11490","title":{"rendered":"GxP\u3068\u306f"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">GCP\u3001GCLP\u3001GDP\u3001GLP\u3001GMP\u3001GQP\u3001GVP\u3001GPSP\u3001GPMSP<\/h2>\n\n\n\n<p>Good \u306a\u306b\u306a\u306b practice\u306e\u7565\u3067\u3001\u88fd\u85ac\u3001\u533b\u7642\u6a5f\u5668\u3001\u5065\u5eb7\u98df\u54c1\u696d\u754c\u3067\u5229\u7528\u3055\u308c\u3066\u304a\u308a\u3001\u98df\u54c1\u3001\u52d5\u7269\u7528\u533b\u85ac\u54c1\u3001\u8fb2\u85ac\u306a\u3069\u306b\u3082\u5e83\u304c\u308a\u3092\u898b\u305b\u3066\u3044\u307e\u3059\u3002\u5b89\u5168\u6027\u3084\u4fe1\u983c\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u304a\u308a\u3001\u653f\u5e9c\u3084\u516c\u7684\u6a5f\u95a2\u3001\u95a2\u4fc2\u56e3\u4f53\u3067\u5236\u5b9a\u3059\u308b\u8a00\u8449\u306e\u7565\u79f0\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u533b\u85ac\u54c1\u306e\u9069\u6b63\u6d41\u901a\uff08GDP\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<br>GDP\uff5cGood Distribution Practice<\/h4>\n\n\n\n<p>[su_document url=&#8221;https:\/\/www.mhlw.go.jp\/content\/11120000\/000466215.pdf&#8221; width=&#8221;200&#8243; height=&#8221;620&#8243;]<\/p>\n\n\n\n<p>\u533b\u85ac\u54c1\u306e\u6d41\u901a\u904e\u7a0b\u306b\u304a\u3051\u308b\u3001\u300c\u54c1\u8cea\u300d\u300c\u507d\u9020\u533b\u85ac\u54c1\u306e\u6df7\u5165\u300d\u300c\u76d7\u96e3\u300d\u306b\u30dd\u30a4\u30f3\u30c8\u3092\u7f6e\u3044\u305f\u56fd\u969b\u30cf\u30fc\u30e2\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u304c\u554f\u308f\u308c\u308b\u57fa\u6e96\u3067\u3059\u3002\u3053\u306e\u5bfe\u8c61\u306b\u306a\u308b\u4e8b\u696d\u8005\u306f\u533b\u85ac\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u3001\u5378\u3001\uff13PL\u3001\u5009\u5eab\u696d\u8005\uff08\u7a7a\u6e2f\uff5c\u6e2f\u542b\u3080\uff09\u3001\u7269\u6d41\u696d\u8005\u306a\u3069\u306e\u7269\u6d41\u306b\u304b\u304b\u308f\u308b\u3059\u3079\u3066\u306e\u4e8b\u696d\u8005\u3067\u3059\u3002\u7269\u6d41\u696d\u8005\u306a\u3069\u306f\u56fd\u571f\u4ea4\u901a\u7701\u7ba1\u8f44\u3068\u8a00\u3046\u3053\u3068\u3082\u3042\u3063\u3066\u3001\u7701\u5e81\u3092\u3082\u307e\u305f\u304c\u304c\u3063\u305f\u3082\u306e\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/www.fsz.co.jp\/?page_id=6689\">\u8a73\u7d30\u306f\u3053\u3061\u3089<\/a><br><a href=\"https:\/\/www.mhlw.go.jp\/content\/11120000\/000466215.pdf\">\u539a\u751f\u52b4\u50cd\u7701\u306e\u30da\u30fc\u30b8<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4<br>GCP\uff5cGood Clinical Practice<\/h4>\n\n\n\n<p>\u88fd\u85ac\u4f1a\u793e\u306f\u6cbb\u9a13\u62c5\u5f53\u533b\u5e2b\u304c\u5408\u610f\u3057\u305f\u300c\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u3092\u539a\u751f\u52b4\u50cd\u7701\u306b\u5c4a\u3051\u51fa\u307e\u3059\u3002\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u306f\u6cbb\u9a13\u306b\u540c\u610f\u3057\u305f\u53c2\u52a0\u8005\u306e\u5065\u5eb7\u3092\u5b88\u308a\u306a\u304c\u3089\u3001\u5bfe\u8c61\u65b0\u85ac\u5019\u88dc\u306e\u52b9\u679c\u304c\u8abf\u3079\u3089\u308c\u308b\u304b\u3092\u5be9\u67fb\u3057\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u306f\u6cbb\u9a13\u62c5\u5f53\u533b\u5e2b\u304c\u6cbb\u9a13\u3092\u9069\u6b63\u306b\u5b9f\u65bd\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u3064\u3064\u3001\u3082\u3057\u6cbb\u9a13\u4e2d\u306b\u91cd\u5927\u306a\u526f\u4f5c\u7528\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306f\u56fd\u306b\u5831\u544a\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/fukyu2.html\">\u539a\u751f\u52b4\u50cd\u7701\u306e\u30da\u30fc\u30b8<\/a><br><a href=\"http:\/\/www.pmda.go.jp\/review-services\/inspections\/gcp\/0007.html\">PMDA\u306e\u30da\u30fc\u30b8<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u533b\u85ac\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u53ca\u3073\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4<br>GPSP\uff5cGood Post-marketing Study Practice<\/h4>\n\n\n\n<ol class=\"wp-block-list\"><li>\u4f7f\u7528\u6210\u7e3e\u8abf\u67fb<br>\u4e00\u822c\u4ed5\u69d8\u6210\u7e3e\u8abf\u67fb<br>\u7279\u5b9a\u4ed5\u69d8\u6210\u7e3e\u8abf\u67fb<br>\u4f7f\u7528\u6210\u7e3e\u6bd4\u8f03\u8abf\u67fb<\/li><li>\u88fd\u9020\u8ca9\u58f2\u5f8c\u3067\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u8abf\u67fb<\/li><li>\u88fd\u9020\u8ca9\u58f2\u5f8c\u81e8\u5e8a\u8a66\u9a13<\/li><\/ol>\n\n\n\n<p>\u539a\u751f\u52b4\u50cd\u7701\u306e\u30da\u30fc\u30b8<br><a href=\"https:\/\/www.pmda.go.jp\/review-services\/inspections\/reexam-reeval\/0004.html\">PMDA\u306e\u30da\u30fc\u30b8<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96<br>GVP\uff5cGood Vigilance Practice<\/h4>\n\n\n\n<p>\u539a\u751f\u52b4\u50cd\u7701\u306e\u30da\u30fc\u30b8<br>PMDA\u306e\u30da\u30fc\u30b8<br><\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-11490","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\/11490","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=11490"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=11490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}