{"id":4822,"date":"2026-01-17T11:14:15","date_gmt":"2026-01-17T04:14:15","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=4422"},"modified":"2026-01-17T11:14:15","modified_gmt":"2026-01-17T04:14:15","slug":"beyond-human-error-mastering-capa-and-bpom-compliance","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/beyond-human-error-mastering-capa-and-bpom-compliance\/","title":{"rendered":"\u300c\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u300d\u3092\u8d85\u3048\u3066\uff1aCAPA\u3068BPOM\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u7fd2\u5f97"},"content":{"rendered":"<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u4f1d\u7d71\u533b\u5b66\uff08OBA\uff09\u3001\u533b\u85ac\u90e8\u5916\u54c1\uff08OK\uff09\u3001\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\uff08SK\uff09\u306e\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u300c\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u300d\u3068\u3044\u3046\u7528\u8a9e\u306f\u3001\u88fd\u9020\u4e0a\u306e\u9038\u8131\u306b\u5bfe\u3059\u308b\u4fbf\u5229\u306a\u7d50\u8ad6\u3068\u3057\u3066\u3088\u304f\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001BPOM\u4f1d\u7d71\u533b\u85ac\u54c1\u304a\u3088\u3073\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u76e3\u7763\u5c40\u306e\u6700\u65b0\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308b\u3068\u3001\u4eba\u70ba\u7684\u30df\u30b9\u3092\u300c\u6839\u672c\u539f\u56e0\u300d\u3068\u3057\u3066\u6271\u3046\u3053\u3068\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u306e\u52b9\u679c\u3092\u4f4e\u4e0b\u3055\u305b\u308b\u91cd\u5927\u306a\u30df\u30b9\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">BPOM\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u306f\u300c\u518d\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u300d\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u306a\u7406\u7531<\/h2>\n\n\n\n<p>\u5f93\u6765\u3001\u751f\u7523\u30e9\u30a4\u30f3\u3067\u30df\u30b9\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u6a19\u6e96\u7684\u306a\u5bfe\u5fdc\u306f\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u8cac\u4efb\u3092\u8ffd\u53ca\u3057\u3001\u300c\u518d\u6559\u80b2\u300d\u3092\u4e88\u5b9a\u3059\u308b\u3053\u3068\u3067\u3057\u305f\u3002BPOM\u306e\u691c\u67fb\u5b98\u306f\u73fe\u5728\u3001\u3088\u308a\u6df1\u304f\u8abf\u67fb\u3057\u3066\u3044\u307e\u3059\u3002\u73fe\u4ee3\u306e\u7523\u696d\u5fc3\u7406\u5b66\u306b\u3088\u308b\u3068\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u306f\u901a\u5e38\u3001\u4ee5\u4e0b\u306e\u554f\u984c\u306e\u5146\u5019\u3068\u3057\u3066\u73fe\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e0d\u660e\u77ad\u306aSOP\uff08\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\uff09<\/li>\n\n\n\n<li>\u8a2d\u8a08\u304c\u4e0d\u5341\u5206\u306a\u30ef\u30fc\u30af\u30b9\u30da\u30fc\u30b9\uff08\u4eba\u9593\u5de5\u5b66\uff09<\/li>\n\n\n\n<li>\u975e\u73fe\u5b9f\u7684\u306a\u751f\u7523\u76ee\u6a19<\/li>\n\n\n\n<li>\u54c1\u8cea\u6587\u5316\u306e\u5f31\u3055<\/li>\n<\/ul>\n\n\n\n<p>\u8abf\u67fb\u304c\u300c\u4eba\u70ba\u7684\u30df\u30b9\u300d\u3067\u7d42\u4e86\u3057\u305f\u5834\u5408\u3001CAPA \u306f\u5931\u6557\u3059\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u304f\u3001\u30df\u30b9\u304c\u518d\u3073\u767a\u751f\u3057\u3001BPOM \u8ca9\u58f2\u8a31\u53ef (NIE) \u3068\u30d6\u30e9\u30f3\u30c9\u306e\u8a55\u5224\u304c\u5371\u967a\u306b\u3055\u3089\u3055\u308c\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u52b9\u679c\u7684\u306a\u8abf\u67fb\uff1a\u4eba\u7684\u30df\u30b9\u306e3\u3064\u306e\u30bf\u30a4\u30d7<\/h2>\n\n\n\n<p>BPOM\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3001\u696d\u52d9\u3092\u6539\u5584\u3059\u308b\u306b\u306f\u3001\u30a8\u30e9\u30fc\u3092\u5206\u985e\u3057\u3066\u3001 <em>\u672c\u7269<\/em> \u4fee\u7406\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u4e0d\u6ce8\u610f\u306b\u3088\u308b\u30a8\u30e9\u30fc\uff08\u610f\u56f3\u3057\u306a\u3044\uff09<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30df\u30b9\u3084\u5931\u6557: \u7269\u7406\u7684\u306a\u30df\u30b9 (\u9593\u9055\u3063\u305f\u30dc\u30bf\u30f3\u3092\u62bc\u3059\u306a\u3069) \u307e\u305f\u306f\u8a18\u61b6\u306e\u5931\u6557 (\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u624b\u9806\u3092\u5fd8\u308c\u308b\u306a\u3069)\u3002.<\/li>\n\n\n\n<li>\u89e3\u6c7a\u7b56\uff1a\u518d\u6559\u80b2\u3067\u306f\u306a\u304f\u3001\u518d\u8a2d\u8a08\u3067\u3059\u3002\u8272\u5206\u3051\u3055\u308c\u305f\u30dc\u30bf\u30f3\u3001\u81ea\u52d5\u30ea\u30de\u30a4\u30f3\u30c0\u30fc\u3001\u305d\u3057\u3066\u4eba\u9593\u5de5\u5b66\u306b\u57fa\u3065\u3044\u305f\u8a2d\u8a08\u3092\u6d3b\u7528\u3057\u3066\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u300c\u30a8\u30e9\u30fc\u9632\u6b62\u300d\u3057\u307e\u3057\u3087\u3046\u3002.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u30eb\u30fc\u30eb\u30d9\u30fc\u30b9\u3068\u77e5\u8b58\u30d9\u30fc\u30b9\u306e\u30df\u30b9<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u554f\u984c\uff1a\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u8a08\u753b\u306b\u5f93\u3044\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u8a08\u753b\u306f\u9593\u9055\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u53e4\u3044\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u3092\u4f7f\u7528\u3057\u3066\u3044\u305f\u304b\u3001\u8907\u96d1\u306a\u6a5f\u68b0\u3092\u6271\u3046\u305f\u3081\u306e\u6280\u8853\u7684\u306a\u77e5\u8b58\u304c\u4e0d\u8db3\u3057\u3066\u3044\u305f\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u89e3\u6c7a\u7b56\uff1a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3092\u66f4\u65b0\u3057\u3001\u7c21\u7d20\u5316\u3057\u307e\u3059\u3002\u7406\u8ad6\u7684\u306a\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304b\u3089\u3001\u5b9f\u8df5\u7684\u306a\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u30d9\u30fc\u30b9\u306e\u6307\u5c0e\u306b\u79fb\u884c\u3057\u307e\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. \u6545\u610f\u306e\u9055\u53cd\uff08\u30b7\u30e7\u30fc\u30c8\u30ab\u30c3\u30c8\uff09<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u554f\u984c: \u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u6642\u9593\u3092\u7bc0\u7d04\u3059\u308b\u305f\u3081\u3001\u307e\u305f\u306f\u9ad8\u3044\u30ce\u30eb\u30de\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u610f\u56f3\u7684\u306b\u624b\u9806\u3092\u7701\u7565\u3057\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u89e3\u6c7a\u7b56\uff1a\u3053\u308c\u306f\u30df\u30b9\u3067\u306f\u306a\u304f\u3001\u4f01\u696d\u6587\u5316\u306e\u554f\u984c\u3067\u3059\u3002\u7d4c\u55b6\u9663\u306f\u3001\u76ee\u6a19\u304c\u73fe\u5b9f\u7684\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u624b\u629c\u304d\u3092\u4e00\u5207\u5bb9\u8a8d\u3057\u306a\u3044\u65b9\u91dd\u3092\u5fb9\u5e95\u3059\u308b\u3053\u3068\u3067\u3001\u300c\u54c1\u8cea\u6587\u5316\u300d\u306b\u53d6\u308a\u7d44\u307e\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">BPOM\u6a19\u6e96\u9762\u63a5\u306e\u5b9f\u65bd\u65b9\u6cd5<\/h2>\n\n\n\n<p>\u9038\u8131\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u8abf\u67fb\u9762\u63a5\u304c\u6700\u3082\u5f37\u529b\u306a\u30c4\u30fc\u30eb\u3068\u306a\u308a\u307e\u3059\u3002BPOM\u306f\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5c0b\u554f\u3067\u306f\u306a\u304f\u9762\u63a5: \u30b9\u30bf\u30c3\u30d5\u304c\u5b89\u5fc3\u3057\u3066\u771f\u5b9f\u3092\u8a71\u305b\u308b\u3088\u3046\u3001\u8105\u5a01\u306e\u306a\u3044\u74b0\u5883\u3092\u4f5c\u308a\u307e\u3057\u3087\u3046\u3002.<\/li>\n\n\n\n<li>\u300c\u306a\u305c\u300d\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b: \u81ea\u7531\u5f62\u5f0f\u306e\u8cea\u554f\u3092\u3057\u3066\u3001SOP \u304c\u8907\u96d1\u3059\u304e\u305f\u306e\u304b\u3001\u90e8\u5c4b\u306e\u7167\u660e\u304c\u60aa\u304b\u3063\u305f\u306e\u304b\u3092\u8abf\u3079\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u975e\u8a00\u8a9e\u7684\u624b\u304c\u304b\u308a\u3092\u89b3\u5bdf\u3059\u308b: \u30d7\u30ed\u30bb\u30b9\u304c\u4eba\u9593\u306e\u7cbe\u795e\u306b\u3068\u3063\u3066\u8ca0\u62c5\u304c\u5927\u304d\u3059\u304e\u308b\u5834\u6240\u3092\u793a\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u30b9\u30c8\u30ec\u30b9\u306e\u30d1\u30bf\u30fc\u30f3\u3092\u63a2\u3057\u307e\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>BPOM\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u78ba\u4fdd<\/strong><\/h2>\n\n\n\n<p>CPOTB\uff08\u4f1d\u7d71\u533b\u5b66\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\uff09\u306eBPOM\u8981\u4ef6\u3092\u6e80\u305f\u3059\u306b\u306f\u3001\u5358\u306b\u30d5\u30a9\u30fc\u30e0\u3092\u63d0\u51fa\u3059\u308b\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002\u691c\u67fb\u306b\u8010\u3048\u3046\u308b\u30b7\u30b9\u30c6\u30e0\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<p><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u767b\u9332<\/a> \u30b0\u30ed\u30fc\u30d0\u30eb\u30d6\u30e9\u30f3\u30c9\u3068\u30ed\u30fc\u30ab\u30eb\u30d6\u30e9\u30f3\u30c9\u304c\u3001\u767b\u9332\u3092\u78ba\u4fdd\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u6c38\u7d9a\u7684\u306a\u69cb\u7bc9\u3082\u652f\u63f4\u3057\u307e\u3059\u3002\u5f53\u793e\u306f\u4ee5\u4e0b\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SOP \u3068\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u30ec\u30d3\u30e5\u30fc: \u30de\u30cb\u30e5\u30a2\u30eb\u304c\u660e\u78ba\u3067\u3001\u6e96\u62e0\u3057\u3066\u304a\u308a\u3001\u300c\u4eba\u7684\u30a8\u30e9\u30fc\u306b\u5f37\u3044\u300d\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u201c<\/li>\n\n\n\n<li>\u6226\u7565\u7684 CAPA \u30ac\u30a4\u30c0\u30f3\u30b9: \u300c\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u300d\u3092\u8d85\u3048\u3066\u3001BPOM \u691c\u67fb\u5b98\u3092\u6e80\u8db3\u3055\u305b\u308b\u8abf\u67fb\u3092\u69cb\u7bc9\u3067\u304d\u308b\u3088\u3046\u306b\u652f\u63f4\u3057\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e BPOM \u30b5\u30dd\u30fc\u30c8: \u521d\u671f\u767b\u9332\u304b\u3089\u5e02\u8ca9\u5f8c\u8abf\u67fb\u307e\u3067\u3002.<\/li>\n<\/ul>\n\n\n\n<p>\u4eba\u9593\u306e\u305b\u3044\u306b\u3059\u308b\u306e\u3092\u3084\u3081\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u6539\u5584\u306b\u53d6\u308a\u7d44\u307f\u307e\u3057\u3087\u3046\u3002\u751f\u7523\u4f53\u5236\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9075\u5b88\u3001\u52b9\u7387\u5316\u3001\u305d\u3057\u3066\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3078\u306e\u5bfe\u5fdc\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u4eca\u3059\u3050\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>For manufacturers of Traditional Medicine (OBA), Quasi-Drugs (OK), and Health Supplements (SK) in Indonesia, the term &#8220;human error&#8221; is often used as a convenient conclusion for production deviations. However, according to the latest guidance from the BPOM Directorate of Supervision of Traditional Medicines and Health Supplements, treating human error as the &#8220;root cause&#8221; is a critical mistake that leads to ineffective Corrective and Preventive Actions (CAPA). Why &#8220;Retraining&#8221; is No Longer Enough for BPOM Compliance Historically, when a mistake happened on the production line, the standard response was to blame the operator and schedule &#8220;retraining.&#8221; BPOM inspectors are now looking deeper. Modern industrial psychology shows that human error is usually [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4836,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[38],"tags":[],"country":[],"class_list":["post-4822","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bpom-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/4822","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=4822"}],"version-history":[{"count":0,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/4822\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/4836"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=4822"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=4822"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=4822"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=4822"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}