{"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\/zh\/beyond-human-error-mastering-capa-and-bpom-compliance\/","title":{"rendered":"\u8d85\u8d8a\u201c\u4eba\u4e3a\u9519\u8bef\u201d\uff1a\u638c\u63e1 CAPA \u548c BPOM 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\u5408\u89c4\u6027\u8981\u6c42<\/h2>\n\n\n\n<p>\u8fc7\u53bb\uff0c\u751f\u4ea7\u7ebf\u4e0a\u51fa\u73b0\u9519\u8bef\u65f6\uff0c\u6807\u51c6\u505a\u6cd5\u662f\u8d23\u602a\u64cd\u4f5c\u5458\u5e76\u5b89\u6392\u201c\u518d\u57f9\u8bad\u201d\u3002\u5982\u4eca\uff0cBPOM\uff08\u751f\u4ea7\u7269\u6599\u6e05\u5355\uff09\u68c0\u9a8c\u5458\u4f1a\u8fdb\u884c\u66f4\u6df1\u5165\u7684\u8c03\u67e5\u3002\u73b0\u4ee3\u5de5\u4e1a\u5fc3\u7406\u5b66\u8868\u660e\uff0c\u4eba\u4e3a\u9519\u8bef\u901a\u5e38\u662f\u4ee5\u4e0b\u95ee\u9898\u7684\u5f81\u5146\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f\u4e0d\u660e\u786e<\/li>\n\n\n\n<li>\u8bbe\u8ba1\u4e0d\u5408\u7406\u7684\u5de5\u4f5c\u7a7a\u95f4\uff08\u4eba\u4f53\u5de5\u7a0b\u5b66\uff09<\/li>\n\n\n\n<li>\u4e0d\u5207\u5b9e\u9645\u7684\u751f\u4ea7\u76ee\u6807<\/li>\n\n\n\n<li>\u8d28\u91cf\u6587\u5316\u8584\u5f31<\/li>\n<\/ul>\n\n\n\n<p>\u5982\u679c\u4f60\u7684\u8c03\u67e5\u6700\u7ec8\u4ee5\u201c\u4eba\u4e3a\u9519\u8bef\u201d\u544a\u7ec8\uff0c\u90a3\u4e48\u4f60\u7684 CAPA \u5f88\u53ef\u80fd\u4f1a\u5931\u8d25\uff0c\u9519\u8bef\u8fd8\u4f1a\u518d\u6b21\u53d1\u751f\uff0c\u4ece\u800c\u5371\u53ca\u4f60\u7684 BPOM \u5206\u9500\u8bb8\u53ef\u8bc1 (NIE) \u548c\u54c1\u724c\u58f0\u8a89\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6709\u6548\u8c03\u67e5\uff1a\u4eba\u4e3a\u5931\u8bef\u7684\u4e09\u79cd\u7c7b\u578b<\/h2>\n\n\n\n<p>\u4e3a\u4e86\u6ee1\u8db3 BPOM \u8981\u6c42\u5e76\u6539\u8fdb\u60a8\u7684\u8fd0\u8425\uff0c\u60a8\u5fc5\u987b\u5bf9\u9519\u8bef\u8fdb\u884c\u5206\u7c7b\u4ee5\u67e5\u627e\u9519\u8bef\u3002 <em>\u771f\u5b9e\u7684<\/em> \u4f7f\u56fa\u5b9a\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u65e0\u610f\u9519\u8bef\uff08\u975e\u6545\u610f\uff09<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5931\u8bef\u548c\u758f\u5ffd\uff1a\u7269\u7406\u9519\u8bef\uff08\u4f8b\u5982\u6309\u9519\u6309\u94ae\uff09\u6216\u8bb0\u5fc6\u5931\u8bef\uff08\u4f8b\u5982\u5fd8\u8bb0\u68c0\u67e5\u6e05\u5355\u4e0a\u7684\u67d0\u4e2a\u6b65\u9aa4\uff09\u3002.<\/li>\n\n\n\n<li>\u89e3\u51b3\u65b9\u6848\uff1a\u4e0d\u8981\u91cd\u65b0\u57f9\u8bad\uff0c\u800c\u662f\u91cd\u65b0\u8bbe\u8ba1\u3002\u4f7f\u7528\u989c\u8272\u7f16\u7801\u7684\u6309\u94ae\u3001\u81ea\u52a8\u63d0\u9192\u548c\u66f4\u597d\u7684\u4eba\u4f53\u5de5\u7a0b\u5b66\u8bbe\u8ba1\u6765\u201c\u9632\u6b62\u201d\u6d41\u7a0b\u51fa\u9519\u3002.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. 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class=\"wp-block-list\">\n<li>\u95ee\u9898\uff1a\u64cd\u4f5c\u5458\u4e3a\u4e86\u8282\u7701\u65f6\u95f4\u6216\u5b8c\u6210\u9ad8\u914d\u989d\u800c\u6545\u610f\u8df3\u8fc7\u67d0\u4e2a\u6b65\u9aa4\u3002.<\/li>\n\n\n\n<li>\u89e3\u51b3\u65b9\u6848\uff1a\u8fd9\u4e0d\u662f\u9519\u8bef\uff0c\u800c\u662f\u6587\u5316\u95ee\u9898\u3002\u7ba1\u7406\u5c42\u5fc5\u987b\u91cd\u89c6\u201c\u8d28\u91cf\u6587\u5316\u201d\uff0c\u786e\u4fdd\u76ee\u6807\u5207\u5408\u5b9e\u9645\uff0c\u5e76\u5bf9\u4efb\u4f55\u5077\u5de5\u51cf\u6599\u7684\u884c\u4e3a\u91c7\u53d6\u96f6\u5bb9\u5fcd\u6001\u5ea6\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u5982\u4f55\u8fdb\u884c\u7b26\u5408BPOM\u6807\u51c6\u7684\u9762\u8bd5<\/h2>\n\n\n\n<p>\u5f53\u51fa\u73b0\u8fdd\u89c4\u884c\u4e3a\u65f6\uff0c\u8c03\u67e5\u9762\u8c08\u662f\u60a8\u6700\u6709\u529b\u7684\u5de5\u5177\u3002BPOM\u5efa\u8bae\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9762\u8c08\u800c\u975e\u5ba1\u95ee\uff1a\u8425\u9020\u4e00\u4e2a\u975e\u5a01\u80c1\u6027\u7684\u73af\u5883\uff0c\u8ba9\u5458\u5de5\u611f\u5230\u5b89\u5168\uff0c\u4ece\u800c\u80fd\u591f\u8bf4\u51fa\u771f\u76f8\u3002.<\/li>\n\n\n\n<li>\u5173\u6ce8\u201c\u4e3a\u4ec0\u4e48\u201d\uff1a\u63d0\u51fa\u5f00\u653e\u5f0f\u95ee\u9898\uff0c\u4ee5\u53d1\u73b0\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f\u662f\u5426\u8fc7\u4e8e\u590d\u6742\uff0c\u6216\u8005\u623f\u95f4\u91cc\u7684\u5149\u7ebf\u662f\u5426\u4e0d\u597d\u3002.<\/li>\n\n\n\n<li>\u89c2\u5bdf\u975e\u8bed\u8a00\u7ebf\u7d22\uff1a\u5bfb\u627e\u538b\u529b\u6a21\u5f0f\uff0c\u8fd9\u4e9b\u6a21\u5f0f\u53ef\u80fd\u8868\u660e\u67d0\u4e2a\u8fc7\u7a0b\u5bf9\u4eba\u7c7b\u5927\u8111\u6765\u8bf4\u8d1f\u62c5\u8fc7\u91cd\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u786e\u4fdd\u60a8\u7684 BPOM 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class=\"wp-block-list\">\n<li>\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\u548c\u6587\u6863\u5ba1\u67e5\uff1a\u786e\u4fdd\u60a8\u7684\u624b\u518c\u6e05\u6670\u3001\u5408\u89c4\u4e14\u201c\u4e0d\u6613\u51fa\u9519\u201d\u3002\u201d<\/li>\n\n\n\n<li>\u6218\u7565\u6027 CAPA \u6307\u5357\uff1a\u5e2e\u52a9\u60a8\u8d85\u8d8a\u201c\u4eba\u4e3a\u9519\u8bef\u201d\uff0c\u6784\u5efa\u80fd\u591f\u6ee1\u8db3 BPOM \u68c0\u67e5\u5458\u8981\u6c42\u7684\u8c03\u67e5\u3002.<\/li>\n\n\n\n<li>\u7aef\u5230\u7aef BPOM \u652f\u6301\uff1a\u4ece\u521d\u59cb\u6ce8\u518c\u5230\u4e0a\u5e02\u540e\u76d1\u6d4b\u3002.<\/li>\n<\/ul>\n\n\n\n<p>\u505c\u6b62\u6307\u8d23\u4eba\u4e3a\u56e0\u7d20\uff0c\u5f00\u59cb\u6539\u8fdb\u7cfb\u7edf\u3002\u7acb\u5373\u8054\u7cfb\u6211\u4eec\uff0c\u786e\u4fdd\u60a8\u7684\u751f\u4ea7\u7b26\u5408\u89c4\u8303\u3001\u9ad8\u6548\u8fd0\u884c\uff0c\u5e76\u4e3a\u5370\u5c3c\u5e02\u573a\u505a\u597d\u51c6\u5907\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 [&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\/zh\/wp-json\/wp\/v2\/posts\/4822","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=4822"}],"version-history":[{"count":0,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/4822\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/4836"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=4822"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=4822"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=4822"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=4822"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}