{"id":5096,"date":"2026-03-16T16:30:44","date_gmt":"2026-03-16T08:30:44","guid":{"rendered":"https:\/\/www.jianpaitech.com\/?post_type=blog&#038;p=5096"},"modified":"2026-03-16T16:30:44","modified_gmt":"2026-03-16T08:30:44","slug":"understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide","status":"publish","type":"blog","link":"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/","title":{"rendered":"\u4e86\u89e3\u5236\u836f\u8bbe\u5907\u91c7\u8d2d\u4e2d\u7684 FAT\u3001SAT\u3001IQ\u3001OQ \u548c PQ\uff1a\u7efc\u5408\u6307\u5357"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u5f55<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"\u5207\u6362\u76ee\u5f55\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">\u5207\u6362<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Introduction\" >\u4ecb\u7ecd<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Phase_1_Pre-Delivery_Testing_FAT\" >\u7b2c\u4e00\u9636\u6bb5\uff1a\u4ea4\u4ed8\u524d\u6d4b\u8bd5 (FAT)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Phase_2_Post-Delivery_Testing_SAT\" >\u7b2c 2 \u9636\u6bb5\uff1a\u4ea4\u4ed8\u540e\u6d4b\u8bd5 (SAT)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Phase_3_The_Qualification_Lifecycle_IQ_OQ_PQ\" >\u7b2c 3 \u9636\u6bb5\uff1a\u8d44\u683c\u751f\u547d\u5468\u671f\uff08IQ\u3001OQ\u3001PQ\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Why_Documentation_is_the_Real_Bottleneck_in_Procurement\" >\u4e3a\u4ec0\u4e48\u6587\u6863\u662f\u91c7\u8d2d\u4e2d\u7684\u771f\u6b63\u74f6\u9888<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Seamless_Compliance_with_JIANPAI_Pharmaceutical_Equipment\" >Seamless Compliance with JIANPAI Pharmaceutical Equipment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jianpaitech.com\/zh\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Frequently_Asked_Questions_FAQs\" >\u5e38\u89c1\u95ee\u9898 (FAQ)<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Introduction\"><\/span><span class=\"ng-star-inserted\">\u4ecb\u7ecd<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u5236\u836f\u884c\u4e1a\uff0c\u8d2d\u4e70\u65b0\u8bbe\u5907\u2014\u2014\u65e0\u8bba\u662f\u9ad8\u526a\u5207\u6df7\u5408\u5668\u3001\u6d41\u5316\u5e8a\u5e72\u71e5\u673a\u8fd8\u662f\u7247\u5242\u5305\u8863\u673a\u2014\u2014\u4e0e\u8d2d\u4e70\u6807\u51c6\u5de5\u4e1a\u673a\u68b0\u6709\u7740\u6839\u672c\u7684\u4e0d\u540c\u3002 You are not just buying stainless steel and motors;\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4f60\u8d2d\u4e70\u7684\u662f\u5408\u89c4\u6027\u3002<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FDA\u3001EMA \u548c WHO \u7b49\u76d1\u7ba1\u673a\u6784\u9700\u8981\u6709\u8bb0\u5f55\u7684\u79d1\u5b66\u8bc1\u636e\uff0c\u8bc1\u660e\u673a\u5668\u6309\u7167\u89c4\u683c\u5236\u9020\u3001\u5b89\u88c5\u6b63\u786e\u4e14\u6027\u80fd\u4e00\u81f4\u3002 For procurement managers and project engineers, navigating the alphabet soup of equipment validation\u2014<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT\u3001SAT\u3001IQ\u3001OQ \u548c PQ<\/span><\/strong><span class=\"ng-star-inserted\">\u2014\u2014\u53ef\u80fd\u4ee4\u4eba\u754f\u60e7\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7136\u800c\uff0c\u4e86\u89e3\u8fd9\u4e2a\u751f\u547d\u5468\u671f\u81f3\u5173\u91cd\u8981\u3002\u6ca1\u6709\u9002\u5f53\u9a8c\u8bc1\u6587\u6863\u7684\u673a\u5668\u5728 cGMP \u73af\u5883\u4e2d\u57fa\u672c\u4e0a\u6beb\u65e0\u7528\u5904\u3002\u5728\u8fd9\u4efd\u7efc\u5408\u6307\u5357\u4e2d\uff0c\u6211\u4eec\u5c06\u8be6\u7ec6\u89e3\u91ca\u8fd9\u4e9b\u672f\u8bed\u7684\u542b\u4e49\u3001\u5b83\u4eec\u4e3a\u4f55\u5bf9\u91c7\u8d2d\u6d41\u7a0b\u81f3\u5173\u91cd\u8981\uff0c\u4ee5\u53ca\u5b83\u4eec\u5982\u4f55\u4fdd\u62a4\u60a8\u7684\u6295\u8d44\u3002<\/span><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft size-full wp-image-3278\" src=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JLB-Series-Fuild-bed-Granulating-Coating-Machine-2-e1758939891270.png?quality=85&strip=all\" alt=\"JLB\u7cfb\u5217\u6d41\u4f53\u5e8a\u9897\u7c92\u6d82\u6599\u673a\" width=\"437\" height=\"437\" \/><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Phase_1_Pre-Delivery_Testing_FAT\"><\/span><span class=\"ng-star-inserted\">\u7b2c\u4e00\u9636\u6bb5\uff1a\u4ea4\u4ed8\u524d\u6d4b\u8bd5 (FAT)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">\u4ec0\u4e48\u662f FAT\uff08\u5de5\u5382\u9a8c\u6536\u6d4b\u8bd5\uff09\uff1f<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT \u5728\u8bbe\u5907\u5236\u9020\u5546\uff08\u4f9b\u5e94\u5546\uff09\u7684\u5de5\u5382\u8fdb\u884c\u00a0<\/span><span class=\"ng-star-inserted\">\u524d<\/span><span class=\"ng-star-inserted\">\u00a0\u673a\u5668\u5df2\u5305\u88c5\u5e76\u53d1\u8d27\u3002\u8fd9\u662f\u4e00\u4e2a\u534f\u4f5c\u8fc7\u7a0b\uff0c\u5236\u836f\u516c\u53f8\u7684\u4ee3\u8868\u524d\u5f80\u4f9b\u5e94\u5546\u73b0\u573a\u68c0\u67e5\u548c\u6d4b\u8bd5\u8bbe\u5907\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u6807\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0To verify that the equipment has been built strictly according to the approved User Requirement Specifications (URS), Functional Design Specification (FDS), and P&amp;ID drawings.<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT \u671f\u95f4\u7684\u4e3b\u8981\u6d3b\u52a8\uff1a<\/span><\/strong><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u89c6\u68c0\u67e5\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u68c0\u67e5\u5c3a\u5bf8\u3001\u8868\u9762\u5149\u6d01\u5ea6\uff08\u4f8b\u5982\uff0c\u786e\u4fdd 316L \u4e0d\u9508\u94a2\u63a5\u89e6\u90e8\u4ef6\u629b\u5149\u81f3\u6b63\u786e\u7684 Ra \u503c\uff09\u548c\u710a\u63a5\u8d28\u91cf\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7ec4\u4ef6\u9a8c\u8bc1\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u786e\u4fdd\u6240\u6709\u6cf5\u3001\u7535\u673a\u548c\u4f20\u611f\u5668\u7b26\u5408\u6279\u51c6\u7684\u7269\u6599\u6e05\u5355\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u57fa\u672c\u529f\u80fd\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u542f\u52a8\u673a\u5668\u4ee5\u6d4b\u8bd5 HMI\/PLC \u7cfb\u7edf\u3001\u57fa\u672c\u673a\u68b0\u8fd0\u52a8\u548c\u5b89\u5168\u8054\u9501\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4e3a\u4ec0\u4e48\u5b83\u5bf9\u91c7\u8d2d\u5f88\u91cd\u8981\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5728 FAT \u671f\u95f4\u53d1\u73b0\u8bbe\u8ba1\u7f3a\u9677\u6216\u7f3a\u5931\u7ec4\u4ef6\u7684\u4fee\u590d\u6210\u672c\u975e\u5e38\u4f4e\u3002\u5728\u673a\u5668\u88ab\u8fd0\u9001\u5230\u5168\u7403\u5404\u5730\u5230\u60a8\u7684\u6d01\u51c0\u5ba4\u540e\u53d1\u73b0\u540c\u6837\u7684\u9519\u8bef\u5c06\u5bfc\u81f4\u5927\u89c4\u6a21\u7684\u9879\u76ee\u5ef6\u8bef\u548c\u9884\u7b97\u8d85\u652f\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Phase_2_Post-Delivery_Testing_SAT\"><\/span><span class=\"ng-star-inserted\">\u7b2c 2 \u9636\u6bb5\uff1a\u4ea4\u4ed8\u540e\u6d4b\u8bd5 (SAT)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">\u4ec0\u4e48\u662f SAT\uff08\u73b0\u573a\u9a8c\u6536\u6d4b\u8bd5\uff09\uff1f<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4e00\u65e6\u8bbe\u5907\u6210\u529f\u901a\u8fc7 FAT\uff0c\u5c31\u4f1a\u88ab\u8fd0\u9001\u5230\u5236\u836f\u516c\u53f8\u7684\u5de5\u5382\u3002 SAT \u5728\u673a\u5668\u5230\u8fbe\u5e76\u653e\u7f6e\u5728\u6700\u7ec8\u4f4d\u7f6e\u540e\u8fdb\u884c\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u6807\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u786e\u4fdd\u8bbe\u5907\u5728\u8fd0\u8f93\u8fc7\u7a0b\u4e2d\u4e0d\u4f1a\u635f\u574f\uff0c\u5e76\u4e0e\u8bbe\u65bd\u7684\u516c\u7528\u8bbe\u65bd\uff08\u7535\u529b\u3001\u538b\u7f29\u7a7a\u6c14\u3001\u51b7\u51bb\u6c34\u3001\u84b8\u6c7d\uff09\u6b63\u786e\u8fde\u63a5\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">SAT \u671f\u95f4\u7684\u4e3b\u8981\u6d3b\u52a8\uff1a<\/span><\/strong><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u89c6\u68c0\u67e5\u8fd0\u8f93\u635f\u574f\u60c5\u51b5\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9a8c\u8bc1\u6240\u6709\u88c5\u8fd0\u7684\u7ec4\u4ef6\u662f\u5426\u4e0e\u88c5\u7bb1\u5355\u76f8\u7b26\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u786e\u8ba4\u8bbe\u65bd\u516c\u7528\u8bbe\u65bd\u6ee1\u8db3\u673a\u5668\u7684\u8981\u6c42\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u6c38\u4e45\u73af\u5883\u4e2d\u6253\u5f00\u673a\u5668\u7535\u6e90\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Phase_3_The_Qualification_Lifecycle_IQ_OQ_PQ\"><\/span><span class=\"ng-star-inserted\">\u7b2c 3 \u9636\u6bb5\uff1a\u8d44\u683c\u751f\u547d\u5468\u671f\uff08IQ\u3001OQ\u3001PQ\uff09<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u867d\u7136 FAT \u548c SAT \u662f\u91cd\u8981\u7684\u5de5\u7a0b\u91cc\u7a0b\u7891\uff0c\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8d44\u683c\u9636\u6bb5\uff08IQ\u3001OQ\u3001PQ\uff09<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u662f\u6ee1\u8db3 cGMP \u76d1\u7ba1\u5ba1\u6838\u6240\u9700\u7684\u6b63\u5f0f\u4e14\u6709\u5927\u91cf\u8bb0\u5f55\u7684\u6b65\u9aa4\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">1. \u5b89\u88c5\u8d44\u8d28\uff08IQ\uff09<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u201c\u5b8c\u5168\u6309\u7167\u89c4\u5b9a\u5b89\u88c5\u4e86\u5417\uff1f\u201d<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">IQ \u662f\u8bbe\u5907\u5df2\u6309\u7167\u5236\u9020\u5546\u6307\u5357\u548c\u5b89\u5168\u89c4\u5b9a\u4ea4\u4ed8\u548c\u5b89\u88c5\u7684\u4e66\u9762\u8bc1\u660e\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9a8c\u8bc1\u5185\u5bb9\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u63a5\u7ebf\u3001\u7ba1\u9053\u8fde\u63a5\u3001\u673a\u5668\u8c03\u5e73\u3001\u6240\u6709\u7528\u6237\u624b\u518c\u7684\u5b58\u5728\u4ee5\u53ca\u6750\u6599\u8bc1\u4e66\u7684\u6536\u96c6\uff08\u8bc1\u660e\u94a2\u6750\u5b9e\u9645\u4e0a\u662f\u533b\u836f\u7ea7\u7684\uff09\u548c\u6240\u6709\u4eea\u8868\u7684\u6821\u51c6\u8bc1\u4e66\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">2. \u64cd\u4f5c\u8d44\u683c\uff08OQ\uff09<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u201c\u5b83\u5b8c\u5168\u6309\u7167\u8bbe\u8ba1\u8fd0\u884c\u5417\uff1f\u201d<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">OQ \u6d4b\u8bd5\u673a\u5668\u7684\u529f\u80fd\u80fd\u529b\u3002\u8fd9\u901a\u5e38\u662f\u4f7f\u7528\u7a7a\u673a\u5668\u6216\u4f7f\u7528\u5b89\u6170\u5242\uff08\u5982\u6c34\u6216\u7a7a\u767d\u8d4b\u5f62\u5242\uff09\u6765\u6d4b\u8bd5\u8bbe\u5907\u7684\u6781\u9650\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6d4b\u8bd5\u4ec0\u4e48\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5982\u679c\u9ad8\u526a\u5207\u6df7\u5408\u5668\u8bbe\u8ba1\u4e3a\u4ee5 3000 RPM \u8fd0\u884c\uff0cOQ \u4f1a\u6d4b\u8bd5\u5b83\u662f\u5426\u786e\u5b9e\u5e73\u7a33\u8fbe\u5230 3000 RPM\u3002\u5b83\u53ef\u4ee5\u6d4b\u8bd5\u7535\u6e90\u6545\u969c\u6062\u590d\u3001E-stop\uff08\u7d27\u6025\u505c\u6b62\uff09\u3001\u8b66\u62a5\u3001\u5bc6\u7801\u5b89\u5168\u7ea7\u522b\uff0821 CFR Part 11 \u5408\u89c4\u6027\uff09\u4ee5\u53ca\u52a0\u70ed\/\u51b7\u5374\u5957\u6548\u7387\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">3. \u7ee9\u6548\u8d44\u683c\uff08PQ\uff09<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u201c\u5b83\u80fd\u6301\u7eed\u751f\u4ea7\u6211\u7684\u7279\u5b9a\u4ea7\u54c1\u5417\uff1f\u201d<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">PQ\u662f\u6700\u540e\u7684\u969c\u788d\u3002\u5b83\u6574\u5408\u4e86\u8bbe\u65bd\u3001\u8bbe\u5907\u3001\u4eba\u5458\u548c\u60a8\u7684\u5b9e\u9645\u836f\u7269\u914d\u65b9\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6d4b\u8bd5\u4ec0\u4e48\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u8be5\u673a\u5668\u4f7f\u7528\u5b9e\u9645\u7684\u6d3b\u6027\u836f\u7269\u6210\u5206 (API) \u548c\u6279\u6b21\u914d\u65b9\u5728\u6b63\u5e38\u7684\u65e5\u5e38\u5236\u9020\u6761\u4ef6\u4e0b\u8fd0\u884c\u3002\u76ee\u6807\u662f\u5728\u591a\u6b21\u8fd0\u884c\u4e2d\u8bc1\u660e\u6279\u6b21\u95f4\u7684\u4e00\u81f4\u6027\u3001\u542b\u91cf\u5747\u5300\u6027\u548c\u6700\u7ec8\u4ea7\u54c1\u8d28\u91cf\u3002\u00a0<\/span><span class=\"ng-star-inserted\">\uff08\u6ce8\uff1a\u867d\u7136\u4f9b\u5e94\u5546\u63d0\u4f9b IQ\/OQ \u534f\u8bae\uff0c\u4f46 PQ \u901a\u5e38\u7531\u5236\u836f\u516c\u53f8\u7f16\u5199\u548c\u6267\u884c\uff09\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Why_Documentation_is_the_Real_Bottleneck_in_Procurement\"><\/span><span class=\"ng-star-inserted\">\u4e3a\u4ec0\u4e48\u6587\u6863\u662f\u91c7\u8d2d\u4e2d\u7684\u771f\u6b63\u74f6\u9888<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5bf9\u4e8e\u91c7\u8d2d\u4e13\u4e1a\u4eba\u58eb\u6765\u8bf4\uff0c\u8c08\u5224\u786c\u4ef6\u4ef7\u683c\u53ea\u662f\u6210\u529f\u7684\u4e00\u534a\u3002\u5236\u836f\u8bbe\u5907\u7684\u9690\u6027\u6210\u672c\u5728\u4e8e\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u9a8c\u8bc1\u534f\u8bae\u3002<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5982\u679c\u4f9b\u5e94\u5546\u4ea4\u4ed8\u4e86\u673a\u5668\uff0c\u4f46\u63d0\u4f9b\u7684 IQ\/OQ \u6587\u6863\u8d28\u91cf\u5dee\u3001\u4e0d\u5b8c\u6574\u6216\u65e0\u6cd5\u7ffb\u8bd1\uff0c\u60a8\u7684\u5185\u90e8 QA \u56e2\u961f\u5c06\u82b1\u8d39\u6570\u767e\u5c0f\u65f6\u91cd\u65b0\u7f16\u5199\u5b83\u4eec\u3002\u8fd9\u63a8\u8fdf\u4e86\u751f\u4ea7\u7ebf\u7684\u201c\u4e0a\u7ebf\u201d\u65e5\u671f\uff0c\u5bfc\u81f4\u8be5\u516c\u53f8\u56e0\u5ef6\u8fdf\u836f\u54c1\u4e0a\u5e02\u6536\u5165\u800c\u635f\u5931\u4e86\u6570\u767e\u4e07\u7f8e\u5143\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u8bc4\u4f30\u8bbe\u5907\u5236\u9020\u5546\u65f6\uff0c\u91c7\u8d2d\u7ecf\u7406\u5fc5\u987b\u8be2\u95ee\uff1a\u00a0<\/span><span class=\"ng-star-inserted\">\u201c\u4f60\u4eec\u63d0\u4f9b\u5168\u9762\u7684\u3001\u53ef\u4f9b\u6267\u884c\u7684\u6587\u6863\u5305\u5417\uff1f\u201d<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Seamless_Compliance_with_JIANPAI_Pharmaceutical_Equipment\"><\/span><span class=\"ng-star-inserted\">Seamless Compliance with JIANPAI Pharmaceutical Equipment<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5728\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6c5f<\/span><\/strong><span class=\"ng-star-inserted\">\uff0c\u6211\u4eec\u660e\u767d\u6211\u4eec\u4e0d\u4ec5\u4ec5\u662f\u63d0\u4f9b\u673a\u68b0\uff1b\u6211\u4eec\u8ba9\u60a8\u5b89\u5fc3\u3002\u4f5c\u4e3a\u503c\u5f97\u4fe1\u8d56\u7684\u9876\u7ea7\u56fa\u4f53\u5236\u5242\u8bbe\u5907\u5236\u9020\u5546\uff0c\u5305\u62ec <a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><strong>\u5e73\u677f\u7535\u8111\u6d82\u6599\u673a<\/strong><\/a>, <a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/high-shear-mixer\/\" target=\"_blank\" rel=\"noopener\"><strong>\u9ad8\u526a\u5207\u6df7\u5408\u5668<\/strong><\/a>\uff0c \u548c <a href=\"https:\/\/www.jianpaitech.com\/zh\/product_category\/high-shear-mixer\/\" target=\"_blank\" rel=\"noopener\"><strong>\u6d41\u5316\u5e8a\u7cfb\u7edf<\/strong><\/a>\u2014\u6211\u4eec\u5c06\u5408\u89c4\u6027\u878d\u5165\u5230\u6d41\u7a0b\u7684\u6bcf\u4e00\u6b65\u4e2d\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5f53\u60a8\u4e0e\u5065\u6d3e\u5408\u4f5c\uff0c\u60a8\u5c06\u83b7\u5f97\u771f\u6b63\u7684\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4ea4\u94a5\u5319\u89e3\u51b3\u65b9\u6848<\/span><\/strong><span class=\"ng-star-inserted\">:<\/span><\/p>\n<ol class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u900f\u660e FAT \u6267\u884c\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u6211\u4eec\u6b22\u8fce\u5168\u7403\u5ba2\u6237\u4f7f\u7528\u6211\u4eec\u6700\u5148\u8fdb\u7684\u8bbe\u65bd\u8fdb\u884c\u4e25\u683c\u3001\u5b8c\u6574\u8bb0\u5f55\u7684\u5de5\u5382\u9a8c\u6536\u6d4b\u8bd5\u3002 \uff08\u89c6\u9891 FAT \u4e5f\u53ef\u4f9b\u8fdc\u7a0b\u56e2\u961f\u4f7f\u7528\uff09\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u7efc\u5408\u9a8c\u8bc1\u5305\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u6211\u4eec\u63d0\u4f9b\u7cbe\u5fc3\u51c6\u5907\u7684\u82f1\u8bed IQ \u548c OQ \u534f\u8bae\uff0c\u4ee5\u53ca\u6240\u6709\u5fc5\u8981\u7684\u6750\u6599\u8bc1\u4e66\u3001\u710a\u63a5\u65e5\u5fd7\u548c\u6821\u51c6\u8bb0\u5f55\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">21 CFR \u7b2c 11 \u90e8\u5206\u5c31\u7eea\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u6211\u4eec\u5148\u8fdb\u7684 PLC\/HMI \u63a7\u5236\u7cfb\u7edf\u5177\u6709\u5185\u7f6e\u5ba1\u8ba1\u8ddf\u8e2a\u3001\u7535\u5b50\u7b7e\u540d\u548c\u5b89\u5168\u914d\u65b9\u7ba1\u7406\u529f\u80fd\uff0c\u786e\u4fdd\u60a8\u7684\u6570\u636e\u5b8c\u6574\u6027\u8f7b\u677e\u901a\u8fc7 FDA \u6216 EMA \u68c0\u67e5\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u4e0d\u8981\u8ba9\u9a8c\u8bc1\u969c\u788d\u803d\u8bef\u60a8\u7684\u4e0b\u4e00\u6761\u751f\u4ea7\u7ebf\u3002\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u3010\u7acb\u5373\u8054\u7cfb\u5efa\u6d3e\u7684\u5de5\u7a0b\u548c\u5408\u89c4\u56e2\u961f\u3011<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u8ba8\u8bba\u6211\u4eec\u5f3a\u5927\u7684\u8bbe\u5907\u548c\u6587\u6863\u5305\u5982\u4f55\u7b80\u5316\u60a8\u7684\u4e0b\u4e00\u4e2a\u91c7\u8d2d\u9879\u76ee\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions_FAQs\"><\/span><span class=\"ng-star-inserted\">\u5e38\u89c1\u95ee\u9898 (FAQ)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Q1\uff1a\u5982\u679cFAT 100%\u6210\u529f\uff0c\u6211\u4eec\u53ef\u4ee5\u8df3\u8fc7SAT\u5417\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u4e0d\u9700\u8981\u3002SAT \u662f\u5f3a\u5236\u6027\u7684\u3002\u8fd0\u8f93\u632f\u52a8\u3001\u6e29\u5ea6\u53d8\u5316\u4ee5\u53ca\u5728\u5de5\u5382\u91cd\u65b0\u7ec4\u88c5\u53ef\u80fd\u4f1a\u6539\u53d8\u673a\u5668\u7684\u72b6\u51b5\u3002\u6b64\u5916\uff0c\u5fc5\u987b\u9488\u5bf9\u60a8\u5de5\u5382\u7684\u7279\u5b9a\u5b9e\u7528\u7a0b\u5e8f\uff08\u5728 FAT \u671f\u95f4\u6a21\u62df\uff09\u5bf9\u673a\u5668\u8fdb\u884c\u6d4b\u8bd5\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Q2\uff1a\u8c01\u8d1f\u8d23\u6267\u884c IQ \u548c OQ\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u901a\u5e38\uff0c\u8bbe\u5907\u4f9b\u5e94\u5546\uff08\u5982\u5efa\u6d3e\uff09\u4f1a\u63d0\u4f9b\u7a7a\u767d\u7684 IQ\/OQ \u534f\u8bae\u6587\u6863\u3002\u6267\u884c\u901a\u5e38\u662f\u534f\u4f5c\u7684\u7ed3\u679c\uff1a\u4f9b\u5e94\u5546\u7684\u8c03\u8bd5\u5de5\u7a0b\u5e08\u5728\u73b0\u573a\u6267\u884c\u6d4b\u8bd5\uff0c\u800c\u5236\u836f\u516c\u53f8\u7684\u8d28\u91cf\u4fdd\u8bc1\u4eba\u5458\u89c1\u8bc1\u5e76\u7b7e\u7f72\u7ed3\u679c\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Q3\uff1a\u8bbe\u5907\u4f9b\u5e94\u5546\u662f\u5426\u8d1f\u8d23PQ\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u4e0d\u4f1a\u3002\u7531\u4e8e\u6027\u80fd\u9a8c\u8bc1 (PQ) \u6d89\u53ca\u5236\u836f\u516c\u53f8\u7684\u4e13\u6709\u836f\u7269\u914d\u65b9\u3001\u6d3b\u6027\u6210\u5206\u548c\u7279\u5b9a\u7684\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f (SOP)\uff0c\u56e0\u6b64\u6700\u7ec8\u7528\u6237\u7684\u9a8c\u8bc1\u56e2\u961f\u8d1f\u8d23\u7f16\u5199\u548c\u6267\u884c PQ\u3002\u4f46\u662f\uff0c\u5982\u679c\u9700\u8981\u8c03\u6574\u673a\u5668\uff0c\u53ef\u9760\u7684\u4f9b\u5e94\u5546\u5c06\u5728\u6b64\u9636\u6bb5\u63d0\u4f9b\u6280\u672f\u652f\u6301\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u7b80\u4ecb \u5728\u5236\u836f\u884c\u4e1a\uff0c\u8d2d\u4e70\u65b0\u8bbe\u5907\uff08\u65e0\u8bba\u662f\u9ad8\u526a\u5207\u6df7\u5408\u5668\u3001\u6d41\u5316\u5e8a\u5e72\u71e5\u673a\u8fd8\u662f\u7247\u5242\u5305\u8863\u673a\uff09\u4e0e\u8d2d\u4e70\u6807\u51c6\u5de5\u4e1a\u673a\u68b0\u6709\u7740\u6839\u672c\u7684\u4e0d\u540c\u3002\u60a8\u8d2d\u4e70\u7684\u4e0d\u4ec5\u4ec5\u662f\u4e0d\u9508\u94a2\u548c\u7535\u673a\uff1b\u60a8\u8fd8\u8d2d\u4e70\u4e86\u4e0d\u9508\u94a2\u548c\u7535\u673a\u3002\u00a0\u4f60\u8d2d\u4e70\u7684\u662f\u5408\u89c4\u6027\u3002 FDA\u3001EMA \u548c WHO \u7b49\u76d1\u7ba1\u673a\u6784\u8981\u6c42 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