{"id":40395,"date":"2026-10-29T16:25:34","date_gmt":"2026-10-29T16:25:34","guid":{"rendered":"https:\/\/dev.accevo.com\/blog\/critical-process-parameters-in-pharma-cpps-quality-and-control\/"},"modified":"2026-10-29T16:25:44","modified_gmt":"2026-10-29T16:25:44","slug":"%e5%88%b6%e8%8d%af%e5%85%b3%e9%94%ae%e5%b7%a5%e8%89%ba%e5%8f%82%e6%95%b0","status":"publish","type":"post","link":"https:\/\/accevo.com\/zh\/blog\/critical-process-parameters-pharma\/","title":{"rendered":"\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5173\u952e\u5de5\u827a\u53c2\u6570\uff1aCPPs\u3001\u8d28\u91cf\u4e0e\u63a7\u5236"},"content":{"rendered":"<p><strong>\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\u662f\u6307\u5176\u53d8\u5316\u4f1a\u5f71\u54cd\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u5de5\u827a\u53d8\u91cf\uff0c\u56e0\u6b64\u9700\u8981\u8fdb\u884c\u76d1\u6d4b\u6216\u63a7\u5236\u3002.<\/strong> \u5728\u5236\u836f\u751f\u4ea7\u4e2d\uff0c\u5206\u7c7b\u53d6\u51b3\u4e8e\u4ea7\u54c1\u548c\u5de5\u827a\uff1a\u4ec5\u56e0\u56e2\u961f\u5bf9\u6e29\u5ea6\u3001\u6df7\u5408\u65f6\u95f4\u6216\u538b\u529b\u8fdb\u884c\u4e86\u6d4b\u91cf\uff0c\u5e76\u4e0d\u610f\u5473\u7740\u8fd9\u4e9b\u53c2\u6570\u81ea\u52a8\u5c31\u5c5e\u4e8e\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\u3002.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/accevo.com\/wp-content\/uploads\/2026\/10\/pharma-mes-integration-illustration.jpg\" alt=\"\u7531\u4eba\u5de5\u667a\u80fd\u751f\u6210\u7684\u5236\u836f\u5de5\u827a\u8bbe\u5907\u53ca\u5e26\u4eea\u8868\u7684\u63a7\u5236\u67dc\u63d2\u56fe\u3002.\" title=\"\"><\/p>\n<p>\u7531\u4eba\u5de5\u667a\u80fd\u751f\u6210\u7684\u63d2\u56fe\u3002\u56fe\u4e2d\u6240\u793a\u5e76\u975e Accevo \u6216\u5176\u5ba2\u6237\u7684\u8bbe\u65bd\u3002.<\/p>\n<h2>\u5173\u952e\u5de5\u827a\u53c2\u6570\u548c\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/h2>\n<p><a href=\"https:\/\/www.ema.europa.eu\/system\/files\/documents\/scientific-guideline\/wc500002872_en.pdf\" rel=\"nofollow noopener\" target=\"_blank\">ICH Q8(R2)<\/a> \u901a\u8fc7\u5176\u53d8\u5f02\u6027\u5bf9\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQA\uff09\u7684\u5f71\u54cd\u6765\u5b9a\u4e49\u5173\u952e\u8fc7\u7a0b\u53c2\u6570\uff08CPP\uff09\u3002\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u662f\u6307\u5e94\u4fdd\u6301\u5728\u9002\u5f53\u7684\u9650\u503c\u3001\u8303\u56f4\u6216\u5206\u5e03\u5185\uff0c\u4ee5\u8fbe\u5230\u9884\u671f\u4ea7\u54c1\u8d28\u91cf\u7684\u7269\u7406\u3001\u5316\u5b66\u3001\u751f\u7269\u6216\u5fae\u751f\u7269\u7279\u6027\u3002.<\/p>\n<p>\u5de5\u827a\u5f00\u53d1\u548c\u8d28\u91cf\u56e2\u961f\u4f1a\u8c03\u67e5\u67d0\u4e2a\u53c2\u6570\u4e0e\u67d0\u4e2a\u5c5e\u6027\u4e4b\u95f4\u7684\u5173\u7cfb\u3002\u4ed6\u4eec\u5229\u7528\u5de5\u827a\u77e5\u8bc6\u3001\u5b9e\u9a8c\u548c\u98ce\u9669\u8bc4\u4f30\u6765\u5224\u65ad\u8be5\u53c2\u6570\u662f\u5426\u4e3a\u5173\u952e\u53c2\u6570\uff0c\u4ee5\u53ca\u5982\u4f55\u5bf9\u5176\u8fdb\u884c\u63a7\u5236\u3002\u5373\u4f7f\u67d0\u4e2a\u53d8\u91cf\u4e0e\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQA\uff09\u4e4b\u95f4\u7684\u5173\u7cfb\u5e76\u672a\u4f7f\u5176\u6210\u4e3a\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\uff0c\u4f46\u82e5\u8be5\u53d8\u91cf\u5bf9\u4ea7\u91cf\u6216\u8bbe\u5907\u4fdd\u62a4\u81f3\u5173\u91cd\u8981\uff0c\u4ecd\u9700\u4e88\u4ee5\u5173\u6ce8\u3002.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/accevo.com\/wp-content\/uploads\/2026\/10\/cpp-quality-link.png\" alt=\"\u5c06\u5de5\u827a\u53c2\u6570\u4e0e\u8d28\u91cf\u5c5e\u6027\u53ca\u63a7\u5236\u7b56\u7565\u8054\u7cfb\u8d77\u6765\u7684\u793a\u610f\u56fe\u3002.\" title=\"\"><\/p>\n<p>\u793a\u610f\u6027\u5173\u7cfb\u3002\u53c2\u6570\u7684\u5206\u7c7b\u53d6\u51b3\u4e8e\u9488\u5bf9\u5177\u4f53\u4ea7\u54c1\u548c\u5de5\u827a\u7684\u8bc1\u636e\u3002.<\/p>\n<h2>\u5236\u836f\u884c\u4e1a\u4e2d\u6f5c\u5728CPP\u7684\u793a\u4f8b<\/h2>\n<p>\u4ee5\u4e0b\u793a\u4f8b\u4ec5\u4f5c\u4e3a\u8bc4\u4f30\u7684\u53c2\u8003\u8d77\u70b9\u3002\u5b83\u4eec\u5e76\u975e\u9488\u5bf9\u5b9e\u9645\u4ea7\u54c1\u7684\u5206\u7c7b\u6216\u64cd\u4f5c\u9650\u503c\u3002\u5404\u5de5\u5382\u5fc5\u987b\u786e\u5b9a\u5176\u4e0e\u81ea\u8eab\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQAs\uff09\u53ca\u5de5\u827a\u4e4b\u95f4\u7684\u5173\u7cfb\uff1a<\/p>\n<ul>\n<li>\n<p><strong>\u8c03\u914d\uff1a<\/strong> \u5728\u7814\u7a76\u6df7\u5408\u5747\u5300\u6027\u548c\u6210\u5206\u5747\u5300\u6027\u7684\u540c\u65f6\uff0c\u8fd8\u5e94\u7814\u7a76\u6df7\u5408\u65f6\u95f4\u6216\u8bbe\u5907\u8f6c\u901f\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u9020\u7c92\u4e0e\u5e72\u71e5\uff1a<\/strong> \u55b7\u96fe\u901f\u7387\u3001\u8fdb\u6599\u6e29\u5ea6\u6216\u5e72\u71e5\u65f6\u95f4\u53ef\u80fd\u9700\u8981\u4e0e\u6c34\u5206\u542b\u91cf\u53ca\u4e0b\u6e38\u4ea7\u54c1\u6027\u80fd\u4e00\u5e76\u8fdb\u884c\u7814\u7a76\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u7247\u5242\u538b\u5236\uff1a<\/strong> \u5e94\u7814\u7a76\u538b\u7f29\u529b\u4e0e\u529b\u5b66\u6027\u80fd\u53ca\u6eb6\u51fa\u5ea6\u4e4b\u95f4\u7684\u5173\u7cfb\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u751f\u7269\u53cd\u5e94\u5668\u7684\u8fd0\u884c\uff1a<\/strong> pH\u503c\u3001\u6e29\u5ea6\u6216\u6eb6\u89e3\u6c27\u53ef\u80fd\u9700\u8981\u4e0e\u76f8\u5173\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u4e00\u5e76\u8fdb\u884c\u7814\u7a76\u3002.<\/p>\n<\/li>\n<\/ul>\n<p>\u540c\u4e00\u4e2a\u53d8\u91cf\u5728\u53e6\u4e00\u79cd\u914d\u65b9\u3001\u8bbe\u5907\u6d41\u7a0b\u6216\u751f\u4ea7\u89c4\u6a21\u4e0b\u53ef\u80fd\u53d1\u6325\u4e0d\u540c\u7684\u4f5c\u7528\u3002\u5e94\u8c03\u67e5\u53d8\u91cf\u4e4b\u95f4\u7684\u53ef\u80fd\u76f8\u4e92\u4f5c\u7528\uff0c\u800c\u4e0d\u662f\u76f4\u63a5\u4ece\u901a\u7528\u5217\u8868\u4e2d\u786e\u5b9a\u5176\u5173\u952e\u6027\u3002.<\/p>\n<h2>\u56e2\u961f\u5982\u4f55\u786e\u5b9a\u5173\u952e\u5de5\u827a\u53c2\u6570<\/h2>\n<ol>\n<li>\n<p><strong>\u5b9a\u4e49\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\uff1a<\/strong> \u8bb0\u5f55\u4e0e\u8be5\u4ea7\u54c1\u76f8\u5173\u7684\u5c5e\u6027\u548c\u8d28\u91cf\u76ee\u6807\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u6620\u5c04\u5355\u5143\u64cd\u4f5c\uff1a<\/strong> \u5217\u51fa\u6bcf\u4e2a\u6b65\u9aa4\u7684\u7269\u6599\u5c5e\u6027\u3001\u5de5\u827a\u53c2\u6570\u3001\u8bbe\u5907\u53ca\u6d4b\u91cf\u70b9\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u8bc4\u4f30\u98ce\u9669\uff1a<\/strong> \u5229\u7528\u79d1\u5b66\u8ba4\u8bc6\u548c\u73b0\u6709\u8bc1\u636e\uff0c\u5bf9\u53ef\u80fd\u5bf9\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQAs\uff09\u4ea7\u751f\u7684\u5f71\u54cd\u8fdb\u884c\u4f18\u5148\u7ea7\u6392\u5e8f\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u7814\u7a76\u5173\u7cfb\uff1a<\/strong> \u5229\u7528\u9002\u5f53\u7684\u5b9e\u9a8c\u3001\u5148\u9a8c\u77e5\u8bc6\u548c\u8fc7\u7a0b\u6570\u636e\u6765\u7814\u7a76\u5404\u79cd\u6548\u5e94\u53ca\u5176\u76f8\u4e92\u4f5c\u7528\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u5b9a\u4e49\u63a7\u4ef6\uff1a<\/strong> \u6587\u4ef6\u76d1\u63a7\u3001\u64cd\u4f5c\u8303\u56f4\u3001\u804c\u8d23\u4ee5\u53ca\u5bf9\u63a7\u5236\u7b56\u7565\u4e2d\u504f\u5dee\u7684\u5e94\u5bf9\u63aa\u65bd\u3002.<\/p>\n<\/li>\n<li>\n<p><strong>\u8d2f\u7a7f\u751f\u547d\u5468\u671f\u7684\u5ba1\u67e5\uff1a<\/strong> \u5f53\u77e5\u8bc6\u3001\u6750\u6599\u3001\u89c4\u6a21\u6216\u8bbe\u5907\u53d1\u751f\u53d8\u5316\u65f6\uff0c\u5e94\u6839\u636e\u8be5\u73b0\u573a\u7684\u53d8\u66f4\u6d41\u7a0b\u66f4\u65b0\u8bc4\u4f30\u7ed3\u679c\u3002.<\/p>\n<\/li>\n<\/ol>\n<p>\u5b9e\u9a8c\u8bbe\u8ba1\u6709\u52a9\u4e8e\u56e2\u961f\u7814\u7a76\u591a\u4e2a\u56e0\u7d20\u53ca\u5176\u76f8\u4e92\u4f5c\u7528\u3002\u5386\u53f2\u6279\u6b21\u6570\u636e\u53ef\u4ee5\u63d0\u4f9b\u80cc\u666f\u4fe1\u606f\uff0c\u4f46\u4ec5\u51ed\u76f8\u5173\u6027\u53ef\u80fd\u65e0\u6cd5\u786e\u7acb\u56e0\u679c\u5173\u7cfb\u3002\u8be5 <a href=\"https:\/\/www.ema.europa.eu\/system\/files\/documents\/scientific-guideline\/wc500123518_en.pdf\" rel=\"nofollow noopener\" target=\"_blank\">ICH Q8\/Q9\/Q10 \u9700\u8003\u8651\u7684\u8981\u70b9<\/a> \u63a2\u8ba8\u4e86\u53c2\u6570\u5173\u952e\u6027\u3001\u8d28\u91cf\u5c5e\u6027\u548c\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u4e4b\u95f4\u7684\u5173\u7cfb\u3002.<\/p>\n<h2>\u5de5\u4f5c\u8303\u56f4\u3001\u6781\u9650\u548c\u8bbe\u8ba1\u7a7a\u95f4<\/h2>\n<p>\u56e2\u961f\u6839\u636e\u53ef\u7528\u7684\u5f00\u53d1\u8bc1\u636e\u3001\u6d4b\u91cf\u80fd\u529b\u548c\u5df2\u6279\u51c6\u7684\u63a7\u5236\u7b56\u7565\uff0c\u786e\u5b9a\u67d0\u53c2\u6570\u7684\u5de5\u4f5c\u8303\u56f4\u3002ICH Q8 \u63cf\u8ff0\u4e86\u5728\u5176\u4ed6\u53c2\u6570\u4fdd\u6301\u6052\u5b9a\u7684\u60c5\u51b5\u4e0b\uff0c\u5355\u4e2a\u53c2\u6570\u7684\u7ecf\u9a8c\u8bc1\u5b9e\u7684\u53ef\u63a5\u53d7\u8303\u56f4\u3002 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decoding=\"async\" src=\"https:\/\/accevo.com\/wp-content\/uploads\/2026\/10\/cpp-illustrative-trend.png\" alt=\"\u516d\u4e2a\u91c7\u6837\u70b9\u7684\u6e29\u5ea6\u8d8b\u52bf\u793a\u610f\u56fe\uff1b\u6570\u503c\u5747\u4e3a\u865a\u6784\uff0c\u4e14\u672a\u663e\u793a\u4efb\u4f55\u7ecf\u9a8c\u8bc1\u7684\u9650\u503c\u3002.\" title=\"\"><\/p>\n<p>\u4ec5\u4f9b\u53c2\u8003\u3002\u6b64\u6570\u636e\u5e76\u975e\u5b9e\u9645\u6d4b\u91cf\u503c\uff0c\u4ea6\u975e\u7ecf\u9a8c\u8bc1\u7684\u8fd0\u884c\u8303\u56f4\u3002.<\/p>\n<h2>MES \u548c\u7535\u5b50\u6279\u6b21\u8bb0\u5f55\u5982\u4f55\u652f\u6301 CPP 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<a href=\"https:\/\/accevo.com\/zh\/%e5%8d%9a%e5%ae%a2\/mes-%e8%af%89-ebr-pharma\/\">MES \u4e0e EBR \u4e4b\u95f4\u7684\u533a\u522b<\/a>\uff0c\u5728 <a href=\"https:\/\/accevo.com\/zh\/%e5%8d%9a%e5%ae%a2\/pharma-mes-integration-erp-lims-scada\/\">\u5236\u836fMES\u96c6\u6210\u6307\u5357<\/a> \u4ee5\u53ca Accevo \u7684 <a href=\"https:\/\/accevo.com\/zh\/%e5%b7%a5%e4%b8%9a-%e8%bd%af%e4%bb%b6\/mes%e5%88%b6%e8%8d%af%e8%bd%af%e4%bb%b6%ef%bc%8c%e9%80%82%e7%94%a8%e4%ba%8e%e5%88%b6%e8%8d%af%e7%94%9f%e4%ba%a7\/\">\u5236\u836f\u751f\u4ea7\u8f6f\u4ef6\u6982\u8ff0<\/a>.<\/p>\n<h2>\u5173\u4e8eCPP\u7684\u5e38\u89c1\u95ee\u9898<\/h2>\n<h3>\u6bcf\u4e2a\u5de5\u827a\u53c2\u6570\u90fd\u662fCPP\u5417\uff1f<\/h3>\n<p>\u4e0d\u3002\u5173\u952e\u6027\u80fd\u53c2\u6570\uff08CPP\uff09\u7684\u786e\u5b9a\uff0c\u53d6\u51b3\u4e8e\u5176\u53d8\u5f02\u6027\u5bf9\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQA\uff09\u7684\u5f71\u54cd\uff0c\u4ee5\u53ca\u7531\u6b64\u4ea7\u751f\u7684\u76d1\u6d4b\u6216\u63a7\u5236\u9700\u6c42\u3002\u5176\u4ed6\u53c2\u6570\u5bf9\u4e8e\u5b89\u5168\u6027\u3001\u6027\u80fd\u6216\u8bbe\u5907\u8fd0\u884c\u800c\u8a00\uff0c\u53ef\u80fd\u4ecd\u7136\u5f88\u91cd\u8981\u3002.<\/p>\n<h3>CPP\u5728\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\u4f1a\u53d1\u751f\u53d8\u5316\u5417\uff1f<\/h3>\n<p>\u968f\u7740\u5de5\u827a\u77e5\u8bc6\u6216\u64cd\u4f5c\u6761\u4ef6\u7684\u53d8\u5316\uff0c\u5404\u56e2\u961f\u53ef\u91cd\u65b0\u8bc4\u4f30\u5173\u952e\u6027\u53ca\u63a7\u5236\u63aa\u65bd\u3002\u5e94\u9075\u5faa\u8be5\u573a\u6240\u7684\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u548c\u53d8\u66f4\u6d41\u7a0b\uff0c\u5e76\u8bc4\u4f30\u9002\u7528\u7684\u76d1\u7ba1\u8981\u6c42\u3002.<\/p>\n<h3>\u7535\u5b50\u8bb0\u5f55\u80fd\u5426\u786e\u4fdd\u5408\u89c4\uff1f<\/h3>\n<p>\u4e0d\u3002\u5408\u89c4\u6027\u53d6\u51b3\u4e8e\u9884\u671f\u7528\u9014\u3001\u9002\u7528\u7684\u8981\u6c42\u3001\u7cfb\u7edf\u914d\u7f6e\u3001\u7a0b\u5e8f\u548c\u8bc1\u636e\u3002\u7535\u5b50\u8bb0\u5f55\u662f\u8be5\u7ad9\u70b9\u8d28\u91cf\u4f53\u7cfb\u7684\u4e00\u90e8\u5206\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Learn what critical process parameters are, how they relate to critical quality attributes, and how pharma teams identify, monitor and document them.<\/p>","protected":false},"author":2,"featured_media":40127,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"wpai_generated_summary":"","footnotes":""},"categories":[30],"tags":[],"class_list":["post-40395","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/40395","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/comments?post=40395"}],"version-history":[{"count":1,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/40395\/revisions"}],"predecessor-version":[{"id":40396,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/40395\/revisions\/40396"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/media\/40127"}],"wp:attachment":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/media?parent=40395"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/categories?post=40395"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/tags?post=40395"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}