{"id":5320,"date":"2022-06-23T11:35:54","date_gmt":"2022-06-23T11:35:54","guid":{"rendered":"https:\/\/dev2.antsolutions.eu\/?p=5320"},"modified":"2023-12-11T12:17:21","modified_gmt":"2023-12-11T12:17:21","slug":"mbr-master-batch-record","status":"publish","type":"post","link":"https:\/\/accevo.com\/zh\/glossary\/mbr-master-batch-record\/","title":{"rendered":"MBR - \u4e3b\u6279\u6b21\u8bb0\u5f55"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>\u4e3b\u6279\u6b21\u8bb0\u5f55\uff08MBR\uff09<\/strong> \u662f\u6307\u5b9a\u4e49\u5236\u9020\u65b9\u6cd5\u3001\u6750\u6599\u548c\u5176\u4ed6\u4e0e\u4ea7\u54c1\u5236\u9020\u548c\u6d4b\u8bd5\u6709\u5173\u7684\u7a0b\u5e8f\u3001\u51c6\u5219\u548c\u63a7\u5236\u7684\u6587\u4ef6\uff0c\u4e5f\u79f0\u4e3a\u5236\u9020\u6a21\u677f\u3002MBR \u662f GMP\uff08\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff09\u4e0d\u53ef\u5206\u5272\u7684\u4e00\u90e8\u5206\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3b\u6279\u6b21\u8bb0\u5f55\u65e8\u5728\u786e\u4fdd\u6dfb\u52a0\u4e86\u6240\u6709\u9002\u5f53\u7684\u6210\u5206\uff0c\u5e76\u5b8c\u6210\u548c\u8bb0\u5f55\u4e86\u6d41\u7a0b\u4e2d\u7684\u6bcf\u4e2a\u6b65\u9aa4\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3b\u6279\u6b21\u8bb0\u5f55 MBR\uff08\u53c8\u79f0\u4e3b\u751f\u4ea7\u8bb0\u5f55 MPR \u6216\u4e3b\u5236\u9020\u914d\u65b9 MMF\uff09\u662f\u8be6\u7ec6\u7684\u751f\u4ea7\u6307\u4ee4\u3002 <strong>\u6bcf\u4e2a\u72ec\u7279\u7684\u914d\u65b9\u548c\u6279\u91cf\u5927\u5c0f\u90fd\u5fc5\u987b\u6709\u81ea\u5df1\u7684 MBR<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f8b\u5982\uff0c\u4e3b\u6279\u6b21\u8bb0\u5f55\u9700\u8981\u4ee5\u4e0b\u4fe1\u606f\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4ea7\u54c1\u540d\u79f0\u6807\u8bc6\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e00\u4efd\u6750\u6599\u6e05\u5355\uff0c\u8be6\u7ec6\u8bf4\u660e\u5236\u4f5c\u6279\u6b21\u6240\u9700\u7684\u6bcf\u79cd\u914d\u6599\u7684\u91cd\u91cf\u3001\u5ea6\u91cf\u6216\u6570\u91cf\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8bbe\u5907\u6e05\u5355\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7ec4\u4ef6\u5217\u8868\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u751f\u4ea7\u8fc7\u7a0b\u6bcf\u4e2a\u9636\u6bb5\u7684\u7406\u8bba\u4ea7\u91cf\u8bf4\u660e\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6210\u54c1\u7684\u9884\u671f\u4ea7\u91cf\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u6bcf\u4e2a\u6761\u4ef6\u7684\u8be6\u7ec6\u8bf4\u660e\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u53d6\u6837\u548c\u6d4b\u8bd5\u7a0b\u5e8f\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u624b\u52a8\u64cd\u4f5c\u8bf4\u660e\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5dee\u5f02\u6570\u636e<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6bcf\u4e2a\u72ec\u7279\u7684\u914d\u65b9\u548c\u6279\u91cf\u90fd\u9700\u8981\u8fd9\u4e9b\u8bb0\u5f55\u5728\u6848\u7684\u8bf4\u660e\uff0c\u4ee5\u786e\u4fdd\u6bcf\u6b21\u751f\u4ea7\u8fc7\u7a0b\u7684\u6807\u51c6\u5316\u548c\u53ef\u91cd\u590d\u6027\u3002\u7531\u4e8e MBR \u662f\u7528\u4e8e\u590d\u5236\u7684\u539f\u59cb\u6a21\u677f\uff0c\u56e0\u6b64\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u65e0\u9700\u586b\u5199\u3002\u5b83\u4e0e\u751f\u4ea7\u7f16\u53f7\u6216\u96f6\u4ef6\u7f16\u53f7\u76f8\u5173\u8054\uff0c\u4f46\u4e0e\u4efb\u4f55\u7279\u5b9a\u6279\u53f7\u65e0\u5173\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-dots\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8ba1\u7b97\u673a\u5316\u7684\u4e3b\u6279\u6b21\u8bb0\u5f55<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ba1\u7b97\u673a\u5316\u7684\u4e3b\u6279\u6b21\u8bb0\u5f55\u662f\u4e00\u79cd\u73b0\u4ee3\u5316\u7684\u751f\u4ea7\u8bb0\u5f55\u4fdd\u5b58\u65b9\u5f0f\uff0c\u5c06\u5148\u8fdb\u7684\u8f6f\u4ef6\u89e3\u51b3\u65b9\u6848\u96c6\u6210\u5230\u751f\u4ea7\u6d41\u7a0b\u4e2d\u3002\u8fd9\u79cd\u6570\u5b57\u5316\u8f6c\u578b\u5f7b\u5e95\u6539\u53d8\u4e86\u751f\u4ea7\u8fd0\u8425\u7ba1\u7406\u65b9\u5f0f\uff0c\u4e3a\u521b\u5efa\u3001\u7ba1\u7406\u548c\u4f18\u5316\u751f\u4ea7\u5de5\u4f5c\u6d41\u7a0b\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5168\u9762\u7684\u7cfb\u7edf\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u4e3b\u8981\u529f\u80fd\u548c\u4f18\u70b9<\/em><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u5b9e\u65f6\u6570\u636e\u6574\u5408<\/strong>:\u6570\u5b57 MBR \u53ef\u4e0e\u5404\u79cd\u5236\u9020\u7cfb\u7edf\u65e0\u7f1d\u96c6\u6210\uff0c\u5b9e\u73b0\u5b9e\u65f6\u6570\u636e\u4ea4\u6362\u3002\u8fd9\u79cd\u8fde\u63a5\u6027\u53ef\u786e\u4fdd\u751f\u4ea7\u4eba\u5458\u968f\u65f6\u83b7\u5f97\u6700\u65b0\u4fe1\u606f\uff0c\u4ece\u800c\u63d0\u9ad8\u51b3\u7b56\u548c\u89e3\u51b3\u95ee\u9898\u7684\u80fd\u529b\u3002<\/li>\n\n\n\n<li><strong>\u51cf\u5c11\u8bef\u5dee<\/strong>:\u6570\u5b57 MBR \u4e2d\u7684\u81ea\u52a8\u5316\u529f\u80fd\u901a\u8fc7\u81ea\u52a8\u8f93\u5165\u6570\u636e\u548c\u8fdb\u884c\u9a8c\u8bc1\u68c0\u67e5\uff0c\u5927\u5927\u964d\u4f4e\u4e86\u4eba\u4e3a\u9519\u8bef\u7684\u98ce\u9669\u3002\u8fd9\u5c06\u63d0\u9ad8\u4e00\u81f4\u6027\u548c\u4ea7\u54c1\u8d28\u91cf\u3002<\/li>\n\n\n\n<li><strong>\u9ad8\u6548\u7684\u914d\u65b9\u7ba1\u7406<\/strong>:\u6570\u5b57 MBR \u7b80\u5316\u4e86\u5bf9\u4e0d\u540c\u4ea7\u54c1\u548c\u6279\u91cf\u7684\u591a\u79cd\u914d\u65b9\u7684\u7ba1\u7406\u3002\u5236\u9020\u5546\u53ef\u4ee5\u6beb\u4e0d\u8d39\u529b\u5730\u521b\u5efa\u3001\u66f4\u65b0\u548c\u7ef4\u62a4\u914d\u65b9\uff0c\u786e\u4fdd\u6bcf\u6b21\u751f\u4ea7\u90fd\u51c6\u786e\u65e0\u8bef\u3002<\/li>\n\n\n\n<li><strong>\u7248\u672c\u63a7\u5236<\/strong>:DMBR \u7cfb\u7edf\u5f3a\u5927\u7684\u7248\u672c\u63a7\u5236\u529f\u80fd\u53ef\u786e\u4fdd\u751f\u4ea7\u6307\u4ee4\u7b26\u5408\u6700\u65b0\u6cd5\u89c4\u3002\u5236\u9020\u5546\u53ef\u4ee5\u8fc5\u901f\u9002\u5e94\u4e0d\u65ad\u53d8\u5316\u7684\u8981\u6c42\uff0c\u800c\u4e0d\u4f1a\u5f71\u54cd\u5408\u89c4\u6027\u3002<\/li>\n\n\n\n<li><strong>\u7535\u5b50\u7b7e\u540d\u548c\u5ba1\u8ba1\u8ddf\u8e2a<\/strong>:\u8ba1\u7b97\u673a\u5316\u7684 MBR \u6709\u5229\u4e8e\u7535\u5b50\u7b7e\u540d\u548c\u7ef4\u62a4\u5168\u9762\u7684\u5ba1\u8ba1\u8ddf\u8e2a\u3002\u8fd9\u4e00\u529f\u80fd\u5bf9\u4e8e\u8ddf\u8e2a\u548c\u9a8c\u8bc1\u5173\u952e\u64cd\u4f5c\u3001\u5e2e\u52a9\u9075\u5b88\u6cd5\u89c4\u548c\u652f\u6301\u8c03\u67e5\u81f3\u5173\u91cd\u8981\u3002<\/li>\n<\/ol>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1-1024x1024.png\" alt=\"\" class=\"wp-image-16095\" title=\"\" srcset=\"https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1-1024x1024.png 1024w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1-300x300.png 300w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1-150x150.png 150w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1-768x768.png 768w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1-12x12.png 12w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-96-1.png 1500w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\">\u73b0\u4ee3 <em>\u8ba1\u7b97\u673a\u5316\u7684 MBR \u5305\u62ec\u8ddf\u8e2a\u6587\u4ef6\u6d41\u7a0b\u548c\u7a0b\u5e8f\u7684\u5de5\u4f5c\u6d41\u7a0b\u5b9a\u5236\u5668\u3002<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large is-resized is-style-default\"><img decoding=\"async\" src=\"https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1-1024x1024.png\" alt=\"\u5c4f\u5e55\u663e\u793a\u5668\" class=\"wp-image-16094\" style=\"width:416px;height:416px\" width=\"416\" height=\"416\" title=\"\" srcset=\"https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1-1024x1024.png 1024w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1-300x300.png 300w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1-150x150.png 150w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1-768x768.png 768w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1-12x12.png 12w, https:\/\/accevo.com\/wp-content\/uploads\/2023\/09\/MicrosoftTeams-image-95-1.png 1500w\" sizes=\"(max-width: 416px) 100vw, 416px\" \/><figcaption class=\"wp-element-caption\"><em>\u6570\u5b57\u4e3b\u6279\u6b21\u8bb0\u5f55\u901a\u8fc7\u62d6\u653e\u5f0f\u8868\u683c\u751f\u6210\u5668\u521b\u5efa\u3002 <\/em><\/figcaption><\/figure>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/accevo.com\/zh\/%e5%b7%a5%e4%b8%9a-%e8%bd%af%e4%bb%b6\/%e5%8c%bb%e8%8d%af\/\">\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee Pharma \u7f51\u7ad9<\/a><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Master Batch Record (MBR) means a document defining manufacturing methods, materials and other procedures, guidelines and controls related to product manufacturing and testing, also referred to as a manufacturing template. MBR is an integral part of GMP &#8211; Good Manufacturing Practice. The Master Batch Record is designed to ensure that all proper ingredients are added [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"wpai_generated_summary":"","footnotes":""},"categories":[32],"tags":[],"class_list":["post-5320","post","type-post","status-publish","format-standard","hentry","category-glossary"],"_links":{"self":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/5320","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=5320"}],"version-history":[{"count":0,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/5320\/revisions"}],"wp:attachment":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/media?parent=5320"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/categories?post=5320"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/tags?post=5320"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}