{"id":1152,"date":"2023-07-04T03:39:37","date_gmt":"2023-07-03T19:39:37","guid":{"rendered":"http:\/\/chinaxfc.com\/index.php\/2023\/07\/04\/%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e9%a3%9f%e5%93%81%e8%a1%8c%e4%b8%9a%e4%b8%ad%e7%9a%84%e5%89%8d%e6%99%af\/"},"modified":"2023-07-04T03:39:37","modified_gmt":"2023-07-03T19:39:37","slug":"%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e9%a3%9f%e5%93%81%e8%a1%8c%e4%b8%9a%e4%b8%ad%e7%9a%84%e5%89%8d%e6%99%af","status":"publish","type":"post","link":"http:\/\/chinaxfc.com\/index.php\/2023\/07\/04\/%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e9%a3%9f%e5%93%81%e8%a1%8c%e4%b8%9a%e4%b8%ad%e7%9a%84%e5%89%8d%e6%99%af\/","title":{"rendered":"\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u98df\u54c1\u884c\u4e1a\u4e2d\u7684\u524d\u666f"},"content":{"rendered":"

\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u98df\u54c1\u884c\u4e1a\u4e2d\u7684\u524d\u666f<\/strong><\/font><\/p>\n

\u4e8e\u662fGMP\u5bf9\u6b64\u4f5c\u4e86\u5168\u9762\u7684\u63a7\u5236\u3002 <\/font><\/p>\n

\u5e94\u8be5\u7406\u89e3GMP\u57fa\u672c\u8981\u7d20\u662f \u5b66\u4e60\u9886\u4f1aGMP\u65f6\u3002<\/font><\/p>\n

1\u5c06\u4eba\u4e3a\u5dee\u9519\u63a7\u5236\u5230\u6700\u4f4e\u9650\u5ea6\uff1b <\/font><\/p>\n

2\u6709\u6548\u5730\u9632\u6b62\u836f\u54c1\u53d7\u5230\u6c61\u67d3\u548c\u8d28\u91cf\u4e0b\u964d\uff1b <\/font><\/p>\n

3\u5efa\u7acb\u5065\u5168\u7684\u751f\u4ea7\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u3002 <\/font><\/p>\n

\u540c\u6837\u4e5f\u9002\u7528\u4e86\u836f\u673a\u4ea7\u54c1\u7684\u751f\u4ea7\u548c\u7ba1\u7406\u3002\u56e0\u4e3aGMP\u5bf9\u8bbe\u5907\u8bbe\u8ba1\u3001\u9009\u7528\u3001\u88c5\u7f6e\u3001\u7ef4\u62a4\u3001\u9890\u517b\u7684\u8981\u6c42\uff0c\u8fd9\u4e9b\u57fa\u672c\u8981\u7d20\u4e0d\u53ea\u9002\u7528\u4e8e\u836f\u54c1\u751f\u4ea7\u548c\u7ba1\u7406\u3002\u4e5f\u662f\u6839\u636eGMP\u57fa\u672c\u8981\u7d20\u63d0\u51fa\u7684\u56fdGMP1998\u9664\u4e86\u5bf9\u201c\u8bbe\u5907\u201d\u4e13\u8bbe\u4e00\u7ae0\uff0c\u5355\u72ec\u5bf9\u8bbe\u5907\u63d0\u51fa\u8981\u6c42\u5916\uff0c\u540c\u65f6\u5728\u5382\u623f\u4e0e\u8bbe\u65bd\u201d\u536b\u751f\u201d\u9a8c\u8bc1\u201d\u6587\u4ef6\u201d\u751f\u4ea7\u7ba1\u7406\u201d\u53ca\u201c\u9644\u5f55\u201d\u7b49\u7ae0\u8282\u4e2d\uff0c\u4e5f\u63d0\u51fa\u4e86\u76f8\u5173\u8981\u6c42\u3002 <\/font><\/p>\n

\u8bbe\u8ba1\u3001\u5236\u9020\u548c\u5b89\u88c5\u65f6\uff0c\u4e3a\u4e86\u9632\u6b62\u836f\u673a\u4ea7\u54c1\u4f7f\u7528\u4e2d\u9020\u6210\u6216\u5f15\u53d1\u836f\u54c1\u751f\u4ea7\u7684\u8fc7\u5931\u548c\u6c61\u67d3\u3002\u5e94\u6ee1\u8db3\u4ee5\u4e0b\u8981\u6c42\uff1a <\/font><\/p>\n

\u5916\u8868\u5149\u6d01\uff0c1\u7ed3\u6784\u7b80\u5355\u3002\u6613\u6e05\u6d01\u3002\u88c5\u6709\u7269\u6599\u7684\u8bbe\u5907\u5c3d\u91cf\u5bc6\u95ed\uff0c\u9632\u6b62\u655e\u53e3\u3002\u4e0e\u7269\u6599\u76f4\u63a5\u63a5\u89e6\u7684\u5185\u58c1\u5e94\u5149\u6ed1\uff0c\u5e73\u6574\u3001\u9632\u6b62\u6b7b\u89d2\uff0c\u6613\u6e05\u6d17\uff0c\u8010\u8150\u8680\uff1b <\/font><\/p>\n

\u4e0d\u91ca\u51fa\u5fae\u7c92\u53ca\u4e0d\u5438\u9644\u7269\u6599\u7684\u8d44\u6599\u3002\u751f\u4ea7\u65e0\u83cc\u836f\u54c1\u7684\u8bbe\u5907\u3001\u5bb9\u5668\u5177\u7b49\u5b9c\u91c7\u7528\u4f18\u8d28\u4f4e\u78b3\u4e0d\u9508\u94a2\uff1b 2\u4e0e\u7269\u6599\u76f4\u63a5\u63a5\u89e6\u7684\u8bbe\u5907\u5185\u8868\u5c42\u5e94\u91c7\u7528\u4e0d\u4e0e\u5176\u53cd\u5e94\u3002<\/font><\/p>\n

\u9632\u6b62\u6da6\u6ed1\u6cb9\u3001\u51b7\u5374\u5242\u7b49\u6cc4\u6f0f\u65f6\u5bf9\u539f\u6599\u3001\u534a\u6210\u54c1\u3001\u5e9f\u54c1\u3001\u5305\u88c5\u5bb9\u5668\u548c\u6750\u6599\u7684\u6c61\u67d3\uff1b 3\u8bbe\u5907\u7684\u4f20\u52a8\u90e8\u4ef6\u8981\u5bc6\u5c01\u826f\u597d\u3002<\/font><\/p>\n

\u9700\u8981\u706d\u83cc\u7684\u8bbe\u5907\u8fd8\u5e94\u6709\u5c31\u5730\u706d\u83cc\u7684\u8bbe\u65bd\u3002\u9700\u8981\u6e05\u6d17\u548c\u706d\u83cc\u7684\u96f6\u90e8\u4ef6\u8981\u6613\u4e8e\u62c6\u88c5\uff1b 4\u8bbe\u5907\u8981\u7ecf\u5e38\u6e05\u6d17\u3002\u65b9\u4fbf\u79fb\u52a8\u7684\u8bbe\u5907\u8981\u6709\u5c31\u5730\u6e05\u6d17\u7684\u8bbe\u65bd\u3002<\/font><\/p>\n

5\u7981\u6b62\u4f7f\u7528\u542b\u6709\u77f3\u68c9\u7684\u8fc7\u6ee4\u5668\u6750\u8fc7\u6ee4\u836f\u6db2\u3002\u4e0d\u5f97\u4f7f\u7528\u5438\u9644\u836f\u7269\u7ec4\u5206\u548c\u91ca\u653e\u5f02\u7269\u7684\u8fc7\u6ee4\u88c5\u7f6e\uff1b <\/font><\/p>\n

\u5b9c\u5c40\u90e8\u52a0\u8bbe\u9632\u5c18\u56f4\u5e18\u548c\u6355\u5c18\u3001\u5438\u7c89\u88c5\u7f6e\uff0c6\u5bf9\u751f\u4ea7\u4e2d\u53d1\u5c18\u91cf\u5927\u7684\u8bbe\u5907\u5982\u7c89\u788e\u3001\u8fc7\u7b5b\u3001\u6df7\u5408\u3001\u5236\u7c92\u3001\u5e72\u71e5\u3001\u538b\u7247\u3001\u5305\u8863\u7b49\u8bbe\u5907\u3002\u5c3e\u6c14\u6392\u653e\u5b9c\u8bbe\u6c14\u4f53\u8fc7\u6ee4\u548c\u9632\u6b62\u7a7a\u6c14\u5012\u704c\u7684\u88c5\u7f6e\uff1b <\/font><\/p>\n

\u6c14\u4f53\u6240\u542b\u5fae\u7c92\u548c\u5fae\u751f\u7269\u5e94\u7b26\u5408\u89c4\u5b9a\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u3002\u5e72\u71e5\u8bbe\u5907\u51fa\u98ce\u53e3\u5e94\u6709\u9632\u6b62\u7a7a\u6c14\u5012\u704c\u7684\u88c5\u7f6e\uff1b 7\u4e0e\u836f\u7269\u76f4\u63a5\u63a5\u89e6\u7684\u5e72\u71e5\u7528\u7a7a\u6c14\u3001\u538b\u7f29\u7a7a\u6c14\u3001\u60f0\u6027\u6c14\u4f53\u7b49\u5747\u5e94\u8bbe\u7f6e\u51c0\u5316\u88c5\u7f6e\u3002\u7ecf\u51c0\u5316\u5904\u7406\u540e\u3002<\/font><\/p>\n

\u9664\u7279\u6b8a\u8981\u6c42\u5916\uff0c8\u6d01\u51c0\u5ba4(\u533a)\u5185\u7684\u8bbe\u5907\u3002\u4e00\u822c\u4e0d\u5b9c\u8bbe\u5730\u811a\u87ba\u6813\uff1b <\/font><\/p>\n

\u5408\u7406\u8bbe\u7f6e\u6709\u5173\u53c2\u6570\u6d4b\u8bd5\u70b9\uff1b 9\u5e94\u80fd\u6ee1\u8db3\u9a8c\u8bc1\u8981\u6c42\u3002<\/font><\/p>\n

\u9664\u7b26\u5408\u4ee5\u4e0a\u8981\u6c42\u5916\uff0c10\u65e0\u83cc\u6d01\u51c0\u5ba4(\u533a)\u5185\u7684\u8bbe\u5907\u3002\u8fd8\u5e94\u6ee1\u8db3\u6d88\u6bd2\u6216\u706d\u83cc\u7684\u9700\u8981\uff1b <\/font><\/p>\n

\u8c03\u8282\u63a7\u5236\u7a33\u5b9a\u53ef\u9760\u3002\u9700\u8981\u91cd\u70b9\u63a7\u5236\u8ba1\u6570\u90e8\u4f4d\u51fa\u73b0\u4e0d\u5408\u683c\u6216\u6027\u80fd\u6545\u969c\u65f6\uff0c11\u8bbe\u5907\u6216\u673a\u68b0\u4e0a\u7684\u4eea\u8868\u3001\u8ba1\u91cf\u88c5\u7f6e\u8981\u8ba1\u6570\u51c6\u786e\u3002\u5e94\u6709\u8c03\u6574\u6216\u663e\u793a\u529f\u80fd\uff1b <\/font><\/p>\n

\u4e0d\u4ea7\u751f\u5dee\u9519\u3002\u51fa\u73b0\u4ea7\u54c1\u4e0d\u5408\u683c\u3001\u5f02\u7269\u6df7\u5165\u6216\u6027\u80fd\u6545\u969c\u65f6\uff0c12\u5236\u5242\u5305\u88c5\u673a\u68b0\u8981\u64cd\u4f5c\u7b80\u5355\u53ef\u9760\u3002\u5e94\u6709\u8c03\u6574\u6216\u663e\u793a\u529f\u80fd\u3002 <\/font><\/p>\n

\u8fd1\u5e74\u6765\u56fd\u5185\u5916\u90fd\u6709\u4e0d\u540c\u7a0b\u5ea6\u7684\u6df1\u5316\uff0c\u5bf9\u4e8e\u4e0a\u8ff0\u57fa\u672c\u8981\u6c42\u3002\u5e94\u5f15\u8d77\u5e7f\u5927\u836f\u673a\u5382\u7684\u5173\u6ce8\u548c\u91cd\u89c6\u3002 <\/font><\/p>\n

\u7279\u522b\u662f\u63a5\u89e6\u836f\u7269\u7684\u5236\u836f\u673a\u68b0\uff0c\u66f4\u6362\u54c1\u79cd\u65f6\u5fc5\u987b\u5f7b\u5e95\u6e05\u6d17\u3002\u5bf9\u4e8e\u65b9\u4fbf\u642c\u52a8\u7684\u8bbe\u5907\uff0c\u8981\u6c42\u5c31\u5730\u6e05\u6d17(cleaninplace,\u6bd4\u5982\u8bbe\u5907\u7684\u6e05\u6d17\u3002\u7b80\u79f0CIP\u6709\u7684\u8fd8\u8981\u5c31\u5730\u706d\u83cc(sterilinplace,\u7b80\u79f0SIP\u4e3a\u6b64\uff0c\u8fd9\u4e9b\u4ea7\u54c1\u5728\u8bbe\u8ba1\u3001\u88c5\u7f6e\u65f6\u8981\u8003\u8651CIP\u548cSIP\u56e0\u7d20\u4ee5\u53ca\u7531\u6b64\u800c\u5f15\u8d77\u7684\u76f8\u5173\u95ee\u9898\uff0c\u5982\u6d17\u6da4\u540e\u7684\u5e72\u71e5\u7b49\u3002 <\/font><\/p>\n

\u5305\u62ec\u8bbe\u5907\u7684\u88c5\u7f6e\u786e\u8ba4(instalQualification,\u8bbe\u5907\u9a8c\u8bc1\u66f4\u662f\u70ed\u95e8\u8bdd\u9898\u3002\u7b80\u79f0IQ\u8fd0\u884c\u786e\u8ba4(operQualification,\u7b80\u79f0OQ\u6027\u80fd\u786e\u8ba4(performQualification,\u7b80\u79f0PQ\u4ee5\u53ca\u6295\u5165\u751f\u4ea7\u540e\u7684\u4ea7\u54c1\u9a8c\u8bc1(ProcluctValidation,\u7b80\u79f0PV\u7b49\u56db\u4e2a\u9636\u6bb5\u3002\u5bf9\u4e8e\u6bcf\u79cd\u836f\u673a\u4ea7\u54c1\u90fd\u6709\u81ea\u5df1IQOQPQ\u548cPV\u5185\u5bb9\u3002\u9a8c\u8bc1\u6d4b\u8bd5\u9879\u76ee\u5df2\u7ecf\u7ed9\u836f\u673a\u4ea7\u54c1\u5e26\u6765\u65b0\u8bfe\u9898\uff0c\u4e00\u4e9b\u65e0\u6cd5\u5f00\u5c55\u9a8c\u8bc1\u7684\u836f\u673a\u4ea7\u54c1\u5df2\u4e0d\u53d7\u836f\u5382\u6b22\u8fce\u3002\u56e0\u6b64<\/font><\/p>\n

\u638c\u63e1\u9a8c\u8bc1\u9879\u76ee\u3001\u89c4\u8303\u3001\u65b9\u6cd5\uff0c\u836f\u673a\u5382\u5fc5\u987b\u4e3b\u52a8\u4e86\u89e3\u836f\u673a\u4ea7\u54c1\u7684\u9a8c\u8bc1\u8981\u6c42\u3002\u6539\u8fdb\u4ea7\u54c1\u6027\u80fd\uff0c\u751a\u81f3\u4e3b\u52a8\u534f\u52a9\u836f\u5382\u9a8c\u8bc1\u81ea\u5df1\u7684\u4ea7\u54c1\u3002\u8fd9\u6837\u4e0d\u4f46\u4f1a\u53d7\u5230\u9752\u7750\uff0c\u540c\u65f6\u4e5f\u6709\u5229\u4e8e\u5f00\u62d3\u670d\u52a1\u9886\u57df\u3002 <\/font><\/p>\n

\u8fd9\u662f\u9632\u6b62\u4eba\u4e3a\u8fc7\u5931\u7684\u9700\u8981\u3002\u6bd4\u5982\u5bf9\u7ecf\u8fc7\u9a8c\u8bc1\u540e\u7684\u836f\u673a\u4ea7\u54c1\uff0cGMP\u8981\u6c42\u751f\u4ea7\u64cd\u4f5c\u5fc5\u9700\u7528\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f(StandardOperatProcedur\u7b80\u79f0SOP<\/font><\/p>\n

\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u98df\u54c1\u884c\u4e1a\u4e2d\u7684\u524d\u666f<\/strong><\/font><\/p>\n","protected":false},"excerpt":{"rendered":"

\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u98df\u54c1\u884c\u4e1a\u4e2d\u7684\u524d\u666f<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[152],"class_list":["post-1152","post","type-post","status-publish","format-standard","hentry","category-service-2","tag-152"],"_links":{"self":[{"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/posts\/1152","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/comments?post=1152"}],"version-history":[{"count":0,"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/posts\/1152\/revisions"}],"wp:attachment":[{"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/media?parent=1152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/categories?post=1152"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/chinaxfc.com\/index.php\/wp-json\/wp\/v2\/tags?post=1152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}