{"id":82485,"date":"2019-04-16T00:00:50","date_gmt":"2019-04-17T02:53:49","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/82485\/"},"modified":"2019-04-17T10:53:49","modified_gmt":"2019-04-17T02:53:49","slug":"322f57a370","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/82485\/","title":{"rendered":"21 CFR11 210 211 \uff08\u4e2d\u82f1\u6587\uff09"},"content":{"rendered":"
\n

\u58f0\u660e\uff1a  \u672c\u6587\u8f6c\u81ea\u300aJulia\u6cd5\u89c4\u7ffb\u8bd1\u300b\uff0c\u4ec5\u4e3a\u4ea4\u6d41\u548c\u5b66\u4e60\u3002\u5982\u6d89\u53ca\u4fb5\u6743\uff0c\u8bf7\u76f4\u63a5\u544a\u8bc9\u5c0f\u7f16\uff0c\u5c0f\u7f16\u5c06\u7b2c\u4e00\u65f6\u95f4\u5220\u9664\u3002\u540c\u65f6\u4e5f\u63d0\u9192\u8bfb\u8005\uff0c\u5c0f\u7f16\u4e0d\u5bf9\u6587\u4e2d\u5185\u5bb9\u7684\u771f\u5b9e\u6027\u3001\u51c6\u786e\u6027\u8d1f\u8d23\u3002\u5728\u6b64\uff0c\u771f\u8bda\u5730\u5bf9\u672c\u6587\u8457\u8005\u9053\u4e00\u58f0\u611f\u8c22\uff01<\/span><\/strong><\/span><\/h2>\n

<\/span>
<\/p>\n

CFR\u4e3a\u7f8e\u56fd\u8054\u90a6\u6cd5\u5178\uff0c21 CFR\u4e3a\u5176\u7b2c21\u7ae0\uff0c\u7b49\u540c\u300a\u8054\u90a6\u98df\u54c1\u836f\u54c1\u5316\u5986\u54c1\u6cd5\u6848\u300b\uff0c\u7b2c11\u90e8\u5206\u4e3a\u7535\u5b50\u7b7e\u540d\u7535\u5b50\u8bb0\u5f55\uff0c\u7b2c210 \u548c211\u90e8\u5206\u4e3a\u5236\u5242CGMP\u3002<\/span>\u4ee5\u4e0b\u4e3a\u7f8e\u56fd\u5b98\u65b9GPO\u7535\u5b50CFR\u7f51\u5740\u94fe\u63a5\uff1a<\/span>
<\/p>\n

https:<\/span>\/\/www.ecfr.gov\/cgi-bin\/text-idx?<\/span>SID=664058f10d03a00fe41ad9c9ba979da0&mc=true&tpl=\/ecfrbrowse\/Title21\/21cfr211_main_02.tpl<\/span><\/p>\n


<\/p>\n

Title 21 <\/span><\/span>\u2192<\/span> <\/span>Chapter I<\/span>\u2192<\/span> <\/span>Subchapter A <\/span><\/span>\u2192<\/span>Part11   <\/span><\/p>\n

TITLE 21<\/span>\u2014<\/span>Food and Drugs<\/span>\u98df\u54c1\u548c\u836f\u54c1<\/span><\/p>\n

CHAPTER I<\/span>\u2014<\/span>FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES<\/span>\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff0c\u536b\u751f\u798f\u5229\u90e8<\/span><\/p>\n

SUBCHAPTER A<\/span>\u2014<\/span>GENERAL<\/span>\u901a\u5219<\/span><\/p>\n

PART 11<\/span>\u2014<\/span>ELECTRONIC RECORDS; ELECTRONIC SIGNATURES<\/span>\u7535\u5b50\u8bb0\u5f55\uff0c\u7535\u5b50\u7b7e\u540d<\/span><\/p>\n

 <\/span><\/p>\n

Subpart A<\/span><\/strong>\u2014<\/span><\/strong>GENERALP ROVISIONS <\/span><\/span><\/strong>\u901a\u5219<\/span><\/strong><\/p>\n

\u00a7<\/span>11.1 <\/span><\/span>Scope.<\/span>\u8303\u56f4<\/span> <\/span>20160527<\/span><\/a><\/p>\n

\u00a7<\/span>11.2 <\/span><\/span>Implementation.<\/span>\u5b9e\u65bd<\/span><\/a><\/p>\n

\u00a7<\/span>11.3 <\/span><\/span>Definitions.<\/span>\u5b9a\u4e49<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart B<\/span><\/strong>\u2014<\/span><\/strong>ELECTRONIC RECORDS <\/span><\/span><\/strong>\u7535\u5b50\u8bb0\u5f55<\/span><\/strong><\/p>\n

\u00a7<\/span>11.10 <\/span><\/span>Controls for closed systems. <\/span><\/span>\u5c01\u95ed\u7cfb\u7edf\u7684\u63a7\u5236<\/span><\/a><\/p>\n

\u00a7<\/span>11.30 <\/span><\/span>Controls for open systems. <\/span><\/span>\u5f00\u653e\u7cfb\u7edf\u7684\u63a7\u5236<\/span><\/a><\/p>\n

\u00a7<\/span>11.50 <\/span><\/span>Signature manifestations. <\/span><\/span>\u7b7e\u540d\u663e\u793a<\/span><\/a><\/p>\n

\u00a7<\/span>11.70 <\/span><\/span>Signature\/record linking. <\/span><\/span>\u7b7e\u540d<\/span>\/<\/span>\u8bb0\u5f55\u94fe\u63a5<\/span><\/a><\/p>\n

<\/mpcpc><\/span><\/p>\n

Subpart C<\/span><\/strong>\u2014<\/span><\/strong>ELECTRONIC SIGNATURES <\/span><\/span><\/strong>\u7535\u5b50\u7b7e\u540d<\/span><\/strong><\/p>\n

\u00a7<\/span>11.100 <\/span><\/span>General requirements. <\/span><\/span>\u901a\u7528\u8981\u6c42<\/span><\/a><\/p>\n

\u00a7<\/span>11.200 <\/span><\/span>Electronic signature components and controls.<\/span>\u7535\u5b50\u7b7e\u540d\u8981\u7d20\u548c\u63a7\u5236<\/span><\/a><\/p>\n

\u00a7<\/span>11.300 <\/span><\/span>Controls for identification codes\/passwords.<\/span>\u8bc6\u522b\u4ee3\u7801<\/span>\/<\/span>\u5bc6\u7801\u63a7\u5236<\/span><\/a><\/p>\n

 VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV<\/span><\/p>\n

 <\/span><\/p>\n

Title 21 <\/span><\/span>\u2192<\/span> <\/span>Chapter I<\/span>\u2192<\/span> <\/span>Subchapter C <\/span><\/span>\u2192<\/span>Part210 <\/span><\/p>\n

SUBCHAPTER C<\/span>\u2014<\/span>DRUGS:GENERAL <\/span><\/span>\u836f\u54c1\uff1a\u901a\u5219<\/span><\/p>\n

 <\/span>PART 210<\/span><\/strong>\u2014<\/span><\/strong>CURRENT GOOD MANUFACTURING PRACTICE INMANUFACTURING, PROCESSING, PACKING, OR HOLDING OFDRUGS; GENERAL <\/span><\/span><\/strong>\u836f\u54c1\u751f\u4ea7\u3001\u52a0\u5de5\u3001\u5305\u88c5\u548c\u5b58\u8d2e<\/span><\/strong>CGMP<\/span><\/strong>\uff1a\u901a\u5219<\/span><\/strong><\/p>\n

\u00a7<\/span>210.1 <\/span><\/span>Status of current good manufacturing practice regulations. CGMP<\/span>\u6cd5\u89c4\u7684\u5730\u4f4d <\/span>20091210<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>210.2 <\/span><\/span>Applicability of current good manufacturing practice regulations. CGMP<\/span>\u6cd5\u89c4\u7684\u9002\u7528\u6027 <\/span>20091210<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>210.3 <\/span><\/span>Definitions. <\/span><\/span>\u5b9a\u4e49 <\/span>20091210<\/span><\/span><\/a><\/p>\n

 <\/span><\/p>\n

PART 211<\/span><\/strong>\u2014<\/span><\/strong>Current Good Manufacturing Practice for Finished Pharmaceuticals<\/span><\/strong> <\/span>\u5236\u5242<\/span><\/strong>CGMP<\/span><\/strong><\/p>\n

Subpart A<\/span><\/strong>\u2014<\/span><\/strong>GENERAL PROVISIONS <\/span><\/span><\/strong>\u901a\u5219<\/span><\/strong><\/p>\n

\u00a7<\/span>211.1 <\/span><\/span>Scope.<\/span>\u8303\u56f4 <\/span>20150917<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.3 <\/span><\/span>Definitions.<\/span>\u5b9a\u4e49<\/span><\/a><\/p>\n

<\/mpcpc><\/span><\/p>\n

Subpart B\u2014ORGANIZATION AND PERSONNEL \u7ec4\u7ec7\u548c\u4eba\u5458
<\/span><\/strong><\/p>\n

\u00a7<\/span>211.22 <\/span><\/span>Responsibilities of quality control unit.<\/span>\u8d28\u91cf\u90e8\u95e8\u804c\u8d23<\/span><\/a><\/p>\n

\u00a7<\/span>211.25 <\/span><\/span>Personnel qualifications.<\/span>\u4eba\u5458\u8d44\u8d28<\/span><\/a><\/p>\n

\u00a7<\/span>211.28 <\/span><\/span>Personnel responsibilities.<\/span>\u4eba\u5458\u804c\u8d23<\/span><\/a><\/p>\n

\u00a7<\/span>211.34 <\/span><\/span>Consultants.<\/span>\u987e\u95ee<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart C<\/span><\/strong>\u2014<\/span><\/strong>BUILDINGS AND FACILITIES <\/span><\/span><\/strong>\u5efa\u7b51\u548c\u8bbe\u65bd<\/span><\/strong><\/p>\n

\u00a7<\/span>211.42 <\/span><\/span>Design and construction features.<\/span>\u8bbe\u8ba1\u548c\u6784\u9020\u7279\u6027<\/span><\/a>19950120<\/span><\/a> <\/span>
<\/p>\n

\u00a7<\/span>211.44 <\/span><\/span>Lighting.<\/span>\u7167\u660e<\/span><\/a><\/p>\n

\u00a7<\/span>211.46 <\/span><\/span>Ventilation, air filtration, air heating and cooling.<\/span>\u6696\u901a<\/span><\/a><\/p>\n

\u00a7<\/span>211.48 <\/span><\/span>Plumbing. <\/span><\/span>\u7ba1\u4ef6 <\/span><\/span><\/a>19830318<\/span><\/a><\/p>\n

\u00a7<\/span>211.50 <\/span><\/span>Sewage and refuse. <\/span><\/span>\u6c61\u6c34\u548c\u5e9f\u7269<\/span><\/a><\/p>\n

\u00a7<\/span>211.52 <\/span><\/span>Washing and toilet facilities.<\/span>\u6d17\u6d74\u548c\u76e5\u6d17\u8bbe\u65bd<\/span><\/a><\/p>\n

\u00a7<\/span>211.56 <\/span><\/span>Sanitation.<\/span>\u536b\u751f<\/span><\/a><\/p>\n

\u00a7<\/span>211.58 <\/span><\/span>Maintenance. <\/span><\/span>\u7ef4\u4fdd<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart D<\/span><\/strong>\u2014<\/span><\/strong>EQUIPMENT <\/span><\/span><\/strong>\u8bbe\u5907<\/span><\/strong><\/p>\n

\u00a7<\/span>211.63 <\/span><\/span>Equipment design, size, and location. <\/span><\/span>\u8bbe\u5907\u8bbe\u8ba1\u3001\u5c3a\u5bf8\u548c\u5b89\u88c5\u4f4d\u7f6e <\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.65 <\/span><\/span>Equipment construction. <\/span><\/span>\u8bbe\u5907\u7ed3\u6784<\/span><\/a><\/p>\n

\u00a7<\/span>211.67 <\/span><\/span>Equipment cleaning and maintenance.<\/span>\u8bbe\u5907\u6e05\u6d01\u548c\u7ef4\u4fdd <\/span>20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.68 <\/span><\/span>Automatic, mechanical, and electronic equipment.<\/span>\u81ea\u52a8\u3001\u673a\u68b0\u548c\u7535\u5b50\u8bbe\u5907 <\/span>20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.72 <\/span><\/span>Filters.<\/span>\u8fc7\u6ee4\u5668 <\/span>20080908<\/span><\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart E<\/span><\/strong>\u2014<\/span><\/strong>CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES <\/span><\/span><\/strong>\u7ec4\u4efd\u548c\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u5668\u7684\u63a7\u5236<\/span><\/strong><\/p>\n

\u00a7<\/span>211.80 <\/span><\/span>General requirements.<\/span>\u901a\u7528\u8981\u6c42<\/span><\/a><\/p>\n

\u00a7<\/span>211.82 <\/span><\/span>Receipt and storage of untested components, drug product containers, and closures. <\/span><\/span>\u672a\u6d4b\u8bd5\u7684\u7ec4\u4efd\u3001\u836f\u54c1\u5bb9\u5668\u548c\u5bc6\u95ed\u5668\u7684\u63a5\u6536\u548c\u5b58\u8d2e20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.84 <\/span>Testing and approval or rejection of components, drug product containers, andclosures<\/a>. <\/span><\/span>\u7ec4\u4efd\u3001\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u7cfb\u7edf\u68c0\u6d4b\u548c\u6279\u51c6\u6216\u62d2\u653620080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.86 <\/span>Useof approved components, drug product containers, and closures.<\/a> <\/span><\/span>\u6279\u51c6\u7684\u7ec4\u4efd\u3001\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u5668\u7684\u4f7f\u7528<\/span><\/a><\/p>\n

\u00a7<\/span>211.87 <\/span>Retesting of approved components, drug product containers, and closures<\/a>.<\/span>\u6279\u51c6\u7684\u7ec4\u4efd\u3001\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u5668\u7684\u590d\u6d4b<\/span><\/a><\/p>\n

\u00a7<\/span>211.89 <\/span>Rejected components, drug product containers, and closures.<\/a> <\/span><\/span>\u62d2\u6536\u7684\u7ec4\u4efd\u3001\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u5668<\/span><\/a><\/p>\n

\u00a7<\/span>211.94 <\/span>Drug product containers and closures<\/a>. <\/span><\/span>\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u5668 <\/span>20161118<\/span><\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart F<\/span><\/strong>\u2014<\/span><\/strong>PRODUCTION AND PROCESS CONTROLS <\/span><\/span><\/strong>\u751f\u4ea7\u548c\u5de5\u827a\u63a7\u5236<\/span><\/strong><\/p>\n

\u00a7<\/span>211.100 <\/span><\/span>Written procedures; deviations.<\/span>\u4e66\u9762\u7a0b\u5e8f\u3001\u504f\u5dee<\/span><\/a><\/p>\n

\u00a7<\/span>211.101 <\/span><\/span>Charge-in of components. <\/span><\/span>\u6210\u5206\u6295\u6599 <\/span>20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.103 <\/span><\/span>Calculation of yield. <\/span><\/span>\u6536\u7387\u8ba1\u7b97 <\/span>20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.105 <\/span><\/span>Equipment identification. <\/span><\/span>\u8bbe\u5907\u8bc6\u522b<\/span><\/a><\/p>\n

\u00a7<\/span>211.110<\/span> <\/span>Sampling and testing of in-process materials and drug products. <\/span><\/span>\u4e2d\u95f4\u4f53\u548c\u836f\u54c1\u53d6\u6837\u548c\u68c0\u6d4b20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.111<\/span> <\/span>Time limitations on production.<\/span>\u751f\u4ea7\u65f6\u95f4\u9650\u5236<\/span><\/a><\/p>\n

\u00a7<\/span>211.113 <\/span><\/span>Control of microbiological contamination.<\/span>\u5fae\u751f\u7269\u6c61\u67d3\u63a7\u5236 <\/span>20080908<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.115 <\/span><\/span>Reprocessing. <\/span><\/span>\u8fd4\u5de5<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart G<\/span><\/strong>\u2014<\/span><\/strong>PACKAGING AND LABELING CONTROL <\/span><\/span><\/strong>\u5305\u88c5\u548c\u8d34\u6807\u63a7\u5236<\/span><\/strong><\/p>\n

\u00a7<\/span>211.122 <\/span><\/span>Materials examination and usage criteria.<\/span>\u7269\u6599\u68c0\u67e5\u548c\u4f7f\u7528\u6807\u51c620120320<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.125 <\/span><\/span>Labeling issuance.<\/span>\u6807\u7b7e\u53d1\u653e<\/span> <\/span>20161118<\/span><\/a><\/p>\n

\u00a7<\/span>211.130 <\/span><\/span>Packaging and labeling operations. <\/span><\/span>\u5305\u88c5\u548c\u8d34\u6807\u64cd\u4f5c19930803<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.132 <\/span><\/span>Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. <\/span><\/span>\u4eba\u7528<\/span>OTC<\/span>\u836f\u54c1\u9632\u4f2a\u5305\u88c5\u8981\u6c4219981104<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.134 <\/span><\/span>Drug product inspection. <\/span><\/span>\u836f\u54c1\u68c0\u67e5<\/span><\/a><\/p>\n

\u00a7<\/span>211.137 <\/span><\/span>Expiration dating.<\/span>\u6709\u6548\u671f19950120<\/span><\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart H<\/span><\/strong>\u2014<\/span><\/strong>HOLDING AND DISTRIBUTION <\/span><\/span><\/strong>\u5b58\u8d2e\u548c\u9500\u552e<\/span><\/strong><\/p>\n

\u00a7<\/span>211.142 <\/span><\/span>Warehousing procedures.<\/span>\u4ed3\u7ba1\u7a0b\u5e8f<\/span><\/a><\/p>\n

\u00a7<\/span>211.150 <\/span><\/span>Distribution procedures.<\/span>\u9500\u552e\u7a0b\u5e8f<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart I<\/span><\/strong>\u2014<\/span><\/strong>LABORATORY CONTROLS <\/span><\/span><\/strong>\u5316\u9a8c\u5ba4\u63a7\u5236<\/span><\/strong><\/p>\n

\u00a7<\/span>211.160 <\/span><\/span>General requirements.<\/span>\u901a\u5219 <\/span><\/span><\/a>20080908<\/span><\/a><\/p>\n

\u00a7<\/span>211.165 <\/span><\/span>Testing and release for distribution. <\/span><\/span>\u9500\u552e\u68c0\u6d4b\u653e\u884c<\/span><\/a><\/p>\n

\u00a7<\/span>211.166 <\/span><\/span>Stability testing. <\/span><\/span>\u7a33\u5b9a\u6027\u8bd5\u9a8c19811117<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.167 <\/span><\/span>Special testing requirements.<\/span>\u7279\u6b8a\u68c0\u6d4b\u8981\u6c42<\/span><\/a><\/p>\n

\u00a7<\/span>211.170 <\/span><\/span>Reserve samples. <\/span><\/span>\u7559\u683719950120<\/span><\/span><\/a><\/p>\n

\u00a7<\/span>211.173 <\/span><\/span>Laboratory animals. <\/span><\/span>\u5b9e\u9a8c\u52a8\u7269<\/span><\/a><\/p>\n

\u00a7<\/span>211.176 <\/span><\/span>Penicillin contamination. <\/span><\/span>\u9752\u9709\u7d20\u6c61\u67d3<\/span><\/a>20160729<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart J<\/span><\/strong>\u2014<\/span><\/strong>RECORDS AND REPORTS <\/span><\/span><\/strong>\u8bb0\u5f55\u548c\u62a5\u544a<\/span><\/strong><\/p>\n

\u00a7<\/span>211.180 <\/span><\/span>General requirements.<\/span>\u901a\u5219<\/span><\/a>19950120<\/span><\/a><\/p>\n

\u00a7<\/span>211.182 <\/span><\/span>Equipment cleaning and use log.<\/span>\u8bbe\u5907\u6e05\u6d01\u548c\u4f7f\u7528\u65e5\u5fd7<\/span><\/a> <\/span>20080908<\/span><\/a><\/p>\n

\u00a7<\/span>211.184 <\/span><\/span>Component, drug product container, closure, and labeling records. <\/span><\/span>\u90e8\u4ef6\u3001\u836f\u54c1\u5bb9\u5668\u3001\u5bc6\u95ed\u5668\u548c\u6807\u7b7e\u8bb0\u5f55<\/span><\/a><\/p>\n

\u00a7<\/span>211.186 <\/span><\/span>Master production and control records. <\/span><\/span>\u4e3b\u751f\u4ea7\u548c\u68c0\u6d4b\u8bb0\u5f55<\/span><\/a><\/p>\n

\u00a7<\/span>211.188 <\/span><\/span>Batch production and control records. <\/span><\/span>\u6279\u751f\u4ea7\u548c\u68c0\u6d4b\u8bb0\u5f55<\/span><\/a>20080908<\/span><\/a><\/p>\n

\u00a7<\/span>211.192 <\/span><\/span>Production record review. <\/span><\/span>\u751f\u4ea7\u8bb0\u5f55\u5ba1\u6838<\/span><\/a><\/p>\n

\u00a7<\/span>211.194 <\/span><\/span>Laboratory records. <\/span><\/span>\u5b9e\u9a8c\u5ba4\u8bb0\u5f55<\/span><\/a>20051108<\/span><\/a><\/p>\n

\u00a7<\/span>211.196 <\/span><\/span>Distribution records. <\/span><\/span>\u9500\u552e\u8bb0\u5f55<\/span><\/a>19840316<\/span><\/a><\/p>\n

\u00a7<\/span>211.198 <\/span><\/span>Complaint files. <\/span><\/span>\u6295\u8bc9\u6587\u4ef6<\/span><\/a>20030331<\/span><\/a><\/p>\n

 <\/span><\/p>\n

Subpart K<\/span><\/strong>\u2014<\/span><\/strong>RETURNED AND SALVAGED DRUG PRODUCTS <\/span><\/span><\/strong>\u9000\u56de\u548c\u56de\u6536\u836f\u54c1<\/span><\/strong><\/p>\n

\u00a7<\/span>211.204 <\/span><\/span>Returned drug products. <\/span><\/span>\u9000\u56de\u836f\u54c1<\/span><\/a><\/p>\n

\u00a7<\/span>211.208 <\/span><\/span>Drug product salvaging. <\/span><\/span>\u836f\u54c1\u56de\u6536<\/span><\/a><\/p>\n


<\/p>\n

————————–\u5206\u9694\u7ebf———————————-<\/p>\n


<\/p>\n

Questions and Answers on Specific Topics: FDA<\/span><\/strong>\u5bf9<\/span><\/strong>CGMP<\/span><\/strong>\u4e3b\u9898\u7684\u5b98\u7f51\u95ee\u7b54<\/span><\/strong><\/p>\n

https:\/\/www.fda.gov\/drugs\/developmentapprovalprocess\/manufacturing\/ucm124740.htm<\/span><\/p>\n

Subpart A – <\/span><\/span>General Provisions<\/span> <\/span><\/span>\u901a\u5219<\/span>  2<\/span>\u95ee<\/span><\/a><\/p>\n

Subpart B – Organization and Personnel <\/span><\/span>\u7ec4\u7ec7\u548c\u4eba\u5458 <\/span>\u6682\u65e0<\/span><\/p>\n

Subpart C – <\/span><\/span>Buildings and Facilities<\/span> <\/span>\u5efa\u7b51\u548c\u8bbe\u65bd<\/span> <\/span>10<\/span>\u95ee<\/span><\/a><\/p>\n

Subpart D – <\/span>Equipment <\/span> <\/span>\u8bbe\u5907 <\/span><\/span>13<\/span>\u95ee<\/span><\/p>\n

Subpart E – <\/span>Control of Components and Drug Product Containers and Closures <\/span><\/span><\/span>\u90e8\u4ef6\u548c\u836f\u54c1\u5bb9\u5668\u5bc6\u95ed\u5668\u63a7\u5236<\/span>15<\/span>\u95ee<\/span><\/p>\n

Subpart F – <\/span>Production and Process Controls<\/span> <\/span>\u751f\u4ea7\u548c\u5de5\u827a\u63a7\u5236<\/span> <\/span>21<\/span>\u95ee<\/span><\/p>\n

Subpart G – Packaging and Labeling Control <\/span><\/span>\u5305\u88c5\u548c\u8d34\u6807\u63a7\u5236\u6682\u65e0<\/span><\/p>\n

Subpart H – <\/span>Holding and Distribution<\/span> <\/span>\u5b58\u8d2e\u548c\u9500\u552e <\/span><\/span>6<\/span>\u95ee<\/span><\/p>\n

Subpart I – <\/span>Laboratory Controls<\/span> <\/span><\/span>\u5316\u9a8c\u5ba4\u63a7\u5236<\/span> <\/span>14<\/span>\u95ee<\/span><\/p>\n

Subpart J – <\/span>Records and Reports <\/span><\/span><\/span>\u8bb0\u5f55\u548c\u62a5\u544a<\/span> <\/span>4<\/span>\u95ee<\/span><\/p>\n

Subpart K – <\/span>Returned and Salvaged Drug Products <\/span><\/span>\u9000\u56de\u548c\u56de\u6536\u836f\u54c1 <\/span><\/span>3<\/span>\u95ee<\/span><\/p>\n


<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u58f0\u660e\uff1a  \u672c\u6587\u8f6c\u81ea\u300aJulia\u6cd5\u89c4\u7ffb\u8bd1\u300b\uff0c\u4ec5\u4e3a\u4ea4\u6d41\u548c\u5b66\u4e60\u3002\u5982\u6d89\u53ca\u4fb5\u6743\uff0c\u8bf7\u76f4\u63a5\u544a\u8bc9\u5c0f\u7f16\uff0c\u5c0f\u7f16 […]<\/p>\n","protected":false},"author":1,"featured_media":82486,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82485"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=82485"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82485\/revisions"}],"predecessor-version":[{"id":82487,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82485\/revisions\/82487"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/82486"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=82485"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=82485"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=82485"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}