{"id":14500,"date":"2018-07-24T01:00:00","date_gmt":"2018-07-30T04:24:42","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/fda%e5%85%b3%e4%ba%8e%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e5%92%8c%e7%94%9f%e7%89%a9%e5%88%a9%e7%94%a8%e5%ba%a6%e6%a0%b7%e5%93%81%e7%9a%84%e5%82%a8%e5%ad%98%e8%a7%84%e5%ae%9a\/"},"modified":"2018-07-30T12:24:43","modified_gmt":"2018-07-30T04:24:43","slug":"fda%e5%85%b3%e4%ba%8e%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e5%92%8c%e7%94%9f%e7%89%a9%e5%88%a9%e7%94%a8%e5%ba%a6%e6%a0%b7%e5%93%81%e7%9a%84%e5%82%a8%e5%ad%98%e8%a7%84%e5%ae%9a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/14500\/","title":{"rendered":"FDA\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u50a8\u5b58\u89c4\u5b9a\u2014\u2014\u57f9\u4f18BE\u7cfb\u521715"},"content":{"rendered":"
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<\/section>\n
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\"FDA\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u50a8\u5b58\u89c4\u5b9a\u2014\u2014\u57f9\u4f18BE\u7cfb\u521715\"<\/section>\n
\"FDA\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u50a8\u5b58\u89c4\u5b9a\u2014\u2014\u57f9\u4f18BE\u7cfb\u521715\"<\/section>\n<\/section>\n
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\n

\u4f1a\u8bae\u901a\u77e5<\/span><\/strong><\/span><\/p>\n

\u5efa\u7acbFDA\u8ba4\u53ef\u7684\u7814\u53d1\u548c\u751f\u4ea7\u6d41\u7a0b\u662f\u6210\u529f\u7684\u5173\u952e\u4e4b\u6240\u5728\uff0c\u800c\u719f\u6089\u7f8e\u56fd\u7684\u6cd5\u89c4\u548c\u6ce8\u518c\u6d41\u7a0b\u53ef\u4ee5\u8ba9\u6211\u4eec\u7684\u5de5\u4f5c\u4e8b\u534a\u529f\u500d\uff01\u672c\u6b21\u4f1a\u8bae\uff0c\u6211\u4eec\u5c06\u5bf9MAH\u5236\u5ea6\u3001\u6539\u826f\u521b\u65b0\u4e2d\u7f8e\u53cc\u62a5\u4f5c\u91cd\u70b9\u4ecb\u7ecd\uff0c\u5bf9\u60a8\u6240\u5173\u6ce8\u7684\u95ee\u9898\u8fdb\u884c\u91cd\u70b9\u89e3\u7b54\u3002\u671f\u5f85\u5e7f\u5927\u670b\u53cb\u7684\u5149\u4e34\u3002<\/p>\n

\u4f1a\u8bae\u94fe\u63a5\uff1a9\u67086\u65e5-MAH\u5236\u5ea6\u89e3\u8bfb\u66a8\u6539\u826f\u521b\u65b0\u4e2d\u7f8e\u53cc\u62a5\u4ea7\u4e1a\u5bf9\u63a5\u7814\u8ba8\u4f1a\u9080\u8bf7\u51fd<\/strong><\/span><\/a><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"FDA\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u50a8\u5b58\u89c4\u5b9a\u2014\u2014\u57f9\u4f18BE\u7cfb\u521715\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n

FDA\u5173\u4e8e\u751f\u7269\u7b49\u6548\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u50a8\u5b58\u89c4\u5b9a<\/strong><\/span><\/p>\n


<\/p>\n

1.  FDA\u5bf9\u751f\u7269\u7b49\u6548\u6027\u6837\u54c1\u7684\u6cd5\u89c4\u76d1\u7ba1\u80cc\u666f<\/span><\/strong><\/p>\n

1)  21CFR Sec. 320.38 Retention of bioavailability samples<\/span><\/p>\n

21CFR 320.38\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u7559\u6837<\/span><\/p>\n

2)  21CFR Sec.320.63 Retention of bioequivalence samples<\/span><\/p>\n

21CFR 320.63\u751f\u7269\u7b49\u6548\u6027\u6837\u54c1\u7684\u7559\u6837<\/span><\/p>\n

3)  Sec. 211.170 Reserve samples<\/span><\/p>\n

\u5236\u5242\u7684cGMP\u7ae0\u8282\u4e0b\u5bf9\u7559\u6837\u7684\u63cf\u8ff0<\/span><\/p>\n

4) Guidance titled as \u201cANDAs: Stability Testing of Drug Substances and Products\u201d Q&A<\/span><\/p>\n

\u300a\u884c\u4e1a\u6307\u5357-ANDA\uff1a\u5236\u5242\u548c\u539f\u6599\u836f\u7a33\u5b9a\u6027\u68c0\u6d4b\u7684\u95ee\u7b54\u300b<\/span><\/p>\n

5)  Guidance titled as \u201cHandling and Retention of BA and BE Testing Samples\u201d<\/span><\/p>\n

\u300a\u884c\u4e1a\u6307\u5357-\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u751f\u7269\u6837\u54c1\u7684\u5904\u7406\u548c\u4fdd\u5b58\u8981\u6c42\u300b<\/span><\/p>\n

 <\/span><\/p>\n

2.\u4e0a\u8ff0\u6cd5\u89c4\u6307\u5357\u5bf9\u6837\u54c1\u50a8\u5b58\u7684\u5177\u4f53\u8981\u6c42<\/span><\/strong><\/p>\n

1)     21CFR 320.38\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u7559\u6837<\/span><\/p>\n

Sec. 320.38 Retention of bioavailability samples. <\/span>\u751f\u7269\u5229\u7528\u5ea6\u6837\u54c1\u7684\u7559\u6837<\/span><\/p>\n

(a) The applicant of an application or supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioavailability testing was performed under contract, the contract research organization shall retain an appropriately identified reserve sample of the drug product for which the applicant is seeking approval (test article) and of the reference standard used to perform an in vivo bioavailability study in accordance with and for the studies described in paragraph (b) of this section that is representative of each sample of the test article and reference standard provided by the applicant for the testing.<\/span><\/p>\n

ANDA\u6216\u8865\u5145\u7533\u8bf7\u7684\u7533\u8bf7\u4eba\u4f9d\u636eFDC&A\u6cd5\u4ee4505\u7ae0\u8282\u9012\u4ea4\u8d44\u6599\u65f6\uff0c\u82e5\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7531CRO\u5f00\u5c55\uff0c\u5219CRO\u5e94\u4fdd\u5b58\u9002\u5f53\u8bc6\u522b\u7684\u7559\u6837\u6837\u54c1\u3002\u7559\u6837\u6837\u54c1\u4e3a\u7533\u8bf7\u4eba\u5bfb\u6c42\u83b7\u6279\u7684\u4ea7\u54c1\uff08\u8bd5\u9a8c\u5236\u5242\uff09\u548c\u53c2\u6bd4\u5236\u5242\uff0c\u4e8c\u8005\u7528\u4e8e\u4f9d\u636e\u7ae0\u8282b\u6216\u7ae0\u8282b\u63cf\u8ff0\u7684\u4f53\u5185\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\uff0c\u7531\u7533\u8bf7\u4eba\u63d0\u4f9b\u7684\u3001\u4e14\u5177\u6709\u4ee3\u8868\u6027\u7684\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(b) Reserve samples shall be retained for the following test articles and reference standards and for the studies described:<\/span><\/p>\n

\u5bf9\u4e8e\u4e0b\u8ff0\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u53ca\u4e0b\u8ff0\u7684\u7814\u7a76\uff0c\u5e94\u4fdd\u5b58\u7559\u6837\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

(1) If the formulation of the test article is the same as the formulation(s) used in the clinical studies demonstrating substantial evidence of safety and effectiveness for the test article’s claimed indications, a reserve sample of the test article used to conduct an in vivo bioavailability study comparing the test article to a reference oral solution, suspension, or injection.<\/span><\/p>\n

\u82e5\u8bd5\u9a8c\u5236\u5242\u4e0e\u4e34\u5e8a\u7814\u7a76\u4e2d\u6240\u4f7f\u7528\u7684\u5904\u65b9\u76f8\u540c\uff0c\u4e14\u5b9e\u8d28\u6027\u8bc1\u636e\u8bba\u8bc1\u4e86\u8bd5\u9a8c\u5236\u5242\u6240\u5ba3\u79f0\u9002\u5e94\u75c7\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0c\u5219\u7528\u4e8e\u4f53\u5185\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\u4e2d\u7684\u8bd5\u9a8c\u5236\u5242\u4e0e\u4e0e\u4e4b\u5bf9\u6bd4\u7684\u53c2\u6bd4\u5236\u5242\u7684\u53e3\u670d\u6db2\u3001\u6df7\u60ac\u6db2\u548c\u6ce8\u5c04\u5242\u9700\u8981\u7559\u6837\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(2) If the formulation of the test article differs from the formulation(s) used in the clinical studies demonstrating substantial evidence of safety and effectiveness for the test article’s claimed indications, a reserve sample of the test article and of the reference standard used to conduct an in vivo bioequivalence study comparing the test article to the formulation(s) (reference standard) used in the clinical studies.<\/span><\/p>\n

\u82e5\u8bd5\u9a8c\u5236\u5242\u4e0e\u4e34\u5e8a\u7814\u7a76\u4e2d\u6240\u4f7f\u7528\u7684\u5904\u65b9\u4e0d\u540c\uff0c\u4e14\u5b9e\u8d28\u6027\u8bc1\u636e\u8bba\u8bc1\u4e86\u8bd5\u9a8c\u5236\u5242\u6240\u5ba3\u79f0\u9002\u5e94\u75c7\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0c\u5219\u7528\u4e8e\u4f53\u5185\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u7684\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u9700\u8981\u7559\u6837<\/span><\/p>\n

 <\/span><\/p>\n

(3) For a new formulation, new dosage form, or a new salt or ester of an active drug ingredient or therapeutic moiety that has been approved for marketing, a reserve sample of the test article and of the reference standard used to conduct an in vivo bioequivalence study comparing the test article to a marketed product (reference standard) that contains the same active drug ingredient or therapeutic moiety.<\/span><\/p>\n

\u9488\u5bf9\u5df2\u83b7\u6279\u51c6\u7684\u65b0\u5904\u65b9\u3001\u65b0\u5242\u578b\u6216API\u7684\u65b0\u76d0\u6216\u916f\u7c7b\u6216\u6cbb\u7597\u5206\u5b50\uff0c\u5219\u7528\u4e8e\u4f53\u5185\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\u4e2d\u7684\u8bd5\u9a8c\u5236\u5242\u4e0e\u4e0e\u4e4b\u5bf9\u6bd4\u7684\u542b\u76f8\u540cAPI\u6216\u6cbb\u7597\u5206\u5b50\u7684\u4e0a\u5e02\u83b7\u6279\u4ea7\u54c1\uff08\u53c2\u6bd4\u5236\u5242\uff09\u9700\u8981<\/span>\u7559\u6837\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(c) Each reserve sample shall consist of a sufficient quantity to permit FDA to perform five times all of the release tests required in the application or supplemental application.<\/span><\/p>\n

\u4fdd\u7559\u6837\u54c1\u7684\u6570\u91cf\u5e94\u8db3\u591f\u5141\u8bb8\u5ba1\u8bc4\u673a\u6784\u80fd\u5c06\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7\u4e2d\u8981\u6c42\u76845\u500d\u5168\u68c0\u653e\u884c\u91cf\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(d) Each reserve sample shall be adequately identified so that the reserve sample can be positively identified as having come from the same sample as used in the specific bioavailability study.<\/span><\/p>\n

\u6bcf\u4e2a\u7559\u6837\u5747\u5e94\u5145\u5206\u8bc6\u522b\uff0c\u4ee5\u4fbf\u80fd\u6e05\u695a\u5730\u8bc6\u522b\u6837\u54c1\u6765\u6e90\u4e8e\u54ea\u4e2a\u7279\u5b9a\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\u8bd5\u9a8c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(e) Each reserve sample shall be stored under conditions consistent with product labeling and in an area segregated from the area where testing is conducted and with access limited to authorized personnel. Each reserve sample shall be retained for a period of at least 5 years following the date on which the application or supplemental application is approved, or, if such application or supplemental application is not approved, at least 5 years following the date of completion of the bioavailability study in which the sample from which the reserve sample was obtained was used.<\/span><\/p>\n

\u7559\u6837\u6837\u54c1\u5e94\u5728\u4ea7\u54c1\u6807\u7b7e\u89c4\u5b9a\u7684\u6761\u4ef6\u4e0b\u50a8\u5b58\uff0c\u50a8\u5b58\u5730\u70b9\u4e0e\u6837\u54c1\u5206\u6790\u5730\u65b9\u8fdb\u884c\u9694\u79bb\u3002<\/span>\u7559\u6837\u6837\u54c1\u50a8\u5b58\u671f\u9650\u5e94\u4e3aANDA\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7\u83b7\u6279\u540e\u81f3\u5c115\u5e74\uff0c\u6216ANDA\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7\u672a\u6279\u51c6\uff0c\u5219\u50a8\u5b58\u671f\u9650\u4e3a\u5b8c\u6210\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\u540e\u81f3\u5c115\u5e74\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(f) Authorized FDA personnel will ordinarily collect reserve samples directly from the applicant or contract research organization at the storage site during a preapproval inspection. If authorized FDA personnel are unable to collect samples, FDA may require the applicant or contract research organization to submit the reserve samples to the place identified in the agency’s request. If FDA has not collected or requested delivery of a reserve sample, or if FDA has not collected or requested delivery of any portion of a reserve sample, the applicant or contract research organization shall retain the sample or remaining sample for the 5-year period specified in paragraph (e) of this section.<\/span><\/p>\n

\u7ecf\u6388\u6743\u7684FDA\u4eba\u5458\u901a\u5e38\u4f1a\u5728\u6279\u51c6\u524d\u68c0\u67e5\u9636\u6bb5\u65f6\u76f4\u63a5\u4ece\u7533\u8bf7\u4eba\u6216CRO\u7684\u6837\u54c1\u50a8\u5b58\u5730\u70b9\u6536\u96c6\u7559\u6837\u3002\u82e5\u6388\u6743\u7684FDA\u4eba\u5458\u65e0\u6cd5\u6536\u96c6\u6837\u54c1\uff0c\u5219FDA\u53ef\u80fd\u4f1a\u8981\u6c42\u7533\u8bf7\u4eba\u6216CRO\u63d0\u4f9b\u6837\u54c1\u81f3FDA\u6307\u5b9a\u7684\u5730\u65b9\u3002\u82e5FDA\u672a\u6536\u96c6\u6837\u54c1\u6216\u672a\u8981\u6c42\u9012\u9001\u7559\u6837\uff0c\u6216FDA\u672a\u6536\u96c6\u6837\u54c1\u7684\u4e00\u90e8\u5206\u6216\u672a\u8981\u6c42\u9012\u9001\u7559\u6837\u7684\u7684\u4e00\u90e8\u5206\uff0c\u5219<\/span>\u7533\u8bf7\u4eba\u6216CRO\u5e94\u5c06\u7559\u6837\u6216\u5269\u4f59\u6837\u54c1\u4f9d\u636eparagraph (e)\u7684\u8981\u6c42\u4fdd\u5b585\u5e74\u671f\u9650\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(g) Upon release of the reserve samples to FDA, the applicant or contract research organization shall provide a written assurance that, to the best knowledge and belief of the individual executing the assurance, the reserve samples came from the same samples as used in the specific bioavailability or bioequivalence study identified by the agency. The assurance shall be executed by an individual authorized to act for the applicant or contract research organization in releasing the reserve samples to FDA.<\/span><\/p>\n

\u5e94\u8981\u6c42\u5c06\u7559\u6837\u53d1\u653e\u7ed9FDA\uff0c\u7533\u8bf7\u4eba\u548cCRO\u5e94\u63d0\u4f9b\u4e00\u4efd\u4e66\u9762\u4fdd\u8bc1\u4e66\uff0c\u5305\u88c5\u7559\u6837\u4e0e\u7279\u5b9a\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7814\u7a76\u4e2d\u6240\u4f7f\u7528\u7684\u6837\u54c1\u4e00\u81f4\u3002\u6388\u6743\u7684\u4e2a\u4eba\u4ee3\u8868\u53d1\u653e\u7559\u6837\u7684\u7533\u529e\u65b9\u6216CRO\u6765\u51fa\u5177\u6b64\u7c7b\u4fdd\u8bc1\u4e66\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(h) A contract research organization may contract with an appropriate, independent third party to provide storage of reserve samples provided that the sponsor of the study has been notified in writing of the name and address of the facility at which the reserve samples will be stored.<\/span><\/p>\n

\u5982\u679cCRO\u5c06\u7b2c\u4e09\u65b9\u673a\u6784\u6837\u54c1\u50a8\u5b58\u5730\u70b9\u7684\u540d\u79f0\u548c\u5730\u5740\u4e66\u9762\u901a\u77e5\u7533\u529e\u65b9\uff0cCRO\u53ef\u4ee5\u4e0e\u4e00\u4e2a\u9002\u5b9c\u4e14\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u673a\u6784\u7b7e\u8ba2\u5408\u540c\uff0c\u8981\u6c42\u7b2c\u4e09\u65b9\u63d0\u4f9b\u7559\u6837\u7684\u50a8\u5b58\u3002<\/span><\/p>\n

 <\/span><\/p>\n

(i) If a contract research organization conducting a bioavailability or bioequivalence study that requires reserve sample retention under this section or 320.63 goes out of business, it shall transfer its reserve samples to an appropriate, independent third party, and shall notify in writing the sponsor of the study of the transfer and provide the study sponsor with the name and address of the facility to which the reserve samples have been transferred.<\/span><\/p>\n

\u5f00\u5c55\u751f\u7269\u5229\u7528\u5ea6\u6216\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684CRO\uff0c\u4f9d\u636e\u672c\u7ae0\u8282\u6216320.63\u7ae0\u8282\u9700\u8981\u5c65\u884c\u50a8\u5b58\u6837\u54c1\u8981\u6c42\u7684\uff0c\u82e5\u7834\u4ea7\u505c\u4e1a\uff0c\u5e94\u5c06\u7559\u6837\u8f6c\u79fb\u81f3\u4e00\u4e2a\u9002\u5b9c\u4e14\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u673a\u6784\uff0c\u5e76\u4e66\u9762\u901a\u77e5\u8bd5\u9a8c\u7533\u529e\u65b9\u6837\u54c1\u7684\u8f6c\u79fb\uff0c\u5e76\u5c06\u6837\u54c1\u8f6c\u79fb\u5730\u70b9\u7684\u540d\u79f0\u548c\u5730\u5740\u544a\u77e5\u7533\u62a5\u65b9\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2)     21CFR 320.63\u751f\u7269\u7b49\u6548\u6027\u6837\u54c1\u7684\u7559\u6837<\/span><\/p>\n

The applicant of an abbreviated application or a supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioequivalence testing was performed under contract, the contract research organization shall retain reserve samples of any test article and reference standard used in conducting an in vivo or in vitro bioequivalence study required for approval of the abbreviated application or supplemental application. The applicant or contract research organization shall retain the reserve samples in accordance with, and for the period specified in 320.38 and shall release the reserve samples to FDA upon request in accordance with 320.38.<\/span><\/p>\n

ANDA\u6216\u8865\u5145\u7533\u8bf7\u7684\u7533\u8bf7\u4eba\u4f9d\u636eFDC&A\u6cd5\u4ee4505\u7ae0\u8282\u9012\u4ea4\u8d44\u6599\u65f6\uff0c\u82e5\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7531CRO\u5f00\u5c55\uff0c\u5219CRO\u5e94\u4fdd\u5b58\u8fdb\u884c\u4f53\u5185\u548c\u4f53\u5916\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u6240\u4f7f\u7528\u7684\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\uff0c\u4ee5\u7b26\u5408ANDA\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7\u7684\u8981\u6c42\u3002CRO\u5e94\u4f9d\u636e320.38\u6240\u89c4\u5b9a\u7684\u4fdd\u5b58\u671f\u9650\u5bf9\u6837\u54c1\u8fdb\u884c\u50a8\u5b58\uff0c\u5e76\u4f9d\u636e320.38\u7684\u89c4\u5b9a\uff0c\u5e94FDA\u8981\u6c42\u5c06\u6837\u54c1\u63d0\u4f9b\u7ed9FDA\u3002<\/span><\/p>\n

 <\/span><\/p>\n

3) \u5236\u5242\u7684cGMP\u7ae0\u8282\u4e0b\u5bf9\u7559\u6837\u7684\u63cf\u8ff0<\/span><\/p>\n

Sec. 211.170 Reserve samples.  211.170\u7559\u6837<\/span><\/p>\n

(a) An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications, except for sterility and pyrogen testing. The retention time is as follows:<\/span><\/p>\n

\u5bf9\u80fd\u4ee3\u8868\u6bcf\u6279API\u3001\u6bcf\u6b21\u88c5\u8fd0\u7684\u7ecf\u9002\u5b9c\u8bc6\u522b\u7684\u6837\u54c1\u8fdb\u884c\u7559\u6837\u3002\u7559\u6837\u91cf\u9664\u65e0\u83cc\u548c\u70ed\u539f\u68c0\u6d4b\u5916\uff0c\u5e94\u542b\u81f3\u5c112\u500dAPI\u5168\u68c0\u91cf\u4ee5\u786e\u5b9aAPI\u662f\u5426\u7b26\u5408\u786e\u7acb\u7684\u8d28\u91cf\u6807\u51c6\u3002\u7559\u6837\u65f6\u95f4\u5982\u4e0b\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

(1) For an active ingredient in a drug product other than those described in paragraphs (a) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the last lot of the drug product containing the active ingredient.<\/span><\/p>\n

\u9664paragraphs (a) (2)\u548c(3)\u7ae0\u8282\u5236\u5242\u4ee5\u5916\u7684API, API\u7684\u7559\u6837\u65f6\u95f4\u4e3a\u6240\u542bAPI\u751f\u4ea7\u7684\u6700\u540e\u4e00\u6279\u5236\u5242\u7684\u6709\u6548\u671f\u540e\u81f3\u5c11\u4fdd\u5b581\u5e74\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(2) For an active ingredient in a radioactive drug product, except for nonradioactive reagent kits, the reserve sample shall be retained for:<\/span><\/p>\n

\u653e\u5c04\u6027\u836f\u54c1\u4e2d\u7684API\uff0c\u9664\u653e\u5c04\u6027\u8bd5\u5242\u76d2\u5916\uff0c\u7559\u6837\u5e94\u50a8\u5b58\uff1a<\/span><\/p>\n


<\/p>\n

(i) Three months after the expiration date of the last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is 30 days or less; or<\/span><\/p>\n

\u82e5\u836f\u54c1\u7684\u6709\u6548\u671f\u4e3a30\u5929\u6216\u66f4\u77ed\uff0c\u5219API\u7684\u7559\u6837\u65f6\u95f4\u4e3a\u6240\u542bAPI\u751f\u4ea7\u7684\u6700\u540e\u4e00\u6279\u5236\u5242\u7684\u6709\u6548\u671f\u540e\u4fdd\u5b583\u4e2a\u6708\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(ii) Six months after the expiration date of the last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is more than 30 days.<\/span><\/p>\n

\u82e5\u836f\u54c1\u7684\u6709\u6548\u671f\u4e3a30\u5929\u6216\u66f4\u957f\uff0c\u5219\u5219API\u7684\u7559\u6837\u65f6\u95f4\u4e3a\u6240\u542bAPI\u751f\u4ea7\u7684\u6700\u540e\u4e00\u6279\u5236\u5242\u6709\u6548\u671f\u540e\u4fdd\u5b586\u4e2a\u6708\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(3) For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient.<\/span><\/p>\n

\u9664211.137\u6307\u5b9a\u6709\u6548\u671f\u5916\u7684\u4ea7\u54c1\uff0cAPI\u7559\u6837\u5e94\u4fdd\u5b58\u5b8c\u6210\u9500\u552e\u6700\u540e\u4e00\u6279\u6240\u542bAPI\u751f\u4ea7\u7684\u5236\u5242\u76843\u5e74\u540e\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(b) An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling. The reserve sample shall be stored in the same immediate container-closure system in which the drug product is marketed or in one that has essentially the same characteristics. The reserve sample consists of at least twice the quantity necessary to perform all the required tests, except those for sterility and pyrogens. Except for those for drug products described in paragraph (b)(2) of this section, reserve samples from representative sample lots or batches selected by acceptable statistical procedures shall be examined visually at least once a year for evidence of deterioration unless visual examination would affect the integrity of the reserve sample. Any evidence of reserve sample deterioration shall be investigated in accordance with 211.192. The results of the examination shall be recorded and maintained with other stability data on the drug product. Reserve samples of compressed medical gases need not be retained. The retention time is as follows:<\/span><\/p>\n

\u5bf9\u80fd\u4ee3\u8868\u6bcf\u6279\u5236\u5242\u4e14\u7ecf\u9002\u5b9c\u8bc6\u522b\u7684\u6837\u54c1\u8fdb\u884c\u7559\u6837\uff0c\u7559\u6837\u5e94\u6839\u636e\u4ea7\u54c1\u6807\u7b7e\u6240\u89c4\u5b9a\u7684\u6761\u4ef6\u8fdb\u884c\u50a8\u5b58\u3002\u7559\u6837\u5e94\u7f6e\u4e0e\u4e8e\u5546\u4e1a\u5316\u5305\u88c5\u4e00\u81f4\u7684\u5305\u88c5\u6750\u6599\u5185\u6216\u5177\u6709\u57fa\u672c\u76f8\u540c\u7279\u6027\u7684\u5305\u88c5\u6750\u6599\u5185\u8fdb\u884c\u50a8\u5b58\u3002\u7559\u6837\u91cf\u9664\u65e0\u83cc\u548c\u70ed\u539f\u5916\uff0c\u81f3\u5c11\u4e3a2\u500d\u5168\u68c0\u91cf\u4ee5\u5f00\u5c55\u6240\u9700\u7684\u8bd5\u9a8c\u3002\u7559\u6837\u91cf\u9664\u65e0\u83cc\u548c\u70ed\u539f\u68c0\u6d4b\u5916\uff0c\u5e94\u542b\u81f3\u5c112\u500d\u5168\u68c0\u91cf\u3002\u9664\u4e86paragraph (b)(2)\u7ae0\u8282\u6240\u8bba\u8ff0\u7684\u836f\u54c1\u5916\uff0c\u6765\u6e90\u4e8e\u4ee3\u8868\u6027\u6279\u6b21\u7684\u7559\u6837\uff0c\u7ecf\u8fc7\u53ef\u63a5\u53d7\u7684\u7edf\u8ba1\u7a0b\u5e8f\u62bd\u6837\uff0c\u5e94\u81f3\u5c11\u6bcf\u5e74\u76ee\u68c0\u4e00\u6b21\u83b7\u53d6\u4ea7\u54c1\u7834\u574f\u7684\u8bc1\u636e\uff0c\u9664\u975e\u76ee\u89c6\u53ef\u80fd\u4f1a\u5f71\u54cd\u7559\u6837\u7684\u5b8c\u6574\u6027\u3002\u4efb\u4f55\u7559\u6837\u7834\u574f\u7684\u8bc1\u636e\u5e94\u4f9d\u636e211.192\u8fdb\u884c\u8c03\u67e5\u3002\u8c03\u67e5\u7ed3\u679c\u5e94\u4e0e\u836f\u54c1\u7684\u5176\u4ed6\u7a33\u5b9a\u6027\u6570\u636e\u4e00\u8d77\u8bb0\u5f55\u5e76\u4fdd\u5b58\u3002\u538b\u7f29\u533b\u7597\u6c14\u4f53\u7684\u7559\u6837\u4e0d\u9700\u8981\u4fdd\u5b58\uff0c\u4fdd\u5b58\u65f6\u95f4\u5982\u4e0b\uff1a<\/span><\/p>\n


<\/p>\n

(1) For a drug product other than those described in paragraphs (b) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the drug product.<\/span><\/p>\n

\u9664paragraphs (a) (2)\u548c(3)\u7ae0\u8282\u5236\u5242\u4ee5\u5916\u7684\u5236\u5242, \u5236\u5242\u7684\u7559\u6837\u65f6\u95f4\u4e3a\u5236\u5242\u6709\u6548\u671f\u540e\u4fdd\u5b581\u5e74\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(2) For a radioactive drug product, except for nonradioactive reagent kits, the reserve sample shall be retained for:<\/span><\/p>\n

\u653e\u5c04\u6027\u836f\u54c1\uff0c\u9664\u653e\u5c04\u6027\u8bd5\u5242\u76d2\u5916\uff0c\u7559\u6837\u5e94\u50a8\u5b58\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

(i) Three months after the expiration date of the drug product if the expiration dating period of the drug product is 30 days or less; or<\/span><\/p>\n

\u82e5\u836f\u54c1\u7684\u6709\u6548\u671f\u4e3a30\u5929\u6216\u66f4\u77ed\uff0c\u5219\u5236\u5242\u7684\u7559\u6837\u65f6\u95f4\u4e3a\u5236\u5242\u7684\u6709\u6548\u671f\u540e\u4fdd\u5b583\u4e2a\u6708\u3002<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

(ii) Six months after the expiration date of the drug product if the expiration dating period of the drug product is more than 30 days.<\/span><\/p>\n

\u82e5\u836f\u54c1\u7684\u6709\u6548\u671f\u4e3a30\u5929\u6216\u66f4\u957f\uff0c\u5219\u5236\u5242\u7684\u7559\u6837\u65f6\u95f4\u4e3a\u5236\u5242\u7684\u6709\u6548\u671f\u540e\u4fdd\u5b586\u4e2a\u6708\u3002<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

(3) For an OTC drug product that is exempt for bearing an expiration date under 211.137, the reserve sample must be retained for 3 years after the lot or batch of drug product is distributed.<\/span><\/p>\n

\u9664211.137\u6307\u5b9a\u6709\u6548\u671f\u5916\u7684\u4ea7\u54c1\uff0cOTC\u4ea7\u54c1\u5e94\u4fdd\u5b58\u5b8c\u6210\u9500\u552e\u5236\u5242\u76843\u5e74\u540e\u3002<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

4)\u300a\u884c\u4e1a\u6307\u5357-ANDA\uff1a\u5236\u5242\u548c\u539f\u6599\u836f\u7a33\u5b9a\u6027\u68c0\u6d4b\u7684\u95ee\u7b54\u300b\u95ee\u9898Q10\u8282\u9009<\/span><\/p>\n

Q10: How long do the three pilot scale batches, submitted as a part of an ANDA, need to be stored before destruction?<\/span><\/p>\n

\u4f5c\u4e3aANDA\u7533\u62a5\u7684\u4e2d\u8bd5\u6279\uff08\u4fd7\u79f0\u5c55\u793a\u6279\uff09\u9700\u8981\u4fdd\u5b58\u591a\u4e45\uff1f<\/span><\/p>\n

 <\/span><\/p>\n

A10: Sample storage times are discussed in 21 CFR 320.38 and 21 CFR 320.63 in connection with bioequivalence study samples. In general, ANDA submission batch samples should be stored for 1 year after approval of the ANDA, and samples of the drug product used for bioequivalence studies must be stored following the requirements listed in 21 CFR 320.38 and 21 CFR 320.63. In addition, the guidance for industry on Handling and Retention of BA and BE Testing Samples may be helpful regarding the procedure for handling reserve samples from relevant bioavailability and bioequivalence studies. Additional information on sample quantities (for retention purposes) is discussed in 21 CFR 211.170 (a) and (b), Reserve Samples.<\/span><\/p>\n

21 CFR 320.38 \u548c21 CFR 320.63\u7ae0\u8282\u5bf9\u751f\u7269\u7b49\u6548\u6027\u6837\u54c1\u7684\u50a8\u5b58\u65f6\u95f4\u6709\u8be6\u7ec6\u8bba\u8ff0\u3002\u901a\u5e38\uff0c<\/span>ANDA\u7533\u62a5\u6279\u5e94\u5728ANDA\u83b7\u6279\u540e\u4fdd\u5b58\u4e00\u5e74<\/span><\/strong>\uff0c\u800c\u751f\u7269\u7b49\u6548\u6027\u6837\u54c1\u5e94\u4f9d\u636e21 CFR 320.38\u548c 21 CFR 320.63\u7684\u89c4\u5b9a\u8fdb\u884c\u4fdd\u5b58\u3002\u53e6\u5916\uff0c\u300a\u884c\u4e1a\u6307\u5357-\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u751f\u7269\u6837\u54c1\u7684\u5904\u7406\u548c\u4fdd\u5b58\u8981\u6c42\u300b\u5728\u5904\u7406\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u6837\u54c1\u7684\u7a0b\u5e8f\u65b9\u9762\u6709\u6240\u5e2e\u52a9\u300221 CFR 211.170 (a)\u548c(b), Reserve Samples\u7559\u6837\u7ae0\u8282\u5bf9\u6837\u54c1\u6570\u91cf\uff08\u7559\u6837\u7528\u9014\uff09\u6709\u5177\u4f53\u8bba\u8ff0\u3002<\/span><\/p>\n

 <\/span><\/p>\n

5)\u300a\u884c\u4e1a\u6307\u5357-\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u751f\u7269\u6837\u54c1\u7684\u5904\u7406\u548c\u4fdd\u5b58\u8981\u6c42\u300b\u8282\u9009\u7ae0\u8282<\/span><\/p>\n

V-\u4fdd\u7559\u6837\u54c1\u6570\u91cf\u7ae0\u8282\u89c4\u5b9a\uff1a\u4fdd\u7559\u6837\u54c1\u7684\u6570\u91cf\u5e94\u8db3\u591f\u5141\u8bb8\u5ba1\u8bc4\u673a\u6784\u80fd\u5c06\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7\u4e2d\u8981\u6c42\u76845\u500d\u5168\u68c0\u653e\u884c\u91cf\u3002\u4e34\u5e8a\u7814\u7a76\u8005\u53ef\u4ee5\u4ece\u7533\u62a5\u8005\u6216\u836f\u54c1\u751f\u4ea7\u5546\u5904\u83b7\u5f975\u500d\u5168\u68c0\u91cf\u3002\u5bf9\u4e8e\u53e3\u670d\u56fa\u4f53\u5236\u5242\uff08\u5982\u7247\u5242\u3001\u80f6\u56ca\uff09\uff0c\u8ba4\u4e3a\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5206\u522b\u4e3a300\u4e2a\u5355\u4f4d\u7684\u4e0a\u9650\u503c\u8db3\u4ee5\u7b26\u54085\u500d\u5168\u68c0\u653e\u884c\u91cf\u7684\u8981\u6c42\u3002<\/span><\/p>\n

 <\/span><\/p>\n

D-\u7814\u7a76\u7533\u62a5\u8005\u548c\u6216\u836f\u54c1\u751f\u4ea7\u5546\u8fdb\u884c\u7684\u4f01\u4e1a\u5185\u5bb9\u7814\u7a76\u7ae0\u8282\u89c4\u5b9a\uff1a\u5982\u679c\u7814\u7a76\u7533\u62a5\u8005\u548c\u6216\u836f\u54c1\u751f\u4ea7\u5546\u8fdb\u884c\u4e86\u4e0a\u8ff0\u7814\u7a76\uff0c\u90a3\u4e48\u5c31\u5e94\u8be5\u5c06\u751f\u4ea7\u4fdd\u7559\u6837\u54c1\uff0821CFR 211.170\uff09\u548cBE\u7814\u7a76\u4fdd\u7559\u6837\u54c1\uff0821CFR 320.38\u548c320.63\uff09\u5206\u5f00\u8fdb\u884c\u4fdd\u5b58\u3002\u5e94\u5c06\u4f01\u4e1a\u5185\u4e34\u5e8a\u7814\u7a76\u5355\u4f4d\u4f5c\u4e3a\u72ec\u7acb\u7684\u5355\u4f4d\u8fdb\u884c\u6837\u54c1\u4fdd\u5b58\u3002\u5e94\u6e05\u695a\u8bb0\u5f55\u5173\u4e8e\u8bd5\u9a8c\u7269\u8d28\u548c\u53c2\u6bd4\u6807\u51c6\u54c1\u7684\u6240\u6709\u4e8b\u9879\uff08\u5982\u751f\u4ea7\u3001\u8d2d\u4e70\u3001\u5305\u88c5\u3001\u8fd0\u9001\u8bb0\u5f55\uff09\uff0c\u5728\u68c0\u67e5\u671f\u95f4\u5e94\u51fa\u793a\u7ed9FDA\u7814\u7a76\u8005\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

1.21CFR\u6570\u636e\u5e93https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm<\/span><\/p>\n

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