{"id":53789,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T01:49:09","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/fda-483%e8%a1%a8%ef%bc%9a%e5%8d%b0%e5%ba%a6-sun-pharmaceutical\/"},"modified":"2018-09-30T09:49:09","modified_gmt":"2018-09-30T01:49:09","slug":"fda-483%e8%a1%a8%ef%bc%9a%e5%8d%b0%e5%ba%a6-sun-pharmaceutical","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/53789\/","title":{"rendered":"FDA 483\u8868\uff1a\u5370\u5ea6 Sun Pharmaceutical"},"content":{"rendered":"
\n

 \u7ffb\u8bd1\uff1aJULIA \u6765\u6e90\uff1aJulia\u6cd5\u89c4\u7ffb\u8bd1 <\/span><\/p>\n


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

\u53d7\u68c0\u516c\u53f8\uff1a<\/span>Sun Pharmaceutical Industries Ltd.<\/span><\/span><\/p>\n

\u53d7\u68c0\u5730\u5740\uff1a<\/span>SEZ Unit 1, Plot No. A-41, Ind. Area Phase VIII-A, S.A.S.Nagar, Mohali, Punjab, 160071 India<\/span><\/span><\/p>\n

\u53d7\u68c0\u8eab\u4efd\uff1a\u5236\u5242\u751f\u4ea7\u5546<\/span><\/p>\n

FEI<\/span>\u53f7\uff1a<\/span>3002807979<\/span><\/span><\/p>\n

\u68c0\u67e5\u5458\uff1a<\/span>NicoleE. Knowlton\/Investigator, Maotang Zhou\/CDER Reviewer<\/span><\/span><\/p>\n

\u68c0\u67e5\u65e5\u671f\uff1a<\/span>2018-09-10<\/span>\u81f3<\/span> 2018-09-14<\/span><\/span><\/p>\n

\u7b7e\u53d1\u65e5\u671f\uff1a<\/span>2018-09-14<\/span><\/span><\/p>\n

\u53d1\u5e03\u65e5\u671f\uff1a<\/span>2018-09-24<\/span><\/span><\/p>\n

 <\/span><\/p>\n

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations. And do not represent a final agency determination regarding your compliance if you have an objection regarding an observation, or have implemented, or plan to implement corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDAto address above. If you have any questions, please contact FDA at the phone number and address above.<\/span><\/p>\n

\u672c\u6587\u4ef6\u5217\u51fa\u4e86<\/span>FDA<\/span>\u4ee3\u8868\u5728\u5bf9\u4f60\u5de5\u5382\u68c0\u67e5\u671f\u95f4\u6240\u53d1\u73b0\u7684\u95ee\u9898\u3002\u8fd9\u4e9b\u53ea\u662f\u68c0\u67e5\u53d1\u73b0\uff0c\u5e76\u4e0d\u4ee3\u8868<\/span>FDA<\/span>\u5bf9\u4f60\u516c\u53f8\u5408\u89c4\u6027\u7684\u6700\u7ec8\u7ed3\u8bba\u3002\u5982\u4f60\u4eec\u5bf9\u67d0\u4e00\u7f3a\u9677\u6709\u5f02\u8bae\uff0c\u6216\u5df2\u5b9e\u65bd\u6216\u8ba1\u5212\u5b9e\u65bd\u7ea0\u6b63\u63aa\u65bd\u6765\u7ea0\u6b63\u67d0\u4e2a\u7f3a\u9677\uff0c\u4f60\u4eec\u5728\u68c0\u67e5\u671f\u95f4\u4e0e<\/span>FDA<\/span>\u4ee3\u8868\u8ba8\u8bba\u4f60\u4eec\u7684\u5f02\u8bae\u4e0e\u63aa\u65bd\uff0c\u6216\u901a\u8fc7\u4e0a\u8ff0\u5730\u5740\u5411<\/span>FDA<\/span>\u63d0\u4ea4\u8d44\u6599\u3002\u5982\u6709\u95ee\u9898\uff0c\u8bf7\u901a\u8fc7\u4e0a\u8ff0\u5730\u5740\u7535\u8bdd\u4e0e<\/span>FDA<\/span>\u53d6\u5f97\u8054\u7cfb\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: <\/span>\u68c0\u67e5\u4f60\u516c\u53f8\u671f\u95f4\u6211\u4eec\u53d1\u73b0<\/span><\/span><\/p>\n

OBSERVATION 1<\/span><\/strong> \u7f3a\u9677 <\/span><\/strong>1<\/span><\/strong><\/span><\/p>\n

The quality control unit lacks the responsibility and authority to approve and reject all in-process materials and drug products.  <\/span>\u8d28\u91cf\u90e8\u95e8\u7f3a\u4e4f\u6279\u51c6\u548c\u62d2\u6536\u6240\u6709\u4e2d\u95f4\u4f53\u548c\u5236\u5242\u7684\u8d23\u4efb\u548c\u6743\u529b\u3002<\/span><\/span><\/p>\n

Specifically, you did not reject the three (b)(4) Tablets (b)(4)mg exhibit batches that failed in-process (b)(4) sampling for (b)(4). Out of Specification Investigation No.283910, 282535, and 285929 approved 30\/Jan\/2018 shows exhibit batches (b)(4) and (b)(4) failed RSD and mean of each location and batch (b)(4) failed RSD for (b)(4) sampling for (b)(4). The results from these batches was submitted in support of drug application (b)(4) Tablets. Additionally, these results were not submitted in one of the appropriate Sections such as 3.2.P.2.3 (Process Development), 3.2.P.3.3 (Manufacturing Process Descriptions), or 3.2.P.3.4 (Controls of Critical Process Parametersand Intermediates); they were submitted in Section 3.2.P.3.5 (Process Validation and Evaluation).<\/span><\/p>\n

\u5177\u4f53\u6765\u8bf4\uff0c\u4f60\u4eec\u6ca1\u6709\u62d2\u6536\u4e2d\u63a7<\/span>XX<\/span>\u6837\u54c1\u4e0d\u5408\u683c\u7684<\/span>3<\/span>\u6279<\/span>XX<\/span>\u7247\u5242\u3002<\/span>20180130<\/span>\u6279\u51c6\u7684<\/span>OOS<\/span>\u8c03\u67e5\u53f7<\/span>283910<\/span>\u3001<\/span>282535<\/span>\u548c<\/span>285929<\/span>\u663e\u793a\u7533\u62a5\u6279\u6b21<\/span>XX<\/span>\u548c<\/span>XX<\/span>\u6bcf\u4e2a\u70b9\u7684<\/span>RSD<\/span>\u548c\u5e73\u5747\u503c\u5747\u4e0d\u5408\u683c\uff0c\u6279\u6b21<\/span>XX<\/span>\u7684<\/span>XX<\/span>\u53d6\u6837<\/span>RSD<\/span>\u4e0d\u5408\u683c\u3002\u8fd9\u4e9b\u6279\u51c6\u7684\u7ed3\u679c\u5747\u63d0\u4ea4\u7ed9<\/span>FDA<\/span>\u7528\u4e8e\u652f\u6301<\/span>XX<\/span>\u7247\u5242\u7684\u836f\u54c1\u7533\u62a5\u3002\u53e6\u5916\uff0c\u8fd9\u4e9b\u7ed3\u679c\u6ca1\u6709\u653e\u5728\u9002\u5f53\u7684\u90e8\u5206\u5982<\/span>3.2.P.2.3<\/span>\uff08\u5de5\u827a\u5f00\u53d1\uff09\u3001<\/span>3.2.P.3.3<\/span>\uff08\u751f\u4ea7\u5de5\u827a\u63cf\u8ff0\uff09\u6216<\/span>3.2.P.3.4<\/span>\uff08\u5173\u952e\u5de5\u827a\u53c2\u6570\u548c\u4e2d\u95f4\u4f53\u63a7\u5236\uff09\u4e2d\u63d0\u4ea4\uff0c\u800c\u662f\u653e\u5728\u4e86<\/span>3.2.P.3.5<\/span>\u90e8\u5206\uff08\u5de5\u827a\u9a8c\u8bc1\u548c\u8bc4\u4f30\uff09\u3002<\/span><\/span><\/p>\n

OBSERVATION 2<\/span><\/strong> \u7f3a\u9677 <\/span><\/strong>2<\/span><\/strong><\/span><\/p>\n

The written stability testing program is not followed. <\/span>\u672a\u9075\u5b88\u4e66\u9762\u7a33\u5b9a\u6027\u8bd5\u9a8c\u8ba1\u5212\u3002<\/span><\/span><\/p>\n

Specifically, your stability data is not representative of the intended manufacturing process for (b)(4) Tablets (b)(4)mg. Exhibit batches (b)(4) and (b)(4) failed in process (b)(4) sampling for (b)(4). These batches were placed on stability and data from these batches was submitted in support of drug application (b)(4) Tablets.<\/span><\/p>\n

To date, your firm has manufactured (b)(4) feasibility\/optimization batches on two different compression machines after the three exhibit batches were manufactured. As documented in Feasibility Trial Report of (b)(4) Tablets (b)(4)mg Report No. FSTR\/02\/1217-00, your firm determined compressed tablets on (b)(4) Compression Machine Model (b)(4) (ID MPDRCM02) will not yield acceptable (b)(4) results. Firm management stated you intended to use (b)(4) Compression machine (b)(4) (ID MPDRCM01) for commercial production of (b)(4) Tablets (b)(4)mg.<\/span><\/p>\n

\u5177\u4f53\u6765\u8bf4\uff0c\u4f60\u4eec\u7684\u7a33\u5b9a\u6027\u6570\u636e\u4e0d\u80fd\u4ee3\u8868<\/span>XX<\/span>\u7247\u5242\u5c06\u8981\u4f7f\u7528\u7684\u751f\u4ea7\u5de5\u827a\u3002\u7533\u62a5\u6279\u51c6<\/span>XX<\/span>\u4e0e<\/span>YY<\/span>\u4e2d\u63a7<\/span>XX<\/span>\u53d6\u6837\u4e0d\u5408\u683c\u3002\u8fd9\u4e9b\u6279\u6b21\u88ab\u653e\u5728\u4e86\u7a33\u5b9a\u6027\u4e2d\uff0c\u5176\u6570\u636e\u88ab\u63d0\u4ea4\u7ed9<\/span>FDA<\/span>\u7528\u4e8e\u652f\u6301<\/span>XX<\/span>\u836f\u54c1\u7533\u62a5\u3002<\/span><\/span><\/p>\n

\u622a\u6b62\u4eca\u65e5\uff0c\u5728\u751f\u4ea7\u4e86<\/span>3<\/span>\u6279\u7533\u62a5\u6279\u6b21\u4e4b\u540e\uff0c\u4f60\u516c\u53f8\u5df2\u5728<\/span>2<\/span>\u53f0\u4e0d\u540c\u538b\u7247\u673a\u4e0a\u751f\u4ea7\u4e86<\/span>XX<\/span>\u6279\u53ef\u884c\u6027<\/span>\/<\/span>\u4f18\u5316\u6279\u6b21\u3002\u6b63\u5982<\/span>XX<\/span>\u7247\u5242\u53ef\u884c\u6027\u8bd5\u9a8c\u62a5\u544a\uff08\u7f16\u53f7<\/span>FSTR\/02\/1217-00<\/span>\uff09\u6240\u8bb0\u5f55\uff0c\u4f60\u4eec\u516c\u53f8\u51b3\u5b9a\u5728<\/span>XX<\/span>\u578b\u53f7\uff08<\/span>ID MPDRCM02<\/span>\uff09<\/span>XX<\/span>\u538b\u7247\u673a\u4e0a\u538b\u7247\u4e0d\u80fd\u5f97\u5230\u53ef\u63a5\u53d7\u7684<\/span>XX<\/span>\u7ed3\u679c\u3002\u516c\u53f8\u7ba1\u7406\u4eba\u5458\u58f0\u79f0\u4f60\u4eec\u8981\u4f7f\u7528<\/span>XX<\/span>\u538b\u7247\u673a\uff08<\/span>ID MPDRCM01<\/span>\uff09\u7528\u4e8e<\/span>XX<\/span>\u7247\u5242\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u3002<\/span><\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

 \u7ffb\u8bd1\uff1aJULIA \u6765\u6e90\uff1aJulia\u6cd5\u89c4\u7ffb\u8bd1  \u53d7\u68c0\u516c\u53f8\uff1aSun Pharmac […]<\/p>\n","protected":false},"author":1,"featured_media":53790,"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\/53789"}],"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=53789"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/53789\/revisions"}],"predecessor-version":[{"id":53791,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/53789\/revisions\/53791"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/53790"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=53789"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=53789"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=53789"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}