{"id":52690,"date":"2018-09-29T01:00:00","date_gmt":"2018-09-30T01:36:34","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e5%8d%8e%e6%b5%b7%e8%8d%af%e4%b8%9a%e5%90%8c%e6%97%a5%e9%81%ad%e9%81%87fda%e8%bf%9b%e5%8f%a3%e7%a6%81%e4%bb%a4%e5%92%8c%e6%ac%a7%e7%9b%9fgmp%e4%b8%8d%e7%ac%a6%e5%90%88%e6%8a%a5%e5%91%8a\/"},"modified":"2018-09-30T09:36:35","modified_gmt":"2018-09-30T01:36:35","slug":"%e5%8d%8e%e6%b5%b7%e8%8d%af%e4%b8%9a%e5%90%8c%e6%97%a5%e9%81%ad%e9%81%87fda%e8%bf%9b%e5%8f%a3%e7%a6%81%e4%bb%a4%e5%92%8c%e6%ac%a7%e7%9b%9fgmp%e4%b8%8d%e7%ac%a6%e5%90%88%e6%8a%a5%e5%91%8a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/52690\/","title":{"rendered":"\u534e\u6d77\u836f\u4e1a\u540c\u65e5\u906d\u9047FDA\u8fdb\u53e3\u7981\u4ee4\u548c\u6b27\u76dfGMP\u4e0d\u7b26\u5408\u62a5\u544a"},"content":{"rendered":"
\n

\"\u534e\u6d77\u836f\u4e1a\u540c\u65e5\u906d\u9047FDA\u8fdb\u53e3\u7981\u4ee4\u548c\u6b27\u76dfGMP\u4e0d\u7b26\u5408\u62a5\u544a\"<\/p>\n

\u7ee7\u7f8e\u56fd FDA \u4e8e 9 \u6708 20 \u65e5\u53d1\u5e03\u9488\u5bf9\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u7684\u68c0\u67e5 483\u62a5\u544a\u4e4b\u540e\uff0cFDA \u4e0e\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u4e8e 9 \u6708 28 \u65e5\u5206\u522b\u53d1\u5e03\u5e7f\u6cdb\u7684\u8fdb\u53e3\u7981\u4ee4\u548c\u4e0d\u5408\u89c4\u62a5\u544a\uff0c\u91c7\u53d6\u6269\u5927\u8303\u56f4\u7684\u7981\u6b62\u8fdb\u53e3\u3001\u53d6\u7f14\u4e0a\u5e02\u8bb8\u53ef\u7b49\u4e25\u5389\u63aa\u65bd\u3002<\/span><\/p>\n


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\u8fd9\u5bf9\u4e8e\u4f5c\u4e3a\u4e2d\u56fd\u5236\u5242\u51fa\u53e3\u9f99\u5934\u534e\u6d77\u836f\u4e1a\u662f\u4e25\u91cd\u6253\u51fb\uff0c\u5bf9\u4e8e\u4e2d\u56fd\u5236\u5242\u51fa\u53e3\u5f71\u54cd\u4e5f\u662f\u610f\u4e49\u6df1\u8fdc\u3002<\/span>
<\/span><\/p>\n

FDA places Zhejiang Huahai Pharmaceuticals on import alert<\/span><\/p>\n

FDA\u5c06\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u5217\u5165\u8fdb\u53e3\u7981\u4ee4<\/span><\/strong><\/p>\n


<\/p>\n

Update [9\/28\/2018] FDA placed Zhejiang Huahai Pharmaceuticals on import alert on September 28, 2018, to protect U.S. patients while the active pharmaceutical ingredient (API) manufacturer fully determines how impurities were introduced into its API and remediates its quality systems. The import alert stops all API made by ZHP and finished drug products made using ZHP\u2019s API from legally entering the United States. FDA\u2019s action follows a recent inspection at ZHP\u2019s facility.<\/span><\/p>\n

\u66f4\u65b0\u65e5\u671f\u301020180928\u3011FDA\u5df2\u4e8e2018\u5e749\u670828\u65e5\u5c06\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u7f6e\u4e8e\u8fdb\u53e3\u7981\u4ee4\u4e2d\uff0c\u4ee5\u5728API\u751f\u4ea7\u5546\u5b8c\u5168\u786e\u5b9a\u6742\u8d28\u662f\u5982\u4f55\u8fdb\u5165\u5176API\u4ee5\u53ca\u8865\u6551\u5176\u8d28\u91cf\u4f53\u7cfb\u671f\u95f4\u4fdd\u62a4\u7f8e\u56fd\u60a3\u8005\u3002\u8be5\u8fdb\u53e3\u7981\u4ee4\u5c06\u53eb\u505c\u5408\u6cd5\u8fdb\u53e3ZHP\u751f\u4ea7\u7684\u6240\u6709API\uff0c\u4ee5\u53ca\u4f7f\u7528ZHP\u7684API\u751f\u4ea7\u7684\u5236\u5242\u81f3\u7f8e\u56fd\u3002FDA\u7684\u63aa\u65bd\u662f\u5728\u6700\u8fd1\u5bf9ZHP\u8bbe\u65bd\u8fdb\u884c\u68c0\u67e5\u7684\u57fa\u7840\u4e0a\u505a\u51fa\u7684\u3002<\/span><\/p>\n

FDA reminds manufacturers that it is their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes. If amanufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients.<\/span><\/p>\n

FDA\u63d0\u9192\u751f\u4ea7\u5546\u6709\u4e49\u52a1\u5f00\u53d1\u548c\u4f7f\u7528\u9002\u5f53\u7684\u65b9\u6cd5\u68c0\u51fa\u6742\u8d28\uff0c\u5305\u62ec\u5728\u5bf9\u5176\u751f\u4ea7\u5de5\u827a\u8fdb\u884c\u53d8\u66f4\u7684\u65f6\u5019\u3002\u5982\u679c\u751f\u4ea7\u5546\u68c0\u51fa\u4e86\u65b0\u6742\u8d28\u6216\u66f4\u9ad8\u6c34\u5e73\u7684\u6742\u8d28\uff0c\u5e94\u8be5\u5168\u9762\u8bc4\u4f30\u8fd9\u4e9b\u6742\u8d28\uff0c\u5e76\u91c7\u53d6\u63aa\u65bd\u786e\u4fdd\u5176\u4ea7\u54c1\u5bf9\u60a3\u8005\u6765\u8bf4\u662f\u5b89\u5168\u7684\u3002<\/span>
<\/p>\n

EudraGMDP \u4e0d\u5408\u89c4\u62a5\u544a<\/strong><\/span><\/p>\n

\u53d1\u5e03\u5b98\u65b9\uff1a<\/span>Italian Medicines Agency <\/span>\u610f\u5927\u5229\u836f\u76d1\u5c40<\/span><\/span><\/span><\/p>\n

\u68c0\u67e5\u65e5\u671f\uff1a<\/span>2018-09-13<\/span><\/span><\/p>\n

\u53d1\u5e03\u65e5\u671f\uff1a<\/span>2018-09-28<\/span><\/span><\/p>\n

\u62a5\u544a\u7f16\u53f7\uff1a<\/span>IT\/NCR\/API\/2\/2018<\/span><\/span><\/p>\n

\u53d7\u68c0\u516c\u53f8<\/span><\/span>\uff1aZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. <\/span>\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u6709\u9650\u516c\u53f8<\/span><\/span><\/p>\n

\u53d7\u68c0\u5730\u5740\uff1a<\/span><\/span>Chuannan Duqiao,Linhai, Zhejiang, 317016, China<\/span> <\/span><\/strong>\u6d59\u6c5f\u4e34\u6d77\u5ddd\u5357\u675c\u6865<\/span><\/span><\/span><\/p>\n

\u53d7\u5f71\u54cd\u4ea7\u54c1\uff1a\u7f2c\u6c99\u5766\u539f\u6599\u836f<\/span><\/p>\n

\u4e0d\u7b26\u5408\u60c5\u51b5\uff1a<\/span><\/p>\n

The joint EMA\/EDQM inspection was initiated as \u201cfor-cause\u201d inspection in the context of the NDMA\/NDEA Valsartan contamination issue. Nine \u201cMajor\u201d and eight \u201cOther\u201d deviations were identified. The Major deficiencies were found in the following areas: <\/span><\/p>\n

EMA\/EDQM\u68c0\u67e5\u5bf9\u7f2c\u6c99\u5766\u7684NDMA\/NDEA\u6c61\u67d3\u4e8b\u4ef6\u542f\u52a8\u4e86\u6709\u56e0\u68c0\u67e5\u3002\u4e5d\u4e2a\u4e3b\u8981\u89c2\u5bdf\u9879\u548c8\u4e2a\u5176\u4ed6\u89c2\u5bdf\u9879\u88ab\u53d1\u73b0\u3002\u53d1\u73b0\u7684\u4e3b\u8981\u7f3a\u9677\u5982\u4e0b\uff1a<\/span><\/p>\n

    \n
  1. \n

    The investigations conducted in the context of the NDMA\/NDEA contamination of Valsartan showed significant flaws; \u5bf9\u4e8e\u7f2c\u6c99\u5766\u4e2d\u7684NDMA\/NDEA\u6c61\u67d3\u7684\u8c03\u67e5\u663e\u793a\u51fa\u91cd\u5927\u7684\u7f3a\u9677\u3002<\/p>\n<\/li>\n

  2. \n

    .\tThe company\u2019s risk assessment performed in the context of the development\/implementation of the optimised Valsartan process, conducted in July\/August 2018, was not satisfactory; moreover, the company did not identify the need to develop a control strategy to reduce the new risks introduced with the optimised process; \u8be5\u516c\u53f8\u57282018\u5e747\u6708\u548c8\u6708\u5728\u5f00\u53d1\u548c\u5b9e\u65bd\u4f18\u5316\u7f2c\u6c99\u5766\u5de5\u827a\u4e2d\u6267\u884c\u7684\u98ce\u9669\u8bc4\u4f30\u4e0d\u7b26\u5408\u8981\u6c42\uff0c\u800c\u4e14\uff0c\u8be5\u516c\u53f8\u5e76\u6ca1\u6709\u8bc6\u522b\u51fa\u9700\u8981\u5f00\u53d1\u4e00\u4e2a\u63a7\u5236\u7b56\u7565\u6765\u964d\u4f4e\u56e0\u4e3a\u4f18\u5316\u5de5\u827a\u4f1a\u5e26\u6765\u7684\u65b0\u7684\u98ce\u9669\u3002<\/p>\n<\/li>\n

  3. \n

    .\tSeveral gaps were identified in the context of the development of the Valsartan process as revised in 2011\/2012. N.B.: the changes introduced with this modified process led to the formation of the NDMA impurity; \u57282011\/2012\u5e74\u5347\u7ea7\u7f2c\u6c99\u5766\u5de5\u827a\u7814\u53d1\u4e2d\u53d1\u73b0\u4e86\u51e0\u4e2a\u5dee\u5f02\u3002\u5728\u6539\u53d8\u5de5\u827a\u65f6\u5f15\u5165\u7684\u53d8\u66f4\u5bfc\u81f4\u4e86NDMA\u6742\u8d28\u7684\u751f\u6210\u3002<\/p>\n<\/li>\n

  4. \n

    Observations related to the handling of the complaints, with specific focus on the NDMA contamination issue; \u5904\u7406\u56e0\u4e3aNDMA\u6c61\u67d3\u6295\u8bc9\u76f8\u5173\u7684\u89c2\u5bdf\u9879<\/p>\n<\/li>\n

  5. \n

    Management of out-of-specification results; OOS\u7ed3\u679c\u7684\u7ba1\u7406<\/p>\n<\/li>\n

  6. \n

    Recall management: no recall was formally initiated to manage the actions related to the contaminated Valsartan batches; \u53ec\u56de\u7ba1\u7406\uff0c\u6ca1\u6709\u6b63\u5f0f\u5730\u542f\u52a8\u53ec\u56de\u7a0b\u5e8f\u6765\u7ba1\u7406\u88ab\u6c61\u67d3\u7684\u7f2c\u6c99\u5766\u6279\u6b21\u7684\u53ec\u56de\u884c\u52a8\u3002<\/p>\n<\/li>\n

  7. \n

    Reprocessing\/blending operations including traceability of reprocessed\/blended material ; \u5305\u542b\u8fd4\u5de5\u548c\u6df7\u5408\u7269\u6599\u7684\u8ffd\u6eaf\u7684\u8fd4\u5de5\/\u6df7\u5408\u64cd\u4f5c\u3002<\/p>\n<\/li>\n

  8. \n

    Data integrity issues in relation to GC-FID analysis; GC-FID\u5206\u6790\u76f8\u5173\u7684\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u3002<\/p>\n<\/li>\n

  9. \n

    Inadequate investigation of unknown peaks detected in GC-MS analysis of batches of Valsartan manufactured with the new process as optimized in July\/August 2018.\u5728\u4f7f\u75282018\u5e747\u6708\/8\u6708\u4f18\u5316\u7684\u65b0\u5de5\u827a\u751f\u4ea7\u7684\u7f2c\u6c99\u5766\u6279\u6b21\u7684GC-MS\u5206\u6790\u4e2d\u68c0\u6d4b\u5230\u672a\u77e5\u5cf0\u7684\u4e0d\u5145\u5206\u7684\u8c03\u67e5\u3002<\/span><\/p>\n


    <\/span><\/p>\n<\/li>\n<\/ol>\n

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

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

    \"\u534e\u6d77\u836f\u4e1a\u540c\u65e5\u906d\u9047FDA\u8fdb\u53e3\u7981\u4ee4\u548c\u6b27\u76dfGMP\u4e0d\u7b26\u5408\u62a5\u544a\"<\/span><\/a><\/p>\n

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


    <\/p>\n

    \u5185\u5bb9\u6765\u6e90\uff1aFDA\u3001EMA\uff0c\u836f\u7814\u7f16\u8f91\u6574\u7406<\/span><\/em><\/p>\n


    <\/p>\n

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

    \u7ee7\u7f8e\u56fd FDA \u4e8e 9 \u6708 20 \u65e5\u53d1\u5e03\u9488\u5bf9\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u7684\u68c0\u67e5 483\u62a5\u544a\u4e4b\u540e\uff0cFDA \u4e0e\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EM […]<\/p>\n","protected":false},"author":1,"featured_media":52691,"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\/52690"}],"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=52690"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52690\/revisions"}],"predecessor-version":[{"id":52694,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52690\/revisions\/52694"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/52691"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=52690"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=52690"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=52690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}